Pfizer–BioNTech COVID-19 vaccine

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Each of the candidates was tested in three dosages, low, medium and high with each given to eight mice, with their blood then sampled and analyzed over the next six weeks. The blood was analyzed by a team led by Lena Kranz and Mathias Vormehr to check to see if the mice's T-cells reacted and carried out the required immune response. These tests showed that all 20 candidates produced an immune response in the mice. In parallel Annette Vogel was also using enzyme-linked immunosorbent assays (ELISA) to determine using a virus neutralisation test (VNT) if the candidates were inducing sufficient neutralising antibodies. Because of the risk that COVID‑19 posed this testing had to be done in a biosafety level three (BSL-3) laboratory, which BioNTech didn't have. Fortunately, they were able to get around this by creating a vesicular stomatitis virus (VSV) pseudovirus to replace the harmful elements with the isolated spike proteins from SARS-CoV-2. A working prototype pseudovirus test was ready by 10 March. This meant the laboratory security requirements could be downgraded to BSL-1, which the company had onsite.

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parallel with clinical trials before human trials could begin. This was important as while the individual components had been shown by trials to not cause any significant issues in humans there was no safety data on the combination of mRNA and lipids. Toxicology studies on mice or rats normally took five months. At this point in time PEI main concerns were about whether there were any benefits in speeding up the normal process. For the vaccine to work it needed to deliver a stable accurate replica of the virus's spike protein so that the body's immune system could recognize and react to COVID‑19 if they became infected. In developing a stable replica, the team was assisted by advice from

4040:, which was Germany's drug regulator to ask for his assistance in arranging a meeting with a panel of experts to discuss a vaccine development strategy and to determine what needed to be done to receive authorisations to undertake a clinical trial. As it was taking the Wuhan developments very seriously PEI was more than willing to help and had already initiated a vaccine development programme and was providing emergency advice to other drug makers and waiving its administration fees. it was more than willing to assist BioNTech and came back two days later to say that provided a detailed briefing dossier could be delivered in time would meet with them the next week. 3837: 3665: 511: 4049:

ALC-0315 lipid formulation was already available at Polymun which was one of the only companies which had the expertise to immediately combine lipids with mRNA. Polymun was located near Vienna in Austria, an eight-hour drive from BioNTech's headquarters, which would be make it easier for material had to transported between the two companies. On Monday 3 February Acuitas Therapeutics agreed to assist. With Acuitas Therapeutics on board the briefing dossier was able to be completed and was sent to PEI late on Tuesday, 4 February, six days after work had commenced on compiling it.

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emergency use for individuals aged 6 months through 11 years of age. The approvals and emergency authorizations for the bivalent versions of the vaccine were revoked. Health Canada approved the Pfizer-BioNTech Comirnaty Omicron XBB.1.5 subvariant, monovalent COVID‑19 vaccine in September 2023. The UK Medicines and Healthcare products Regulatory Agency approved the used of the Comirnaty Omicron XBB.1.5 vaccine in September 2023.

2243:(tozinameran/famtozinameran) booster versions of the bivalent vaccine. In August 2024, the FDA approved and granted emergency authorization for a monovalent Omicron KP.2 version of the Pfizer–BioNTech COVID-19 vaccine. The approval of Comirnaty (COVID-19 Vaccine, mRNA) (2024-2025 Formula) was granted to BioNTech Manufacturing GmbH. The EUA amendment for the Pfizer-BioNTech COVID-19 Vaccine (2024-2025 Formula) was issued to Pfizer Inc. 4728: 2306: 18016: 2398: 30136: 4020:. Şahin called Pfizer's chief scientific officer, Phil Dormitzer later that Tuesday to tell them what they were doing and ask if they were interested in collaborating with BioNTech. Dormitzer was lukewarm as he felt that this new virus would be able to controlled and confined to China by public health measures and a few hours later confirmed on behalf of Pfizer that they were not interested. 30124: 5170: 4081:

50 to 80 smaller building blocks. Once these DNA templates was produced another team created the actual mRNA vaccine candidates, the first batch of which was produced on 2 March. This was then poured into a 50 ml bag, frozen to minus 70 degrees Celsius and dispatched by a waiting car to Polymun to be combined with the lipids, a process that was to followed by the rest of the 20 candidates.

16523: 16230: 16130: 16083: 16036: 14665: 14486: 14280: 11353: 10277: 8333: 8253: 8040: 7993: 7953: 6694: 6488: 3328:) 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 5420:. 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. 4669:

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.

4110:, it was only now that their two chief executives became personally acquainted. After a few phone calls, Bourla agreed that Pfizer would work with BioNTech on the development of BioNTech's COVID-19 vaccine a with work commencing immediately, with no formal written legal agreement in place to govern the new collaboration. BioNTech transferred its 3969:

people to give a best case scenario of two million deaths worldwide. This would expose him, his family, colleagues to danger. At the time there were 1,000 internationally confirmed cases of the virus. Later that day he sent an email to Helmut Jeggle, chairman of BioNTech to alert him of his conclusions. The next day he discussed it with his wife

4310:, observer-blind, dose-finding, vaccine candidate-selection, and efficacy study in healthy individuals". 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. 4995:(CDC) authorized the use of an additional mRNA vaccine dose for immunocompromised individuals at that time. 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. In a statement, the WHO and 3211:) 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 3270:

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.

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whose proprietary wrapper technology was already being used in human trials and for which all of the necessary safety data was available. This would assist in gaining PEI approval. This small Canadian company of 25 staff was led by Tom Madden. An advantage of using Acuitas Therapeutics was that their

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technology that the company had been developing offered the possibly of being used to create a suitable vaccine. While the company had a small team which had started developing vaccines for infectious disease and had collaborating with Pfizer on a flu vaccine BioNTech was after 11 years of financial

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for regular use. In December 2020, the United Kingdom was the first country to authorize its use on an emergency basis. It is authorized for use at some level in the majority of countries. On 23 August 2021, the Pfizer–BioNTech vaccine became the first COVID-19 vaccine to be approved in the US by the

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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. The country expanded the availability

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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,

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to Pfizer the next day. Bouria agreed on the 50:50 partnership that Şahin proposed with each company equally sharing costs and any potential profits. Because of BioNTech's limited financial ability Pfizer agreed to fund Biontech's cost which was expected to be $ 190 million which would be paid back.

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Using the genetic sequences that were available on Virological.org a team at BioNTech led by Stephanie Hein used gene synthesis to create DNA hardcopies, which were to be used to create the templates to make the mRNA. These hardcopies each contained up to 4,000 nucleotides, which were assembled from

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Corinna Rosenbaum who was the lead project manager on the BioNTech flu project was asked to prepare what eventually was a 50-page dossier detailing how the company had the expertise and technology to create a safe vaccine. Crucial to the delivery of an mRNA vaccine to its cellular destination via an

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At the board meeting the next day Şahin received permission to spend over the next weeks a limited amount of money that the company and its 1,300 personnel investigating the development of a vaccine, after which they would reevaluate whether to continue. The board then considered whether to build up

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However, realizing the risk and believing that the company's proprietary mRNA technology at now at the stage where they had the tools to create a vaccine Şahin after discussing it with his wife, spent that weekend outlining the technical construction of eight possible vaccine candidates based on the

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While no infectious disease expert Şahin did some quick calculations based on Wuhan's population and transport links and came to the conclusion that if this virus was possible of person-to-person transmission then it could cause a morality rate somewhere between 0.3 and 10 out of every 100 inflected

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in which they discussed a cluster of pneumonia associated with coronavirus and an indication of person-to-person transmission that had affected a family that had recently returned from Wuhan. The authors of the submission were of the opinion that they were observing the early stages of an epidemic,

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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

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for Novartis. 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. Besides making mRNA, the Marburg facility also performs the step of combining mRNA with lipids to form lipid

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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. Due to the urgency presented by the COVID-19 pandemic, Pfizer and BioNTech began production immediately with the process

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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. More than half the days in the production process are dedicated to rigorous testing and quality assurance

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of the Pfizer–BioNTech COVID‑19 vaccine are mild to moderate in severity, and are gone within a few days. They are similar to other adult vaccines and are normal signs that the body is building protection to the virus. During clinical trials, the common side effects affecting more than one in

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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. For other variants, the effectiveness of the initial doses starts to decline in about six months. A case-control study

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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. Notably, effectiveness after one dose

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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

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Once the first vials containing the lipid wrapped mRNA candidates were revied back in Mainz on 9 March a team led by Annette Vogel began testing them to determine which using at various dosage amounts induced the best immune responses, first in glass dishes and then at a separate location, in mice.

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

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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; and authorized the Pfizer-BioNTech COVID-19 Vaccine 2023–2024 formula under

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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, the neutralization responses of Omicron BA.4/BA.5 monovalent, Omicron BA.1 mononvalent, Omicron BA.4/BA.5 bivalent and

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The first dose administered outside of a clinical trial was given to 90-year-old Margaret Keenan in the outpatient ward at Coventry University Hospital on 8 December 2020. The vial and syringe used for her injection was subsequently sent for display to the Science Museum in London. The first dose

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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

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On Monday 27 January Şahin had a series of meetings with the company's few infectious experts and the leaders of most of the departments to discuss his concerns about the virus and to announce his decision to establish a new project called 'Lightspeed' that would use all of the company's available

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while at his home in Mainz on Friday 24 January 2020, was checking out his regular websites when he noted a report in the science section of Der Spiegel website about novel respiratory illness that had affected approximately 50 people in Wuhan. He then came across a submission from Hong Kong-based

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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. 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. The

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in individuals aged twelve and older in the US. The following month, the BA.1 version of the bivalent vaccine (Comirnaty Original/Omicron BA.1 or tozinameran/riltozinameran) was authorized as a booster for use in the UK. The same month, the European Union authorized both the BA.1 and the BA.4/BA.5

4194:. 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. 4919:

approved the Pfizer–BioNTech COVID‑19 vaccine under its standard marketing authorization procedure. In June 2021, the approval was extended to those aged twelve or over. Pfizer's negotiation process with Brazil (and other Latin American countries) was described as "bullying". The contract

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III clinical trial to finalize safety and efficacy data, leading to application for licensure (approval) of the vaccine in the United States. On 10 May 2021, the US FDA also authorized the vaccine for people aged 12 to 15 under an expanded EUA. The FDA recommendation was endorsed by the ACIP and

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for the development of the vaccine "because I wanted to liberate our scientists 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

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To obtain a return on its investment in 'Project Lightspeed Helmut' Jeggle was of the opinion that the company had to take advantage of the massive demand by being among the first three to the market with a vaccine. To do this BioNTech needed the evolvement of either GSK, Johnson & Johnston,

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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

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Before COVID‑19 vaccines, creating a vaccine for an infectious disease from scratch had never before been produced in less than the five years it had taken in 1967 when Maurice Hilleman had set the modern record with a vaccine for mumps, followed by the vaccine for Ebola also taking five

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December 2020 that people who have a history of "significant" allergic reaction should not receive the Pfizer–BioNTech COVID‑19 vaccine. 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

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On 6 February Şahin, Türeci and Rosenbaum together with Tom Madden and Chris Barbosa from Acuitas Therapeutics met with PEI who were happy with what BioNTech proposed, with the only point of contention being PEI rejecting BioNTech proposal to either skip altogether or run toxicology studies in

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subsidiary Avanti Polar Lipids is providing the requisite lipids. As of November 2020, the major bottleneck in the manufacturing process is combining mRNA with lipid nanoparticles. At this stage, it takes only four days to go from mRNA and lipids to finished vials, but each lot must then spend

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million doses administered in the European Union. 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." Rare side effects (that may affect up to one in 1,000 people)

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In August 2024, the FDA approved and granted emergency authorization for a monovalent Omicron KP.2 version of the Pfizer–BioNTech COVID-19 vaccine. In June 2024, the FDA advised manufacturers of licensed and authorized COVID-19 vaccines that the COVID-19 vaccines (2024-2025 formula) should be

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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

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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; a codon-optimized gene of the full-length spike protein of SARS-CoV-2 (bases

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In September 2022, the CHMP of the EMA recommended converting the conditional marketing authorizations of the vaccine into standard marketing authorizations. The recommendation covers all existing and upcoming adapted Comirnaty vaccines, including the adapted Comirnaty Original/Omicron BA.1

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resources to develop a vaccine. He also decided that rather than follow the traditional method of developing a single prototype and then discard it if it didn't work and then start again they would develop and test multiple vaccines in parallel. They would then discard the least promising.

