Get Pfizer%E2%80%93BioNTech COVID-19 Vaccine essential facts below. View Videos or join the Pfizer%E2%80%93BioNTech COVID-19 Vaccine discussion. Add Pfizer%E2%80%93BioNTech COVID-19 Vaccine to your PopFlock.com topic list for future reference or share this resource on social media.
Clinical trials began in April 2020; by November 2020, the vaccine entered phaseIII clinical trials, with over 40,000 people participating. An interim analysis of study data showed a potential efficacy of 91.3% in preventing infection within seven days of a second dose. The most common side effects include mild to moderate pain at the injection site, fatigue, and headaches. Reports of serious side effects, such as allergic reactions, are very rare,[a] and no long-term complications have been reported. Monitoring of the primary outcomes from the trials will continue until August 2021, while monitoring of the secondary outcomes will continue until January 2023.
The vaccine was the first COVID-19 vaccine to be authorized by a stringent regulatory authority for emergency use and the first cleared 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 84 countries including the United States, countries in the European Union, the United Kingdom, Ukraine, Israel, Brazil, Mexico, Japan and Singapore.
As of March 30, 2021, Pfizer and BioNTech aimed to manufacture about 2.5billion doses in 2021. Pfizer has advance purchase agreements of about US$3billion to provide a licensed vaccine in the United States, the European Union, the United Kingdom, Japan, Canada, Peru, Singapore and Mexico. Distribution and storage is a logistical challenge because the vaccine needs to be stored at extremely low temperatures. Pfizer is testing a freeze-dried version that would not need ultracold storage.
BioNTech started its program 'Project Lightspeed' to develop a vaccine against the new COVID-19 virus based on its already established mRNA-technology. Several variants of the vaccine were created in their laboratories in Mainz, and 20 of those were presented to experts of the Paul Ehrlich Institute in Langen.
BioNTech received a US$135million investment from Fosun in March 2020, in exchange for 1.58million shares in BioNTech and the future development and marketing rights of BNT162b2 in China.
In April 2020, BioNTech signed a partnership with Pfizer and received $185million, including an equity investment of approximately $113million.
In June 2020, BioNTech received EUR100million (US$119million) in financing from the European Commission and European Investment Bank. In September 2020, the German government granted BioNTech EUR375million (US$445million) for its COVID-19 vaccine development program.
Pfizer CEO Albert Bourla said he decided against taking funding from the US government's Operation Warp Speed for the development of the vaccine "because I wanted to liberate our scientists [from] any bureaucracy that comes with having to give reports and agree how we are going to spend the money in parallel or together, etc." Pfizer did enter into an agreement with the US for the eventual distribution of the vaccine, as with other countries.
Cumulative incidence curves for symptomatic COVID-19 infections after the first dose of the Pfizer-BioNTech vaccine (tozinameran) or placebo in a double-blind clinical trial. (red: placebo; blue: tozinameran)
PhaseI-II Trials were started in Germany on 23 April 2020, and in the U.S. on 4May 2020, with four vaccine candidates entering clinical testing. The Initial Pivotal PhaseII-III Trial with the lead vaccine candidate "BNT162b2" began in July. The PhaseIII results indicating a 95% effectiveness of the developed vaccine were published on 18 November 2020.
The study of BNT162b2 is a continuous-phase trial in PhaseIII as of November 2020. It is a "randomized, placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection, and efficacy study in healthy individuals". The early-stage research determined the safety and dose level for two vaccine candidates, with the trial expanding 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.
The Phase III trial assesses the safety, efficacy, tolerability, and immunogenicity of BNT162b2 at a mid-dose level (two injections separated by 21 days) in three age groups: 12-15 years, 16-55 years or above 55 years. 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.
