Pfizer–BioNTech COVID-19 vaccine
A vial of the Pfizer–BioNTech COVID‑19 vaccine for the U.S. market
Vaccine description
TargetSARS-CoV-2
Vaccine typemRNA
Clinical data
Trade namesComirnaty[1][2][3]
Other namesBNT162b2, COVID-19 mRNA vaccine (nucleoside-modified), COVID-19 Vaccine (mRNA)[4]
AHFS/Drugs.comMonograph
MedlinePlusa621003
License data
Pregnancy
category
Routes of
administration		Intramuscular
ATC code
Legal status
Legal status

ZA: Section 21[40][41]

Full list of Pfizer-BioNTech vaccine authorizations
Identifiers
CAS Number
PubChem SID
DrugBank
UNII
KEGG
ChEMBL

The Pfizer–BioNTech COVID-19 vaccine, sold under the brand name Comirnaty,[2][30] is an mRNA-based COVID-19 vaccine developed by the German biotechnology company BioNTech. For its development, BioNTech collaborated with the American company Pfizer to carry out clinical trials, logistics, and manufacturing.[42][43] It is authorized for use in humans to provide protection against COVID-19, caused by infection with the SARS-CoV-2 virus.[2][28] The vaccine is given by intramuscular injection.[32] It is composed of nucleoside-modified mRNA (modRNA) encoding a mutated form of the full-length spike protein of SARS-CoV-2, which is encapsulated in lipid nanoparticles.[44] Initial advice indicated that vaccination required two doses given 21 days apart,[32][45][46][47] but the interval was later extended to up to 42 days in the US,[32][48] and up to four months in Canada.[49][50]

Clinical trials began in April 2020;[45] by November 2020, the vaccine had entered phase III clinical trials, with over 40,000 people participating.[51] An interim analysis of study data showed a potential efficacy of 91.3% in preventing symptomatic infection within seven days of a second dose and no serious safety concerns.[47][52] Most side effects are mild to moderate in severity and are gone within a few days.[2][53] The most common include mild to moderate pain at the injection site, fatigue, and headaches.[54][55] Reports of serious side effects, such as allergic reactions, are very rare[lower-alpha 1] and no long-term complications have been reported.[2][57]

The vaccine is the first COVID‑19 vaccine to be authorized by a stringent regulatory authority for emergency use[58][59] and the first cleared for regular use.[39] In December 2020, the United Kingdom was the first country to authorize its use on an emergency basis.[57] It is authorized for use at some level in the majority of countries.[60][61][62][63] On 23 August 2021, the Pfizer–BioNTech vaccine became the first COVID-19 vaccine to be approved in the United States by the Food and Drug Administration (FDA).[27][30][64] Distribution and storage are logistical challenges because the vaccine needs to be stored at extremely low temperatures.[65]

In August 2022, a bivalent version of the vaccine (Pfizer-BioNTech COVID-19 Vaccine, Bivalent) was authorized for use as a booster dose in individuals twelve years of age and older in the United States.[66][67][68][69] In September 2022, the BA.1 version of the bivalent vaccine (Comirnaty Original/Omicron BA.1 or tozinameran/riltozinameran)[70] was authorized as a booster for use in the United Kingdom.[71][72][73] In September 2022, the European Union authorized both the BA.1 and the BA.4/BA.5 (tozinameran/famtozinameran) booster versions of the bivalent vaccine.[2][3][38]

Medical uses

The Pfizer–BioNTech COVID-19 vaccine is used to provide protection against COVID-19, caused by infection with the SARS-CoV-2 virus, by eliciting an immune response to the S antigen.[1][2][28][37] The vaccine is used to reduce morbidity and mortality from COVID-19.[32]

The vaccine is supplied in a multidose vial as "a white to off-white, sterile, preservative-free, frozen suspension for intramuscular injection".[28][37][74] It must be thawed to room temperature and diluted with normal saline before administration.[37][74]

The initial course consists of two doses.[32][37] The World Health Organization (WHO) recommends an interval of three to four weeks between doses. Delaying the second dose by up to twelve weeks increases immunogenicity, even in older adults, against all variants of concern.[75] Authors of the Pitch study think that the optimal interval against the Delta variant is around eight weeks, with longer intervals leaving receptors vulnerable between doses.[75]

A third, fourth, or fifth dose can be added in some countries.[66][76][77][78][79][80]

Effectiveness

A test-negative[note 1] case-control study published in August 2021, found that two doses of the BNT162b2 (Pfizer) vaccine had 93.7% effectiveness against symptomatic disease caused by the alpha (B.1.1.7) variant and 88.0% effectiveness against symptomatic disease caused by the delta (B.1.617.2) variant.[81] Notably, effectiveness after one dose of the Pfizer vaccine was 48.7% against alpha and 30.7% against delta, similar to effectiveness provided by one dose of the ChAdOx1 nCoV-19 vaccine.[82]

On 27 August, the U.S. Centers for Disease Control and Prevention (CDC) published a study reporting that the effectiveness against infection decreased from 91% (81–96%) to 66% (26–84%) when the Delta variant became predominant in the US, which may be due to unmeasured and residual confounding related to a decline in vaccine effectiveness over time.[83]

Unless indicated otherwise, the following effectiveness ratings are indicative of clinical effectiveness two weeks after the second dose. A vaccine is generally considered effective if the estimate is ≥50% with a >30% lower limit of the 95% confidence interval.[84] Effectiveness is generally expected to slowly decrease over time.[85]

Initial effectiveness by variant
Doses Severity of illness Alpha Beta Gamma Delta Omicron Others circulating previously[upper-alpha 1]
1 Asymptomatic 38% (29–45%)[87] 17% (10–23%)[88] Not reported 30% (17–41%)[87] Not reported 60% (53–66%)
Symptomatic 27% (13–39%)[87] 43% (22–59%)[89] 33% (15–47%)[87] Not reported 66% (57–73%)
Hospitalization 83% (62–93%)[upper-alpha 2] 0% (0–19%)[88] 56% (−9 to 82%)[89] 94% (46–99%)[upper-alpha 2] Not reported 78% (61–91%)
2 Asymptomatic 92% (90–93%)[87] 75% (71–79%)[88] Not reported 79% (75–82%)[87] Not reported 92% (88–95%)
Symptomatic 92% (88–94%)[87] 88% (61–96%)[89] 83% (78–87%)[87] 88% (66–96%)[upper-alpha 3] 94% (87–98%)
Hospitalization 95% (78–99%)[upper-alpha 2] 100% (74–100%)[88] 100%[upper-alpha 4][89] 96% (86–99%)[upper-alpha 2] 70% (62–76%)[93] 87% (55–100%)
3[upper-alpha 5] Symptomatic Not reported Not reported Not reported 96% (89–99%)[upper-alpha 6] 76% (56–86%)[upper-alpha 7] Not reported
  1. ↑ Surveillance study from 20 December 2020 to 1 February 2021 in Israel.[86] During this period, according to Nextstrain, the dominant variant in Israel was lineage B.1.1.50 and the Alpha variant was becoming dominant.
  2. 1 2 3 4 Preliminary data of effectiveness against hospitalization referenced by Public Health England.[90][91]
  3. ↑ Effectiveness drops to 49% (24–65%) in weeks 10–14 after the second dose and then stabilizes at 34%–37% thereafter.[92]
  4. ↑ A confidence interval was not provided, so it is not possible to know the accuracy of this measurement.
  5. ↑ Booster dose.
  6. ↑ Efficacy data from a study with more than 10,000 participants.[94]
  7. ↑ Effectiveness drops to about 45% 10 weeks after the booster dose.[95][92]

On 12 November, Public Health England reported a possible but extremely small reduction in effectiveness against symptomatic disease from the Delta sublineage AY.4.2 at longer intervals after the second dose.[96]

Preliminary data suggest that the effectiveness against the Omicron variant starts to decline in about 10 weeks, either after the initial two-dose regimen or after the booster dose.[92][95] For other variants, the effectiveness of the initial doses starts to decline in about six months.[97] A case-control study in Qatar from 1 January to 5 September 2021 found that effectiveness against infection peaked at 78% (95% CI, 76–79%) in the first month after the second dose, followed by a slow decline that accelerated after the fourth month, reaching 20% at months 5 to 7. A similar trajectory was observed against symptomatic disease and against specific variants. Effectiveness against severe disease, hospitalization and death was more robust, peaking at 96% (93–98%) in the second month and remaining almost stable through the sixth month, declining thereafter.[98]

On 21 October, a phase 3 trial showed that a booster dose given approximately 11 months after the second dose restored the protective effect to the 96% (95% CI, 89–99%) efficacy level against symptomatic disease from the Delta variant.[99][94]

On 8 December, Pfizer and BioNTech reported that preliminary data indicated that a third dose of the vaccine would provide a similar level of neutralizing antibodies against the Omicron variant as seen after two doses against other variants.[100]

On 14 December, private health insurer Discovery Health, in collaboration with the South African Medical Research Council, reported that real-world data from more than 211,000 cases of COVID-19 in South Africa, of which 78,000 were of the Omicron variant, indicate that effectiveness against the variant after two doses is about 70% against hospital admission and 33% against symptomatic disease. Protection against hospital admission is maintained for all ages and groups with comorbidities.[101]

A study of the bivalent booster effectiveness against severe COVID-19 outcomes in Finland, September 2022–January 2023, has shown that it reduced the risk of severe COVID-19 outcomes among the elderly. By contrast, among the chronically-ill 18–64-year-olds the risk was similar among those who received bivalent vaccine and those who did not. Among the elderly a bivalent booster provided highest protection during the first two months after vaccination, but thereafter signs of waning were observed. The effectiveness among individuals aged 65–79 years and those aged 80 years or more was similar.[102]

Specific populations

Based on the results of a preliminary study, the U.S. Centers for Disease Control and Prevention (CDC) recommends that pregnant women get vaccinated with the COVID‑19 vaccine.[103][104]

A statement by the British Medicines and Healthcare products Regulatory Agency (MHRA) and the Commission on Human Medicines (CHM) reported that the two agencies had reached a conclusion that the vaccine is safe and effective in children aged between 12 and 15 years.[105][106]

On 19 May 2021, experts commissioned by the Norwegian Medicines Agency concluded that the Pfizer-BioNTech vaccine is the likely cause of ten deaths of frail elderly patients in Norwegian nursing homes. They said that people with very short life expectancies have little to gain from vaccination, having a real risk of adverse reactions in the last days of life and of dying earlier.[107]

A 2021 report by the New South Wales Government (NSW Health) in Australia found that the Pfizer-BioNTech vaccine is safe for those with various forms of immunodeficiency or immunosuppression, though it does note that the data on said groups is limited, due to their exclusion from many of the vaccine earlier trials held in 2020. It notes that the World Health Organization advises that the vaccine is among the three COVID-19 vaccines (alongside that of Moderna and AstraZeneca) it deems safe to give to immunocompromised individuals, and that expert consensus generally recommends their vaccination. The report states that the vaccines were able to generate an immune response in those individuals, though it does also note that this response is weaker than in those that are not immunocompromised. It recommends that specific patient groups, such as those with cancer, inflammatory bowel disease and various liver diseases be prioritised in the vaccination schedules over other patients that do not have said conditions.[108]

On 20 September 2021, Pfizer announced that a clinical trial conducted in more than 2,200 children aged 5–11 has generated a "robust" response and is safe.[109][110]

Adverse effects

In Phase III trials for the vaccine, there were no safety concerns and few adverse events.[47][52]

Most side effects of the Pfizer–BioNTech COVID‑19 vaccine are mild to moderate in severity, and are gone within a few days.[53][2] They are similar to other adult vaccines and are normal signs that the body is building protection to the virus.[53] During clinical trials, the common side effects affecting more than one in 10 people are (in order of frequency): pain and swelling at the injection site, tiredness, headache, muscle aches, chills, joint pain, fever or diarrhea.[111] Fever is more common after the second dose.[111]

The European Medicines Agency (EMA) regularly reviews the data on the vaccine's safety. The safety report published on 8 September 2021 by the EMA was based on over 392 million doses administered in the European Union.[2] According to the EMA "the benefits of Comirnaty in preventing COVID‑19 continue to outweigh any risks, and there are no recommended changes regarding the use of this vaccine."[2] Rare side effects (that may affect up to one in 1,000 people) include temporary one sided facial drooping and allergic reactions, such as hives or swelling of the face.[2]

Allergy

Documented hypersensitivity to polyethylene glycol (PEG) (a very rare allergy) is listed as a contraindication to the COVID-19 Pfizer vaccine.[112] Severe allergic reaction has been observed in approximately eleven cases per million doses of vaccine administered.[113][114] According to a report by the US Centers for Disease Control and Prevention, 71% of those allergic reactions happened within 15 minutes of vaccination and mostly (81%) among people with a documented history of allergies or allergic reactions.[113] The UK's Medicines and Healthcare products Regulatory Agency (MHRA) advised on 9 December 2020 that people who have a history of "significant" allergic reaction should not receive the Pfizer–BioNTech COVID‑19 vaccine.[115][116][117] On 12 December, the Canadian regulator followed suit, noting that: "Both individuals in the U.K. had a history of severe allergic reactions and carried adrenaline auto injectors. They both were treated and have recovered."[118]

Myocarditis

In June 2021, the Israel's Ministry of Health announced a probable relationship between the second dose and myocarditis in a small group of 16–30-year-old men.[119] Between December 2020 and May 2021, there were 55 cases of myocarditis per 1 million people vaccinated, 95% of which were classified as mild and most spent no more than four days in the hospital.[119] Since April 2021, increasing number of cases of myocarditis and pericarditis have been reported in the United States in about 13 per 1 million young people, mostly male and over the age of 16, after vaccination with the Pfizer–BioNTech or the Moderna vaccine.[120][121] Most affected individuals recover quickly with adequate treatment and rest.[122] Since February 2022, the German Standing Committee on Vaccination recommends aspiration for COVID-19 vaccination as precautionary measure.[123]

Pharmacology

The BioNTech technology for the BNT162b2 vaccine is based on use of nucleoside-modified mRNA (modRNA) which encodes a mutated form of the full-length spike protein found on the surface of the SARS-CoV-2 virus,[124] triggering an immune response against infection by the virus protein.[125]

Sequence

The modRNA sequence of the vaccine is 4,284 nucleotides long.[126] It consists of a five-prime cap; a five prime untranslated region derived from the sequence of human alpha globin; a signal peptide (bases 55–102) and two proline substitutions (K986P and V987P, designated "2P") that cause the spike to adopt a prefusion-stabilized conformation reducing the membrane fusion ability, increasing expression and stimulating neutralizing antibodies;[44][127] a codon-optimized gene of the full-length spike protein of SARS-CoV-2 (bases 103–3879); followed by a three prime untranslated region (bases 3880–4174) combined from AES and mtRNR1 selected for increased protein expression and mRNA stability[128] and a poly(A) tail comprising 30 adenosine residues, a 10-nucleotide linker sequence, and 70 other adenosine residues (bases 4175–4284).[126] The sequence contains no uridine residues; they are replaced by 1-methyl-3'-pseudouridylyl.[126] The 2P proline substitutions in the spike proteins were originally developed for a Middle East respiratory syndrome (MERS) vaccine by researchers at the National Institute of Allergy and Infectious Diseases' Vaccine Research Center, Scripps Research, and Jason McLellan's team (at the University of Texas at Austin, previously at Dartmouth College).[127]

Chemistry

In addition to the mRNA molecule, the vaccine contains the following inactive ingredients (excipients):[24][118][111]

The first four of these are lipids. The lipids and modRNA together form nanoparticles that act not only as carriers to get the modRNA into the human cells, but also as adjuvants.[129] ALC-0159 is a polyethylene glycol conjugate, i.e., a PEGylated lipid.[130]

Manufacturing

A US soldier holding the Pfizer–BioNTech vaccine

Pfizer and BioNTech are manufacturing the vaccine in their own facilities in the United States and in Europe. The license to distribute and manufacture the vaccine in China was purchased by Fosun, alongside its investment in BioNTech.[43][131]