5013:(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. It also stated that people with "severely weakened" immune systems can receive an extra dose of either the Pfizer-BioNTech vaccine or the 4896:

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. This is the first authorization under a standard procedure.

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After the United Kingdom, the following countries and regions expedited processes to approve the Pfizer–BioNTech COVID‑19 vaccine for use: Argentina, Australia, Bahrain, Canada, Chile, Costa Rica, Ecuador, Hong Kong, Iraq, Israel, Jordan, Kuwait, Malaysia, Mexico, Oman, Panama, the

4064:(ADE) complications. The other was to reproduce only the tip of the spike protein which was known as binding domain receptor (RBD). RDB was simpler as it would contain approximately 200 amino acids and risk of ADE would be reduced. Şahin decided that BioNTech would explore both methods. 17986:

World Health Organization (2021). Background document on the mRNA vaccine BNT162b2 (Pfizer–BioNTech) against COVID-19: background document to the WHO interim recommendations for use of the Pfizer–BioNTech COVID-19 vaccine, BNT162b2, under emergency use listing, 14 January 2021 (Report).

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their capability to fully manufacture, document, sell and distribute any potential vaccine they decided that this would take too long and it would be better to partner with a pharma giant. Since the company had been collaborating with Pfizer since 2018 on developing a mRNA vaccine for

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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.

3706:, 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. 4321:

III results indicating a 95% efficacy of the developed vaccine were published on 18 November 2020. For approval in the EU, an overall vaccine efficacy of 95% was confirmed by the EMA. The EMA clarified that the second dose should be administered three weeks after the first dose.

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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.

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monovalent JN.1 vaccines. Based on the further evolution of SARS-CoV-2 and a rise in cases of COVID-19, the agency subsequently determined and advised manufacturers that the preferred JN.1-lineage for the COVID-19 vaccines (2024-2025 formula) is the KP.2 strain.

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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.

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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

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20 possible COVID‑19 vaccine permutations in different doses based on all four versions of synthetic mRNA platforms that they had developed, modified mRNA (modRNA), uridine RNA (uRNA), self-amplifying mRNA (saRNA) and trans-amplifying mRNA (taRNA).

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The release of news of the partnership bought BioNTech publicity that resulted the company receiving letters and telephone calls containing racists views and often death threats. Security was tightened and board members were offered personal protection.

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million people vaccinated, 95% of which were classified as mild and most spent no more than four days in the hospital. Since April 2021, increasing number of cases of myocarditis and pericarditis have been reported in the United States in about 13 per

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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

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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.

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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

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Despite the earlier rebuff from Pfizer the company still preferred to partner with them. In the meantime they were able to reach what was in effect a licensing agreement on 16 March with Shanghai-based Fosun. On 3 March Şahin was able to contact

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designation for the biologics license application (BLA) for the Pfizer–BioNTech COVID-19 vaccine with a goal date for the decision in January 2022. On 23 August 2021, the FDA approved the vaccine for use for those aged sixteen years and older.

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Before May 2021, the Pfizer plant in Puurs was responsible for all vials for destinations outside the United States. Therefore, all doses administered in the Americas outside of the United States before that point in time required at least two

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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%

7389: 28812: 25393: 1839: 12495: 9096: 3266:, 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. 10765: 4920:

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.

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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.

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and his belief that once it reached Germany local schools would be closed by April. During a telephone call with Jeggle that same day he discussed potential impact of such a virus. Şahin and Türeci had previously identified that the

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In 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.

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adopted by the CDC on 12 May 2021. In October 2021, the EUA was expanded to include children aged 5 through 11 years of age. In June 2022, the EUA was expanded to include children aged six months through four years of age.

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May 2020, with four vaccine candidates entering clinical testing. The vaccine candidate BNT162b2 was chosen as the most promising among three others with similar technology developed by BioNTech. Before choosing BNT162b2,

16021: 8238: 6242: 6209: 14650: 9319: 12583: 7834: 17355: 15095: 4102:, head of vaccine research and development at Pfizer that BioNTech who by now was of the opinion that mRNA was the best means of creating a COVID‑19 vaccine. She took the idea of a collaboration to Pfizer CEO 30008: 10949: 7305: 10809: 6398: 28839: 15523: 14142: 12098: 4089:

Merck, Pfizer or Sanofi, who alone had the financial resources, manufacturing ability and territorial coverage to undertake the massive Phase 3 trials needed to prove to the regulators that the vaccine was safe.

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In November 2021, 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.

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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. The US

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as "a striking alignment of political survival and corporate hustle". Shots worth €4 billion were reportedly wasted before the deal was re-negotiated. In early 2023, Belgian prosecutors began investigating

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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. On 31 March 2021, Pfizer and BioNTech announced from initial

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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:

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January 2021, each vial contains six doses. 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.

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the desired mRNA strands, which takes about four days. 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

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10 people are (in order of frequency): pain and swelling at the injection site, tiredness, headache, muscle aches, chills, joint pain, fever or diarrhea. Fever is more common after the second dose.

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injection into a human muscle was the availability of a suitable wrapper made of lipid nano particles to protect it from the body's enzymes. The company had no experience in them they approached

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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.

14324: 12705: 11330: 6137: 28995: 24894: 23626: 22963: 20491: 20410: 16854: 14946: 14824: 13078: 11099: 9499: 21244: 14854: 12736: 12553: 9714: 7027: 21657: 20191: 9670: 14368: 13694: 13108: 11779: 11414: 11234: 8134: 7050: 6007: 5891: 30065: 30050: 29122: 29062: 24190: 24074: 21895: 21652: 20331: 19278: 16540: 12877: 9128: 1687: 15035: 7718: 7336: 30070: 29830: 29803: 24561: 24323: 22171: 22164: 22159: 22154: 21890: 20673: 20326: 16207: 13663: 1723: 25244: 16832: 16500: 16329: 13497: 11597: 11562: 10980: 7934: 7469:"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" 7366: 6592: 5464: 4060:

There were two options, one was to reproduce a full likeness of entire spike protein which would contain approximately 1,200 amino acids (protein building blocks) increase the risk of

2180:. Initial guidance recommended a two-dose regimen, given 21 days apart; this interval was subsequently extended to up to 42 days in the United States, and up to four months in Canada. 30038: 29627: 29512: 29168: 24136: 24064: 23016: 22577: 21623: 17487: 10079: 1677: 13921: 13435: 9522: 5136:

Comirnaty JN.1 contains bretovameran, an mRNA molecule with instructions for producing a protein from the Omicron JN.1 subvariant of SARS-CoV-2. It is under evaluation in Australia.

4908:(EMA) recommended granting conditional marketing authorization for the Pfizer–BioNTech COVID‑19 vaccine under the brand name Comirnaty. The recommendation was accepted by the 270: 30055: 29998: 29712: 29642: 24148: 24007: 22176: 20668: 20264: 15459: 15125: 14257: 13951: 12777: 7890:

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.).

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The bivalent vaccine authorized in the United States is different from the one that was authorized for use in the United Kingdom as the latter contains as second modRNA component 15

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In December 2021, 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

2046: 1595: 14781: 14302: 12959:"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" 9276: 7685: 6369: 5221:

million doses of a COVID‑19 vaccine for use in the United States if the vaccine was shown to be safe and effective. By mid-December 2020, Pfizer had agreements to supply 300

30017: 29901: 29434: 28949: 28864: 28854: 28730: 25182: 24415: 21603: 20186: 17267: 13541: 8388: 6469: 1172: 1157: 17237: 16009: 14471: 13404: 11642: 9900: 9173: 8230: 6805: 6274: 157: 30060: 29949: 29798: 29449: 29390: 29183: 29090: 29005: 28954: 28871: 28777: 25738: 24069: 22468: 21237: 21117: 16931:"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" 16798: 14514: 6234: 6201: 3401:, 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. The UK's 1682: 17590: 15436: 14638: 14434: 9310: 9043:"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" 7085: 4603:

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

30089: 29881: 29793: 29773: 29529: 29483: 29400: 29300: 29283: 29205: 29156: 29117: 29107: 28983: 28966: 28849: 28817: 28802: 24631: 24588: 21618: 21574: 14023: 12575: 8197: 7826: 6769: 1743: 17324: 12672: 5798: 29993: 29766: 29461: 29439: 29342: 29230: 29188: 29074: 29037: 29010: 28807: 24593: 22988: 22976: 22971: 20767: 17347: 15656: 15087: 14884: 13307: 7650: 1748: 17462: 10941: 8092:"Comirnaty Original/Omicron BA.1 15/15 micrograms per dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified) - Summary of Product Characteristics (SmPC)" 7295: 29973: 29913: 29896: 29842: 29610: 29493: 29378: 29320: 29163: 29151: 29047: 29020: 28973: 28911: 28881: 28760: 28755: 28740: 28725: 27670: 26568: 25763: 24660: 24379: 23799: 21711: 21706: 21701: 21613: 15554: 9473: 8475: 6917: 6874: 6567: 2066: 1930: 1893: 15819: 15346: 13776: 13720: 10801: 8509: 8022: 6174: 5181:(INN), and Comirnaty is the brand name. According to BioNTech, the name Comirnaty "represents a combination of the terms COVID‑19, mRNA, community, and immunity". 29968: 29854: 29783: 29705: 29695: 29683: 29661: 29654: 29637: 29617: 29593: 29583: 29576: 29566: 29536: 29337: 29310: 29215: 29112: 29095: 29069: 29057: 29000: 28891: 28844: 28832: 28822: 28745: 28735: 28710: 25800: 24609: 24466: 23026: 22983: 21213: 21208: 21203: 15519: 14134: 13338: 12088: 5551:"Comirnaty 30 micrograms/dose concentrate for dispersion for injection 12+ years COVID-19 mRNA Vaccine (nucleoside modified) - Summary of Product Characteristics (SmPC)" 5105:

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.