Vaccine efficacy - After dose1 or dose2 overall, and after dose2 overall and by age groups
Vaccine efficacy (95% confidence interval) [%]
After dose 1 and before dose 2
52.4 (29.5, 68.4)
>=10 days after dose 1 and before dose 2
86.7 (68.6, 95.4)
After dose 2 and within 7 days after
90.5 (61.0, 98.9)
>=7 days after dose 2
94.8 (89.8, 97.6)
95.0 (90.0, 97.9)
95.6 (89.4, 98.6)
93.7 (80.6, 98.8)
94.7 (66.7, 99.9)
The ongoing Phase III trial, which is scheduled to run from 2020 to 2022, is designed to assess the ability of BNT162b2 to prevent severe infection, as well as the duration of immune effect.
Pfizer and BioNTech started a PhaseII-III randomized control trial in healthy pregnant women 18 years of age and older (NCT04754594). The study will evaluate 30µg of BNT162b2 or placebo administered via intramuscular injection in two doses, 21 days apart. The PhaseII 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 PhaseIII 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.
In January 2021, Pfizer said it had finished enrolling 2,259 children aged between 12-15 years to study the vaccine's safety and efficacy.
On 31 March 2021, Pfizer and BioNTech announced from initial phaseIII 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. On 10 May 2021, the vaccine was granted an emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for those aged 12 to 15 years of age.
The vaccine candidate BNT162b2 was chosen as the most promising among three others with similar technology developed by BioNTech. Before choosing BNT162b2, BioNTech and Pfizer had conducted PhaseI trials on BNT162b1 in Germany and the United States, while Fosun performed a PhaseI trial in China. In these PhaseI studies, BNT162b2 was shown to have a better safety profile than the other three BioNTech candidates.
The vaccine is supplied in a multidose vial as "a white to off-white, sterile, preservative-free, frozen suspension for intramuscular injection". It must be thawed to room temperature and diluted with normal saline before administration.
The United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) gave the vaccine "rapid temporary regulatory approval to address significant public health issues such as a pandemic" on 2December 2020, which it is permitted to do under the Medicines Act 1968. It was the first COVID-19 vaccine to be approved for national use after undergoing large scale trials, and the first mRNA vaccine to be authorized for use in humans. The United Kingdom thus became the first Western country to approve a COVID-19 vaccine for national use, although the decision to fast-track the vaccine was criticised by some experts.
In the United States, an emergency use authorization (EUA) is "a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current COVID-19 pandemic", according to the FDA. Pfizer applied for EUA on 20 November 2020 and the FDA approved the application three weeks later on 11 December 2020. Following the EUA issuance, BioNTech and Pfizer are expected to continue the PhaseIII clinical trial to finalize safety and efficacy data, leading to application for licensure (approval) of the vaccine in the United States. The United States Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) approved recommendations for vaccination of those aged sixteen years or older.
On 16 February 2021, the South African Health Products Regulatory Authority (SAHPRA) in South Africa issues Section 21, Emergency Use Approval for the vaccine.
On 31 March 2021, the Turkish ministry of health gave Emergency Use Approval for the vaccine.
On 5 May 2021, Health Canada authorized the vaccine for people aged 12 to 15. On 10 May 2021, the US FDA authorized the vaccine for people aged 12 to 15 under an expanded EUA. The FDA recommendation was endorsed by the ACIP and adopted by the CDC on 12 May.
On 19 December 2020, the Swiss Agency for Therapeutic Products (Swissmedic) approved 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. On 23 December, a Lucerne resident, a 90-year-old woman, became the first person to receive the vaccine in Switzerland. This marked the beginning of mass vaccination in continental Europe.
On 23 February 2021, the Brazilian Health Regulatory Agency approved the Pfizer-BioNTech COVID-19 vaccine under its standard marketing authorization procedure. It became the first COVID-19 vaccine to receive definitive registration rather than emergency use authorization in the country.
The side effect profile of the Pfizer-BioNTech COVID-19 vaccine is similar to that of other adult vaccines. During clinical trials, the side effects deemed very common[a] are (in order of frequency): pain and swelling at the injection site, tiredness, headache, muscle aches, chills, joint pain, and fever. Fever is more common after the second dose.