Manufacturing the vaccine requires a three-stage process. The first stage involves the molecular cloning of DNA plasmids that code for the spike protein by infusing them into Escherichia coli bacteria. For all markets, this stage is conducted in the United States,[132] at a small Pfizer pilot plant in Chesterfield, Missouri[133][134] (near St. Louis). After four days of growth, the bacteria are killed and broken open, and the contents of their cells are purified over a week and a half to recover the desired DNA product. The DNA is bottled and frozen for shipment. Safely and quickly transporting the DNA at this stage is so important that Pfizer has used its company jet and helicopter to assist.[135]

The second stage is being conducted at a Pfizer plant in Andover, Massachusetts,[136] in the United States, and at BioNTech's plants in Germany.[132] The DNA is used as a template to build the desired mRNA strands,[135] which takes about four days.[132] Once the mRNA has been created and purified, it is frozen in plastic bags about the size of a large shopping bag, of which each can hold up to 10 million doses. The bags are placed on trucks which take them to the next plant.[135]

A Pfizer employee putting dry ice in a box to protect the COVID-19 vaccines during transport at the Puurs factory
Boxes containing the COVID‑19 vaccines at the Pfizer factory in Puurs
Inside view of Pfizer factory in Puurs
External videos
video icon Loading dock operations at Pfizer's Portage, Michigan facility, December 13, 2020, C-SPAN
video icon President Joe Biden and Michigan Gov. Gretchen Whitmer tour the Portage, Michigan Pfizer facility with Pfizer CEO Albert Bourla, February 19, 2021, C-SPAN

The third stage is being conducted at Pfizer plants in Portage, Michigan[137] (near Kalamazoo) in the United States, and Puurs in Belgium. This stage involves combining the mRNA with lipid nanoparticles, then filling vials, boxing vials, and freezing them.[135] Croda International subsidiary Avanti Polar Lipids is providing the requisite lipids.[138] As of November 2020, the major bottleneck in the manufacturing process is combining mRNA with lipid nanoparticles.[135] At this stage, it takes only four days to go from mRNA and lipids to finished vials, but each lot must then spend several weeks in deep-freeze storage while undergoing verification against 40 quality-control measures.[132]

Before May 2021,[139] the Pfizer plant in Puurs was responsible for all vials for destinations outside the United States.[132] Therefore, all doses administered in the Americas outside of the United States before that point in time required at least two transatlantic flights (one to take DNA to Europe and one to bring back finished vaccine vials).[132]

In February 2021, BioNTech announced it would increase production by more than 50% to manufacture 2 billion doses in 2021,[140] raised again at the end of March to 2.5 billion doses in 2021.[141]

In February 2021, Pfizer revealed that the entire sequence initially took about 110 days on average from start to finish, and that the company is making progress on reducing the time to 60 days.[142] More than half the days in the production process are dedicated to rigorous testing and quality assurance at each of the three stages.[142] Pfizer also revealed that the process requires 280 components and relies upon 25 suppliers located in 19 countries.[132]

Vaccine manufacturers normally take several years to optimize the process of making a particular vaccine for speed and cost-effectiveness before attempting large-scale production.[142] Due to the urgency presented by the COVID‑19 pandemic, Pfizer and BioNTech began production immediately with the process by which the vaccine had been originally formulated in the laboratory, then started to identify ways to safely speed up and scale up that process.[142]

Syringes containing Pfizer COVID-19 vaccine doses

BioNTech announced in September 2020, that it had signed an agreement to acquire a manufacturing facility in Marburg, Germany, from Novartis to expand their vaccine production capacity.[143] Once fully operational, the facility would produce up to 750 million doses per year, or more than 60 million doses per month. The site will be the third BioNTech facility in Europe that produces the vaccine, while Pfizer operates at least four production sites in the United States and Europe.[143]

The Marburg facility had previously specialized in cancer immunotherapy for Novartis.[144] By the end of March 2021, BioNTech had finished retrofitting the facility for mRNA vaccine production and retraining its 300 staff, and obtained approval to begin manufacturing.[144] Besides making mRNA, the Marburg facility also performs the step of combining mRNA with lipids to form lipid nanoparticles, then ships the vaccine in bulk to other facilities for fill and finish (i.e., filling and boxing vials).[144]

On 23 April 2021, the EMA authorized an increase in batch size and associated process scale up at Pfizer's plant in Puurs. This increase is expected to have a significant impact on the supply of the vaccine in the European Union.[145][146]

At the end of April 2021, it was reported that Pfizer had started to export vaccine doses to Mexico and Canada from the Kalamazoo plant, which is much closer geographically to both countries than the Puurs plant.[139]

Logistics

The vaccine is delivered in vials that, once diluted, contain 2.25 mL of vaccine, comprising 0.45 mL frozen and 1.8 mL diluent.[147] According to the vial labels, each vial contains five 0.3 mL doses, however excess vaccine may be used for one, or possibly two, additional doses.[147][148] The use of low dead space syringes to obtain the additional doses is preferable, and partial doses within a vial should be discarded.[147][149] The Italian Medicines Agency officially authorized the use of excess doses remaining within single vials.[150] The Danish Health Authority allows mixing partial doses from two vials.[151] As of 8 January 2021, each vial contains six doses.[111][152][153][149] In the United States, vials will be counted as five doses when accompanied by regular syringes and as six doses when accompanied by low dead space syringes.[154]

The Pfizer–BioNTech vaccine must be kept at extremely low temperatures to ensure effectiveness, roughly between −80 and −60 °C (−112 and −76 °F).

The vaccine can be stored at 2 to 8 °C (36 to 46 °F) for thirty days before use[155][156] and at 25 °C (77 °F)[24][28] or 30 °C (86 °F) [157][8] for up to two hours before use. During distribution the vaccine is stored in special containers that maintain temperatures between −80 and −60 °C (−112 and −76 °F).[158]

Low-income countries have limited cold chain capacity for ultracold transport and storage of a vaccine.[159] The necessary storage temperatures for the vaccine[158][160][159][161][162] are much lower than for the similar Moderna vaccine. The head of Indonesia's Bio Farma Honesti Basyir said purchasing the vaccine is out of the question for the world's fourth-most populous country, given that it did not have the necessary cold chain capability. Similarly, India's existing cold chain network can handle only temperatures between 2 and 8 °C (36 and 46 °F), far above the requirements of the vaccine.[163][164]

History

Before COVID‑19 vaccines, a vaccine for an infectious disease had never before been produced in less than several years, and no vaccine existed for preventing a coronavirus infection in humans.[165] The SARS-CoV-2 virus, which causes COVID‑19, was detected in December 2019,[166] and BioNTech began development of a COVID‑19 vaccine on 10 January 2020, when the SARS-CoV-2 genetic sequences were released by the Chinese Center for Disease Control and Prevention triggering an urgent international response to prepare for an outbreak and hasten development of preventive vaccines.[167][168]

The vaccine's development began when BioNTech founder Uğur Şahin read an article in the medical journal The Lancet that convinced him the COVID‑19 coronavirus in China would soon become a global pandemic, so he called for scientists at the company to cancel their vacations and start development of a COVID‑19 vaccine in January 2020.[169] BioNTech started its program 'Project Lightspeed' to develop a vaccine against the new COVID‑19 virus based on its already established mRNA-technology,[51] which they had been developing since leading mRNA researcher Katalin Karikó joined the company in 2013.[170] Several variants of the vaccine were created in their laboratories in Mainz, and 20 of those were presented to experts of the Paul Ehrlich Institute in Langen.[171]

Meanwhile, since 2018, Pfizer had been working with BioNTech on developing a mRNA vaccine for influenza, but the chief executive officers of the two companies did not become personally acquainted until COVID-19 came along.[172] After a few phone calls, Pfizer CEO Albert Bourla and Şahin agreed that their companies would work together on the development of BioNTech's COVID-19 vaccine.[172] The two agreed to begin work immediately, with no formal written legal agreement in place to govern the new collaboration.[172] BioNTech transferred its know-how to Pfizer the next day.[172] A letter of intent was signed three weeks later, and the formal commercial agreement between Pfizer and BioNTech for the COVID-19 vaccine was signed in January 2021.[172]

Funding

According to Pfizer, research and development for the vaccine cost close to US$1 billion.[173]

BioNTech received a US$135 million investment from Fosun in March 2020, in exchange for 1.58 million shares in BioNTech and the future development and marketing rights of BNT162b2 in China.[174][131]

In April 2020, BioNTech signed a partnership with Pfizer and received $185 million, including an equity investment of approximately $113 million.[175][176][177]

In June 2020, BioNTech received €100 million (US$119 million) in financing from the European Commission and European Investment Bank.[178] The Bank's deal with BioNTech started early in the pandemic, when the Bank's staff reviewed its portfolio and came up with BioNTech as one of the companies capable of developing a COVID‑19 vaccine. The European Investment Bank had already signed a first transaction with BioNTech in 2019.[179]

In September 2020, the German government granted BioNTech €375 million (US$445 million) for its COVID‑19 vaccine development program.[180]

Pfizer CEO Albert Bourla said he decided against taking funding from the US government's Operation Warp Speed for the development of the vaccine "because I wanted to liberate our scientists [from] any bureaucracy that comes with having to give reports and agree how we are going to spend the money in parallel or together, etc." Pfizer did enter into an agreement with the US for the eventual distribution of the vaccine, as with other countries.[181]

Clinical trials

Phase I–II Trials were started in Germany on 23 April 2020, and in the U.S. on 4 May 2020, with four vaccine candidates entering clinical testing.[45][51] The vaccine candidate BNT162b2 was chosen as the most promising among three others with similar technology developed by BioNTech.[125] Before choosing BNT162b2, BioNTech and Pfizer had conducted phase I trials on BNT162b1 in Germany and the United States, while Fosun performed a Phase I trial in China. In these Phase I studies, BNT162b2 was shown to have a better safety profile than the other three BioNTech candidates.[182][44][183][184]

The Pivotal Phase II–III Trial with the lead vaccine candidate "BNT162b2" began in July. Preliminary results from Phase I–II clinical trials on BNT162b2, published in October 2020, indicated potential for its safety and efficacy.[44] During the same month, the European Medicines Agency (EMA) began a periodic review of BNT162b2.[185]

The study of BNT162b2 is a continuous-phase trial in phase III as of November 2020.[45] It is a "randomized, placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection, and efficacy study in healthy individuals".[45] The study expanded during mid-2020 to assess efficacy and safety of BNT162b2 in greater numbers of participants, reaching tens of thousands of people receiving test vaccinations in multiple countries in collaboration with Pfizer and Fosun.[47][131]

The phase III trial assesses the safety, efficacy, tolerability, and immunogenicity of BNT162b2 at a mid-dose level (two injections separated by 21 days) in three age groups: 12–15 years, 16–55 years or above 55 years.[45] The Phase III results indicating a 95% efficacy of the developed vaccine were published on 18 November 2020.[51] For approval in the EU, an overall vaccine efficacy of 95% was confirmed by the EMA.[186] The EMA clarified that the second dose should be administered three weeks after the first dose.[187]

Cumulative incidence curves for symptomatic COVID‑19 infections after the first dose of the Pfizer–BioNTech vaccine (tozinameran) or placebo in a double-blind clinical trial (red: placebo; blue: tozinameran)[188]

At 14 days after dose 1, the cumulative incidence begins to diverge between the vaccinated group and the placebo group. The highest concentration of neutralizing antibodies is reached 7 days after dose 2 in younger adults and 14 days after dose 2 in older adults.[186]

Vaccine efficacy against confirmed symptomatic COVID‑19[186]
Endpoint subgroup Efficacy (95% confidence interval)
All ages 95.0% (90.0–97.9%)
Age 12–17 Not estimable[lower-alpha 2]
Age 18–64 95.1% (89.6–98.1%)
Age 65–74 92.9% (53.1–99.8%)
Age ≥75 100.0% (−13.1 to 100.0%)
All ages, after dose 1, before dose 2 52.4% (29.5–68.4%)
All ages, ≥10 days after dose 1, before dose 2 86.7% (68.6–95.4%)
All ages, <7 days after dose 2 90.5% (61.0–98.9%)
All ages, ≥7 days after dose 2 94.8% (89.8–97.6%)
All ages, USA 94.9% (88.6–98.2%)
All ages, Argentina 97.2% (83.3–99.9%)
All ages, Brazil 87.7% (8.1–99.7%)

The ongoing phase III trial, which is scheduled to run from 2020 to 2022, is designed to assess the ability of BNT162b2 to prevent severe infection, as well as the duration of immune effect.[47][189][160]

High antibody activity persists for at least three months after the second dose, with an estimated antibody half-life of 55 days. From these data, one study suggested that antibodies might remain detectable for around 554 days.[190]

Specific populations

Pfizer and BioNTech started a Phase II–III randomized control trial in healthy pregnant women 18 years of age and older (NCT04754594).[191] The study will evaluate 30 mcg of BNT162b2 or placebo administered via intramuscular injection in two doses, 21 days apart. The Phase II portion of the study will include approximately 350 pregnant women randomized 1:1 to receive BNT162b2 or placebo at 27 to 34 weeks' gestation. The Phase III portion of this study will assess the safety, tolerability, and immunogenicity of BNT162b2 or placebo among pregnant women enrolled at 24 to 34 weeks' gestation. Pfizer and BioNTech announced on 18 February 2021 that the first participants received their first dose in this trial.[192]

A study published in March 2021, in the American Journal of Obstetrics and Gynecology came to the conclusion that messenger RNA vaccines against the novel coronavirus, such as the Pfizer-BioNTech and Moderna vaccines were safe and effective at providing immunity against infection to pregnant and breastfeeding mothers. Furthermore, they found that naturally occurring antibodies created by the mother's immune system were passed on to their children via the placenta and/or breastmilk, thus resulting in passive immunity among the child, effectively giving the child protection against the disease. The study also found that vaccine-induced immunity among the study's participants was stronger in a statistically significant way over immunity gained through recovery from a natural COVID‑19 infection. In addition, the study reported that the occurrence and intensity of potential side effects in those undergoing pregnancy or lactating was very similar to those expected from non-pregnant populations, remaining generally very minor and well tolerated, mostly including injection site soreness, minor headaches, muscles aches or fatigue for a short period of time.[193]

In January 2021, Pfizer said it had finished enrolling 2,259 children aged between 12 and 15 years to study the vaccine's safety and efficacy.[194] On 31 March 2021, Pfizer and BioNTech announced from initial Phase III trial data that the vaccine is 100% effective for those aged 12 to 15 years of age, with trials for those younger still in progress.[195]

A research letter published in JAMA reported that the vaccines appeared to be safe for immunosuppressed organ transplant recipients, but that the resulting antibody response was considerably poorer than in the non-immunocompromised population after only one dose. The paper admitted the limitation of only reviewing the data following the first dose of a two-dose cycle vaccine.[196]

On 2 November 2021, The BMJ published a piece by journalist Paul D. Thacker alleging there has been "poor practice" at Ventavia, one of the companies involved in the phase III evaluation trials of the Pfizer vaccine.[197] The report was enthusiastically embraced by anti-vaccination activists. David Gorski commented in Science-Based Medicine that Thacker's article presented facts without necessary context to misleading effect, playing up the seriousness of the noted problems.[198]

Authorizations

  Full authorization
  Emergency authorization
  Eligible COVAX recipient

Although jointly developed with Pfizer,[199] Comirnaty is based on BioNTech's proprietary mRNA technology,[199] and BioNTech holds the Marketing Authorization in the United States, the European Union, the UK, and Canada;[199] expedited licenses such as the US emergency use authorization (EUA) are held jointly with Pfizer in many countries.[199]

Expedited

The United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) gave the vaccine "rapid temporary regulatory approval to address significant public health issues such as a pandemic" on 2 December 2020, which it is permitted to do under the Medicines Act 1968.[58] It is the first COVID‑19 vaccine to be approved for national use after undergoing large scale trials,[200] and the first mRNA vaccine to be authorized for use in humans.[58][201] The United Kingdom thus became the first Western country to approve a COVID‑19 vaccine for national use,[202] although the decision to fast-track the vaccine was criticized by some experts.[203]

After the United Kingdom, the following countries and regions expedited processes to approve the Pfizer–BioNTech COVID‑19 vaccine for use: Argentina,[204] Australia,[205] Bahrain,[206] Canada,[207][208] Chile,[209] Costa Rica,[210] Ecuador,[209] Hong Kong,[211] Iraq,[212] Israel,[213] Jordan,[214] Kuwait,[215] Malaysia,[216] Mexico,[217][218] Oman,[219] Panama,[220] the Philippines,[221] Qatar,[222] Saudi Arabia,[223][224][225] Singapore,[226][227][228] South Korea,[229][230] the United Arab Emirates,[231] the United States,[232] and Vietnam.[233]