2071: 1883: 1152: 14691: 11011: 10220: 7515: 6733: 29961: 29937: 29886: 29864: 29825: 29813: 29788: 29756: 29746: 29690: 29671: 29622: 29558: 29505: 29471: 29417: 29395: 29293: 29278: 29259: 29200: 29141: 29134: 29042: 29030: 28901: 28896: 28859: 28792: 28715: 25164: 24083: 24039: 23555: 20704: 15875: 15005: 14639:"Coronavirus (COVID-19) Update: FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Adolescents in Another Important Action in Fight Against Pandemic" 6997: 2041: 2022: 1701: 1622: 17619: 17104: 17068: 15191: 12462: 11598:"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" 11563:"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" 11068: 5977: 5047: 29944: 29925: 29778: 29729: 29548: 29466: 29444: 29407: 29385: 29354: 29271: 29220: 29210: 29193: 29015: 28876: 28787: 28782: 28770: 28750: 28720: 27466: 25317: 25177: 23011: 21289: 20119: 19915: 13467: 12352: 7255: 6641: 2002: 1290: 16103: 15621: 12404: 11164: 11042: 5947: 30045: 29874: 29739: 29524: 29427: 29366: 29249: 29242: 29052: 28990: 28978: 28886: 28797: 25883: 24621: 23743: 22720: 17765: 15398: 15368: 14073: 13889: 10194: 10102: 9785: 7468: 1605: 1366: 1248: 25015: 15057: 11129: 10038: 5017:

starting at least 28 days after their second dose. The final approval to provide booster shots in the European Union will be decided by each national government.

2231:(FDA). The logistics of distributing and storing the vaccine present significant challenges due to the requirement for its storage at extremely low temperatures. 30033: 29761: 29734: 29541: 29225: 28929: 24899: 24578: 24211: 24044: 23738: 23731: 23726: 23721: 23716: 23490: 23021: 21806: 21220: 21110: 21077: 16620: 16155: 15646:"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" 14759: 12251: 12221: 10918: 4656:

vaccines were safe and effective at providing immunity against infection to pregnant and breastfeeding mothers. Furthermore, they found that naturally occurring

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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.

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being signed on 17 March. However it wasn't until January 2021the formal commercial agreement between Pfizer and BioNTech for the COVID-19 vaccine was signed.

2027: 1990: 1960: 1657: 16566: 16185: 15729: 15147: 13519: 8353: 3320:, 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 29849: 29700: 29678: 29649: 29632: 29588: 29571: 29332: 28934: 28827: 25052: 24904: 24456: 24346: 24126: 24049: 23760: 23645: 23638: 23618: 23398: 22874: 22853: 22732: 22710: 22112: 21907: 21796: 21021: 21016: 21011: 20974: 20642: 20476: 20351: 20257: 20213: 20205: 19837: 17960: 16488:

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 ...

12988: 11863: 7770: 7443: 6107: 4979: 3539: 2056: 1925: 1652: 1253: 1228: 1208: 225: 17131: 14235: 13982: 12426: 11802: 11256: 10262: 8437: 8156: 7907: 6140:[Anvisa grants first definitive registration for Covid-19 vaccine in the Americas] (in Portuguese). Federal government of Brazil. 23 February 2021. 5067:(CDC) authorized the use of either homologous or heterologous vaccine booster doses. The authorization was expanded to include all adults in November 2021. 5054: 29956: 29932: 29859: 29820: 29808: 29751: 29666: 29500: 29412: 29288: 29254: 29129: 29025: 28944: 28939: 25936: 25518: 24626: 24573: 24425: 24371: 24253: 24195: 22311: 21902: 21738: 21733: 21728: 21586: 21150: 21145: 21140: 21135: 21105: 20732: 19745: 19590: 19435: 14725: 11436: 11384: 4638:

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

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

1888: 1797: 1728: 1637: 1278: 1268: 1263: 1184: 975: 824: 673: 27460: 17961:"A Phase 1/2/3 Study to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals" 17206: 14547: 9822: 6946: 4965: 29920: 29724: 29349: 29266: 28961: 28765: 27408: 24914: 24670: 24351: 24141: 24105: 22550: 22545: 22540: 22129: 21851: 21846: 21841: 21669: 21664: 20687: 20652: 19740: 19661: 19626: 19614: 19585: 19506: 19471: 19459: 19430: 19351: 16752: 16625: 16597: 13575: 13272: 10726: 8160: 8130: 7681: 6436: 6403: 6363: 6085: 4881: 4850:(ACIP) approved recommendations for vaccination of those aged sixteen years or older. Following the EUA issuance, BioNTech and Pfizer continued the Phase 4801: 3402: 3343:

In 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.

3286: 2113: 1970: 1903: 1233: 1223: 970: 891: 860: 848: 819: 740: 709: 697: 668: 589: 15588: 15253: 13809: 10358: 5400:). They then survey these individuals for factors which may have affected whether or not they developed the disease (in this case, vaccination status) ( 5034:

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.

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In October 2021, a phase III trial showed that a booster dose given approximately 11 months after the second dose restored the protective effect to the

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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

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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) (

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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

2377: 2051: 1910: 1738: 1713: 1243: 1238: 1113: 999: 994: 987: 886: 879: 855: 843: 836: 735: 728: 704: 692: 685: 584: 577: 20134: 17378: 17153: 16501:"Coronavirus (COVID-19) Update: FDA Authorizes Moderna and Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose in Younger Age Groups" 15316: 14104: 13832: 11699: 7811: 6830: 4234: 27598: 27503: 25312: 25086: 24556: 23540: 23310: 22760: 22618: 22604: 21765: 21760: 21755: 21581: 21225: 21127: 20680: 20637: 20608: 20198: 20109: 19752: 19733: 19644: 19597: 19578: 19489: 19442: 19423: 19334: 19113: 15984: 15223: 14571:"The Advisory Committee on Immunization Practices' Interim Recommendation for Use of Pfizer–BioNTech COVID-19 Vaccine – United States, December 2020" 12695: 12065: 12034: 9583: 5693: 5663: 3996: 2349: 2316: 1718: 1273: 982: 963: 874: 831: 812: 723: 680: 661: 572: 15920: 14938: 14816: 13070: 11091: 9979:"Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Pfizer-BioNTech COVID-19 Vaccine - United States, December 14-23, 2020" 9495: 6037: 5921: 29454: 26729: 24876: 24731: 24233: 23794: 23655: 23003: 21996: 21038: 20346: 19728: 19685: 19673: 19573: 19530: 19518: 19418: 19375: 19363: 14846: 12549: 11632:"Recommendation for an Emergency Use Listing of Tozinameran (Covid-19 Mrna Vaccine (Nucleoside Modified)) Submitted by Biontech Manufacturing Gmbh" 9696: 7019: 6336: 4710:

commented that Thacker's article presented facts without necessary context to misleading effect, playing up the seriousness of the noted problems.

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capacity for ultracold transport and storage of a vaccine. The necessary storage temperatures for the vaccine are much lower than for the similar

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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.

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President Joe Biden and Michigan Gov. Gretchen Whitmer tour the Portage, Michigan Pfizer facility with Pfizer CEO Albert Bourla, February 19, 2021

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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

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at each of the three stages. Pfizer also revealed that the process requires 280 components and relies upon 25 suppliers located in 19 countries.

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Public Assessment Report Authorisation for Temporary Supply COVID-19 mRNA Vaccine BNT162b2 (BNT162b2 RNA) concentrate for solution for injection

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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. The Phase

2356: 27795: 27477: 26755: 25893: 25865: 22993: 22517: 22512: 22430: 21681: 21472: 21028: 20777: 20697: 20124: 19716: 19704: 19697: 19561: 19549: 19542: 19406: 19394: 19387: 18261: 17728: 17409: 17294: 17207:"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" 15027: 7708: 7328: 4901: 3724: 3526:

comprising 30 adenosine residues, a 10-nucleotide linker sequence, and 70 other adenosine residues (bases 4175–4284). The sequence contains no

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Documented hypersensitivity to polyethylene glycol (PEG) (a very rare allergy) is listed as a contraindication to the COVID-19 Pfizer vaccine.

3293:(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. 1405: 946: 934: 927: 795: 783: 776: 644: 632: 625: 16772:

Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.

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Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.

27454: 25860: 24773: 24263: 24258: 24221: 24059: 23845: 23193: 21984: 21496: 21050: 20986: 19692: 19537: 19382: 19308: 18150: 16824: 16307: 13489: 11406: 11204: 10972: 7358: 5425: 4648: 1807: 1802: 1772: 1672: 1647: 1388: 922: 771: 620: 106: 12776:(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. 10075: 7225:"Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals" 1667: 174: 27682: 27621: 25748: 24811: 24648: 24243: 24093: 23828: 22490: 22294: 22252: 22146: 22024: 21369: 21072: 20657: 18301: 18296: 17656: 13929: 13427: 5267:

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

4847: 1945: 1915: 1898: 1787: 1103: 17732: 15117: 12764: 11496: 3376:(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 2363: 29476: 27646: 27615: 24866: 24486: 24318: 24216: 23958: 23882: 23670: 23259: 23215: 22924: 22680: 22446: 22124: 21959: 21919: 21774: 21489: 21457: 20824: 19220: 16592: 16330:"Coronavirus (COVID-19) Update: FDA Expands Eligibility for Pfizer-BioNTech COVID-19 Vaccine Booster Dose to Children 5 through 11 Years" 14298: 11439:[The Danish Health Authority updates guidelines on handling of vaccination against COVID-19 in the general vaccination program]. 7677: 6358: 5624: 4999:(SAGE) said that, while protection against infection may be diminished, protection against severe disease will likely be retained due to 4842:(FDA). Pfizer applied for an EUA on 20 November 2020, and the FDA approved the application three weeks later on 11 December 2020. The US 4677:

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.

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are mild to moderate in severity and resolve within a few days. Common side effects include mild to moderate pain at the injection site,

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to approve a COVID‑19 vaccine for national use, although the decision to fast-track the vaccine was criticized by some experts.

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million doses in children and adolescents (below 18 years of age) were administered in the EU/EEA from authorization to 26 June 2022.

28607: 27676: 26903: 26583: 26278: 25508: 25425: 24886: 24854: 24675: 24162: 24022: 23857: 23765: 23562: 23520: 23133: 22589: 21425: 20981: 19790: 19785: 19318: 17582: 16956: 15428: 14423: 7081: 2345: 2034: 1755: 1662: 1610: 1145: 1006: 560: 23816: 14204: 14013: 8189: 6758: 6526: 28632: 28622: 28617: 28572: 28554: 27472: 25572: 25452: 25093: 24711: 24513: 24451: 24420: 24226: 23572: 22715: 22648: 21334: 17316: 14173: 5784: 2472: 1878: 1873: 1584: 28681: 22848: 16783: 16464: 15645: 14876: 13303: 7646: 6593:"Coronavirus (COVID-19) Update: FDA Authorizes Moderna and Pfizer-BioNTech COVID-19 Vaccines for Children Down to 6 Months of Age" 3801:

in Belgium. This stage involves combining the mRNA with lipid nanoparticles, then filling vials, boxing vials, and freezing them.

28627: 28612: 28567: 27730: 27694: 26689: 26122: 25850: 25835: 25753: 25561: 25142: 25008: 24833: 24778: 24499: 23418: 22750: 22284: 22043: 21524: 21249: 20076: 19865: 18693: 17453: 15148:"COVID-19 vaccine from Pfizer/BioNTech: Swissmedic approves the extension of the booster dose to everyone aged 16 years and over" 8091: 5758: 5558: 4804:(MHRA) gave the vaccine "rapid temporary regulatory approval to address significant public health issues such as a pandemic" on 2 3325: 2106: 1995: 1935: 1452: 1378: 1356: 1213: 1108: 18482: 16930: 15546: 9465: 8464: 6909: 6866: 6559: 28688: 28662: 28602: 27367: 26644: 25805: 25147: 24801: 24566: 24308: 24295: 23951: 23695: 23597: 23084: 22951: 22053: 21398: 21319: 21304: 21230: 20804: 20742: 20481: 20165: 19832: 18311: 15811: 15338: 13772: 13750: 13716: 8497: 8011: 6166: 5287: 3259: 1851: 1140: 13330: 7232: 6723:"Pfizer–BioNTech COVID-19 Vaccine Standing Orders for Administering Vaccine to Persons 12 Years of Age and Older (Purple Cap)" 5831: 5116:

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

28642: 28637: 28582: 28577: 27718: 27442: 26983: 24871: 23930: 23650: 23550: 23500: 23480: 23423: 23337: 23281: 22497: 21693: 21294: 21259: 20799: 19164: 19092: 18045: 14683: 12966: 11983: 11003: 7935:"Coronavirus (COVID-19) Update: FDA Authorizes Moderna, Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose" 7901: 7503: 6722: 4935:

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

4812:. It is the first COVID‑19 vaccine to be approved for national use after undergoing large scale trials, and the first 4784:

Although jointly developed with Pfizer, Comirnaty is based on BioNTech's proprietary mRNA technology, and BioNTech holds the

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II–III randomized control trial in healthy pregnant women 18 years of age and older (NCT04754594). The study will evaluate 30

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million shares in BioNTech and the future development and marketing rights of BNT162b2 in China and surrounding territories.