Severe allergic reaction has been observed in approximately eleven cases per million doses of vaccine administered. According to a report by the US Centers for Disease Control and Prevention, 71% of those allergic reactions happened within 15 minutes of vaccination and mostly (81%) among people with a documented history of allergies or allergic reactions. The UK's Medicines and Healthcare products Regulatory Agency (MHRA) advised on 9December 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 adrenaline auto injectors. They both were treated and have recovered."
The European Medicines Agency regularly reviews the data on the vaccine's safety. In a report published on 4March 2021 it concluded that "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." The EMA added skin rash and pruritus (itching of the skin) as uncommon side effects (occurring in fewer than 1 in 100 persons), and urticaria (raised, red and itchy skin rash) and angioedema (rapid swelling under the skin) as rare side effects (occurring in fewer than 1 in 1,000 persons) in April 2021.
A US soldier holding the Pfizer-BioNTech vaccine
Tips with tozinameran in a vaccination center
Pfizer and BioNTech are manufacturing the vaccine in their own facilities in the United States and in Europe. The license to distribute and manufacture in China was purchased by Fosun, alongside its investment in BioNTech.
Manufacturing the vaccine requires a three-stage process. The first stage involves the molecular cloning of DNA plasmids that code for the spike protein by infusing them into Escherichia coli bacteria. For all markets, this stage is conducted in the United States, at a small Pfizer pilot plant in Chesterfield, Missouri (near St. Louis). After four days of growth, the bacteria are killed and broken open, and the contents of their cells are purified over a week and a half to recover the desired DNA product. The DNA is bottled and frozen for shipment. Safely and quickly transporting the DNA at this stage is so important that Pfizer has used its company jet and helicopter to assist.
The second stage is being conducted at a Pfizer plant in Andover, Massachusetts, in the United States, and at BioNTech's plants in Germany. The DNA is used as a template to build 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 10million doses. The bags are placed on trucks which take them to the next plant.
The third stage is being conducted at Pfizer plants in Portage, Michigan (near Kalamazoo) in the United States, and Puurs in Belgium. This stage involves combining the mRNA with lipid nanoparticles, then filling vials, boxing vials, and freezing them.Croda International subsidiary Avanti Polar Lipids is providing the requisite lipids. As of November 2020, the major bottleneck in the manufacturing process was 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 several weeks in deep-freeze storage while undergoing verification against 40 quality-control measures.
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 transatlantic flights (one to take DNA to Europe and one to bring back finished vaccine vials).
In February 2021, Pfizer revealed that the entire sequence initially took about 110 days on average from start to finish, and that the company was 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 at each of the three stages. Pfizer also revealed that the process requires 280 components and relies upon 25 suppliers located in 19 different countries.
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 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.
BioNTech announced in September 2020, that it had signed an agreement to acquire a manufacturing facility in Marburg, Germany from Novartis to expand their vaccine production capacity. Once fully operational, the facility would produce up to 750million doses per year, or more than 60million doses per month. The site will be the third BioNTech facility in Europe which produces the vaccine, while Pfizer operates at least four production sites in the United States and Europe.
The Marburg facility had previously specialized in cancer immunotherapy 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 nanoparticles, then ships the vaccine in bulk to other facilities for fill and finish (i.e., filling and boxing vials).
On 23 April 2021 the EMA authorised 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.
At the end of April 2021, it was reported that Pfizer had started to export vaccine doses to Mexico and Canada from the Kalamazoo plant, which is much closer geographically to both countries than the Puurs plant.
The vaccine is being delivered in vials that, once diluted, contain 2.25ml of vaccine (0.45ml frozen plus 1.8ml diluent). According to the vial labels, each vial contains five 0.3ml doses, however excess vaccine may be used for one, or possibly two, additional doses. The use of low dead space syringes to obtain the additional doses is preferable, and partial doses within a vial should be discarded. The Italian Medicines Agency officially authorized the use of excess doses remaining within single vials. As of 8January 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.