The World Health Organization (WHO) authorized it for emergency use.[234][235][236][237]

In the United States, an emergency use authorization (EUA) is "a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current COVID‑19 pandemic", according to the Food and Drug Administration (FDA).[238] Pfizer applied for an EUA on 20 November 2020,[239] and the FDA approved the application three weeks later on 11 December 2020. The US Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) approved recommendations for vaccination of those aged sixteen years or older.[240][241] Following the EUA issuance, BioNTech and Pfizer continued the Phase III clinical trial to finalize safety and efficacy data, leading to application for licensure (approval) of the vaccine in the United States.[238][31][147] On 10 May 2021, the US FDA also authorized the vaccine for people aged 12 to 15 under an expanded EUA.[242][31][147][243][148] The FDA recommendation was endorsed by the ACIP and adopted by the CDC on 12 May 2021.[244][245] In October 2021, the EUA was expanded to include children aged 5 through 11 years of age.[246] In June 2022, the EUA was expanded to include children aged six months through four years of age.[29]

On 16 February 2021, the South African Health Products Regulatory Authority (SAHPRA) in South Africa issued Section 21, Emergency Use Approval for the vaccine.[247][248]

On 5 May 2021, Health Canada authorized the vaccine for people aged 12 to 15.[249][250] On 18 May 2021, Singapore's Health Sciences Authority authorized the vaccine for people aged 12 to 15.[251] The European Medicines Agency (EMA) followed suit on 28 May 2021.[252]

On 4 June 2021, the UK Medicines and Healthcare products Regulatory Agency (MHRA) came to a similar decision and approved the use of the vaccine for people twelve years of age and older.[24][105][106]

Standard

On 19 December 2020, the Swiss Agency for Therapeutic Products (Swissmedic) granted temporary authorization for the Pfizer–BioNTech COVID‑19 vaccine for regular use, two months after receiving the application, saying the vaccine fully complied with the requirements of safety, efficacy and quality.[39][253][254][255][256][257][258] This is the first authorization under a standard procedure.[39][253]

On 21 December 2020, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended granting conditional marketing authorization for the Pfizer–BioNTech COVID‑19 vaccine under the brand name Comirnaty.[2][259][3] The recommendation was accepted by the European Commission the same day.[259][260]

On 23 February 2021, the Brazilian Health Regulatory Agency approved the Pfizer–BioNTech COVID‑19 vaccine under its standard marketing authorization procedure.[261][262][263][264] In June 2021, the approval was extended to those aged twelve or over.[265][266] Pfizer's negotiation process with Brazil (and other Latin American countries) was described as "bullying". The contract prohibits the state of Brazil from publicly discussing the existence or the terms of their agreement with Pfizer–BioNTech without the former's written consent. Brazil was also restricted from donating or receiving donations of vaccines.[267][268]

In July 2021, the U.S. Food and Drug Administration (FDA) granted priority review designation for the biologics license application (BLA) for the Pfizer–BioNTech COVID-19 vaccine with a goal date for the decision in January 2022.[269][270] On 23 August 2021, the FDA approved the vaccine for use for those aged sixteen years and older.[30][64][27]

The Pfizer-BioNTech Comirnaty COVID-19 vaccine was authorized in Canada in September 2021, for people aged twelve and older.[18][19][17][271]

In July 2022, the FDA approved the vaccine for use for those aged twelve years and older.[272][27]

In September 2022, the CHMP of the EMA recommended converting the conditional marketing authorizations of the vaccine into standard marketing authorizations.[38] The recommendation covers all existing and upcoming adapted Comirnaty vaccines, including the adapted Comirnaty Original/Omicron BA.1 (tozinameran/riltozinameran) and Comirnaty Original/Omicron BA.4/5 (tozinameran/famtozinameran).[2][38]

Further development

Homologous prime-boost vaccination

In July 2021, Israel's Prime Minister announced that the country was rolling out a third dose of the Pfizer-BioNTech vaccine to people over the age of 60, based on data that suggested significant waning immunity from infection over time for those with two doses.[273] The country expanded the availability to all Israelis over the age of 12, after five months since their second shot. On 29 August 2021, Israel's coronavirus czar announced that Israelis who had not received a booster shot within six months of their second dose would lose access to the country's green pass vaccine passport.[274] Studies performed in Israel found that a third dose reduced the incidence of serious illness.[275]

In August 2021, the United States Department of Health and Human Services (HHS) announced a plan to offer a booster dose eight months after the second dose, citing evidence of reduced protection against mild and moderate disease and the possibility of reduced protection against severe disease, hospitalization, and death.[276] The US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) authorized the use of an additional mRNA vaccine dose for immunocompromised individuals at that time.[76][77] Scientists and the WHO noted in August 2021, the lack of evidence on the need for a booster dose for healthy people and that the vaccine remains effective against severe disease months after administration.[277] In a statement, the WHO and Strategic Advisory Group of Experts (SAGE) said that, while protection against infection may be diminished, protection against severe disease will likely be retained due to cell-mediated immunity.[278] Research into optimal timing for boosters is ongoing, and a booster too early may lead to less robust protection.[279]

In September 2021, the FDA and CDC authorizations were extended to provide a third shot for other specific groups.[280][281][282]

In October 2021, the European Medicines Agency (EMA) stated that a booster shot of the vaccine could be given to healthy people, aged 18 years and older, at least six months after their second dose.[78] It also stated that people with "severely weakened" immune systems can receive an extra dose of either the Pfizer-BioNTech vaccine or the Moderna vaccine starting at least 28 days after their second dose.[78] The final approval to provide booster shots in the European Union will be decided by each national government.[283]

In October 2021, the FDA and the CDC authorized the use of either homologous or heterologous vaccine booster doses.[284][285][286]

In October 2021, the Australian Therapeutic Goods Administration (TGA) provisionally approved a booster dose of Comirnaty for people 18 years of age and older.[287][288]

In January 2022, the FDA expanded the emergency use authorization to provide for the use of a vaccine booster dose to those aged 12 through 15 years of age, and it shortened the waiting period after primary vaccination to five months from six months.[289][290][291][292]

In May 2022, the FDA expanded the emergency use authorization to provide for the use of a vaccine booster dose to those aged 5 through 11 years of age.[293]

In August 2022, the FDA revoked the emergency use authorization for the monovalent vaccine booster for people aged twelve years of age and older and replaced it with an emergency use authorization for the bivalent vaccine booster dose for the same age group.[66]

Heterologous prime-boost vaccination

In October 2021, the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) authorized the use of either homologous or heterologous vaccine booster doses.[284][285] The authorization was expanded to include all adults in November 2021.[286]

Bivalent booster vaccination

In August 2022, the "Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5)" (in short: "COVID-19 Vaccine, Bivalent") received an emergency use authorization from the US Food and Drug Administration (FDA) for use as a booster dose in individuals aged twelve years of age and older. One dose contains 15 mcg of "a nucleoside-modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2 Wuhan-Hu-1 strain (Original)" and 15 mcg "of modRNA encoding the S glycoprotein of SARS-CoV-2 Omicron variant lineages BA.4 and BA.5 (Omicron BA.4/BA.5)".[294]

The bivalent vaccine authorized in the United States is different from the one that was authorized for use in the United Kingdom[71] as the latter contains as second modRNA component 15 mcg of modRNA enocoding the S gylcoprotein of the earlier BA.1 variant.[71]

In September 2022, the European Union authorized both the BA.1 and the BA.4/BA.5 booster versions of the bivalent vaccine for people aged twelve years of age and older.[2][3][73]

While the Omicron BA.1 vaccine has been tested in a clinical study, the Omicron BA.4/BA.5 vaccine was only tested in pre-clinical studies. According to the published presentation,[295] the neutralization responses of Omicron BA.4/BA.5 monovalent, Omicron BA.1 mononvalent, Omicron BA.4/BA.5 bivalent and the original BNT162b2 vaccine have been explored in a study with BALB/c-mice.[296][297]

In October 2022, the FDA amended the authorization for the bivalent booster to cover people aged five years of age and older.[298]

In December 2022, the FDA amended the authorization for the bivalent booster to be used as the third dose in people aged six months through four years of age.[299]

XBB.1.5 monovalent vaccine

In September 2023, the FDA approved an updated monovalent (single) component Omicron variant XBB.1.5 version of the vaccine (Comirnaty 2023–2024 formula) as a single dose for individuals aged twelve years of age and older;[27] and authorized the Pfizer-BioNTech COVID-19 Vaccine 2023–2024 formula under emergency use for individuals aged 6 months through 11 years of age.[26][300] The approvals and emergency authorizations for the bivalent versions of the vaccine were revoked.[26] Health Canada approved the Pfizer-BioNTech Comirnaty Omicron XBB.1.5 subvariant, monovalent COVID‑19 vaccine in September 2023.[18] The UK Medicines and Healthcare products Regulatory Agency approved the used of the Comirnaty Omicron XBB.1.5 vaccine in September 2023.[301][302]

Society and culture

About 649 million doses of the Pfizer–BioNTech COVID-19 vaccine, including about 55 million doses in children and adolescents (below 18 years of age) were administered in the EU/EEA from authorization to 26 June 2022.[303]

Brand names

Comirnaty

BNT162b2 was the code name during development and testing,[44][54] tozinameran is the international nonproprietary name (INN),[37][304] and Comirnaty is the brand name.[39][2] According to BioNTech, the name Comirnaty "represents a combination of the terms COVID‑19, mRNA, community, and immunity".[305][306]

Famtozinameran is the INN for the BA.5 variant in the bivalent version of the vaccine.[307][308][309][310][6]

Raxtozinameran is the INN for the XBB 1.5 variant version of the vaccine.[37][311][312][313][6]

Economics

Pfizer reported revenue of US$154 million from the Pfizer–BioNTech COVID-19 vaccine in 2020,[177] and $36 billion in 2021.[314][315]

In July 2020, the vaccine development program Operation Warp Speed placed an advance order of US$1.95 billion with Pfizer to manufacture 100 million doses of a COVID‑19 vaccine for use in the United States if the vaccine was shown to be safe and effective.[43][316][317][318][319] By mid-December 2020, Pfizer had agreements to supply 300 million doses to the European Union,[320] 120 million doses to Japan,[321] 40 million doses (10 million before 2021) to the United Kingdom,[160] 20 million doses to Canada,[322] an unspecified number of doses to Singapore,[323] and 34.4 million doses to Mexico.[324] Fosun also has agreements to supply 10 million doses to Hong Kong and Macau.[325]

Accounts of how Pfizer's got its way into a large deal to provide 1.8 billion doses of its vaccine to the European Union were described by the New York Times as "a striking alignment of political survival and corporate hustle".[326]

Access

Pfizer has been accused of hindering vaccine equity. In 2021, Pfizer delivered only 39% of the contractually agreed doses to the COVAX programme, a number that equals 1.5% of all vaccines produced by Pfizer. The company sold 67% of their doses to high-income countries and sold none directly to low-income countries.[327]

Pfizer actively lobbied against the temporary lift of intellectual property rights which would allow the vaccine to be produced by others without having to pay a royalty fee.[328][329]

Misinformation

Videos on video-sharing platforms circulated around May 2021 showing people having magnets stick to their arms after receiving the vaccine, purportedly demonstrating the conspiracy theory that vaccines contain microchips, but these videos have been debunked.[330][331][332][333]

Notes

  1. ↑ According to the British National Formulary and MedDRA conventions, side effects are "very common" when they occur in more than 1 in 10 instances; "common", 1 in 100 to 1 in 10; "uncommon", 1 in 1,000 to 1 in 100; "rare", 1 in 10,000 to 1 in 1,000; and "very rare" when they occur in less than 1 in 10,000 instances.[56]
  2. ↑ No cases in the placebo group results in division by zero.
  1. ↑ This is a type of study where researchers recruit two groups: people who test positive for the disease (cases) and those who test negative (controls) (Vandenbroucke 2019). They then survey these individuals for factors which may have affected whether or not they developed the disease (in this case, vaccination status) (Patel 2020). In the case of Lopez Bernal et al, they also assessed which variant each "case" contracted (e.g. alpha [B.1.1.7] or delta [B.1.617.2]) using both RT-PCR testing and whole genome sequencing. To evaluate efficacy, the researchers determined how much less likely a person was to contract each variant based on their vaccination status. In this case, a person who received two doses of the Pfizer vaccine was 93.7% less likely to contract the alpha variant and 88.0% less likely to contract the delta variant, when compared to an unvaccinated person.
    • Vandenbroucke JP, Pearce N (November 2019). "Test-Negative Designs: Differences and Commonalities with Other Case-Control Studies with "Other Patient" Controls" (PDF). Epidemiology. 30 (6): 838–844. doi:10.1097/EDE.0000000000001088. PMID 31430265. S2CID 201117050. Archived (PDF) from the original on 21 September 2021. Retrieved 31 August 2021.
    • Patel MM, Jackson ML, Ferdinands J (November 2020). "Postlicensure Evaluation of COVID-19 Vaccines". JAMA. 324 (19): 1939–40. doi:10.1001/jama.2020.19328. PMID 33064144. S2CID 222819843.