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Getting a booster too soon after primary inoculation might not teach the body's immune system to mount a more robust defense

15001: 11064: 9442: 6989: 6831:"Pfizer–BioNTech COVID-19 Vaccine Standing Orders for Administering Vaccine to Persons 12 Years of Age and Older (Gray Cap)" 4003:. This triggered an urgent international response to prepare for an outbreak and hasten development of preventive vaccines. 2412:

of the Pfizer vaccine was 48.7% against alpha and 30.7% against delta, similar to effectiveness provided by one dose of the

2277:(WHO) recommends an interval of three to four weeks between doses. Delaying the second dose by up to twelve weeks increases 2215:. Reports of serious side effects, such as allergic reactions, remain very rare with no long-term complications documented. 30188: 28657: 28652: 28597: 28592: 27001: 26613: 26533: 26381: 25790: 25378: 25103: 24394: 24361: 24017: 23748: 23680: 23660: 22225: 22036: 21974: 21779: 21386: 21329: 21299: 21284: 21192: 17612: 17094: 17061: 15180: 12455: 11720:

Vaccine goes bad five days after thawing, requires two shots; Many nations face costly ramp up of cold-chain infrastructure

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As far as Bourla was concerned COVID‑19 was so important that he had told his staff that they had an “open cheque”.

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has been observed in approximately eleven cases per million doses of vaccine administered. According to a report by the US

2012: 1965: 1342: 13457: 12336: 11437:"Sundhedsstyrelsen opdaterer retningslinje for håndtering af vaccination mod COVID-19 i det generelle vaccinationsprogram" 10639:"Improving mRNA-Based Therapeutic Gene Delivery by Expression-Augmenting 3' UTRs Identified by Cellular Library Screening" 6633: 5729: 30173: 28647: 28587: 27498: 27493: 27483: 26936: 26845: 26704: 26563: 24783: 24535: 23937: 23665: 23475: 23366: 23320: 23300: 23074: 22818: 21264: 20939: 20841: 20737: 20513: 20456: 19910: 18730: 18487: 18413: 18266: 16541:"Coronavirus (COVID-19) Update: FDA Authorizes Updated (Bivalent) COVID-19 Vaccines for Children Down to 6 Months of Age" 15118:"COVID-19 vaccines from Moderna and Pfizer/BioNTech: Swissmedic approves third vaccination for certain population groups" 12400: 11034: 10871: 7158: 5943: 4996: 3761: 1863: 1162: 24384: 18093: 17755: 9853:"Pfizer and BioNTech Announce Positive Topline Results From Pivotal Trial of COVID-19 Vaccine in Children 5 to 11 Years" 3979:

losses totalling more than €400 million was concentrating its efforts on developing mRNA as a means of fighting cancer.

2262:

The vaccine is supplied in a multidose vial as "a white to off-white, sterile, preservative-free, frozen suspension for

28549: 27766: 27760: 27627: 27018: 26674: 26634: 26548: 25840: 25003: 24706: 24701: 24399: 23862: 23833: 23779: 23530: 23485: 23435: 23391: 23286: 23266: 23200: 23036: 22507: 22403: 22341: 22087: 21408: 21279: 20911: 20881: 20227: 19140: 18452: 18085: 16439: 16370: 16271: 16247: 12846: 11305: 9738:"Covid-19: Pfizer-BioNTech vaccine is "likely" responsible for deaths of some elderly patients, Norwegian review finds" 8318: 7978: 6759:"Pfizer–BioNTech COVID-19 Vaccine Standing Orders for Administering Vaccine to Persons 6 Months Through 4 Years of Age" 6679: 4916: 2099: 1361: 1337: 1063: 1053: 16248:"Fact Sheet for Healthcare Providers Administering Vaccine - Pfizer-BioNTech COVID-19 Vaccine for 5 - 11 Years of Age" 16147: 15975:"The European Medicines Agency said that a booster shot of the Pfizer-BioNTech vaccine can be given to healthy adults" 15611: 14747: 14325:"WHO issues its first emergency use validation for a COVID-19 vaccine and emphasizes need for equitable global access" 13371: 12213: 11746: 11130:"Pfizer expects to cut COVID-19 vaccine production time by close to 50% as production ramps up, efficiencies increase" 10908: 10405:[In an animal model, perimyocarditis had occurred after direct intravenous administration of an mRNA vaccine.] 5091:

mcg "of modRNA encoding the S glycoprotein of SARS-CoV-2 Omicron variant lineages BA.4 and BA.5 (Omicron BA.4/BA.5)".

3262:, reported that real-world data from more than 211,000 cases of COVID-19 in South Africa, of which 78,000 were of the 2370: 30178: 26952: 26926: 26709: 26699: 26654: 25956: 25211: 24949: 24821: 23925: 23371: 23361: 23349: 23344: 23305: 22792: 22613: 22389: 21875: 21467: 21324: 21309: 21167: 21033: 20762: 20498: 20365: 20274: 20155: 20071: 19266: 18552: 15214:"Statement by President von der Leyen on the marketing authorisation of the BioNTech-Pfizer vaccine against COVID-19" 13601: 12000: 11833: 8231:"FDA Approves and Authorizes Updated mRNA COVID-19 Vaccines to Better Protect Against Currently Circulating Variants" 7860: 5854:"COVID-19 vaccine: Pfizer Australia - Comirnaty BNT162b2 (mRNA) - approved for use in individuals 12 years and older" 5178: 3466: 3440: 2169: 1920: 1075: 553: 15943: 13862: 11529: 10186: 5426:"Test-Negative Designs: Differences and Commonalities with Other Case-Control Studies with "Other Patient" Controls" 5020:

In October 2021, the FDA and the CDC authorized the use of either homologous or heterologous vaccine booster doses.

5003:. Research into optimal timing for boosters is ongoing, and a booster too early may lead to less robust protection. 4824:

Philippines, Qatar, Saudi Arabia, Singapore, South Korea, the United Arab Emirates, the United States, and Vietnam.

4287:

on BNT162b2, published in October 2020, indicated potential for its safety and efficacy. During the same month, the

3426:

in a small group of 16–30-year-old men. Between December 2020 and May 2021, there were 55 cases of myocarditis per 1

2335: 28693: 28392: 27886: 27700: 27688: 27610: 27387: 26962: 26820: 26760: 26719: 26679: 26618: 26588: 26573: 26553: 26543: 26528: 26523: 26179: 25115: 24976: 24806: 23946: 23705: 23356: 23234: 23118: 22904: 22869: 22705: 22653: 22522: 22358: 21122: 21055: 20921: 20916: 20846: 20836: 20571: 20424: 20419: 20232: 20010: 19938: 19181: 19119: 18094: 16177: 13511: 13462: 13273:"Pfizer and BioNTech Announce Phase 3 Trial Data Showing High Efficacy of a Booster Dose of Their COVID-19 Vaccine" 9248:"Pfizer and BioNTech Announce Phase 3 Trial Data Showing High Efficacy of a Booster Dose of Their COVID-19 Vaccine" 6064:

Australian Public Assessment Reports (AusPAR), Department of Health and Aged Care, Therapeutic Goods Administration

6034:

Australian Public Assessment Reports (AusPAR), Department of Health and Aged Care, Therapeutic Goods Administration

5792: 5723: 5024: 5006:

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

4699: 4299: 4057:

who had been studying the MERS virus, which was approximately 54% identical to the uploaded COVID-19 genetic code.

3535: 3358: 2184: 1080: 17967: 14258:"FDA Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for First COVID-19 Vaccine" 7432: 4652:

came to the conclusion that messenger RNA vaccines against the novel coronavirus, such as the Pfizer-BioNTech and

2331: 2251:

The Pfizer–BioNTech COVID-19 vaccine is used to provide protection against COVID-19, caused by infection with the

27724: 27712: 27604: 27488: 27040: 26888: 26876: 26850: 26825: 26810: 26795: 26790: 26780: 26770: 26765: 26750: 26734: 26608: 26603: 26598: 26538: 26513: 26494: 26335: 26078: 25981: 25976: 25845: 24998: 23986: 23920: 23675: 23276: 23271: 23096: 23041: 22899: 22843: 22838: 22755: 22582: 22384: 22215: 22097: 22082: 21969: 21936: 21860: 21364: 21269: 21254: 20961: 20896: 20876: 20757: 20576: 20559: 20528: 20370: 20360: 20313: 20308: 20170: 20160: 20061: 20005: 19988: 19963: 19885: 19213: 18740: 18708: 18703: 18537: 17127: 14227: 12427:"Pfizer and BioNTech announce further details on collaboration to accelerate global COVID-19 vaccine development" 12401:"Pfizer and BioNTech Announce Further Details on Collaboration to Accelerate Global COVID-19 Vaccine Development" 10250: 8425: 8389:"Coronavirus (COVID-19) Update: FDA Authorizes Additional Vaccine Dose for Certain Immunocompromised Individuals" 7891: 7621: 6795:"Pfizer–BioNTech COVID-19 Vaccine Standing Orders for Administering Vaccine to Persons 5 Through 11 Years of Age" 6059: 4257: 3728:

A Pfizer employee putting dry ice in a box to protect the COVID-19 vaccines during transport at the Puurs factory

3511: 1825: 1462: 1373: 1038: 255: 138: 22787: 22092: 19978: 17781:

Dickerman BA, Gerlovin H, Madenci AL, Kurgansky KE, Ferolito BR, Figueroa Muñiz MJ, et al. (January 2022).

16010:"Coronavirus (COVID-19) Update: FDA Takes Additional Actions on the Use of a Booster Dose for COVID-19 Vaccines" 14713: 14424:"Interim recommendations for use of the Pfizer–BioNTech COVID-19 vaccine, BNT162b2, under Emergency Use Listing" 11474: 11373: 7591: 5306:

programme, a number that equals 1.5% of all vaccines produced by Pfizer. The company sold 67% of their doses to

4975:

vaccine passport. Studies performed in Israel found that a third dose reduced the incidence of serious illness.

4884:(MHRA) came to a similar decision and approved the use of the vaccine for people twelve years of age and older. 30203: 28505: 28266: 27929: 26957: 26898: 26881: 26871: 26840: 26830: 26815: 26785: 26775: 26724: 26714: 26694: 26664: 26639: 26518: 26505: 25192: 25132: 24993: 24932: 23904: 23789: 23607: 23440: 23376: 23229: 23178: 22936: 22929: 22909: 22463: 22425: 22210: 21811: 21003: 20966: 20901: 20886: 20856: 20814: 20809: 20615: 20444: 20390: 19968: 18798: 18408: 14537: 12662: 8798:"Neutralizing antibody levels are highly predictive of immune protection from symptomatic SARS-CoV-2 infection" 5307: 4972: 4951:

administered outside of a clinical trial in the United States was given to Sandra Lindsay on 14 December 2020.