The Pfizer-BioNTech vaccine must be kept at extremely low temperatures to ensure effectiveness, roughly between -80 and -60 °C (-112 and -76 °F)
The vaccine needs to be stored at temperatures between -80 and -60 °C (-112 and -76 °F), until five days before vaccination when it can be stored at 2 to 8 °C (36 to 46 °F), and up to two hours at temperatures up to 25 °C (77 °F) or 30 °C (86 °F). In February 2021, the U.S. Food and Drug Administration (FDA) updated the emergency use authorization (EUA) to permit undiluted frozen vials of the vaccine to be transported and stored at between -25 and -15 °C (-13 and 5 °F) for up to two weeks before use.
Even high-income countries have limited cold chain capacity for ultracold transport and storage of a vaccine that degrades within five days when thawed, and requires two shots three weeks apart. The vaccine needs to be stored and transported at ultracold temperatures between -80 and -60 °C (-112 and -76 °F), much lower than for the similar Moderna vaccine. The head of Indonesia's Bio Farma Honesti Basyir said purchasing the vaccine is out of the question for the world's fourth-most populous country, given that it did not have the necessary cold chain capability. Similarly, India's existing cold chain network can handle only temperatures between 2 and 8 °C (36 and 46 °F), far above the requirements of the vaccine.
Pfizer indicated in its 9 November press release that 50million doses could be available by the end of 2020, with about 1.3billion doses provided globally by 2021. In February 2021, BioNTech announced it would increase production by more than 50% to manufacture 2billion doses in 2021, raised again at the end of March to 2.5billion doses in 2021.
In July 2020, the vaccine development program Operation Warp Speed placed an advance order of US$1.95billion with Pfizer to manufacture 100million 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 300million doses to the European Union, 120million doses to Japan, 40million doses (10million before 2021) to the United Kingdom, 20million doses to Canada, an unspecified number of doses to Singapore, and 34.4million doses to Mexico. Fosun also has agreements to supply 10million doses to Hong Kong and Macau. The Hong Kong government said it would receive its first batch of 1million doses by the first quarter of 2021.
BioNTech and Fosun agreed to supply China with a batch of 100million doses in 2021, subject to regulatory approval. The initial supply will be delivered from BioNTech's production facilities in Germany.
In January 2021, Pfizer and BioNTech offered to supply 50million doses of COVID-19 vaccine for health workers across Africa between March and the end of 2021, at a discounted price of US$10 per dose. In response South Africa has secured 20million doses expected to be delivered in consignments after March.
On 23 April 2021, the European Union announced a third contract with Pfizer-BioNTech for up to 1.8 billion doses of the companies' mRNA vaccine for distribution within two years.
Society and culture
BNT162b2 was the code name during development and testing, tozinameran is the recommended international nonproprietary name (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".
The vaccine also has the common name "COVID-19 mRNA vaccine (nucleoside-modified)" and may be distributed in packaging with the name "Pfizer-BioNTech COVID-19 Vaccine" in the US.
Pfizer reported revenue of US$154 million from the BNT162b2 vaccine in 2020.
^ abAccording to the British National Formulary and MedDRA conventions, side effects are "very common" when they occur in more than 1 in 10 instances; "common", 1 in 100 to 1 in 10; "uncommon", 1 in 1,000 to 1 in 100; "rare", 1 in 10,000 to 1 in 1,000; and "very rare" when they occur in less than 1 in 10,000 instances.
^ abcdefClinical trial number NCT04368728 for "NCT04368728: Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals" at ClinicalTrials.gov
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). World Health Organization (WHO). hdl:10665/339218. WHO/2019-nCoV/vaccines/SAGE_recommendation/BNT162b2/background/2021.1.