References

  1. 1 2 3 "Comirnaty 30 micrograms/dose concentrate for dispersion for injection 12+ years COVID-19 mRNA Vaccine (nucleoside modified) - Summary of Product Characteristics (SmPC)". (emc). Archived from the original on 4 February 2022. Retrieved 4 February 2022.
  2. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 "Comirnaty EPAR". European Medicines Agency (EMA). 21 December 2020. Archived from the original on 18 June 2022. Retrieved 18 June 2022.
  3. 1 2 3 4 5 "Comirnaty". Union Register of medicinal products. European Commission. Archived from the original on 24 January 2021. Retrieved 8 January 2021.
  4. ↑ "Updates to the Prescribing Medicines in Pregnancy database". Therapeutic Goods Administration (TGA). 21 December 2022. Retrieved 2 January 2023.
  5. 1 2 "Comirnaty". Therapeutic Goods Administration (TGA). 25 January 2021. Archived from the original on 1 February 2021. Retrieved 25 January 2021.
  6. 1 2 3 "COVID-19 vaccines regulatory status". Therapeutic Goods Administration (TGA). 21 June 2022. Retrieved 8 October 2023.
  7. ↑ "Comirnaty (BNT162b2 [mRNA]) COVID-19 Vaccine Product Information" (PDF). Therapeutic Goods Administration (TGA). 11 May 2022. Archived from the original on 2 February 2021. Retrieved 25 January 2021.
  8. 1 2 "AusPAR: Tozinameran". Therapeutic Goods Administration (TGA). 8 February 2022. Archived from the original on 24 March 2022. Retrieved 24 March 2022.
  9. ↑ "COVID-19 vaccine: Pfizer Australia - Comirnaty BNT162b2 (mRNA) - approved for use in individuals 12 years and older". Therapeutic Goods Administration (TGA). 27 August 2021. Archived from the original on 23 July 2021. Retrieved 22 October 2021.
  10. ↑ "TGA Provisional Approval of Pfizer-BioNTech COVID-19 vaccine to include 12-15 years age group". Therapeutic Goods Administration (TGA). 23 July 2021. Archived from the original on 22 October 2021. Retrieved 22 October 2021.
  11. ↑ "AusPAR: Tozinameran (mRNA Covid 19 vaccine)". Therapeutic Goods Administration (TGA). 13 December 2021. Archived from the original on 23 March 2022. Retrieved 23 March 2022.
  12. ↑ "Comirnaty original/Omicron BA.1 COVID-19 Vaccine | Therapeutic Goods Administration (TGA)". 8 November 2022.
  13. ↑ "Comirnaty Original/Omicron BA.4-5 COVID-19 vaccine". Therapeutic Goods Administration (TGA). 27 January 2023. Retrieved 8 April 2023.
  14. ↑ "Pfizer) Labelling Exemption (No.2) 2021". Therapeutic Goods Administration (TGA). 21 June 2022. Retrieved 8 April 2023.
  15. ↑ "Brazil approves Pfizer's COVID-19 shot, but has none to use". Reuters. 23 February 2021. Archived from the original on 20 November 2021. Retrieved 20 November 2021.
  16. ↑ "Anvisa concede primeiro registro definitivo para vacina contra a Covid-19 nas Américas" [Anvisa grants first definitive registration for Covid-19 vaccine in the Americas] (in Portuguese). Federal government of Brazil. 23 February 2021. Archived from the original on 20 November 2021. Retrieved 20 November 2021.
  17. 1 2 "Regulatory Decision Summary - Comirnaty". Health Canada. 15 September 2021. Archived from the original on 19 September 2021. Retrieved 18 September 2021.
  18. 1 2 3 "Pfizer-BioNTech Comirnaty COVID-19 vaccine". Health Canada. 9 December 2020. Archived from the original on 5 June 2021. Retrieved 18 September 2021.
  19. 1 2 "Drug and vaccine authorizations for COVID-19: List of authorized drugs, vaccines and expanded indications". Health Canada. 17 September 2020. Archived from the original on 24 March 2021. Retrieved 17 September 2021.
  20. ↑ "Summary Basis of Decision (SBD) for Comirnaty". Health Canada. 23 October 2014. Archived from the original on 30 May 2022. Retrieved 29 May 2022.
  21. ↑ "Comirnaty (tozinameran)". Health Canada. 9 December 2020. Archived from the original on 9 May 2022. Retrieved 31 May 2022.
  22. ↑ "Summary Basis of Decision (SBD) for Comirnaty Omicron XBB.1.5". Drug and Health Products Portal. 1 September 2012. Retrieved 11 December 2023.
  23. ↑ "Regulatory approval of Pfizer/BioNTech vaccine for COVID-19". Medicines and Healthcare products Regulatory Agency (MHRA). 27 September 2021. Archived from the original on 19 January 2021. Retrieved 24 October 2021.
  24. 1 2 3 4 "Information for Healthcare Professionals on Pfizer/BioNTech COVID-19 vaccine". Medicines and Healthcare products Regulatory Agency (MHRA). 10 December 2020. Archived from the original on 15 March 2021. Retrieved 21 December 2020.
  25. ↑ "Conditions of Authorisation for Pfizer/BioNTech COVID-19 vaccine". Medicines and Healthcare products Regulatory Agency (MHRA). 31 December 2020. Archived from the original on 26 February 2021. Retrieved 8 January 2021.
  26. 1 2 3 "FDA Takes Action on Updated mRNA COVID-19 Vaccines to Better Protect Against Currently Circulating Variants". U.S. Food and Drug Administration (FDA). 11 September 2023. Retrieved 12 September 2023. Public Domain This article incorporates text from this source, which is in the public domain.
  27. 1 2 3 4 5 "Comirnaty". U.S. Food and Drug Administration (FDA). 23 August 2021. STN: 125742. Archived from the original on 3 December 2021. Retrieved 23 August 2021.
  28. 1 2 3 4 5 6 "Pfizer-Biontech COVID-19 Vaccine- bnt162b2 injection, suspension". DailyMed. Archived from the original on 16 November 2020. Retrieved 24 October 2021.
  29. 1 2 "Coronavirus (COVID-19) Update: FDA Authorizes Moderna and Pfizer-BioNTech COVID-19 Vaccines for Children Down to 6 Months of Age". U.S. Food and Drug Administration (FDA) (Press release). 17 June 2022. Archived from the original on 17 June 2022. Retrieved 17 June 2022.
  30. 1 2 3 4 "FDA Approves First COVID-19 Vaccine" (Press release). U.S. Food and Drug Administration (FDA). 23 August 2021. Archived from the original on 23 August 2021. Retrieved 23 August 2021.
  31. 1 2 3 "Pfizer–BioNTech COVID-19 Vaccine EUA Letter of Authorization" (PDF). U.S. Food and Drug Administration (FDA). 12 August 2021. Archived from the original on 14 August 2021. Retrieved 13 August 2021. Public Domain This article incorporates text from this source, which is in the public domain.
  32. 1 2 3 4 5 6 "Pfizer–BioNTech COVID-19 Vaccine Standing Orders for Administering Vaccine to Persons 12 Years of Age and Older (Purple Cap)" (PDF). U.S. Centers for Disease Control and Prevention (CDC). 24 May 2022. Retrieved 14 July 2022.
  33. ↑ "Pfizer–BioNTech COVID-19 Vaccine Standing Orders for Administering Vaccine to Persons 6 Months Through 4 Years of Age" (PDF). U.S. Centers for Disease Control and Prevention (CDC). 21 June 2022. Retrieved 14 July 2022.
  34. ↑ "Pfizer–BioNTech COVID-19 Vaccine Standing Orders for Administering Vaccine to Persons 5 Through 11 Years of Age" (PDF). U.S. Centers for Disease Control and Prevention (CDC). 24 May 2022. Retrieved 14 July 2022.
  35. ↑ "Pfizer–BioNTech COVID-19 Vaccine Standing Orders for Administering Vaccine to Persons 12 Years of Age and Older (Gray Cap)" (PDF). U.S. Centers for Disease Control and Prevention (CDC). 24 May 2022. Retrieved 14 July 2022.
  36. ↑ "Pfizer-BioNTech COVID-19 Vaccine- bnt162b2 injection, suspension". DailyMed. Archived from the original on 21 October 2021. Retrieved 24 October 2021.
  37. 1 2 3 4 5 6 7 "Comirnaty- covid-19 vaccine, mrna injection, suspension". DailyMed. Archived from the original on 4 February 2022. Retrieved 4 February 2022.
  38. 1 2 3 4 "EMA recommends standard marketing authorisations for Comirnaty and Spikevax COVID-19 vaccines". European Medicines Agency (EMA) (Press release). 16 September 2022. Retrieved 18 September 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  39. 1 2 3 4 5 "Swissmedic grants authorisation for the first COVID-19 vaccine in Switzerland" (Press release). Swiss Agency for Therapeutic Products (Swissmedic). 19 December 2020. Archived from the original on 10 January 2021. Retrieved 19 December 2020.
  40. ↑ "South Africa approves Pfizer Covid-19 vaccine for emergency use". BusinessTech. 16 March 2021. Archived from the original on 18 March 2021. Retrieved 18 March 2021.
  41. ↑ Nkanjeni U (18 March 2021). "Pfizer-BioNTec approved for emergency use in SA: here is what you need to know about the vaccine". TimesLIVE. Archived from the original on 19 April 2021. Retrieved 19 March 2021.
  42. ↑ Browne R (11 November 2020). "What you need to know about BioNTech – the European company behind Pfizer's Covid-19 vaccine". CNBC. Archived from the original on 4 March 2021. Retrieved 14 January 2021.
  43. 1 2 3 Thomas K, Gelles D, Zimmer C (9 November 2020). "Pfizer's early data shows vaccine is more than 90% effective". The New York Times. Archived from the original on 23 November 2020. Retrieved 9 November 2020.
  44. 1 2 3 4 5 Walsh EE, Frenck RW, Falsey AR, Kitchin N, Absalon J, Gurtman A, et al. (October 2020). "Safety and Immunogenicity of Two RNA-Based Covid-19 Vaccine Candidates". The New England Journal of Medicine. 383 (25): 2439–50. doi:10.1056/NEJMoa2027906. PMC 7583697. PMID 33053279.{{cite journal}}: CS1 maint: overridden setting (link)
  45. 1 2 3 4 5 6 "Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals". ClinicalTrials.gov. 30 April 2020. Archived from the original on 11 October 2020. Retrieved 5 August 2021.
  46. ↑ Palca J (9 November 2020). "Pfizer says experimental COVID-19 vaccine is more than 90% effective". NPR.org. NPR. Archived from the original on 9 November 2020. Retrieved 9 November 2020.
  47. 1 2 3 4 5 Herper M (9 November 2020). "Covid-19 vaccine from Pfizer and BioNTech is strongly effective, early data from large trial indicate". Stat News. Archived from the original on 9 November 2020. Retrieved 9 November 2020.
  48. ↑ Ellis R (22 January 2021). "CDC: Gap Between Vaccine Doses Could Be 6 Weeks". WebMD. Archived from the original on 4 May 2021. Retrieved 8 July 2021.
  49. ↑ "Canada vaccine panel recommends 4 months between COVID doses". ABC News. 4 March 2021. Archived from the original on 26 July 2021. Retrieved 9 July 2021.
  50. ↑ Public Health Agency of Canada (2 July 2021). Recommendations on the use of COVID-19 vaccines (PDF). Health Canada (Report). Archived (PDF) from the original on 23 June 2021. Retrieved 9 July 2021.
  51. 1 2 3 4 "Update on our COVID-19 vaccine development program with BNT162b2" (PDF) (Press release). BioNTech. 2 December 2020. Archived from the original on 3 December 2020. Retrieved 12 December 2020.
  52. 1 2 "Pfizer and BioNTech Confirm High Efficacy and No Serious Safety Concerns Through Up to Six Months Following Second Dose in Updated Topline Analysis of Landmark COVID-19 Vaccine Study". BioNTech (Press release). 1 April 2021. Archived from the original on 4 April 2021. Retrieved 11 April 2021.
  53. 1 2 3 "Pfizer-BioNTech COVID-19 Vaccine (also known as Comirnaty) Overview and Safety". U.S. Centers for Disease Control and Prevention (CDC). 19 November 2021. Archived from the original on 6 December 2021. Retrieved 27 September 2021.
  54. 1 2 Polack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A, Lockhart S, et al. (December 2020). "Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine". N Engl J Med. 383 (27): 2603–15. doi:10.1056/NEJMoa2034577. PMC 7745181. PMID 33301246.{{cite journal}}: CS1 maint: overridden setting (link)
  55. ↑ "Questions and Answers About Pfizer–BioNTech COVID-19 Vaccine". Pfizer. Archived from the original on 23 December 2020. Retrieved 16 December 2020.
  56. ↑ "Adverse reactions to drugs". British National Formulary. Archived from the original on 16 February 2021. Retrieved 19 December 2020.
  57. 1 2 "Coronavirus vaccine". National Health Service. 7 December 2020. Archived from the original on 7 December 2020. Retrieved 7 December 2020.
  58. 1 2 3 "UK medicines regulator gives approval for first UK COVID-19 vaccine" (Press release). Medicines and Healthcare products Regulatory Agency (MHRA). 2 December 2020. Archived from the original on 17 March 2021. Retrieved 2 December 2020.
  59. ↑ Boseley S, Halliday J (2 December 2020). "UK approves Pfizer/BioNTech Covid vaccine for rollout next week". The Guardian. Archived from the original on 2 December 2020. Retrieved 14 December 2020.
  60. ↑ "COVID-19 Vaccine Tracker: Pfizer/BioNTech: BNT162b2". McGill University. Archived from the original on 8 May 2021. Retrieved 8 May 2021.
  61. ↑ "Pfizer–BioNTech COVID-19 Vaccine". U.S. Food and Drug Administration (FDA). 3 February 2021. Archived from the original on 14 January 2021. Retrieved 5 February 2021.
  62. ↑ Thomas K (20 November 2020). "F.D.A. Clears Pfizer Vaccine, and Millions of Doses Will Be Shipped Right Away". The New York Times. Archived from the original on 12 December 2020.
  63. ↑ Australian Government Department of Health (24 January 2021). "About the Pfizer/BioNTech COVID-19 vaccine". Australian Government Department of Health. Archived from the original on 23 May 2021. Retrieved 31 May 2021.
  64. 1 2 Howard J (23 August 2021). "FDA grants full approval to Pfizer/BioNTech Covid-19 vaccine, opening door to more vaccine mandates". CNN. Archived from the original on 23 August 2021. Retrieved 23 August 2021.
  65. ↑ Rosales-Mendoza S, Wong-Arse A, de Lourdes Betancourt-Mendiola M (2021). "8. RNA based vaccines against SARS COV-2". In Rosales-Mendoza S, Comas-García M, González-Ortega O (eds.). Biomedical Innovations to Combat COVID-19. London: Academic Press. pp. 129–152. ISBN 978-0-323-90248-9. Archived from the original on 11 January 2022. Retrieved 19 December 2021.
  66. 1 2 3 "Coronavirus (COVID-19) Update: FDA Authorizes Moderna, Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose" (Press release). U.S. Food and Drug Administration. 31 August 2022. Retrieved 1 September 2022. Public Domain This article incorporates text from this source, which is in the public domain.
  67. ↑ Marks P (30 June 2022). "Fall 2022 COVID-19 Vaccine Strain Composition Selection Recommendation" (PDF). U.S. Food and Drug Administration. Retrieved 1 September 2022. Public Domain This article incorporates text from this source, which is in the public domain.
  68. ↑ Hall E, Twentyman E (1 September 2022). "Interim Clinical Considerations for COVID-19 Vaccines: Bivalent Boosters" (PDF). U.S. Centers for Disease Control and Prevention (CDC). Retrieved 1 September 2022. Public Domain This article incorporates text from this source, which is in the public domain.
  69. ↑ "CDC Recommends the First Updated COVID-19 Booster". U.S. Centers for Disease Control and Prevention (CDC) (Press release). 1 September 2022. Retrieved 2 September 2022.
  70. ↑ "Comirnaty Original/Omicron BA.1 15/15 micrograms per dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified) - Summary of Product Characteristics (SmPC)". (emc). 5 September 2022. Retrieved 21 October 2022.
  71. 1 2 3 "Pfizer/BioNTech bivalent COVID-19 booster approved by UK medicines regulator" (Press release). Medicines and Healthcare products Regulatory Agency (MHRA). 3 September 2022. Retrieved 5 September 2022.
  72. ↑ "Regulatory approval of Pfizer/BioNTech bivalent Original/Omicron booster vaccine". Medicines and Healthcare products Regulatory Agency (MHRA). 3 September 2022. Retrieved 5 September 2022.