4061: 3494: 2219: 1955: 24389: 15576: 11257:"Increase in vaccine manufacturing capacity and supply for COVID-19 vaccines from BioNTech/Pfizer and Moderna" 11165:"BioNTech to Acquire GMP Manufacturing Site to Expand COVID-19 Vaccine Production Capacity in First Half 2021" 10296:"Myocarditis Cases Reported After mRNA-Based COVID-19 Vaccination in the US From December 2020 to August 2021" 6077: 4618:

of 55 days. From these data, one study suggested that antibodies might remain detectable for around 554 days.

3439:. Most affected individuals recover quickly with adequate treatment and rest. Since February 2022, the German 28024: 27314: 27139: 26893: 26835: 26805: 26684: 26669: 26649: 26593: 26578: 25420: 25290: 24749: 23894: 23872: 23840: 23753: 23690: 23685: 23515: 23428: 23413: 23327: 23249: 23239: 23224: 23188: 23173: 23153: 23123: 23113: 23091: 22914: 22740: 22675: 22658: 22599: 22502: 22351: 22279: 22264: 22259: 22242: 22107: 22014: 21870: 21789: 21720: 21403: 21314: 21182: 21089: 21045: 20956: 20866: 20709: 20603: 20593: 20545: 20523: 20518: 20434: 20104: 20088: 20046: 20041: 20015: 19998: 19953: 19943: 18596: 18306: 17317:"Pfizer and BioNTech to Supply Singapore with their BNT162b2 mRNA-based Vaccine Candidate to Combat COVID-19" 16208:"Coronavirus (COVID-19) Update: FDA Takes Multiple Actions to Expand Use of Pfizer-BioNTech COVID-19 Vaccine" 15245: 13799: 10637:

Orlandini von Niessen AG, Poleganov MA, Rechner C, Plaschke A, Kranz LM, Fesser S, et al. (April 2019).

10346: 8271:"Pfizer and BioNTech Receive U.S. FDA Approval & Authorization for Omicron KP.2-adapted COVID-19 Vaccine" 6470:"FDA Takes Action on Updated mRNA COVID-19 Vaccines to Better Protect Against Currently Circulating Variants" 3844:

BioNTech announced in September 2020, that it had signed an agreement to acquire a manufacturing facility in

3555: 3531: 3290: 1858: 1487: 1325: 1128: 25415: 22070: 17828:"Tozinameran (BNT162b2) Vaccine: The Journey from Preclinical Research to Clinical Trials and Authorization" 15490:"U.S. FDA Grants Priority Review for the Biologics License Application for Pfizer-BioNTech COVID-19 Vaccine" 12802: 5099: 3777: 3435:

million young people, mostly male and over the age of 16, after vaccination with the Pfizer–BioNTech or the

27904: 27652: 27561: 27424: 26967: 26931: 26659: 26558: 26427: 25855: 25775: 25069: 25064: 23899: 23852: 23806: 23592: 23577: 23463: 23445: 23408: 23244: 23158: 23128: 23079: 23064: 22808: 22695: 22685: 22567: 22532: 22527: 22485: 22420: 22374: 22336: 22299: 22247: 22141: 22119: 22102: 22065: 22060: 22048: 22019: 22009: 22004: 21954: 21926: 21865: 21833: 21641: 21447: 21376: 21359: 21177: 21067: 20998: 20906: 20861: 20851: 20794: 20789: 20535: 20486: 20269: 20252: 20237: 20066: 20051: 19993: 19973: 19948: 19933: 19905: 19895: 19890: 19860: 16570: 16433: 16335: 16276: 16252: 16109: 16015: 15881: 15582: 15308: 14787: 14644: 14465: 14261: 12842: 12288:"The Race to Develop the Pfizer-BioNTech COVID-19 Vaccine: From the Pharmaceutical Scientists' Perspective" 11603: 11568: 11334: 8394: 8312: 7801: 7774: 6675: 6637: 6598: 6520: 6473: 6235:"Drug and vaccine authorizations for COVID-19: List of authorized drugs, vaccines and expanded indications" 5080: 5060: 4988: 4924: 4839: 2228: 1058: 429: 18054: 15974: 15213: 13132:"Immunogenicity of a Single Dose of SARS-CoV-2 Messenger RNA Vaccine in Solid Organ Transplant Recipients" 12057: 12026: 9579: 9466:"Booster dose of Pfizer/BioNTech coronavirus vaccine shows 95.6% efficacy in Phase 3 trial, companies say" 5655: 5344: 4634:

mcg of BNT162b2 or placebo administered via intramuscular injection in two doses, 21 days apart. The Phase

478: 28380: 27914: 27573: 27309: 25503: 25081: 24981: 23867: 23811: 23587: 23510: 23332: 23254: 23210: 23168: 23143: 23069: 22941: 22919: 22894: 22594: 22557: 22379: 22346: 22306: 22237: 22205: 22193: 22136: 22077: 22031: 21979: 21964: 21931: 21914: 21882: 21784: 21676: 21515: 21484: 21442: 21437: 21432: 21381: 21274: 20951: 20891: 20871: 20831: 20819: 20588: 20439: 20318: 20222: 20083: 20056: 20036: 20020: 19983: 19825: 15910: 14782:"FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Children 5 through 11 Years of Age" 13632: 9553:"Bivalent booster effectiveness against severe COVID-19 outcomes in Finland, September 2022–January 2023" 6029: 5913: 5076: 4835: 4789: 4307: 4280: 3852:

to expand their vaccine production capacity. Once fully operational, the facility would produce up to 750

3419: 1048: 1033: 317: 14074:"First shipments of Pfizer–BioNTech vaccine in Singapore by end-Dec; enough vaccines for all by Q3 2021" 10403:

Im Tiermodell seien nach direkter intravenöser Gabe eines mRNA-Impfstoffs Perimyokarditiden aufgetreten.

6328: 4272:

I studies, BNT162b2 was shown to have a better safety profile than the other three BioNTech candidates.

3806:

several weeks in deep-freeze storage while undergoing verification against 40 quality-control measures.

3460: 116: 30114: 28087: 27894: 27516: 27436: 27430: 27304: 27276: 27236: 26376: 26127: 25482: 25047: 23887: 23823: 23582: 23567: 23545: 23525: 23381: 23183: 23148: 22782: 22690: 22625: 22289: 22269: 22220: 22188: 21747: 21501: 21479: 21462: 21393: 21172: 21162: 20772: 20752: 20747: 20647: 20625: 20598: 20540: 20508: 20503: 20464: 20429: 20405: 20395: 20247: 20175: 20150: 20129: 19958: 19900: 19880: 19875: 19870: 19206: 18718: 18160: 18143: 17488:"Covid-19: New research reveals Pfizer is making misleading claims about fair distribution of vaccines" 17455:

Dose of Reality: How rich countries and pharmaceutical corporations are breaking their vaccine promises

16393: 8913:"SARS-CoV-2 Delta VOC in Scotland: demographics, risk of hospital admission, and vaccine effectiveness" 7296:"Covid-19 vaccine from Pfizer and BioNTech is strongly effective, early data from large trial indicate" 5364: 5083:(FDA) for use as a booster dose in individuals aged twelve years of age and older. One dose contains 15 3889:

to obtain the additional doses is preferable, and partial doses within a vial should be discarded. The

3333: 3297: 3263: 3248: 2511: 1571: 1526: 1514: 1467: 494: 13235: 9395:

Chemaitelly H, Tang P, Hasan MR, AlMukdad S, Yassine HM, Benslimane FM, et al. (6 October 2021).

8735:

Krause P, Fleming TR, Longini I, Henao-Restrepo AM, Peto R, Dean NE, et al. (12 September 2020).

8057: 7113: 3444: 30208: 28206: 27448: 27362: 27266: 27013: 26284: 25743: 24944: 23877: 23535: 23505: 23495: 23403: 23315: 23163: 23138: 22813: 22663: 21452: 21420: 21415: 20993: 20293: 20279: 20242: 20114: 18768: 18049: 17988: 17739: 17348:"233. Firma secretario de Salud convenio con Pfizer para fabricación y suministro de vacuna COVID-19" 17037: 16759: 15815: 15678:

Bar-On YM, Goldberg Y, Mandel M, Bodenheimer O, Freedman L, Kalkstein N, et al. (October 2021).

15185: 14569:

Oliver SE, Gargano JW, Marin M, Wallace M, Curran KG, Chamberland M, et al. (18 December 2020).

14428: 14395: 14362: 14329: 12807: 12773: 12030: 11638: 11378: 11261: 10538: 10045: 9896: 9605:

Shimabukuro TT, Kim SY, Myers TR, Moro PL, Oduyebo T, Panagiotakopoulos L, et al. (April 2021).

8469: 8193: 7861:"FDA grants full approval to Pfizer/BioNTech Covid-19 vaccine, opening door to more vaccine mandates" 6951: 5618: 5010: 4905: 4874: 4870: 4828: 4288: 3470: 3373: 3321: 2324: 2274: 2173: 1556: 1332: 1098: 1043: 514:

Scientifically accurate atomic model of the external structure of SARS-CoV-2. Each "ball" is an atom.

398: 152: 17290: 5290:

citing "interference in public functions, destruction of SMS, corruption and conflict of interest."

4740: 3953:

The development of the Pfizer- BioNTech COVID‑19 vaccine began when BioNTech founder and CEO

30213: 28669: 28272: 28105: 27736: 27392: 27261: 27251: 27231: 27226: 27216: 26417: 26257: 26117: 26068: 26009: 25991: 25496: 25477: 25462: 25356: 25127: 20784: 18723: 18688: 18683: 18678: 16621:"MHRA approves Pfizer/BioNTech's adapted COVID-19 vaccine (Comirnaty) that targets Omicron XBB.1.5" 16056: 14358:"WHO recommendation BioNtech Tozinameran – COVID-19 mRNA vaccine (nucleoside modified) – Comirnaty" 13627: 12989:"Pfizer and BioNTech Commence Global Clinical Trial to Evaluate COVID-19 Vaccine in Pregnant Women" 12518: 12120:

Thanh Le T, Andreadakis Z, Kumar A, Gómez Román R, Tollefsen S, Saville M, et al. (May 2020).

10187:"Pfizer–BioNTech COVID-19 vaccine: Health Canada recommendations for people with serious allergies" 8784:

Food and Drug Administration includes this lower limit of 30% as a criterion for vaccine licensure.

8564:

Lopez Bernal J, Andrews N, Gower C, Gallagher E, Simmons R, Thelwall S, et al. (August 2021).

7617: 5014: 4653: 4191: 3921: 3890: 3817:

In February 2021, BioNTech announced it would increase production by more than 50% to manufacture 2

3436: 2506: 2501: 2491: 2452: 2286: 2177: 1551: 1541: 1509: 1504: 1494: 1447: 1442: 1432: 1320: 542: 18040:

Global Information About Pfizer–BioNTech COVID-19 Vaccine (also known as BNT162b2 or as Comirnaty)

18025: 16784:"International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 85" 16295: 11196: 10103:"Britain warns against Pfizer vaccine for people with history of 'significant' allergic reactions" 9344:

Thomas SJ, Moreira ED, Kitchin N, Absalon J, Gurtman A, Lockhart S, et al. (September 2021).

7051:"Pfizer-BioNTec approved for emergency use in SA: here is what you need to know about the vaccine" 3340:

be prioritised in the vaccination schedules over other patients that do not have said conditions.

3099:, the dominant variant in Israel was lineage B.1.1.50 and the Alpha variant was becoming dominant. 28562: 28218: 27748: 27658: 27256: 27241: 27221: 27076: 26447: 26289: 26205: 25966: 25732: 25120: 25108: 25098: 25025: 25020: 24969: 24964: 24793: 24739: 19169: 19102: 19083: 18879: 18851: 18813: 18808: 18788: 18316: 15944:"C.D.C. Chief Overrules Agency Panel and Recommends Pfizer-BioNTech Boosters for Workers at Risk" 15651: 14105:"Pfizer–BioNTech COVID-19 vaccine approved by Singapore, first shipment expected by end-December" 12216:[Chronology – That's how the Covid-vaccine of Biontech was being developed] (in German). 11803:"Daunting task of distribution exposed as it emerges some vaccines must be 'deep frozen' at −70C" 10688:"Suspicions grow that nanoparticles in Pfizer's COVID-19 vaccine trigger rare allergic reactions" 9823:"Pfizer says its Covid vaccine is safe and generates robust immune response in kids ages 5 to 11" 9312:

SARS-CoV-2 variants of concern and variants under investigation in England, technical briefing 28

9130:

SARS-CoV-2 variants of concern and variants under investigation in England, technical briefing 17

5417: 5330: 4942:(tozinameran/riltozinameran) and Comirnaty Original/Omicron BA.4/5 (tozinameran/famtozinameran). 4785: 3894: 3714: 3610: 3543: 3225:) in the second month and remaining almost stable through the sixth month, declining thereafter. 3195:

in Qatar from 1 January to 5 September 2021 found that effectiveness against infection peaked at

2496: 2320: 2263: 2165: 2153:, logistics, and manufacturing. It is authorized for use in humans to provide protection against 1844: 1546: 1531: 1499: 1135: 537: 218: 211: 88: 35: 17644: 10578:

Pallesen J, Wang N, Corbett KS, Wrapp D, Kirchdoerfer RN, Turner HL, et al. (August 2017).

10385: 9098:

Effectiveness of COVID-19 vaccines against hospital admission with the Delta (B.1.617.2) variant

7540:

Polack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A, Lockhart S, et al. (December 2020).

5944:"Comirnaty original/Omicron BA.1 COVID-19 Vaccine | Therapeutic Goods Administration (TGA)" 4788:

in the United States, the European Union, the UK, and Canada; expedited licenses such as the US

4279:

II–III Trial with the lead vaccine candidate "BNT162b2" began in July. Preliminary results from

4106:. While the two companies had been working together since 2018 on developing a mRNA vaccine for 2238:

version of the vaccine (Pfizer-BioNTech COVID-19 Vaccine, Bivalent) was authorized for use as a

28469: 27246: 27198: 27169: 27116: 25137: 24954: 19150: 19079: 18078: 13239: 12605:

Mulligan MJ, Lyke KE, Kitchin N, Absalon J, Gurtman A, Lockhart S, et al. (October 2020).

11503: 6947:"EMA recommends standard marketing authorisations for Comirnaty and Spikevax COVID-19 vaccines" 5884:"TGA Provisional Approval of Pfizer-BioNTech COVID-19 vaccine to include 12-15 years age group" 5409: 5027:(TGA) provisionally approved a booster dose of Comirnaty for people 18 years of age and older. 5000: 4033: 3886: 3710: 3695: 2476: 1536: 1480: 1179: 15460:"'Held to ransom': Pfizer demands governments gamble with state assets to secure vaccine deal" 7082:"What you need to know about BioNTech – the European company behind Pfizer's Covid-19 vaccine" 5613: 3312:) in Australia found that the Pfizer-BioNTech vaccine is safe for those with various forms of 3115:

Preliminary data of effectiveness against hospitalization referenced by Public Health England.

30193: 28314: 28029: 27271: 27096: 25888: 25598: 25583: 25551: 25513: 25400: 25057: 25042: 24986: 19145: 18979: 18974: 18430: 18376: 18286: 14570: 12374: 11864:"Pfizer's Vaccine Is Out of the Question as Indonesia Lacks Refrigerators: State Pharma Boss" 10542: 9978: 8667: 7152:

Walsh EE, Frenck RW, Falsey AR, Kitchin N, Absalon J, Gurtman A, et al. (October 2020).

3984: 3352: 3324:

advises that the vaccine is among the three COVID-19 vaccines (alongside that of Moderna and

1975: 1561: 1400: 372: 15911:"Advisory committee recommends wide swath of Americans be offered Covid-19 vaccine boosters" 14714:"CDC Director Statement on Pfizer's Use of COVID-19 Vaccine in Adolescents Age 12 and Older" 12899:

Favresse J, Bayart J, Mullier F, Elsen M, Eucher C, Eeckhoudt S, et al. (7 July 2021).

11670: 11530:"Biden wants to squeeze an extra shot of vaccine out of every Pfizer vial. It won't be easy" 10136:"Allergic reactions to the first COVID-19 vaccine: A potential role of polyethylene glycol?" 6296: 5321:

which would allow the vaccine to be produced by others without having to pay a royalty fee.

3664: 28398: 28320: 28134: 27419: 27382: 27377: 26104: 26058: 25877: 25795: 25770: 25683: 25361: 25254: 25229: 24922: 22765: 21593: 19028: 18969: 18760: 18403: 18281: 18232: 18199: 18133: 17683:

Barda N, Dagan N, Ben-Shlomo Y, Kepten E, Waxman J, Ohana R, et al. (September 2021).

17551: 16982: 16880: 15767: 15088:"Swissmedic approves COVID-19 vaccine from Pfizer/BioNTech for children aged 5 to 11 years" 14197:"S. Korea begins rolling out Pfizer vaccines on second day of national vaccination program" 13183:"Covid-19: Researcher blows the whistle on data integrity issues in Pfizer's vaccine trial" 13020:"Coronavirus disease 2019 vaccine response in pregnant and lactating women: a cohort study" 12618: 10591: 10489: 10429: 5279: 5206: 4221: 4045: 3864: 3836: 3811: 3690:

bacteria. For all markets, this stage is conducted in the United States, at a small Pfizer

3645: 3570:

In addition to the mRNA molecule, the vaccine contains the following inactive ingredients (

3027: 2845: 2768: 2601: 2524: 2200: 1437: 1383: 438: 16296:"CDC Expands Booster Shot Eligibility and Strengthens Recommendations for 12-17 Year Olds" 13130:

Boyarsky BJ, Werbel WA, Avery RK, Tobian AA, Massie AB, Segev DL, et al. (May 2021).

8796:

Khoury DS, Cromer D, Reynaldi A, Schlub TE, Wheatley AK, Juno JA, et al. (May 2021).

4938:

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

2423:(CDC) published a study reporting that the effectiveness against infection decreased from 8: 28338: 28194: 28146: 27413: 27068: 26457: 26195: 26142: 25928: 25758: 25368: 25076: 25032: 23046: 18951: 18917: 18803: 18626: 18569: 18564: 18515: 18346: 18214: 18186: 18138: 15876:"FDA Authorizes Booster Dose of Pfizer-BioNTech COVID-19 Vaccine for Certain Populations" 15547:"Pfizer, Moderna vaccines granted full approval by Health Canada; get unique name change" 15218: 14542: 14196: 13628:"SFH authorises COVID-19 vaccine by Fosun Pharma/BioNTech for emergency use in Hong Kong" 11534: 10913: 10580:"Immunogenicity and structures of a rationally designed prefusion MERS-CoV spike antigen" 10383:[STIKO recommends aspiration for COVID-19 vaccination as precautionary measure]. 10344: 10107: 9095:

Stowe J, Andrews N, Gower C, Gallagher E, Utsi L, Simmons R, et al. (14 June 2021).

8977:"Effectiveness of the BNT162b2 Covid-19 Vaccine against the B.1.1.7 and B.1.351 Variants" 6514: 5275: 4909: 4351: 4187: 4118:

On 13 March it was formally announced that BioNTech was collaborating with Pfizer with a

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is around eight weeks, with longer intervals leaving receptors vulnerable between doses.

363: 28362: 18621: 18366: 18021: 17914:

Mevorach D, Anis E, Cedar N, Bromberg M, Haas EJ, Nadir E, et al. (December 2021).

17869:

Levin EG, Lustig Y, Cohen C, Fluss R, Indenbaum V, Amit S, et al. (December 2021).

15771: 15732:(Press release). United States Department of Health and Human Services. 18 August 2021. 14165: 12696:"Pfizer and BioNTech's favored Covid-19 vaccine has fewer side effects than their first" 12622: 10595: 10493: 10433: 9041:

Chung H, He S, Nasreen S, Sundaram ME, Buchan SA, Wilson SE, et al. (August 2021).

6138:"Anvisa concede primeiro registro definitivo para vacina contra a Covid-19 nas Américas" 5962: 28099: 26171: 25785: 25467: 24937: 24744: 21598: 18984: 18818: 18559: 18525: 18510: 18386: 18371: 18356: 18276: 18194: 17942: 17897: 17852: 17827: 17809: 17760: 17711: 16364:"EUA Fact Sheet For Healthcare Providers Administering Vaccine (Vaccination Providers)" 15979: 15793: 15706: 14939:"Children aged 12 to 15 years to receive Pfizer-BioNTech COVID-19 vaccine in Singapore" 14600: 13493: 13428:"Coronavirus en la Argentina: La ANMAT aprobo el uso de emergencia de la vacuna Pfizer" 13212: 13158: 13046: 12940: 12927: 12644: 12312: 12287: 12189: 11407:"AIFA, possibile ottenere almeno 6 dosi da ogni flaconcino del vaccino BioNTech/Pfizer" 10833:"Pfizer's Chesterfield workforce playing a key role in coronavirus vaccine development" 10663: 10638: 10614: 10515: 10322: 10165: 10008: 9951: 9926: 9767: 9633: 9429: 9372: 9221: 9196: 9069: 9011: 8945: 8912: 8873: 8827: 8769: 8736: 8697: 8643: 8592: 7806: 7568: 7190: 5514: 5456: 5311: 5269: 5184:

Famtozinameran is the INN for the BA.5 variant in the bivalent version of the vaccine.

4809: 3676:

Manufacturing the vaccine requires a three-stage process. The first stage involves the

3615: 3605: 2408: 2282: 1588: 1123: 1118: 185: 27028: 16855:"Pfizer and BioNTech Receive Authorization in the European Union for COVID-19 Vaccine" 16726: 16700: 16674: 16648: 16104:"Coronavirus (COVID-19) Update: FDA Expands Eligibility for COVID-19 Vaccine Boosters" 15730:"Joint Statement from HHS Public Health and Medical Experts on COVID-19 Booster Shots" 13018:

Gray KJ, Bordt EA, Atyeo C, Deriso E, Akinwunmi B, Young N, et al. (March 2021).

12217: 10802:"From science to syringe: COVID-19 vaccines are miracles of science and supply chains" 10416:

Vogel AB, Kanevsky I, Che Y, Swanson KA, Muik A, Vormehr M, et al. (April 2021).