  73. 1 2 "First adapted COVID-19 booster vaccines recommended for approval in the EU" (Press release). European Medicines Agency (EMA). 1 September 2022. Retrieved 3 September 2022.
  74. 1 2 Pfizer–BioNTech COVID-19 Vaccine Emergency Use Authorization Review Memorandum (PDF). U.S. Food and Drug Administration (FDA) (Report). 14 December 2020. Archived from the original on 29 January 2021. Retrieved 14 December 2020. Public Domain This article incorporates text from this source, which is in the public domain.
  75. 1 2 "Pfizer vaccine second dose has 'sweet spot' after eight weeks, UK scientists say". The Guardian. 22 July 2021. Archived from the original on 18 November 2021. Retrieved 26 July 2021.
  76. 1 2 "Coronavirus (COVID-19) Update: FDA Authorizes Additional Vaccine Dose for Certain Immunocompromised Individuals". U.S. Food and Drug Administration (FDA) (Press release). 12 August 2021. Archived from the original on 7 December 2021. Retrieved 13 August 2021.
  77. 1 2 "COVID-19 Vaccines for Moderately or Severely Immunocompromised People". U.S. Centers for Disease Control and Prevention (CDC). 13 August 2021. Archived from the original on 10 December 2021. Retrieved 13 August 2021.
  78. 1 2 3 "Comirnaty and Spikevax: EMA recommendations on extra doses and boosters". European Medicines Agency (EMA). 4 October 2021. Archived from the original on 11 December 2021. Retrieved 4 October 2021.
  79. ↑ "Sweden: 5th COVID-19 shot to people over 65, pregnant women". ABC News. Associated Press. 24 May 2022. Archived from the original on 18 June 2022. Retrieved 18 June 2022.
  80. ↑ Vanttinen P (17 June 2022). "Finland recommends fifth COVID booster for vulnerable patients". Euractiv. Archived from the original on 18 June 2022. Retrieved 18 June 2022.
  81. ↑ Lopez Bernal J, Andrews N, Gower C, Gallagher E, Simmons R, Thelwall S, et al. (August 2021). "Effectiveness of Covid-19 Vaccines against the B.1.617.2 (Delta) Variant". The New England Journal of Medicine. 385 (7): 585–594. doi:10.1056/NEJMoa2108891. PMC 8314739. PMID 34289274.{{cite journal}}: CS1 maint: overridden setting (link)
  82. ↑ Evans SJ, Jewell NP (August 2021). "Vaccine Effectiveness Studies in the Field". The New England Journal of Medicine. 385 (7): 650–651. doi:10.1056/NEJMe2110605. PMC 8314732. PMID 34289269.
  83. ↑ Fowlkes A, Gaglani M, Groover K, Thiese MS, Tyner H, Ellingson K (27 August 2021). "Effectiveness of COVID-19 Vaccines in Preventing SARS-CoV-2 Infection Among Frontline Workers Before and During B.1.617.2 (Delta) Variant Predominance — Eight U.S. Locations, December 2020–August 2021" (PDF). MMWR. Morbidity and Mortality Weekly Report. 70 (34): 1167–9. doi:10.15585/mmwr.mm7034e4. PMC 8389394. PMID 34437521. Archived (PDF) from the original on 5 February 2022. Retrieved 15 September 2021.
  84. ↑ Krause P, Fleming TR, Longini I, Henao-Restrepo AM, Peto R, Dean NE, et al. (12 September 2020). "COVID-19 vaccine trials should seek worthwhile efficacy". The Lancet. 396 (10253): 741–743. doi:10.1016/S0140-6736(20)31821-3. ISSN 0140-6736. PMC 7832749. PMID 32861315. WHO recommends that successful vaccines should show an estimated risk reduction of at least one-half, with sufficient precision to conclude that the true vaccine efficacy is greater than 30%. This means that the 95% CI for the trial result should exclude efficacy less than 30%. Guidance from the US Food and Drug Administration includes this lower limit of 30% as a criterion for vaccine licensure.{{cite journal}}: CS1 maint: overridden setting (link)
  85. ↑ Khoury DS, Cromer D, Reynaldi A, Schlub TE, Wheatley AK, Juno JA, et al. (May 2021). "Neutralizing antibody levels are highly predictive of immune protection from symptomatic SARS-CoV-2 infection". Nature Medicine. 27 (7): 1205–11. doi:10.1038/s41591-021-01377-8. PMID 34002089. S2CID 234769053.{{cite journal}}: CS1 maint: overridden setting (link)
  86. ↑ Dagan N, Barda N, Kepten E, Miron O, Perchik S, Katz MA, et al. (April 2021). "BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Mass Vaccination Setting". New England Journal of Medicine. 384 (15). Table 2. doi:10.1056/NEJMoa2101765. PMC 7944975. PMID 33626250.{{cite journal}}: CS1 maint: overridden setting (link)
  87. 1 2 3 4 5 6 7 8 Sheikh A, McMenamin J, Taylor B, Robertson C (14 June 2021). "SARS-CoV-2 Delta VOC in Scotland: demographics, risk of hospital admission, and vaccine effectiveness". The Lancet. 397 (10293). Table S4. doi:10.1016/S0140-6736(21)01358-1. ISSN 0140-6736. PMC 8201647. PMID 34139198.
  88. 1 2 3 4 Abu-Raddad LJ, Chemaitelly H, Butt AA (5 May 2021). "Effectiveness of the BNT162b2 Covid-19 Vaccine against the B.1.1.7 and B.1.351 Variants". New England Journal of Medicine. 385 (2). Table 1. doi:10.1056/NEJMc2104974. ISSN 0028-4793. PMC 8117967. PMID 33951357.
  89. 1 2 3 4 Chung H, He S, Nasreen S, Sundaram ME, Buchan SA, Wilson SE, et al. (August 2021). "Effectiveness of BNT162b2 and mRNA-1273 covid-19 vaccines against symptomatic SARS-CoV-2 infection and severe covid-19 outcomes in Ontario, Canada: test negative design study". BMJ. 374: n1943. doi:10.1136/bmj.n1943. PMC 8377789. PMID 34417165. Tables 6 and 7{{cite journal}}: CS1 maint: overridden setting (link)
  90. ↑ Stowe J, Andrews N, Gower C, Gallagher E, Utsi L, Simmons R, et al. (14 June 2021). Effectiveness of COVID-19 vaccines against hospital admission with the Delta (B.1.617.2) variant (Preprint). Public Health England. Table 1. Archived from the original on 23 June 2021. Retrieved 25 June 2021 – via Knowledge Hub.{{cite tech report}}: CS1 maint: overridden setting (link)
  91. ↑ SARS-CoV-2 variants of concern and variants under investigation in England, technical briefing 17 (PDF) (Briefing). Public Health England. 25 June 2021. GOV-8576. Archived (PDF) from the original on 25 June 2021. Retrieved 26 June 2021.
  92. 1 2 3 Weekly epidemiological update on COVID-19 - 14 December 2021 (Situation report). World Health Organization. 14 December 2021. Archived from the original on 16 December 2021. Retrieved 17 December 2021.
  93. ↑ Collie S, Champion J, Moultrie H, Bekker LG, Gray G (December 2021). "Effectiveness of BNT162b2 Vaccine against Omicron Variant in South Africa". N Engl J Med (letter). 386 (5): 494–496. doi:10.1056/NEJMc2119270. PMC 8757569. PMID 34965358.
  94. 1 2 "Pfizer and BioNTech Announce Phase 3 Trial Data Showing High Efficacy of a Booster Dose of Their COVID-19 Vaccine" (Press release). BioNTech. 21 October 2021. Archived from the original on 9 November 2021. Retrieved 10 November 2021.
  95. 1 2 COVID-19 vaccine surveillance report, week 51 (PDF) (Technical report). UK Health Security Agency. 23 December 2021. GOV-10820. Archived (PDF) from the original on 23 December 2021. Retrieved 24 December 2021.
  96. ↑ SARS-CoV-2 variants of concern and variants under investigation in England, technical briefing 28 (PDF) (Briefing). Public Health England. 12 November 2021. Figures 21 and 22. GOV-10349. Archived (PDF) from the original on 12 November 2021. Retrieved 18 November 2021.
  97. ↑ Thomas SJ, Moreira ED, Kitchin N, Absalon J, Gurtman A, Lockhart S, et al. (September 2021). "Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine through 6 Months". The New England Journal of Medicine. 385 (19): 1761–1773. doi:10.1056/nejmoa2110345. PMC 8461570. PMID 34525277.{{cite journal}}: CS1 maint: overridden setting (link)
  98. ↑ Chemaitelly H, Tang P, Hasan MR, AlMukdad S, Yassine HM, Benslimane FM, et al. (6 October 2021). "Waning of BNT162b2 Vaccine Protection against SARS-CoV-2 Infection in Qatar". New England Journal of Medicine. 385 (24): e83. doi:10.1056/NEJMoa2114114. ISSN 0028-4793. PMC 8522799. PMID 34614327. Archived from the original on 29 January 2022. Retrieved 9 November 2021.{{cite journal}}: CS1 maint: overridden setting (link)
  99. ↑ Howard J (21 October 2021). "Booster dose of Pfizer/BioNTech coronavirus vaccine shows 95.6% efficacy in Phase 3 trial, companies say". CNN. Archived from the original on 9 November 2021. Retrieved 10 November 2021.
  100. ↑ "Pfizer And BioNTech Provide Update On Omicron Variant" (Press release). New York City and Mainz: Pfizer. 8 December 2021. Archived from the original on 21 December 2021. Retrieved 8 December 2021.
  101. ↑ Winning A, Roelf W (14 December 2021). "Pfizer shot less effective against hospitalisation in South Africa - study". Reuters. Archived from the original on 21 December 2021. Retrieved 14 December 2021.
  102. ↑ "Bivalent booster effectiveness against severe COVID-19 outcomes in Finland, September 2022–January 2023". ResearchGate. 2 March 2023. Retrieved 8 March 2023.
  103. ↑ Smith K (24 April 2021). "New CDC guidance recommends pregnant people get the COVID-19 vaccine". CBS News. Archived from the original on 24 April 2021. Retrieved 24 April 2021.
  104. ↑ Shimabukuro TT, Kim SY, Myers TR, Moro PL, Oduyebo T, Panagiotakopoulos L, et al. (April 2021). "Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons". N Engl J Med. 384 (24): 2273–2282. doi:10.1056/NEJMoa2104983. PMC 8117969. PMID 33882218.{{cite journal}}: CS1 maint: overridden setting (link)
  105. 1 2 Boseley S (4 June 2021). "UK regulator approves Pfizer Covid vaccine for 12- to 15-year-olds". The Guardian. Archived from the original on 4 June 2021. Retrieved 4 June 2021.
  106. 1 2 Reynolds J (4 June 2021). "Pfizer vaccine approved for use in children aged 12 to 15 in the UK". The Times. ISSN 0140-0460. Archived from the original on 4 June 2021. Retrieved 4 June 2021.
  107. ↑ Torjesen I (May 2021). "Covid-19: Pfizer-BioNTech vaccine is "likely" responsible for deaths of some elderly patients, Norwegian review finds". BMJ. 373: n1372. doi:10.1136/bmj.n1372. PMID 34045236. S2CID 235204094.
  108. ↑ "Immunocompromised patients and COVID-19 vaccines" (PDF). NSW Health. 28 April 2021. Archived (PDF) from the original on 20 May 2021. Retrieved 2 June 2021.
  109. ↑ Lovelace Jr B (20 September 2021). "Pfizer says its Covid vaccine is safe and generates robust immune response in kids ages 5 to 11". CNBC. Archived from the original on 27 October 2021. Retrieved 26 November 2021.
  110. ↑ "Pfizer and BioNTech Announce Positive Topline Results From Pivotal Trial of COVID-19 Vaccine in Children 5 to 11 Years". Pfizer (Press release). 20 September 2021. Archived from the original on 25 November 2021. Retrieved 26 November 2021.
  111. 1 2 3 4 Comirnaty: Product Information (PDF) (Report). European Medicines Agency (EMA). Archived (PDF) from the original on 24 December 2020. Retrieved 23 December 2020.
  112. ↑ Rutkowski K, Mirakian R, Till S, Rutkowski R, Wagner A (June 2021). "Adverse reactions to COVID-19 vaccines: A practical approach". Clinical and Experimental Allergy. 51 (6): 770–777. doi:10.1111/cea.13880. PMC 8250847. PMID 33813758.
  113. 1 2 COVID-19 Response Team (January 2021). "Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Pfizer-BioNTech COVID-19 Vaccine - United States, December 14-23, 2020" (PDF). MMWR. Morbidity and Mortality Weekly Report. 70 (2): 46–51. doi:10.15585/mmwr.mm7002e1. PMC 7808711. PMID 33444297. Archived (PDF) from the original on 24 April 2022.{{cite journal}}: CS1 maint: numeric names: authors list (link)
  114. ↑ "COVID-19 vaccine safety update: Comirnaty" (PDF). European Medicines Agency (EMA). 28 January 2021. Archived (PDF) from the original on 2 June 2021. Retrieved 30 January 2021.
  115. ↑ Bostock N (9 December 2020). "MHRA warning after allergic reactions in NHS staff given COVID-19 vaccine". GP. Archived from the original on 9 December 2020. Retrieved 9 December 2020.
  116. ↑ Booth W, Cunningham E (9 December 2020). "Britain warns against Pfizer vaccine for people with history of 'significant' allergic reactions". The Washington Post. Archived from the original on 9 December 2020. Retrieved 9 December 2020.
  117. ↑ Cabanillas B, Akdis CA, Novak N (June 2021). "Allergic reactions to the first COVID-19 vaccine: A potential role of polyethylene glycol?". Allergy. 76 (6): 1617–1618. doi:10.1111/all.14711. PMID 33320974. S2CID 229284320.
  118. 1 2 "Pfizer–BioNTech COVID-19 vaccine: Health Canada recommendations for people with serious allergies". Health Canada. 12 December 2020. Archived from the original on 22 December 2020. Retrieved 21 December 2020.
  119. 1 2 Heller J (2 June 2021). "Israel sees probable link between Pfizer vaccine and myocarditis cases". Reuters. Archived from the original on 25 June 2021. Retrieved 3 June 2021.
  120. ↑ "Clinical Considerations: Myocarditis after mRNA COVID-19 Vaccines". U.S. Centers for Disease Control and Prevention (CDC). Archived from the original on 27 June 2021. Retrieved 27 June 2021. Public Domain This article incorporates text from this source, which is in the public domain.
  121. ↑ Oster ME, Shay DK, Su JR, Gee J, Creech CB, Broder KR, et al. (January 2022). "Myocarditis Cases Reported After mRNA-Based COVID-19 Vaccination in the US From December 2020 to August 2021". JAMA. 327 (4): 331–340. doi:10.1001/jama.2021.24110. PMC 8790664. PMID 35076665.{{cite journal}}: CS1 maint: overridden setting (link)
  122. ↑ National Center for Immunization and Respiratory Diseases (23 June 2021). "Myocarditis and Pericarditis Following mRNA COVID-19 Vaccination". U.S. Centers for Disease Control and Prevention (CDC). Archived from the original on 3 July 2021. Retrieved 2 July 2021.
  123. ↑ "STIKO empfiehlt Aspiration bei COVID-19-Impfung als Vorsichtsmaßnahme" [STIKO recommends aspiration for COVID-19 vaccination as precautionary measure]. Deutsches Ärzteblatt (in German). 18 February 2022. Retrieved 25 September 2022. Im Tiermodell seien nach direkter intravenöser Gabe eines mRNA-Impfstoffs Perimyokarditiden aufgetreten. [In an animal model, perimyocarditis had occurred after direct intravenous administration of an mRNA vaccine.]
  124. ↑ Vogel AB, Kanevsky I, Che Y, Swanson KA, Muik A, Vormehr M, et al. (April 2021). "BNT162b vaccines protect rhesus macaques from SARS-CoV-2". Nature. 592 (7853): 283–289. Bibcode:2021Natur.592..283V. doi:10.1038/s41586-021-03275-y. ISSN 0028-0836. PMID 33524990.{{cite journal}}: CS1 maint: overridden setting (link)
  125. 1 2 Gaebler C, Nussenzweig MC (October 2020). "All eyes on a hurdle race for a SARS-CoV-2 vaccine". Nature. 586 (7830): 501–2. Bibcode:2020Natur.586..501G. doi:10.1038/d41586-020-02926-w. PMID 33077943. S2CID 224808629.
  126. 1 2 3 World Health Organization (WHO) (September 2020). "Messenger RNA encoding the full-length SARS-CoV-2 spike glycoprotein" (DOC). WHO MedNet. Archived from the original on 5 January 2021. Retrieved 16 December 2020.
  127. 1 2 Pallesen J, Wang N, Corbett KS, Wrapp D, Kirchdoerfer RN, Turner HL, et al. (August 2017). "Immunogenicity and structures of a rationally designed prefusion MERS-CoV spike antigen". Proceedings of the National Academy of Sciences of the United States of America. 114 (35): E7348–E7357. Bibcode:2017PNAS..114E7348P. doi:10.1073/pnas.1707304114. PMC 5584442. PMID 28807998.{{cite journal}}: CS1 maint: overridden setting (link)
  128. ↑ Orlandini von Niessen AG, Poleganov MA, Rechner C, Plaschke A, Kranz LM, Fesser S, et al. (April 2019). "Improving mRNA-Based Therapeutic Gene Delivery by Expression-Augmenting 3' UTRs Identified by Cellular Library Screening". Molecular Therapy. 27 (4): 824–836. doi:10.1016/j.ymthe.2018.12.011. PMC 6453560. PMID 30638957.{{cite journal}}: CS1 maint: overridden setting (link)
  129. ↑ de Vrieze J (21 December 2020). "Suspicions grow that nanoparticles in Pfizer's COVID-19 vaccine trigger rare allergic reactions". Science. doi:10.1126/science.abg2359.
  130. ↑ Public Assessment Report Authorisation for Temporary Supply COVID-19 mRNA Vaccine BNT162b2 (BNT162b2 RNA) concentrate for solution for injection (PDF). Regulation 174 (Report). Medicines and Healthcare products Regulatory Agency (MHRA). 15 December 2020. Archived (PDF) from the original on 16 December 2020. Retrieved 23 April 2021.
  131. 1 2 3 Burger L (15 March 2020). "BioNTech in China alliance with Fosun over coronavirus vaccine candidate". Reuters. Archived from the original on 14 November 2020. Retrieved 10 November 2020.
  132. 1 2 3 4 5 6 7 Rabson M (27 February 2021). "From science to syringe: COVID-19 vaccines are miracles of science and supply chains". CTV News. Bell Media. Archived from the original on 27 February 2021. Retrieved 28 February 2021.
  133. ↑ Gray B (23 November 2020). "Pfizer's Chesterfield workforce playing a key role in coronavirus vaccine development". St. Louis Post-Dispatch. Archived from the original on 18 January 2021. Retrieved 28 January 2021.
  134. ↑ Gosk S (1 April 2021). "Inside Lab Where Every Pfizer Dose Originates". NBC Nightly News With Lester Holt. NBC News. Archived from the original on 2 June 2021. Retrieved 5 April 2021. Via YouTube. Gosk's segment on Pfizer begins at 7:10 of the video file.
  135. 1 2 3 4 5 Johnson CY (17 November 2020). "A vial, a vaccine and hopes for slowing a pandemic – how a shot comes to be". The Washington Post. Archived from the original on 21 March 2021. Retrieved 21 December 2020.
  136. ↑ Hughes M (20 December 2020). "Andover's piece of the vaccine: Pfizer". The Eagle-Tribune. Archived from the original on 26 January 2021. Retrieved 28 January 2021.
  137. ↑ Shamus KJ (13 December 2020). "Historic journey: Pfizer prepares to deliver 6.4 million doses of COVID-19 vaccines". Detroit Free Press. Archived from the original on 29 January 2021. Retrieved 28 January 2021.
  138. ↑ Mullin R (25 November 2020). "Pfizer, Moderna ready vaccine manufacturing networks". Chemical & Engineering News. Washington, D.C.: American Chemical Society. Archived from the original on 11 December 2020. Retrieved 21 December 2020.
  139. 1 2 Panetta A (30 April 2021). "Canada to start receiving U.S. shipments of Pfizer-BioNTech vaccine next week". CBC News. CBC/Radio-Canada. Archived from the original on 5 May 2021. Retrieved 4 May 2021.
  140. ↑ "Statement on Manufacturing" (Press release). BioNTech. 1 February 2021. Archived from the original on 7 February 2021. Retrieved 5 February 2021.
  141. ↑ Kresge N (30 March 2021). "BioNTech Raises Covid Vaccine Target to 2.5 Billion Doses". Bloomberg. Archived from the original on 11 April 2021. Retrieved 11 April 2021.
  142. 1 2 3 4 Weise E (7 February 2021). "Pfizer expects to cut COVID-19 vaccine production time by close to 50% as production ramps up, efficiencies increase". USA Today. Archived from the original on 2 June 2021. Retrieved 17 February 2021.
  143. 1 2 "BioNTech to Acquire GMP Manufacturing Site to Expand COVID-19 Vaccine Production Capacity in First Half 2021" (Press release). BioNTech. 17 September 2020. Archived from the original on 7 February 2021. Retrieved 5 February 2021.
  144. 1 2 3 Solomon E (1 April 2021). "'Where the magic happens' – inside BioNTech's innovative vaccine plant". Financial Times. Archived from the original on 4 April 2021. Retrieved 5 April 2021.
  145. ↑ "EU approves ramp-up of Pfizer vaccine manufacturing site in Belgium". Reuters. 23 April 2021. Archived from the original on 25 April 2021. Retrieved 25 April 2021.
  146. ↑ "Increase in vaccine manufacturing capacity and supply for COVID-19 vaccines from BioNTech/Pfizer and Moderna". European Medicines Agency (EMA). 23 April 2021. Archived from the original on 25 April 2021. Retrieved 25 April 2021.
  147. 1 2 3 4 5 "Pfizer–BioNTech COVID-19 Vaccine EUA Fact Sheet for Healthcare Providers" (PDF). Pfizer. 12 August 2021. Archived from the original on 14 August 2021. Retrieved 13 August 2021.
  148. 1 2 "Pfizer–BioNTech COVID-19 Vaccine Frequently Asked Questions". U.S. Food and Drug Administration. 11 December 2020. Archived from the original on 14 February 2021. Retrieved 11 May 2021. Public Domain This article incorporates text from this source, which is in the public domain.
  149. 1 2 "Extra dose from vials of Comirnaty COVID-19 vaccine". European Medicines Agency (EMA). 8 January 2021. Archived from the original on 8 January 2021. Retrieved 8 January 2021.
  150. ↑ "AIFA, possibile ottenere almeno 6 dosi da ogni flaconcino del vaccino BioNTech/Pfizer". aifa.gov.it (in Italian). 28 December 2020. Archived from the original on 21 March 2021. Retrieved 29 December 2020.
  151. ↑ "Sundhedsstyrelsen opdaterer retningslinje for håndtering af vaccination mod COVID-19 i det generelle vaccinationsprogram" [The Danish Health Authority updates guidelines on handling of vaccination against COVID-19 in the general vaccination program]. The Danish Health Authority (in Danish). 20 May 2021. Archived from the original on 20 May 2021. Retrieved 21 May 2021.
  152. ↑ "Global information about Comirnaty". ComirnatyEducation.ie. Pfizer Inc. 8 January 2021. Archived from the original on 9 January 2021. Retrieved 16 January 2021.
  153. ↑ "Comirnaty Package Insert" (PDF). BioNTech Manufacturing GmbH. January 2021. Archived from the original (PDF) on 2 June 2021. Retrieved 16 January 2021.
  154. ↑ Rowland C (22 January 2021). "Biden wants to squeeze an extra shot of vaccine out of every Pfizer vial. It won't be easy". The Washington Post. Archived from the original on 29 January 2021. Retrieved 29 January 2021.
  155. ↑ Office of the Commissioner (19 May 2021). "FDA In Brief: FDA Authorizes Longer Time for Refrigerator Storage of Thawed Pfizer-BioNTech COVID-19 Vaccine Prior to Dilution, Making Vaccine More Widely Available". U.S. Food and Drug Administration (FDA). Archived from the original on 22 May 2021. Retrieved 17 September 2021.
  156. ↑ Office of the Commissioner (19 May 2021). "FDA In Brief: FDA Authorizes Longer Time for Refrigerator Storage of Thawed Pfizer-BioNTech COVID-19 Vaccine Prior to Dilution, Making Vaccine More Widely Available". U.S. Food and Drug Administration (FDA). Archived from the original on 22 May 2021. Retrieved 22 May 2021.
  157. ↑ "Recommendation for an Emergency Use Listing of Tozinameran (Covid-19 Mrna Vaccine (Nucleoside Modified)) Submitted by Biontech Manufacturing Gmbh" (PDF). World Health Organization (WHO). 26 January 2021. Archived (PDF) from the original on 12 March 2021. Retrieved 31 January 2021.
  158. 1 2 "Pfizer–BioNTech COVID-19 Vaccine Vaccination Storage & Dry Ice Safety Handling". Pfizer-BioNTech. Archived from the original on 24 January 2021. Retrieved 17 December 2020.
  159. 1 2 "Deep-freeze hurdle makes Pfizer's vaccine one for the rich". Bloomberg. 10 November 2020. Archived from the original on 22 November 2020. Retrieved 12 November 2020. Vaccine goes bad five days after thawing, requires two shots; Many nations face costly ramp up of cold-chain infrastructure
  160. 1 2 3 Gallagher J (9 November 2020). "Covid vaccine: First 'milestone' vaccine offers 90% protection". BBC News. Archived from the original on 26 November 2020. Retrieved 9 November 2020.
  161. ↑ Kollewe J (10 November 2020). "Pfizer and BioNTech's vaccine poses global logistics challenge". The Guardian. Archived from the original on 10 November 2020. Retrieved 10 November 2020.
  162. ↑ Newey S (8 September 2020). "Daunting task of distribution exposed as it emerges some vaccines must be 'deep frozen' at −70C". The Telegraph. Archived from the original on 9 November 2020. Retrieved 10 November 2020.
  163. ↑ McGregor G (5 December 2020). "How China's COVID-19 could fill the gaps left by Pfizer, Moderna, AstraZeneca". Fortune. Archived from the original on 12 December 2020. Retrieved 5 December 2020.
  164. ↑ "Pfizer's Vaccine Is Out of the Question as Indonesia Lacks Refrigerators: State Pharma Boss". Jakarta Globe. 22 November 2020. Archived from the original on 7 December 2020. Retrieved 5 December 2020.
  165. ↑ Gates B (30 April 2020). "The vaccine race explained: What you need to know about the COVID-19 vaccine". The Gates Notes. Archived from the original on 14 May 2020. Retrieved 2 May 2020.
  166. ↑ "World Health Organization timeline – COVID-19". World Health Organization (WHO). 27 April 2020. Archived from the original on 29 April 2020. Retrieved 2 May 2020.
  167. ↑ Thanh Le T, Andreadakis Z, Kumar A, Gómez Román R, Tollefsen S, Saville M, et al. (May 2020). "The COVID-19 vaccine development landscape". Nature Reviews. Drug Discovery. 19 (5): 305–306. doi:10.1038/d41573-020-00073-5. PMID 32273591.
  168. ↑ Fauci AS, Lane HC, Redfield RR (March 2020). "Covid-19 – Navigating the Uncharted". The New England Journal of Medicine. 382 (13): 1268–69. doi:10.1056/nejme2002387. PMC 7121221. PMID 32109011.
  169. ↑ Gelles D (10 November 2020). "The Husband-and-Wife Team Behind the Leading Vaccine to Solve Covid-19". The New York Times. Archived from the original on 13 November 2020. Retrieved 17 November 2020.
  170. ↑ Garde D, Saltzman J (10 November 2020). "The story of mRNA: From a loose idea to a tool that may help curb Covid". Stat News. Archived from the original on 15 April 2021. Retrieved 16 May 2021.
  171. ↑ Papadopoulos C (14 December 2020). "Chronologie – So entstand der Corona-Impfstoff von Biontech" [Chronology – That's how the Covid-vaccine of Biontech was being developed] (in German). Südwestrundfunk. Archived from the original on 2 December 2020. Retrieved 20 December 2020.
  172. 1 2 3 4 5 Ravi V (24 June 2021). "How Pfizer Crafted Its Own 'Operation Warp Speed' For The COVID-19 Vaccine". Scrip Informa Pharma Intelligence. Informa. Archived from the original on 20 November 2021. Retrieved 20 November 2021.
  173. ↑ Kaplan DA, Wehrwein P (15 March 2021). "The Price Tags on the COVID-19 Vaccines". Managed Healthcare Executive. Vol. 31, no. 3. ISSN 1533-9300. Archived from the original on 23 June 2021. Retrieved 20 June 2021.
  174. ↑ "Fosun Pharma and BioNTech form COVID-19 vaccine strategic alliance in China" (Press release). Fosun Pharma. 15 March 2020. Archived from the original on 15 August 2020. Retrieved 20 March 2021.
  175. ↑ "Pfizer and BioNTech Announce Further Details on Collaboration to Accelerate Global COVID-19 Vaccine Development". Reuters. 9 April 2020. Archived from the original on 11 May 2021. Retrieved 21 March 2021.
  176. ↑ "Pfizer and BioNTech announce further details on collaboration to accelerate global COVID-19 vaccine development" (Press release). Pfizer. 9 April 2020. Archived from the original on 19 April 2021. Retrieved 19 April 2021.
  177. 1 2 "Pfizer Inc. 2020 Form 10-K Annual Report" (PDF). Pfizer. Archived (PDF) from the original on 23 March 2021. Retrieved 8 May 2021.
  178. ↑ "Germany: Investment Plan for Europe – EIB to provide BioNTech with up to €100 million in debt financing for COVID-19 vaccine development and manufacturing". European Investment Bank. 11 June 2020. Archived from the original on 9 November 2020. Retrieved 10 November 2020.
  179. ↑ Knight C (17 November 2020). "BioNTech moves to head of pack for COVID-19 vaccine with EU finance". European Investment Bank. Archived from the original on 1 May 2021. Retrieved 30 June 2021.
  180. ↑ Kresge N (15 September 2020). "BioNTech gets $445 million in German funding for vaccine". Bloomberg L.P. Archived from the original on 9 November 2020. Retrieved 10 November 2020.
  181. ↑ "Pfizer CEO says he would've released vaccine data before election if possible". Axios. 9 November 2020. Archived from the original on 10 November 2020. Retrieved 11 November 2020.
  182. ↑ Mulligan MJ, Lyke KE, Kitchin N, Absalon J, Gurtman A, Lockhart S, et al. (October 2020). "Phase I–II study of COVID-19 RNA vaccine BNT162b1 in adults". Nature. 586 (7830): 589–593. Bibcode:2020Natur.586..589M. doi:10.1038/s41586-020-2639-4. PMID 32785213. S2CID 221126922.{{cite journal}}: CS1 maint: overridden setting (link)
  183. ↑ "China's Fosun to end BioNTech's COVID-19 vaccine trial, seek approval for another". Reuters. 3 November 2020. Archived from the original on 12 December 2020. Retrieved 21 November 2020.
  184. ↑ Herper M (20 August 2020). "Pfizer and BioNTech's favored Covid-19 vaccine has fewer side effects than their first". Stat News. Archived from the original on 11 June 2021. Retrieved 11 June 2021.
  185. ↑ Hannah B (7 October 2020). "EMA begins rolling review of BNT162b2 COVID-19 vaccine". European Pharmaceutical Review. Archived from the original on 11 November 2020. Retrieved 11 November 2020.
  186. 1 2 3 Committee for Medicinal Products for Human Use (19 February 2021). Assessment report: Comirnaty (PDF) (European public assessment report). Corr.1. European Medicines Agency (EMA). COVID-19 Case Definitions; tables 2, 7, 8 and 10; All Confirmed Cases of COVID-19 After Dose 1; Favourable effects. EMA/707383/2020. Archived (PDF) from the original on 20 June 2021. Retrieved 23 June 2021.
  187. ↑ "Clarification of Comirnaty dosage interval". European Medicines Agency (EMA). 28 January 2021. Archived from the original on 17 February 2021. Retrieved 28 January 2021.
  188. ↑ "FDA Briefing Document: Pfizer–BioNTech COVID-19 Vaccine" (PDF). U.S. Food and Drug Administration (FDA). 10 December 2020. p. 30. Archived from the original on 1 January 2021. Retrieved 1 January 2021.
  189. ↑ Edwards E (9 November 2020). "Pfizer's Covid-19 vaccine promising, but many questions remain". NBC News. Archived from the original on 22 November 2020. Retrieved 12 November 2020.
  190. ↑ Favresse J, Bayart J, Mullier F, Elsen M, Eucher C, Eeckhoudt S, et al. (7 July 2021). "Antibody titers decline 3-month post-vaccination with BNT162b2". Emerging Microbes & Infections. 10 (1): 1495–1498. doi:10.1080/22221751.2021.1953403. PMC 8300930. PMID 34232116. S2CID 235757143.{{cite journal}}: CS1 maint: overridden setting (link)
  191. ↑ "Study to Evaluate the Safety, Tolerability, and Immunogenicity of SARS CoV-2 RNA Vaccine Candidate (BNT162b2) Against COVID-19 in Healthy Pregnant Women 18 Years of Age and Older". ClinicalTrials.gov. Archived from the original on 19 February 2021. Retrieved 21 February 2021.
  192. ↑ "Pfizer and BioNTech Commence Global Clinical Trial to Evaluate COVID-19 Vaccine in Pregnant Women". Pfizer (Press release). 18 February 2021. Archived from the original on 21 February 2021. Retrieved 21 February 2021.
  193. ↑ Gray KJ, Bordt EA, Atyeo C, Deriso E, Akinwunmi B, Young N, et al. (March 2021). "Coronavirus disease 2019 vaccine response in pregnant and lactating women: a cohort study". American Journal of Obstetrics & Gynecology. 225 (3): 303.e1–303.e17. doi:10.1016/j.ajog.2021.03.023. PMC 7997025. PMID 33775692.{{cite journal}}: CS1 maint: overridden setting (link)
  194. ↑ Tirrell M, Wells N (22 January 2021). "Pfizer says its Covid vaccine trial for kids ages 12 to 15 is fully enrolled". CNBC. Archived from the original on 16 May 2021. Retrieved 11 May 2021.
  195. ↑ "BioNTech-Pfizer say COVID-19 vaccine 100% effective on 12- to 15-year-olds". CNA. 31 March 2021. Archived from the original on 31 March 2021. Retrieved 31 March 2021.
  196. ↑ Boyarsky BJ, Werbel WA, Avery RK, Tobian AA, Massie AB, Segev DL, et al. (May 2021). "Immunogenicity of a Single Dose of SARS-CoV-2 Messenger RNA Vaccine in Solid Organ Transplant Recipients". JAMA. 325 (17): 1784–86. doi:10.1001/jama.2021.4385. PMC 7961463. PMID 33720292.{{cite journal}}: CS1 maint: overridden setting (link)
  197. ↑ Thacker PD (November 2021). "Covid-19: Researcher blows the whistle on data integrity issues in Pfizer's vaccine trial". BMJ. 375: n2635. doi:10.1136/bmj.n2635. PMID 34728500. S2CID 240424253. A regional director who was employed at the research organisation Ventavia Research Group has told The BMJ that the company falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events reported
  198. ↑ Gorski D (8 November 2021). "What the heck happened to The BMJ?". Science-Based Medicine. Archived from the original on 8 November 2021. Retrieved 8 November 2021.
  199. 1 2 3 4 "Pfizer and BioNTech Announce Phase 3 Trial Data Showing High Efficacy of a Booster Dose of Their COVID-19 Vaccine" (Press release). Pfizer, Inc. 21 October 2021. Archived from the original on 22 October 2021. Retrieved 23 October 2021.
  200. ↑ Neergaard L, Kirka D (2 December 2020). "Britain OKs Pfizer vaccine and will begin shots within days". Associated Press. Archived from the original on 6 December 2020. Retrieved 6 December 2020.
  201. ↑ Mueller B (2 December 2020). "U.K. Approves Pfizer Coronavirus Vaccine, a First in the West". The New York Times. Archived from the original on 28 January 2021. Retrieved 2 December 2020.
  202. ↑ Roberts M (2 December 2020). "Covid Pfizer vaccine approved for use next week in UK". BBC News. Archived from the original on 2 December 2020. Retrieved 2 December 2020.
  203. ↑ Henley J, Connolly, Jones S (3 December 2020). "European and US experts question UK's fast-track of Covid vaccine". The Guardian. Archived from the original on 9 December 2020. Retrieved 9 December 2020.
  204. ↑ Costa JM. "Coronavirus en la Argentina: La ANMAT aprobo el uso de emergencia de la vacuna Pfizer". La Nación (in Spanish). Archived from the original on 26 January 2021. Retrieved 25 December 2020.
  205. ↑ "TGA provisionally approves Pfizer COVID-19 vaccine". Therapeutic Goods Administration (Press release). 25 January 2021. Archived from the original on 26 January 2021. Retrieved 26 January 2021.
  206. ↑ "Bahrain becomes second country to approve Pfizer COVID-l19 vaccine". Al Jazeera. 4 December 2020. Archived from the original on 4 December 2020.
  207. ↑ "Pfizer–BioNTech COVID-19 Vaccine (tozinameran)". Health Canada. 9 December 2020. Archived from the original on 16 December 2020. Retrieved 15 December 2020.
  208. ↑ "Drug and vaccine authorizations for COVID-19: List of applications received". Health Canada. 9 December 2020. Archived from the original on 18 March 2021. Retrieved 9 December 2020.
  209. 1 2 Montes R, España S (16 December 2020). "Chile y Ecuador se adelantan en Sudamérica y autorizan la vacuna de Pfizer". El Pais. Archived from the original on 16 December 2020. Retrieved 17 December 2020.
  210. ↑ "First Pfizer COVID-19 vaccines set to reach Costa Rica on Wednesday – president". Reuters. 23 December 2020. Archived from the original on 9 March 2021. Retrieved 24 December 2020.
  211. ↑ "SFH authorises COVID-19 vaccine by Fosun Pharma/BioNTech for emergency use in Hong Kong". The Government of Hong Kong (Press release). 25 January 2021. Archived from the original on 19 March 2021. Retrieved 26 January 2021.
  212. ↑ "Iraq grants emergency approval for Pfizer COVID-19 vaccine". MSN. 27 December 2020. Archived from the original on 8 January 2021. Retrieved 27 December 2020.
  213. ↑ Jaffe-Hoffman M (12 December 2020). "Israeli Health Minister 'pleased' as FDA approves Pfizer COVID-19 vaccine". The Jerusalem Post. Archived from the original on 19 March 2021. Retrieved 28 December 2020.
  214. ↑ "Jordan approves Pfizer–BioNTech Covid vaccine". France 24. 15 December 2020. Archived from the original on 9 March 2021. Retrieved 15 December 2020.
  215. ↑ "Kuwait authorizes emergency use of Pfizer–BioNTech COVID-19 vaccine". Arab News. 13 December 2020. Archived from the original on 19 March 2021. Retrieved 15 December 2020.
  216. ↑ "Malaysia's NPRA Approves Pfizer Covid-19 Vaccine". CodeBlue. 8 January 2021. Archived from the original on 20 January 2021. Retrieved 25 February 2021.
  217. ↑ Solomon DB, Torres N (11 December 2020). "Mexico approves emergency use of Pfizer's COVID-19 vaccine". Reuters. Archived from the original on 15 January 2021. Retrieved 14 December 2020.
  218. ↑ Quinn D (12 December 2020). "Mexico Approves Pfizer Vaccine for Emergency Use as Covid Surges". Bloomberg. Archived from the original on 8 January 2021. Retrieved 12 December 2020.
  219. ↑ "Oman issues licence to import Pfizer BioNTech Covid vaccine – TV". Reuters. 15 December 2020. Archived from the original on 9 March 2021. Retrieved 16 December 2020.
  220. ↑ Moreno E (15 December 2020). "Panama approves Pfizer's COVID-19 vaccine – health ministry". Reuters. Archived from the original on 8 February 2021. Retrieved 8 May 2021.
  221. ↑ "PH authorizes Pfizer's COVID-19 vaccine for emergency use". CNN Philippines. 14 January 2021. Archived from the original on 27 February 2021. Retrieved 21 January 2021.
  222. ↑ "Qatar, Oman to receive Pfizer–BioNTech COVID-19 vaccine this week". Reuters. 21 December 2020. Archived from the original on 9 March 2021. Retrieved 24 December 2020.
  223. ↑ Krimly R (10 December 2020). "Coronavirus: Saudi Arabia approves Pfizer COVID-19 vaccine for use". Al Arabiya English. Archived from the original on 11 December 2020. Retrieved 10 December 2020.
  224. ↑ Al Mulla Y (13 December 2020). "Kuwait approves emergency use of Pfizer vaccine". Gulf News. Archived from the original on 14 December 2020. Retrieved 14 December 2020.
  225. ↑ Khraiche D (15 December 2020). "Saudi Arabia to Launch Its Coronavirus Vaccination Program". Bloomberg. Retrieved 17 December 2020.
  226. ↑ Tan A (14 December 2020). "First shipments of Pfizer–BioNTech vaccine in Singapore by end-Dec; enough vaccines for all by Q3 2021". The Straits Times. Archived from the original on 14 December 2020. Retrieved 14 December 2020.
  227. ↑ Abdullah Z (14 December 2020). "Pfizer–BioNTech COVID-19 vaccine approved by Singapore, first shipment expected by end-December". CNA. Archived from the original on 4 February 2021. Retrieved 16 January 2021.
  228. ↑ "Singapore approves use of Pfizer's COVID-19 vaccine". AP News. 14 December 2020. Archived from the original on 22 January 2021. Retrieved 15 December 2020.
  229. ↑ Lim JY (3 February 2021). "South Korea approves special import of Pfizer vaccine". The Korea Herald. Archived from the original on 16 February 2021. Retrieved 28 February 2021.
  230. ↑ Lee K (27 February 2021). "S. Korea begins rolling out Pfizer vaccines on second day of national vaccination program". Arirang News. Archived from the original on 10 March 2021. Retrieved 28 February 2021.
  231. ↑ Morris O (23 December 2020). "Dubai approves the Pfizer–BioNTech vaccine which will be free of charge". Emirates Woman. Archived from the original on 31 January 2021. Retrieved 28 December 2020.
  232. ↑ "FDA Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for First COVID-19 Vaccine" (Press release). U.S. Food and Drug Administration (FDA). 11 December 2020. Archived from the original on 18 March 2021. Retrieved 11 December 2020. Public Domain This article incorporates text from this source, which is in the public domain.
  233. ↑ Nga L (12 June 2021). "Vietnam approves Pfizer Covid vaccine for emergency use". VnExpress. Archived from the original on 15 June 2021. Retrieved 15 June 2021.
  234. ↑ "WHO issues its first emergency use validation for a COVID-19 vaccine and emphasizes need for equitable global access". World Health Organization (WHO) (Press release). 31 December 2020. Archived from the original on 17 March 2021. Retrieved 6 January 2021.
  235. ↑ "WHO recommendation BioNtech Tozinameran – COVID-19 mRNA vaccine (nucleoside modified) – Comirnaty". World Health Organization (WHO). 31 December 2020. Archived from the original on 9 May 2021. Retrieved 30 May 2021.
  236. ↑ "The Pfizer BioNTech (BNT162b2) COVID-19 vaccine: What you need to know". World Health Organization (WHO) (Press release). 18 August 2022. Retrieved 2 September 2022.
  237. ↑ "Interim recommendations for use of the Pfizer–BioNTech COVID-19 vaccine, BNT162b2, under Emergency Use Listing". World Health Organization (WHO). 18 August 2022. Retrieved 2 September 2022.
  238. 1 2 "Emergency Use Authorization for vaccines explained". U.S. Food and Drug Administration (FDA). 20 November 2020. Archived from the original on 20 November 2020. Retrieved 20 November 2020. Public Domain This article incorporates text from this source, which is in the public domain.
  239. ↑ Edwards E (20 November 2020). "Pfizer has applied for emergency use for its Covid-19 vaccine". NBC News. Archived from the original on 18 March 2021. Retrieved 13 April 2021.
  240. ↑ Sun LH, Stanley-Becker I (12 December 2020). "CDC greenlights advisory group's decision to recommend Pfizer vaccine for use". The Washington Post. Archived from the original on 13 December 2020. Retrieved 14 December 2020.
  241. ↑ Oliver SE, Gargano JW, Marin M, Wallace M, Curran KG, Chamberland M, et al. (18 December 2020). "The Advisory Committee on Immunization Practices' Interim Recommendation for Use of Pfizer–BioNTech COVID-19 Vaccine – United States, December 2020" (PDF). MMWR. Morbidity and Mortality Weekly Report. 69 (50): 1922–24. doi:10.15585/mmwr.mm6950e2. PMC 7745957. PMID 33332292. Archived (PDF) from the original on 19 December 2020. Retrieved 16 December 2020.{{cite journal}}: CS1 maint: overridden setting (link)
  242. ↑ "Coronavirus (COVID-19) Update: FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Adolescents in Another Important Action in Fight Against Pandemic". U.S. Food and Drug Administration (FDA) (Press release). 10 May 2021. Archived from the original on 10 May 2021. Retrieved 11 May 2021. Public Domain This article incorporates text from this source, which is in the public domain.
  243. ↑ Saltzman J, Weisman R (10 May 2021). "FDA authorizes Pfizer COVID-19 vaccine for adolescents 12 to 15 years old". The Boston Globe. Archived from the original on 11 May 2021. Retrieved 11 May 2021.
  244. ↑ "CDC Director Statement on Pfizer's Use of COVID-19 Vaccine in Adolescents Age 12 and Older". U.S. Centers for Disease Control and Prevention (CDC) (Press release). 12 May 2021. Archived from the original on 17 May 2021. Retrieved 12 May 2021.
  245. ↑ "COVID-19 Vaccines for Children and Teens". U.S. Centers for Disease Control and Prevention (CDC). 12 May 2021. Archived from the original on 18 May 2021. Retrieved 12 May 2021.
  246. ↑ "FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Children 5 through 11 Years of Age". U.S. Food and Drug Administration (FDA) (Press release). 29 October 2021. Archived from the original on 3 November 2021. Retrieved 4 November 2021.
  247. ↑ Karrim A (16 March 2021). "Covid-19: Sahpra approves Section 21 use of Pfizer vaccine". News24. Archived from the original on 18 March 2021. Retrieved 18 March 2021.
  248. ↑ "South Africa approves Pfizer Covid-19 vaccine for emergency use". BusinessTech. 16 March 2021. Archived from the original on 18 March 2021. Retrieved 18 March 2021.
  249. ↑ "Regulatory Decision Summary - Pfizer-BioNTech COVID-19 Vaccine". Health Canada. 5 May 2021. Archived from the original on 12 May 2021. Retrieved 11 May 2021.
  250. ↑ Aiello R (5 May 2021). "Children 12 and older now cleared to receive Pfizer vaccine: Health Canada". CTV News. Archived from the original on 6 May 2021. Retrieved 7 May 2021.
  251. ↑ Ang HM (18 May 2021). "Children aged 12 to 15 years to receive Pfizer-BioNTech COVID-19 vaccine in Singapore". CNA. Archived from the original on 18 May 2021. Retrieved 18 May 2021.
  252. ↑ "EU regulator backs Pfizer-BioNTech COVID-19 vaccine for children aged 12 to 15". CNA. 28 May 2021. Archived from the original on 2 June 2021. Retrieved 31 May 2021.
  253. 1 2 "COVID-19: Switzerland can start vaccinating vulnerable groups already in December" (Press release). Federal Office of Public Health. 19 December 2020. Archived from the original on 9 January 2021. Retrieved 19 December 2020.
  254. ↑ "Swissmedic grants authorisation for the first COVID-19 vaccine in Switzerland" (Press release). Swiss Agency for Therapeutic Products (Swissmedic). 18 December 2020. Archived from the original on 2 May 2021. Retrieved 5 July 2022.
  255. ↑ "Pfizer/BioNTech COVID-19 vaccine approved for young people in Switzerland" (Press release). Swiss Agency for Therapeutic Products (Swissmedic). 7 May 2021. Archived from the original on 4 June 2022. Retrieved 5 July 2022.
  256. ↑ "Swissmedic approves COVID-19 vaccine from Pfizer/BioNTech for children aged 5 to 11 years" (Press release). Swiss Agency for Therapeutic Products (Swissmedic). 7 December 2021. Archived from the original on 15 June 2022. Retrieved 5 July 2022.
  257. ↑ "COVID-19 vaccines from Moderna and Pfizer/BioNTech: Swissmedic approves third vaccination for certain population groups" (Press release). Swiss Agency for Therapeutic Products (Swissmedic). 26 October 2021. Archived from the original on 30 May 2022. Retrieved 5 July 2022.
  258. ↑ "COVID-19 vaccine from Pfizer/BioNTech: Swissmedic approves the extension of the booster dose to everyone aged 16 years and over" (Press release). Swiss Agency for Therapeutic Products (Swissmedic). 26 October 2021. Archived from the original on 4 April 2022. Retrieved 5 July 2022.
  259. 1 2 "EMA recommends first COVID-19 vaccine for authorisation in the EU". European Medicines Agency (EMA) (Press release). 21 December 2020. Archived from the original on 30 January 2021. Retrieved 21 December 2020.
  260. ↑ "Statement by President von der Leyen on the marketing authorisation of the BioNTech-Pfizer vaccine against COVID-19". European Commission. 21 December 2020. Archived from the original on 11 January 2021. Retrieved 21 December 2020.
  261. ↑ "Brazil approves Pfizer's COVID-19 shot, but has none to use". Reuters. 23 February 2021. Archived from the original on 25 February 2021. Retrieved 18 July 2021.
  262. ↑ Cancian N (23 February 2021). "Anvisa aprova registro da vacina da Pfizer contra Covid". Folha de S. Paulo (in Portuguese). Archived from the original on 23 February 2021. Retrieved 23 February 2021.
  263. ↑ "ANVISA aprova vacina da Pfizer contra a COVID-19". Pfizer Brasil (Press release) (in Portuguese). Archived from the original on 18 July 2021. Retrieved 18 July 2021.
  264. ↑ "Informe à população brasileira". Agência Nacional de Vigilância Sanitária - Anvisa (in Portuguese). 23 February 2021. Archived from the original on 18 July 2021. Retrieved 18 July 2021.
  265. ↑ "Brazil approves Pfizer COVID-19 vaccine for children over 12". Reuters. 11 June 2021. Archived from the original on 18 July 2021. Retrieved 18 July 2021.
  266. ↑ "Anvisa autoriza vacina da Pfizer para crianças com mais de 12 anos". Agência Nacional de Vigilância Sanitária - Anvisa (in Portuguese). 11 June 2021. Archived from the original on 23 June 2021. Retrieved 18 July 2021.
  267. ↑ "Report: How Pfizer Silences World Governments in Vaccine Negotiations". Public Citizen. 19 October 2021. Archived from the original on 24 June 2022. Retrieved 24 June 2022.
  268. ↑ Davies M, Furneaux R, Ruiz I, Langlois J (23 February 2021). "'Held to ransom': Pfizer demands governments gamble with state assets to secure vaccine deal". The Bureau of Investigative Journalism. Archived from the original on 24 June 2022. Retrieved 24 June 2022.
  269. ↑ "U.S. FDA Grants Priority Review for the Biologics License Application for Pfizer-BioNTech COVID-19 Vaccine". BioNTech (Press release). 16 July 2021. Archived from the original on 18 July 2021. Retrieved 18 July 2021.
  270. ↑ "U.S. FDA sets January target to decide on approval of Pfizer's COVID-19 shot". Reuters. 16 July 2021. Archived from the original on 16 July 2021. Retrieved 16 July 2021.
  271. ↑ Casaletto L (16 September 2021). "Pfizer, Moderna vaccines granted full approval by Health Canada; get unique name change". CityNews. Archived from the original on 9 October 2021. Retrieved 17 September 2021.
  272. ↑ "FDA Roundup: July 8, 2022". U.S. Food and Drug Administration (FDA) (Press release). 8 July 2022. Retrieved 9 July 2022.
  273. ↑ Tal A (30 July 2021). "Israel to offer third Covid-19 vaccine dose to people over 60". CNN. Archived from the original on 3 December 2021. Retrieved 3 September 2021.
  274. ↑ Lieber D (31 August 2021). "In Israel, Being Fully Vaccinated Now Means Three Shots - Israeli study finds booster shot of Pfizer vaccine can give 10-fold protection against severe illness". The Wall Street Journal. Archived from the original on 30 November 2021. Retrieved 3 September 2021.
  275. ↑ Bar-On YM, Goldberg Y, Mandel M, Bodenheimer O, Freedman L, Kalkstein N, et al. (October 2021). "Protection of BNT162b2 Vaccine Booster against Covid-19 in Israel". The New England Journal of Medicine. 385 (15). Table 2. doi:10.1056/nejmoa2114255. PMC 8461568. PMID 34525275.{{cite journal}}: CS1 maint: overridden setting (link)
  276. ↑ "Joint Statement from HHS Public Health and Medical Experts on COVID-19 Booster Shots" (Press release). United States Department of Health and Human Services. 18 August 2021. Archived from the original on 7 December 2021. Retrieved 21 August 2021.
  277. ↑ "The WHO is right to call a temporary halt to COVID vaccine boosters". Nature (Editorial). 596 (7872): 317. August 2021. Bibcode:2021Natur.596..317.. doi:10.1038/d41586-021-02219-w. PMID 34404945. S2CID 237199262.
  278. ↑ "Interim statement on COVID-19 vaccine booster doses" (Press release). World Health Organization (WHO). 10 August 2021. Archived from the original on 27 November 2021. Retrieved 26 August 2021.
  279. ↑ Kramer J (18 August 2021). "The U.S. plans to authorize boosters—but many already got a third dose". National Geographic. Archived from the original on 10 October 2021. Retrieved 21 August 2021. Getting a booster too soon after primary inoculation might not teach the body's immune system to mount a more robust defense
  280. ↑ "FDA Authorizes Booster Dose of Pfizer-BioNTech COVID-19 Vaccine for Certain Populations". U.S. Food and Drug Administration (FDA) (Press release). 22 September 2021. Archived from the original on 8 December 2021. Retrieved 23 September 2021.
  281. ↑ Branswell H (23 September 2021). "Advisory committee recommends wide swath of Americans be offered Covid-19 vaccine boosters". Stat News. Archived from the original on 16 November 2021. Retrieved 23 September 2021.
  282. ↑ Mandavilli A, Mueller B (21 October 2021) [Original date 24 September 2021]. "C.D.C. Chief Overrules Agency Panel and Recommends Pfizer-BioNTech Boosters for Workers at Risk". The New York Times. Archived from the original on 24 September 2021. Retrieved 24 September 2021.
  283. ↑ Pronczuk M (4 October 2021). "The European Medicines Agency said that a booster shot of the Pfizer-BioNTech vaccine can be given to healthy adults". The New York Times. Archived from the original on 4 October 2021. Retrieved 4 October 2021.
  284. 1 2 "Coronavirus (COVID-19) Update: FDA Takes Additional Actions on the Use of a Booster Dose for COVID-19 Vaccines". U.S. Food and Drug Administration (FDA). 21 October 2021. Archived from the original on 7 December 2021. Retrieved 22 October 2021. Public Domain This article incorporates text from this source, which is in the public domain.
  285. 1 2 "CDC Expands Eligibility for COVID-19 Booster Shots". U.S. Centers for Disease Control and Prevention (CDC) (Press release). 21 October 2021. Archived from the original on 7 December 2021. Retrieved 22 October 2021. Public Domain This article incorporates text from this source, which is in the public domain.
  286. 1 2 "Coronavirus (COVID-19) Update: FDA Expands Eligibility for COVID-19 Vaccine Boosters". U.S. Food and Drug Administration (FDA) (Press release). 19 November 2021. Archived from the original on 19 November 2021. Retrieved 19 November 2021. Public Domain This article incorporates text from this source, which is in the public domain.
  287. ↑ "TGA approves booster doses of the Pfizer COVID-19 vaccine, Comirnaty". Therapeutic Goods Administration (TGA). 27 October 2021. Archived from the original on 14 November 2021. Retrieved 14 November 2021.
  288. ↑ "COVID-19 vaccine: Pfizer Australia - Comirnaty BNT162b2 (mRNA)". Therapeutic Goods Administration (TGA). 2 November 2021. Archived from the original on 9 June 2021. Retrieved 14 November 2021.
  289. ↑ "Coronavirus (COVID-19) Update: FDA Takes Multiple Actions to Expand Use of Pfizer-BioNTech COVID-19 Vaccine". U.S. Food and Drug Administration. 3 January 2022. Archived from the original on 3 January 2022. Retrieved 3 January 2022. Public Domain This article incorporates text from this source, which is in the public domain.
  290. ↑ "Fact Sheet for Healthcare Providers Administering Vaccine - Pfizer-BioNTech COVID-19 Vaccine for 5 - 11 Years of Age". Food and Drug Administration. 3 January 2022. Archived from the original on 21 January 2022.
  291. ↑ "Pfizer-BioNTech COVID-19 Vaccine EUA LOA reissued August 12 2021". Food and Drug Administration. 12 August 2021. Archived from the original on 14 August 2021.
  292. ↑ "CDC Expands Booster Shot Eligibility and Strengthens Recommendations for 12-17 Year Olds". U.S. Centers for Disease Control and Prevention (CDC) (Press release). 5 January 2022. Archived from the original on 6 January 2022. Retrieved 5 January 2022.
  293. ↑ "Coronavirus (COVID-19) Update: FDA Expands Eligibility for Pfizer-BioNTech COVID-19 Vaccine Booster Dose to Children 5 through 11 Years". U.S. Food and Drug Administration (FDA). 17 May 2022. Archived from the original on 17 May 2022. Retrieved 18 May 2022.
  294. ↑ "EUA Fact Sheet For Healthcare Providers Administering Vaccine (Vaccination Providers)" (PDF). Pfizer. 31 August 2022. Retrieved 3 September 2022.
  295. ↑ No publication in a peer-reviewed journal but re-published by the ACIP and CDC, see "ACIP Presentation Slides: September 1-2, 2022 Meeting". U.S. Centers for Disease Control and Prevention (CDC). September 2022. Retrieved 17 September 2022.
  296. ↑ "Pfizer/BioNTech COVID-19 Omicron-Modified Bivalent Vaccine". U.S. Food and Drug Administration (FDA). 28 June 2022. p. Slide CC-25. Retrieved 17 September 2022. N=8 mice Balb/c mice. Mice preimmunized with 2 doses of BNT162b2; boosters given at day 104 | Pseudovirus neutralization assay; LOD, Limit of Detection
  297. ↑ "Pfizer/BioNTech COVID-19 Omicron-Modified Bivalent Vaccine" (PDF). U.S. Centers for Disease Control and Prevention (CDC). 1 September 2022. p. Slide CC-16. Retrieved 17 September 2022. Mice preimmunized with 2 doses of BNT162b2; boosters given at day 104 post Dose 2 | Vaccines administered at 1 mcg dose level; Wild type, Wuhan-Hu-1; LOD ...
  298. ↑ "Coronavirus (COVID-19) Update: FDA Authorizes Moderna and Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose in Younger Age Groups". U.S. Food and Drug Administration (Press release). 12 October 2022. Retrieved 13 October 2022. Public Domain This article incorporates text from this source, which is in the public domain.
  299. ↑ "Coronavirus (COVID-19) Update: FDA Authorizes Updated (Bivalent) COVID-19 Vaccines for Children Down to 6 Months of Age". U.S. Food and Drug Administration (Press release). 8 December 2022. Retrieved 16 December 2022.
  300. ↑ "Pfizer-BioNTech COVID-19 Vaccine". U.S. Food and Drug Administration (FDA). 11 September 2023. Retrieved 12 September 2023.
  301. ↑ "Regulatory approval of Pfizer/BioNTech vaccine for COVID-19". Medicines and Healthcare products Regulatory Agency. 2 December 2020. Retrieved 6 October 2023.
  302. ↑ "MHRA approves Pfizer/BioNTech's adapted COVID-19 vaccine (Comirnaty) that targets Omicron XBB.1.5". Medicines and Healthcare products Regulatory Agency. 5 September 2023. Retrieved 6 October 2023.
  303. ↑ "COVID-19 vaccines safety update" (PDF). European Medicines Agency (EMA). 3 August 2022. Retrieved 3 August 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  304. ↑ World Health Organization (2021). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 85" (PDF). WHO Drug Information. 35 (1): 259–60. Archived (PDF) from the original on 19 April 2021. Retrieved 19 April 2021.
  305. ↑ Bulik BS (23 December 2020). "The inside story behind Pfizer and BioNTech's new vaccine brand name, Comirnaty". FiercePharma. Archived from the original on 25 December 2020. Retrieved 25 December 2020.
  306. ↑ "Pfizer and BioNTech Receive Authorization in the European Union for COVID-19 Vaccine" (Press release). BioNTech. 21 December 2020. Archived from the original on 26 December 2020. Retrieved 26 December 2020 – via GlobeNewswire.
  307. ↑ "UNII - JSV288Q5CV". precisionFDA. Retrieved 6 October 2023.
  308. ↑ "Famtozinameran". Inxight Drugs. Retrieved 6 October 2023.
  309. ↑ "Pfizer–BioNTech COVID-19 Vaccine, Bivalent- original and omicron ba.4/ba.5 injection, suspension Pfizer–BioNTech COVID-19 Vaccine- covid-19 vaccine, mrna injection, suspension". DailyMed. 19 September 2023. Retrieved 6 October 2023.
  310. ↑ "Famtozinameran (Code C190751)". NCI Thesaurus. 25 September 2023. Retrieved 6 October 2023.
  311. ↑ "UNII - N36VHK46PR". precisionFDA. Retrieved 6 October 2023.
  312. ↑ "BNT162b2 Omicron (XBB.1.5)". Inxight Drugs. Retrieved 6 October 2023.
  313. ↑ "INN Proposed List 129". World Health Organization (WHO). 1 January 1900. Retrieved 6 October 2023.
  314. ↑ "Pfizer Inc. 2021 Form 10-K Annual Report" (PDF). Pfizer. Archived (PDF) from the original on 7 March 2022. Retrieved 7 March 2022.
  315. ↑ Kollewe J (8 February 2022). "Pfizer accused of pandemic profiteering as profits double". The Guardian. Archived from the original on 30 June 2022. Retrieved 24 June 2022.
  316. ↑ Erman M, Ankur B (22 July 2020). "U.S. to pay Pfizer, BioNTech $1.95 bln for millions of COVID-19 vaccine doses". Reuters. Archived from the original on 22 July 2020. Retrieved 22 July 2020.
  317. ↑ "U.S. Government Engages Pfizer to Produce Millions of Doses of COVID-19 Vaccine" (Press release). US Department of Health and Human Services. 22 July 2020. Archived from the original on 22 July 2020. Retrieved 23 July 2020.
  318. ↑ Nazaryan A (9 November 2020). "So is Pfizer part of Operation Warp Speed or not? Yes and no". Yahoo!. Archived from the original on 10 November 2020. Retrieved 9 November 2020.
  319. ↑ "Pfizer and BioNTech Announce an Agreement with U.S. Government for up to 600 Million Doses of mRNA-based Vaccine Candidate Against SARS-CoV-2" (Press release). Pfizer. 22 July 2020. Archived from the original on 22 July 2020. Retrieved 2 July 2021.
  320. ↑ Pleitgen F (11 November 2020). "EU agrees to buy 300 million doses of the Pfizer/BioNTech Covid-19 vaccine". CNN. Archived from the original on 24 November 2020. Retrieved 26 November 2020.
  321. ↑ "Japan and Pfizer reach COVID-19 vaccine deal to treat 60 million people". The Japan Times. 1 August 2020. Archived from the original on 10 November 2020. Retrieved 21 November 2020.
  322. ↑ Tasker JP (9 November 2020). "Trudeau says promising new Pfizer vaccine could be 'light at the end of the tunnel'". CBC News. Archived from the original on 9 November 2020. Retrieved 9 November 2020.
  323. ↑ "Pfizer and BioNTech to Supply Singapore with their BNT162b2 mRNA-based Vaccine Candidate to Combat COVID-19". pfizer.com.sg. Pfizer Singapore. 14 December 2020. Archived from the original on 27 January 2021. Retrieved 1 February 2021.
  324. ↑ de Salud S (2 December 2020). "233. Firma secretario de Salud convenio con Pfizer para fabricación y suministro de vacuna COVID-19". gob.mx (in Spanish). Archived from the original on 24 December 2020. Retrieved 17 December 2020.
  325. ↑ Ng E (27 August 2020). "Fosun Pharma to supply Covid-19 vaccine to Hong Kong, Macau once approved". South China Morning Post. Archived from the original on 20 November 2020. Retrieved 21 November 2020.
  326. ↑ Stevis-Gridneff M (28 April 2021). "How Europe Sealed a Pfizer Vaccine Deal With Texts and Calls". The New York Times. Retrieved 16 October 2022.
  327. ↑ Malpani R, Maitland A (21 October 2021). Dose of Reality: How rich countries and pharmaceutical corporations are breaking their vaccine promises (PDF). The People's Vaccine Alliance. Archived (PDF) from the original on 18 January 2022. Retrieved 24 June 2022.
  328. ↑ "Covid-19: New research reveals Pfizer is making misleading claims about fair distribution of vaccines". Amnesty International. 11 November 2021. Archived from the original on 7 January 2022. Retrieved 24 June 2022.
  329. ↑ Karp P (12 May 2021). "Pfizer warns Australia a Covid vaccine patent waiver could harm supply and safety". The Guardian. Archived from the original on 24 June 2022. Retrieved 24 June 2022.
  330. ↑ Lee J (14 May 2021). "Do Videos Show Magnets Sticking to People's Arms After COVID-19 Vaccine?". Snopes.com. Archived from the original on 9 November 2021. Retrieved 7 June 2021.
  331. ↑ Fichera A (14 May 2021). "Magnet Videos Refuel Bogus Claim of Vaccine Microchips". FactCheck.org. Annenberg Public Policy Center. Archived from the original on 17 May 2021. Retrieved 7 June 2021.
  332. ↑ "COVID-19 Vaccine Myths And Facts" (PDF). Los Angeles County Department of Public Health. 15 December 2021. Archived (PDF) from the original on 25 August 2021. Retrieved 27 August 2021.
  333. ↑ "Myths and Facts about COVID-19 Vaccines". U.S. Centers for Disease Control and Prevention (CDC). 18 August 2021. Archived from the original on 11 December 2021. Retrieved 27 August 2021.

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