8928: 8752: 8099: 7889: 5936: 5550: 3282:(CDC) recommends that pregnant women get vaccinated with the COVID‑19 vaccine. 30168: 28676: 28479: 28188: 28128: 27924: 27909: 27742: 27510: 27372: 25447: 25249: 25197: 24356: 24174: 19298: 19229: 19107: 19074: 18907: 18748: 18638: 18532: 18393: 18218: 18181: 18071: 17947: 17902: 17857: 17814: 17716: 17291:"Trudeau says promising new Pfizer vaccine could be 'light at the end of the tunnel'" 17032: 15797: 15785: 15711: 15281: 14605: 13216: 13204: 13163: 13051: 12944: 12932: 12648: 12636: 12344: 12317: 12194: 12143: 11979: 10973:"Historic journey: Pfizer prepares to deliver 6.4 million doses of COVID-19 vaccines" 10668: 10619: 10519: 10507: 10455: 10447: 10327: 10169: 10157: 10013: 9956: 9771: 9759: 9706: 9638: 9552: 9434: 9416: 9377: 9226: 9074: 9016: 8998: 8950: 8932: 8878: 8831: 8819: 8774: 8756: 8702: 8648: 8597: 7897: 7744: 7573: 7195: 7177: 5518: 5506: 5460: 5448: 5202:

million from the Pfizer–BioNTech COVID-19 vaccine in 2020, and $ 36 billion in 2021.

4858:

In February 2021, the South African Health Products Regulatory Authority (SAHPRA) in

4702:

evaluation trials of the Pfizer vaccine. The report was enthusiastically embraced by

4614:

persists for at least three months after the second dose, with an estimated antibody

3970: 3790: 3677: 3559: 3534:. The 2P proline substitutions in the spike proteins were originally developed for a 3382: 3317: 3255: 502: 313: 291: 156: 130: 28344: 27964: 24313: 19053: 16391:

No publication in a peer-reviewed journal but re-published by the ACIP and CDC, see

11671:"Pfizer–BioNTech COVID-19 Vaccine Vaccination Storage & Dry Ice Safety Handling" 5718: 3740: 43: 28386: 28248: 28158: 28140: 27866: 27579: 27057: 26032: 25820: 25708: 25643: 25608: 25457: 25373: 22316: 19033: 19018: 18874: 18735: 18648: 17992: 17937: 17927: 17892: 17882: 17847: 17839: 17804: 17794: 17706: 17696: 17519:"Pfizer warns Australia a Covid vaccine patent waiver could harm supply and safety" 15775: 15701: 15691: 15002:"COVID-19: Switzerland can start vaccinating vulnerable groups already in December" 14595: 14585: 13194: 13153: 13143: 13041: 13031: 12922: 12912: 12663:"China's Fosun to end BioNTech's COVID-19 vaccine trial, seek approval for another" 12626: 12307: 12299: 12184: 12174: 12133: 10695: 10658: 10650: 10609: 10599: 10497: 10437: 10317: 10307: 10294:

Oster ME, Shay DK, Su JR, Gee J, Creech CB, Broder KR, et al. (January 2022).

10147: 10003: 9993: 9946: 9938: 9749: 9628: 9618: 9424: 9408: 9367: 9357: 9318:(Briefing). Public Health England. 12 November 2021. Figures 21 and 22. GOV-10349. 9216: 9208: 9064: 9054: 9006: 8988: 8940: 8924: 8868: 8858: 8845:

Dagan N, Barda N, Kepten E, Miron O, Perchik S, Katz MA, et al. (April 2021).

8809: 8764: 8748: 8692: 8682: 8666:

Fowlkes A, Gaglani M, Groover K, Thiese MS, Tyner H, Ellingson K (27 August 2021).

8638: 8628: 8587: 8577: 8505: 7563: 7553: 7185: 7167: 5823: 5496: 5440: 4703: 4665: 4339: 4119: 4054: 3988: 3686: 3547: 3313: 2235: 2196: 2192: 2138: 1349: 1315: 238: 28212: 18574: 16727:"Comirnaty JN.1 30 micrograms/dose dispersion for injection in pre-filled syringe" 12958: 12917: 12900: 8354:"Pfizer vaccine second dose has 'sweet spot' after eight weeks, UK scientists say" 8157:"Regulatory approval of Pfizer/BioNTech bivalent Original/Omicron booster vaccine" 7224: 4736: 3644:

that act not only as carriers to get the modRNA into the human cells, but also as

21:"Pfizer vaccine" and "BioNTech vaccine" redirect here. For the manufacturers, see 30183: 30152: 30128: 28410: 28182: 28170: 28164: 28152: 27899: 27856: 27045: 26063: 26024: 25951: 25638: 25556: 25472: 25269: 25152: 24330: 22480: 22475: 19313: 19038: 18836: 18643: 18601: 18492: 18472: 18442: 18425: 18351: 18341: 18271: 18210: 18206: 18155: 17154:"U.S. Government Engages Pfizer to Produce Millions of Doses of COVID-19 Vaccine" 16825:"The inside story behind Pfizer and BioNTech's new vaccine brand name, Comirnaty" 13602:"First Pfizer COVID-19 vaccines set to reach Costa Rica on Wednesday – president" 5444: 4928: 4691: 4604: 4325: 4000: 3954: 3893:

officially authorized the use of excess doses remaining within single vials. The

3869: 3762:

Loading dock operations at Pfizer's Portage, Michigan facility, December 13, 2020

3620: 3523: 3478: 3305: 3155:

was not provided, so it is not possible to know the accuracy of this measurement.

2089: 30147: 27154: 17128:"U.S. to pay Pfizer, BioNTech $ 1.95 bln for millions of COVID-19 vaccine doses" 14969:"EU regulator backs Pfizer-BioNTech COVID-19 vaccine for children aged 12 to 15" 10654: 7802:"F.D.A. Clears Pfizer Vaccine, and Millions of Doses Will Be Shipped Right Away" 7740: 7504:"Pfizer-BioNTech COVID-19 Vaccine (also known as Comirnaty) Overview and Safety" 3721:

million doses. The bags are placed on trucks which take them to the next plant.

2084: 30140: 28404: 28374: 28332: 28254: 28122: 28059: 28044: 28019: 27999: 27567: 27131: 27051: 25653: 25234: 24530: 20714: 19175: 18902: 18793: 18753: 18633: 18459: 18398: 17843: 17783:"Comparative Effectiveness of BNT162b2 and mRNA-1273 Vaccines in U.S. Veterans" 15915: 15780: 15755: 15028:"Swissmedic grants authorisation for the first COVID-19 vaccine in Switzerland" 14538:"CDC greenlights advisory group's decision to recommend Pfizer vaccine for use" 13036: 13019: 12700: 12576:"Pfizer CEO says he would've released vaccine data before election if possible" 12303: 12138: 12121: 12093: 11834:"How China's COVID-19 could fill the gaps left by Pfizer, Moderna, AstraZeneca" 11035:"Canada to start receiving U.S. shipments of Pfizer-BioNTech vaccine next week" 10584:

Proceedings of the National Academy of Sciences of the United States of America

10502: 10477: 10442: 10417: 8814: 8797: 7300: 6990:"Swissmedic grants authorisation for the first COVID-19 vaccine in Switzerland" 5343:

stick to their arms after receiving the vaccine, purportedly demonstrating the

5299: 5048:

Oxford–AstraZeneca COVID-19 vaccine § Heterologous prime-boost vaccination

4660:

created by the mother's immune system were passed on to their children via the

4314: 4295: 4099: 4029: 3992: 3551: 3502: 3490: 3489:

The modRNA sequence of the vaccine is 4,284 nucleotides long. It consists of a

2932: 2675: 2278: 2183:

Clinical trials began in April 2020; by November 2020, the vaccine had entered

2150: 28296: 28278: 17727: 17007: 16905: 15520:"U.S. FDA sets January target to decide on approval of Pfizer's COVID-19 shot" 13071:"Pfizer says its Covid vaccine trial for kids ages 12 to 15 is fully enrolled" 12762: 12631: 12606: 12488:"Germany: Investment Plan for Europe – EIB to provide BioNTech with up to €100 12001:"The vaccine race explained: What you need to know about the COVID-19 vaccine" 10863: 8304:

Pfizer–BioNTech COVID-19 Vaccine Emergency Use Authorization Review Memorandum

8127:"Pfizer/BioNTech bivalent COVID-19 booster approved by UK medicines regulator" 6399:"Information for Healthcare Professionals on Pfizer/BioNTech COVID-19 vaccine" 5302:. In 2021, Pfizer delivered only 39% of the contractually agreed doses to the 5241:

million doses to Canada, an unspecified number of doses to Singapore, and 34.4

5177:

BNT162b2 was the code name during development and testing, tozinameran is the

5055:

COVID-19 vaccine clinical research § Heterologous prime-boost vaccination

4072:

BioNTech decided to simultaneously develop in parallel in their laboratory in

3904: 101:

BNT162b2, COVID-19 mRNA vaccine (nucleoside-modified), COVID-19 Vaccine (mRNA)

30162: 28484: 28454: 28422: 28308: 28200: 28176: 28093: 28064: 28039: 28014: 28004: 27984: 27959: 27949: 27939: 27876: 27801: 27789: 26273: 26132: 26088: 26073: 25698: 25693: 25623: 25528: 25224: 20692: 19058: 19043: 19013: 19008: 18863: 18616: 18611: 18520: 18165: 16527: 16234: 16134: 16087: 16040: 14880: 14669: 14490: 14284: 13545: 13542:"Drug and vaccine authorizations for COVID-19: List of applications received" 13515: 12492:

million in debt financing for COVID-19 vaccine development and manufacturing"

12375:"Fosun Pharma and BioNTech form COVID-19 vaccine strategic alliance in China" 12348: 11357: 10909:"A vial, a vaccine and hopes for slowing a pandemic – how a shot comes to be" 10636: 10451: 10281: 10190: 9710: 9420: 9397:"Waning of BNT162b2 Vaccine Protection against SARS-CoV-2 Infection in Qatar" 9002: 8936: 8760: 8337: 8257: 8044: 7997: 7957: 7181: 6698: 6554: 6552: 6550: 6548: 6546: 6544: 6492: 6301: 6269: 6238: 6205: 6170: 6161: 6159: 5283: 4869:

authorized the vaccine for people aged 12 to 15. On 18 May 2021, Singapore's

4866: 4817: 4816:

to be authorized for use in humans. The United Kingdom thus became the first

4217: 4103: 4037: 3641: 3337: 2267: 2223: 1189: 18420: 17234:"EU agrees to buy 300 million doses of the Pfizer/BioNTech Covid-19 vaccine" 16427: 16363: 16281: 16257: 14908:"Children 12 and older now cleared to receive Pfizer vaccine: Health Canada" 13576:"Chile y Ecuador se adelantan en Sudamérica y autorizan la vacuna de Pfizer" 13101:"BioNTech-Pfizer say COVID-19 vaccine 100% effective on 12- to 15-year-olds" 12835: 12252:"How Pfizer Crafted Its Own 'Operation Warp Speed' For The COVID-19 Vaccine" 11298: 10700: 10687: 10604: 10579: 10312: 10295: 9523:"Pfizer shot less effective against hospitalisation in South Africa - study" 9346:"Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine through 6 Months" 9284:(Technical report). UK Health Security Agency. 23 December 2021. GOV-10820. 8303: 8190:"First adapted COVID-19 booster vaccines recommended for approval in the EU" 7971: 6859: 6668: 5501: 5484: 4966:

COVID-19 vaccine clinical research § Homologous prime-boost vaccination

4134:

According to Pfizer, research and development for the vaccine cost close to

3736:

Boxes containing the COVID‑19 vaccines at the Pfizer factory in Puurs

28489: 28416: 28350: 28302: 28290: 28284: 28242: 28224: 28054: 28034: 27994: 27969: 27919: 27164: 27149: 27091: 27081: 26370: 26048: 26001: 25728: 25678: 25633: 25618: 25536: 19135: 18778: 18673: 18606: 18547: 18227: 18118: 18098: 17951: 17906: 17871:"Waning Immune Humoral Response to BNT162b2 Covid-19 Vaccine over 6 Months" 17861: 17818: 17720: 17523: 17379:"Fosun Pharma to supply Covid-19 vaccine to Hong Kong, Macau once approved" 17156:(Press release). US Department of Health and Human Services. 22 July 2020. 17099: 16701:"Comirnaty JN.1 3 micrograms/dose concentrate for dispersion for injection" 15789: 15715: 15058:"Pfizer/BioNTech COVID-19 vaccine approved for young people in Switzerland" 14684:"FDA authorizes Pfizer COVID-19 vaccine for adolescents 12 to 15 years old" 14609: 14590: 13687:"Israeli Health Minister 'pleased' as FDA approves Pfizer COVID-19 vaccine" 13399: 13361: 13276: 13208: 13167: 13148: 13131: 13055: 12936: 12640: 12321: 12198: 12147: 11774: 11738: 10672: 10623: 10511: 10459: 10331: 10161: 10076:"MHRA warning after allergic reactions in NHS staff given COVID-19 vaccine" 10017: 9998: 9960: 9763: 9665: 9642: 9438: 9381: 9230: 9197:"Effectiveness of BNT162b2 Vaccine against Omicron Variant in South Africa" 9078: 9020: 8954: 8882: 8823: 8778: 8706: 8687: 8652: 8601: 8358: 7713: 7577: 7199: 5510: 5452: 5336: 4983: 4859: 4813: 4707: 4264:

on BNT162b1 in Germany and the United States, while Fosun performed a Phase

4159:

In April 2020, BioNTech signed a partnership with Pfizer and received $ 185

3975: 2239: 2135: 233: 76: 27707:

Inter-Agency Task Force for the Management of Emerging Infectious Diseases

17932: 17915: 17887: 17870: 17799: 17782: 17701: 17684: 17552:"Do Videos Show Magnets Sticking to People's Arms After COVID-19 Vaccine?" 15696: 15679: 11299:"Pfizer–BioNTech COVID-19 Vaccine EUA Fact Sheet for Healthcare Providers" 10762:"BioNTech in China alliance with Fosun over coronavirus vaccine candidate" 10345:

National Center for Immunization and Respiratory Diseases (23 June 2021).

9623: 9607:"Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons" 9606: 9412: 9362: 9345: 8863: 8846: 8582: 8566:"Effectiveness of Covid-19 Vaccines against the B.1.617.2 (Delta) Variant" 8565: 8012:"Interim Clinical Considerations for COVID-19 Vaccines: Bivalent Boosters" 7824: 7558: 7541: 7172: 7153: 6541: 6156: 5785:"Comirnaty (BNT162b2 [mRNA]) COVID-19 Vaccine Product Information" 5187:

Raxtozinameran is the INN for the XBB 1.5 variant version of the vaccine.

4243:

I–II Trials were started in Germany on 23 April 2020, and in the U.S. on 4

3814:(one to take DNA to Europe and one to bring back finished vaccine vials). 2455:

became predominant in the US, which may be due to unmeasured and residual

28449: 28428: 28368: 28230: 28009: 27974: 27934: 27861: 27144: 27121: 27101: 27023: 26402: 26315: 26083: 25971: 25910: 25668: 25628: 25603: 25588: 25566: 25219: 24034: 18922: 18912: 18773: 18579: 18467: 18435: 18361: 18223: 18114: 18106: 17260:"Japan and Pfizer reach COVID-19 vaccine deal to treat 60 million people" 14228:"Dubai approves the Pfizer–BioNTech vaccine which will be free of charge" 12179: 12162: 12089:"The story of mRNA: From a loose idea to a tool that may help curb Covid" 9212: 8993: 8976: 8847:"BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Mass Vaccination Setting" 8633: 8616: 8465:"Comirnaty and Spikevax: EMA recommendations on extra doses and boosters" 5157:

million doses of the Pfizer–BioNTech COVID-19 vaccine, including about 55

3943: 3691: 3600: 3456: 3423: 3394: 3365: 2456: 2285:. Authors of the Pitch study think that the optimal interval against the 2204: 124: 48:

A vial of the Pfizer–BioNTech COVID‑19 vaccine for the U.S. market

25187: 18001:. WHO/2019-nCoV/vaccines/SAGE_recommendation/BNT162b2/background/2021.1. 17997: 15843:"The U.S. plans to authorize boosters—but many already got a third dose" 14391:"The Pfizer BioNTech (BNT162b2) COVID-19 vaccine: What you need to know" 12058:"The Husband-and-Wife Team Behind the Leading Vaccine to Solve Covid-19" 11325: 11323: 11197:"'Where the magic happens' – inside BioNTech's innovative vaccine plant" 10221:"Israel sees probable link between Pfizer vaccine and myocarditis cases" 9396: 7972:"Fall 2022 COVID-19 Vaccine Strain Composition Selection Recommendation" 7154:"Safety and Immunogenicity of Two RNA-Based Covid-19 Vaccine Candidates" 5753: 5751: 5749: 5747: 4235:

COVID-19 vaccine clinical research § Trial and authorization status

3983:

company's mRNA platforms. He was assisted in his work by the SARS-CoV-2

2203:

within seven days of a second dose and no serious safety concerns. Most

418: 28555:

Tests, cases, tests per capita, cases per capita by country subdivision

28260: 28049: 27989: 27979: 27944: 27111: 26475: 26355: 26112: 25810: 25688: 25673: 25383: 25264: 25239: 19249: 19048: 19023: 18713: 18663: 17826:

Khehra N, Padda I, Jaferi U, Atwal H, Narain S, Parmar MS (June 2021).

15429:"Report: How Pfizer Silences World Governments in Vaccine Negotiations" 15151: 15121: 15091: 15061: 15031: 13504: 10381:"STIKO empfiehlt Aspiration bei COVID-19-Impfung als Vorsichtsmaßnahme" 8426:"COVID-19 Vaccines for Moderately or Severely Immunocompromised People" 6993: 5262: 4893: 3960: 3917: 3474: 3410:

adrenaline auto injectors. They both were treated and have recovered."

3361:

for the vaccine, there were no safety concerns and few adverse events.

3309: 3096: 2334:

if you can. Unsourced or poorly sourced material may be challenged and

2259:. The vaccine is used to reduce morbidity and mortality from COVID-19. 2218:

The vaccine is the first COVID‑19 vaccine to be authorized by a

2145:. For its development, BioNTech collaborated with the American company 1832: 1427: 1194: 529: 71: 17685:"Safety of the BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Setting" 16148:"TGA approves booster doses of the Pfizer COVID-19 vaccine, Comirnaty" 13199: 13182: 10543:"Messenger RNA encoding the full-length SARS-CoV-2 spike glycoprotein" 10152: 10135: 9942: 9754: 9737: 9580:"New CDC guidance recommends pregnant people get the COVID-19 vaccine" 9271: 9269: 9059: 9042: 7256:"Pfizer says experimental COVID-19 vaccine is more than 90% effective" 4735:

Graphs are unavailable due to technical issues. There is more info on

3868:

nanoparticles, then ships the vaccine in bulk to other facilities for

3581:, ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate) 28464: 28356: 28326: 28236: 27871: 27299: 27106: 26442: 26422: 26325: 26268: 26226: 25961: 25941: 25658: 25648: 25578: 25541: 25295: 25274: 25259: 24839: 24665: 19303: 19097: 18668: 18541: 18110: 15756:"The WHO is right to call a temporary halt to COVID vaccine boosters" 14018: 13743:"Kuwait authorizes emergency use of Pfizer–BioNTech COVID-19 vaccine" 12519:"BioNTech moves to head of pack for COVID-19 vaccine with EU finance" 11466: 11320: 11227:"EU approves ramp-up of Pfizer vaccine manufacturing site in Belgium" 11134: 9701: 9697:"Pfizer vaccine approved for use in children aged 12 to 15 in the UK" 9195:

Collie S, Champion J, Moultrie H, Bekker LG, Gray G (December 2021).

7678:"UK medicines regulator gives approval for first UK COVID-19 vaccine" 7595: 5744: 4615: 4313:

The phase III trial assesses the safety, efficacy, tolerability, and

4107: 4017: 3929: 3925: 3713:, in the United States, and at BioNTech's plants in Germany. The DNA 3699: 3653: 3571: 3244:) efficacy level against symptomatic disease from the Delta variant. 1566: 1417: 383: 110: 19198: 17916:"Myocarditis after BNT162b2 mRNA Vaccine against Covid-19 in Israel" 17618:. Los Angeles County Department of Public Health. 15 December 2021. 15399:"Anvisa autoriza vacina da Pfizer para crianças com mais de 12 anos" 15004:(Press release). Federal Office of Public Health. 19 December 2020. 13983:"Coronavirus: Saudi Arabia approves Pfizer COVID-19 vaccine for use" 13490:"Bahrain becomes second country to approve Pfizer COVID-l19 vaccine" 9925:

Rutkowski K, Mirakian R, Till S, Rutkowski R, Wagner A (June 2021).

9661:"UK regulator approves Pfizer Covid vaccine for 12- to 15-year-olds" 9242: 9240: 7937:(Press release). U.S. Food and Drug Administration. 31 August 2022. 3465:

The BioNTech technology for the BNT162b2 vaccine is based on use of

2467:. Effectiveness is generally expected to slowly decrease over time. 28474: 28459: 26480: 26437: 26432: 26345: 26340: 26252: 26247: 26242: 26043: 26037: 25986: 25703: 25663: 25546: 19241: 18939: 18932: 18927: 18897: 18653: 18589: 18584: 15680:"Protection of BNT162b2 Vaccine Booster against Covid-19 in Israel" 15181:"EMA recommends first COVID-19 vaccine for authorisation in the EU" 14509: 13952:"Qatar, Oman to receive Pfizer–BioNTech COVID-19 vaccine this week" 13395:"European and US experts question UK's fast-track of Covid vaccine" 13366: 12763:

Committee for Medicinal Products for Human Use (19 February 2021).

12119: 10251:"Clinical Considerations: Myocarditis after mRNA COVID-19 Vaccines" 9498:(Press release). New York City and Mainz: Pfizer. 8 December 2021. 9266: 9102: 8537: 7439: 4661: 4657: 4249: 4111: 4092: 3849: 3584: 3578: 3522:

selected for increased protein expression and mRNA stability and a

2212: 2154: 2142: 523: 458: 409: 169: 26: 16272:"Pfizer-BioNTech COVID-19 Vaccine EUA LOA reissued August 12 2021" 13863:"Oman issues licence to import Pfizer BioNTech Covid vaccine – TV" 13833:"Mexico Approves Pfizer Vaccine for Emergency Use as Covid Surges" 10347:"Myocarditis and Pericarditis Following mRNA COVID-19 Vaccination" 8734: 7433:"Update on our COVID-19 vaccine development program with BNT162b2" 6867:"Pfizer-BioNTech COVID-19 Vaccine- bnt162b2 injection, suspension" 6560:"Pfizer-Biontech COVID-19 Vaccine- bnt162b2 injection, suspension" 6432:"Conditions of Authorisation for Pfizer/BioNTech COVID-19 vaccine" 27954: 27664: 26465: 26412: 26407: 26350: 26320: 26310: 26305: 26053: 25946: 25918: 18658: 18102: 17780: 16526: