Comirnaty Vaccine (BNT162b2) Description
BioNTech and Pfizer developed the Comirnaty (BNT162b2) vaccine to prevent severe COVID-19 disease caused by the SARS-CoV-2 coronavirus. Comirnaty is a nucleoside-modified RNA formulated in lipid nanoparticles and encodes an optimized SARS-CoV-2 full-length spike protein antigen.
The Comirnaty (BNT162b2) (Tozinameran) mRNA vaccine was issued the first U.S. FDA emergency use authorization for a vaccine to prevent COVID-19 individuals 16 years of age and older on December 11, 2020. However, the Pfizer-BioNTech COVID-19 vaccine has not been Approved or Licensed by the U.S. FDA.
On December 31, 2020, the World Health Organization (WHO) issued an Emergency Use Listing (EUL) for the Comirnaty vaccine. The WHO stated, 'novel Covid-19 mRNA vaccine does not contain the SARS-CoV-2 coronavirus itself and cannot cause COVID-19.'
On July 1, 2020, the manuscript describing the preliminary clinical data for BNT162 was available online for scientific peer-review for potential publication.
On July 27, 2020, the Companies advanced nucleoside-modRNA candidate BNT162b2, which encodes an optimized SARS-CoV-2 full-length spike glycoprotein, at a 30µg dose level, in a 2-dose regimen, into Phase 2/3 study of up to 30,000 participants aged 18 – 85 years, and is expected to include approximately 120 sites globally.
Pfizer and BioNTech stated on August 5, 2020, they began a Phase 2b/3 safety and efficacy trial and remained on track to seek regulatory review as early as October 2020. This study was last updated on September 4, 2020.
On August 20, 2020, a non-peer-reviewed abstract found BNT162b2 was associated with less systemic reactogenicity, particularly in older adults.
Pfizer provided an update on September 15, 2020, stating: 'Limited blinded tolerability data from the ongoing Phase 3 trial, confirming the mild to moderate tolerability profile as was observed in Phase 1. In the blinded data presented, 50% of trial participants received a placebo, and 50% received BNT162b2.'
On September 12, 2020, the companies announced they have submitted a request to the U.S. FDA to expand the enrollment of their Phase 3 pivotal COVID-19 vaccine trial to up to approximately 44,000 participants, which increases the study's population diversity, and include adolescents as young as 16 years of age and people with chronic, stable HIV, Hepatitis C, or Hepatitis B infection.
On September 17, 2020, Pfizer's overview document for the 'Phase 1/2/3 Study to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals' became available.
On November 9, 2020, the companies issued a press statement that said 'the vaccine candidate was found to be more than 90% effective in preventing COVID-19 in (94) participants without evidence of prior SARS-CoV-2 infection the first interim efficacy analysis. The phase 3 clinical trial will continue through to final analysis at 164 confirmed cases to collect further data and characterize the vaccine candidate’s performance against other study endpoints.'
“The first interim analysis of our global Phase 3 study provides evidence that a vaccine may effectively prevent COVID-19. This is a victory for innovation, science, and a global collaborative effort,” said Prof. Ugur Sahin, BioNTech's CEO.
And on November 18, 2020, Pfizer and BioNTech announced that, after conducting the final efficacy analysis in their ongoing Phase 3 study, their vaccine candidate, BNT162b2, met all of the study’s primary efficacy endpoints.
On December 10, 2020, the NEJM published original research that confirmed a 2-dose regimen of BNT162b2 conferred 95% protection against COVID-19 in persons 16 years of age or older. And, safety over a median of 2 months was similar to that of other viral vaccines.
An early release of the CDC's Morbidity and Mortality Weekly Report published on December 13, 2020, stated 'after an explicit, evidence-based review of all available data, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation for the use of the Pfizer-BioNTech COVID-19 vaccine in persons aged ≥16 years for the prevention of COVID-19. And, the ACIP will continue to review additional data as they become available; updates to recommendations or clinical considerations will be posted on the ACIP website.'
On December 14, 2020, the companies announced additional data on neutralizing antibody and T cell responses from the Phase 1/2 trial with BNT162b2 conducted in Germany. The study results demonstrate that BNT162b2 elicits a combined adaptive humoral and cellular immune response against SARS-CoV-2 and provide insights into the composite nature of BNT162b2-induced T cell immunity. The results were published on the preprint server MedRxiv.
Ugur Sahin, M.D., CEO and Co-founder of BioNTech, stated in a press release: “While there is a broad consensus that vaccines should induce antibody responses against the virus, experiences from the prior SARS pandemic indicate that CD8+ T cell responses may be of critical importance to achieve long-term protection.”
BioNTech will provide its partners' clinical supply of the vaccine from its GMP-certified mRNA manufacturing facilities in Europe during the clinical development stage.
BioNTech is also collaborating with Fosun Pharma to develop BNT162 in China. On March 13, 2020, Fosun Pharma became the strategic partner of BioNTech in China, jointly developing and commercializing vaccine products for COVID-19 based on its proprietary mRNA technology platform in Mainland China, Hong Kong, the Macau Special Administration Region, and the Taiwan Region.
Biopharmaceutical New Technologies is an immunotherapy company pioneering novel therapies for cancer and other serious diseases. The company published a corporate update on December 2, 2020.
Pfizer's corporation information is updated at this link.
Comiranty Vaccine (BNT162b2) Side Effects
Summary of safety data: In clinical trials, reactogenicity symptoms (side effects that happen within 7 days of getting vaccinated were common but were mostly mild to moderate. Side effects, such as fever, chills, tiredness, and headache, were more common throughout the body after the second vaccine dose. Most side effects were mild to moderate. However, a small number of people had severe side effects—defined as side effects affecting a person’s ability to do daily activities.
The U.S. CDC publishes 'Understanding Side Effects and Adverse Events.'
Anaphylaxis, an acute and potentially life-threatening allergic reaction, has been reported following the COVID-19 vaccination. Detailed information on CDC recommendations for vaccination, including contraindications and precautions to vaccination, can be found in the Clinical Considerations for the use of mRNA COVID-19 Vaccines Currently Authorized in the USA.
Comirnaty Vaccine (BNT162b2) Coronavirus Variants
A non-peer-reviewed study published on January 19, 2021, investigated SARS-CoV-2-S pseudoviruses bearing either the Wuhan reference strain or the B.1.1.7 lineage spike protein with sera of 16 participants in a previously reported trial with the COVID-19 vaccine BNT162b2. The vaccine's immune sera had equivalent neutralizing titers to both variants. Together with the combined immunity involving humoral and cellular effectors induced by this vaccine, these data make it unlikely that the B.1.1.7 lineage will escape BNT162b2-mediated protection.
Comirnaty Vaccine (BNT162b2) Ingredients
Each dose of the Pfizer-BioNTech COVID-19 Vaccine contains 30 mcg of a nucleoside-modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2.
And each dose of the Pfizer-BioNTech COVID-19 Vaccine also includes the following ingredients: lipids (0.43 mg (4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.05 mg 2[(polyethylene glycol)-2000]- N,N-ditetradecylacetamide, 0.09 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.2 mg cholesterol), 0.01 mg potassium chloride, 0.01 mg monobasic potassium phosphate, 0.36 mg sodium chloride, 0.07 mg dibasic sodium phosphate dihydrate, and 6 mg sucrose. The diluent (0.9% Sodium Chloride Injection, USP) contributes an additional 2.16 mg sodium chloride per dose.
The Pfizer-BioNTech COVID-19 Vaccine does not contain preservatives. The vial stoppers are not made with natural rubber latex.
The U.S. CDC publishes 'Common Ingredients in U.S. Licensed Vaccines.'
Comirnaty Vaccine (BNT162b2) Distribution
On January 8, 2021, the EMA’s Human Medicines Committee recommended updating the product information for Comirnaty to clarify that each vial contains 6 doses of the vaccine. To extract six doses from a single vial, low dead-volume syringes and/or needles should be used. The low dead-volume syringe and needle combination should have a dead volume of no more than 35 microliters. If standard syringes and needles are used, there may not be enough of the vaccine to extract the sixth dose from a vial if the amount of vaccine remaining in the vial after the fifth dose cannot provide a full dose (0.3 ml). Further information on all the steps for using Comirnaty is available in the EMA's updated product information.
As of December 20, 2020, the companies stated, 'the vaccine has been authorized or approved for emergency use in more than 15 countries.'
On July 31, 2020, the companies agreed to supply 120 million vaccine doses to Japan in the first half of 2021, subject to regulatory approval.
And on August 9, 2020, the companies finalized discussions to supply European countries with 200 million doses and an option to purchase additional 100 million doses, with deliveries starting by the end of 2020, subject to regulatory approval. In case safety and efficacy studies are successful and the vaccine receives regulatory approval, the companies are expecting to manufacture up to 100 million doses by the end of 2020 and potentially more than 1.3 billion vaccine doses by the end of 2021.
On August 27, 2020, BioNTech SE and Shanghai Fosun Pharmaceutical Co. announced an intended collaboration to supply 10 million doses of their BNT162 mRNA-based vaccine to Hong Kong (Special Administrative Region of China, SAR) and Macao (SAR).
On November 3, 2020, Fosun’s Chief Medical Officer Hui Aimin told Reuters in an interview 'they could seek emergency use authorization in China for BNT162b2. Hui said Fosun was applying for a bridge study for BNT162b2, designed to evaluate whether the large trial data gathered overseas could be extrapolated to the populace of China.'
On November 10, 2020, the companies disclosed an agreement with the European Union (EU) to deliver 200 million vaccine doses, with an option to purchase an additional 100 million doses. BioNTech’s manufacturing sites in Germany and Pfizer’s manufacturing site in Belgium will produce the vaccine supply for the EU. Based on current projections, the companies expect to produce globally up to 1.3 billion doses in 2021.
Pfizer announced a pilot delivery program in four US states; Rhode Island, Texas, New Mexico, and Tennessee. “We are hopeful that results from this vaccine delivery pilot will serve as the model for other U.S. states and international governments, as they prepare to implement effective COVID-19 vaccine programs,” reported Reuters on November 16, 2020.
The UK announced the first Emergency Use Authorization following a worldwide Phase 3 trial of a vaccine to help fight the pandemic on December 2, 2020. Pfizer and BioNTech anticipate further regulatory decisions across the globe in the coming days and weeks and are ready to deliver vaccine doses following potential regulatory authorizations or approvals.
The Honourable Anita Anand, Minister of Public Services and Procurement announced on December 7, 2020, Canada will receive up to 249,000 doses of the Pfizer-BioNTech COVID-19 vaccine in December 2020, contingent on Health Canada authorization of the vaccine. These doses are part of the up to 76 million doses Canada has secured through its existing agreement with Pfizer. On December 9, 2020, Health Canada issued authorization.
The US government issued distribution authorization on December 11, 2020.
Prime Minister Lee Hsien Loong announced on December 14, 2020, the city-state of Singapore would receive its first batch of the Pfizer-BioNTech coronavirus vaccine by the end of December 2020 and plans to offer it on a free and voluntary basis to the entire population before the second half of 2021.
On December 22, 2020, Malaysia announced it would begin administering Pfizer's Covid-19 vaccine as early as February 2021. The government will also procure enough vaccines to cover more than 80% of the population.
On December 23, 2020, the U.S. government announced it would purchase an additional 100 million doses of the Pfizer/BioNTech COVID-19 vaccine.
BioNTech announced on December 29, 2020, the European Union ordered 100 million additional doses of COMIRNATY bringing total doses to 300 million for EU member states. All 300 million doses are expected to be delivered before 2022.
Comirnaty Vaccine (BNT162b2) Cold Storage
The BNT162b2 vaccine candidate needs to be stored and transported at ultracold temperatures below −70 °C (−94 °F) since the vaccine degrades within 5 days when thawed, says the company.
Failure to store and handle vaccines properly can reduce vaccine potency, resulting in inadequate immune responses in patients and poor protection against disease because the vaccines they received may have been compromised, said the U.S. CDC in 2018.
The Pfizer-BioNTech COVID-19 Vaccine Multiple Dose Vial contains a frozen suspension that does not contain preservatives and must be thawed and diluted before administration. • Vials may be thawed in the refrigerator [2ºC to 8ºC (35ºF to 46ºF)] or at room temperature [up to 25ºC (77ºF).
Comirnaty Vaccine (BNT162b2) Indication
BNT162 is an experimental vaccine candidate that intends to prevent COVID-19 disease in humans aged 16-85. Do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with a known history of a severe allergic reaction (e.g., anaphylaxis) to any component Pfizer-BioNTech COVID-19 Vaccine.
No pediatric, oncology, or pregnancy vaccine efficacy data has been disclosed. Religious considerations, such as Kosher or Halal, are pending.
Data are not available to assess Pfizer-BioNTech COVID-19 Vaccine's effects on the breastfed infant or milk production/excretion.
On December 9, 2020, the UK's NHS issued an advisory regarding a potential risk for those with severe allergies. The NHS stated, 'the COVID-19 mRNA Vaccine BNT162b2 is not recommended during pregnancy. For women of childbearing age, pregnancy should be excluded before vaccination. Also, women of childbearing age should be advised to avoid pregnancy for at least 2-months after their second dose. Furthermore, risks are unknown whether COVID-19 mRNA Vaccine BNT162b2 is excreted in human milk. A risk to the newborns/infants cannot be excluded. COVID-19 mRNA Vaccine BNT162b2 should not be used during breast-feeding.'
However, on December 10, 2020, the ACOG 'urged the CDC's ACIP committee to include pregnant and lactating individuals in its guidance, providing a permissive recommendation based on an appropriate discussion of risks and benefits between clinicians and pregnant and lactating patients.
Comirnaty Vaccine (BNT162b2) Dosage
The Pfizer-BioNTech COVID-19 Vaccine is administered intramuscularly as a series of two doses (0.3 mL each) three weeks apart.
There are no data to assess the Pfizer-BioNTech COVID-19 Vaccine administration with other vaccines.
Older adults will only be immunized with a given dose level of a vaccine candidate once testing that candidate and dose level in younger adults has provided initial evidence of safety and immunogenicity. Subjects with a higher risk for a severe COVID-19 infection will be included in the second part of the study.
The dose-escalation portion of the study, healthy adults 18–55 and 65–85 years of age were randomized in an ongoing, placebo-controlled, observer-blinded dose-escalation study to receive 2 doses at 21-day intervals of placebo or either of 2 lipid nanoparticle–formulated, nucleoside-modified RNA vaccine candidates: BNT162b1, which encodes a secreted trimerized SARS-CoV-2 receptor-binding domain, or BNT162b2, which encodes a prefusion stabilized membrane-anchored SARS-CoV-2 full-length spike. In each of 13 groups of 15 participants, 12 received a vaccine, and 3 received a placebo.
Groups were distinguished by a vaccine candidate, age of the participant, and vaccine dose level. Interim safety and immunogenicity data of BNT162b1 in younger adults have been reported previously from US and German trials. We now present additional safety and immunogenicity data from the Phase 1 trial that supported the vaccine candidate's selection advanced to a pivotal Phase 2/3 safety and efficacy evaluation.
Comirnaty Vaccine (BNT162b2) News
January 15, 2021 - Pfizer and BioNTech announced they had developed a plan that will allow the scale-up of manufacturing capacities in Europe and delivers significantly more doses in the second quarter. To accomplish this, certain modifications of production processes are required now. As a result, our facility in Puurs, Belgium, will temporarily reduce the number of doses delivered in the upcoming week. We will be back to the original schedule of deliveries to the European Union beginning the week of January 25, with increased delivery beginning the week of February 15, resulting in our ability to deliver the fully committed quantity of vaccine doses in the first quarter and significantly more in the second quarter. The companies will inform the European Commission, EU member states, and other countries impacted by the updated delivery schedule changes.
January 13, 2021 - The Lancet published 'European Medicines Agency's EU conditional marketing authorizations for COVID-19 vaccines.' Few medicines are awaited as eagerly as COVID-19 vaccines. Extraordinary efforts by scientists, regulators, and developers enabled the European Medicines Agency (EMA) to recommend the first EU conditional marketing authorization (CMA) for the BioNTech COVID-19 mRNA vaccine (nucleoside-modified) BNT162b2 (Comirnaty) some 9 months after the COVID-19 pandemic was declared. On Dec 21, 2020, the European Commission granted CMA, following the EMA's positive opinion, to BNT162b2 for active immunization of individuals aged 16 years and older to prevent COVID-19. The first EU marketing authorizations for COVID-19 vaccines offer hope to control the pandemic and provide proof of concept for a new approach to vaccine development in response to future emerging health threats.
January 12, 2021 - The Times of Israel reported initial data shows that Pfizer’s coronavirus vaccine curbs coronavirus infections by some 50% 14 days after the first vaccination is administered, said Sharon Alroy-Preis, head of the Health Ministry’s public health department.
January 8, 2021 - Statement regarding European Commission’s Proposal to Purchase Additional Doses of BioNTech-Pfizer Vaccine - The amendment being discussed is for a firm order for an additional 200 million doses of COMIRNATY® to be supplied to the 27 EU member states, with an option for the EC to request an additional 100 million doses. This amendment would add to the 300 million doses that have already been committed to the EU through 2021 under the original supply agreement signed last year. The additional doses would be delivered starting in the second quarter of 2021. This would bring the total number of doses to be delivered to EU member states by the end of 2021 to 500 million doses, with the potential for an additional 100 million if the option is exercised.
January 8, 2021 - BioNTech SE announced results from an in vitro study conducted by Pfizer and the University of Texas Medical Branch that shows the antibodies from people who have received the Pfizer-BioNTech COVID-19 vaccine effectively neutralize SARS-CoV-2 with a key mutation that is also found in two highly transmissible strains. While the virus tested in this experiment did not include the full set of spike mutations found on the rapidly spreading strains in the U.K. or South Africa, neutralization of the virus with the N501Y mutation by the Pfizer-BioNTech vaccine-elicited human sera is consistent with preserved neutralization of a panel of 15 pseudoviruses bearing spikes with other mutations found in circulating SARS-CoV-2 strains. This indicates that the key N501Y mutation found in the emerging U.K and South Africa variants does not create resistance to the Pfizer-BioNTech vaccine-induced immune responses.
January 6, 2021 - Nearly 1.5 million Israelis have received the first dose of the Pfizer coronavirus vaccine, Health Minister Yuli Edelstein said Wednesday morning.
December 31, 2020 - The NEJM study reported, 'A two-dose regimen of BNT162b2 conferred 95% protection against Covid-19 in persons 16 years of age or older. Safety over a median of 2 months was similar to that of other viral vaccines.'
December 31, 2020 - The WHO listed the Comirnaty COVID-19 mRNA vaccine for emergency use, making it the first to receive emergency validation from the WHO. The WHO’s Emergency Use Listing opens the door for countries to expedite their own regulatory approval processes to import and administer the vaccine. It also enables UNICEF and the Pan-American Health Organization to procure the vaccine for distribution to countries in need.
December 30, 2020 - Following U.S. FDA approval, reports of possible allergic reactions have raised public concern. To provide reassurance and support during widespread vaccination across America, allergists must offer clear guidance to patients based on the best information available and per the broader recommendations of our US regulatory agencies. This review summarizes vaccine allergy epidemiology and proposes risk stratification schema: (1) for individuals with different allergy histories to safely receive their first COVID-19 vaccine and (2) for individuals who develop a reaction to their first dose of COVID-19 vaccine.
December 29, 2020 - Pfizer Inc. and BioNTech SE announced they would supply an additional 100 million doses of COMIRNATY®, the companies’ COVID-19 Vaccine, to the 27 European Union (EU) member states in 2021. This announcement results from the European Commission’s decision to exercise its option to purchase an additional 100 million doses under its Advanced Purchase Agreement signed on November 11, 2020. This agreement brings the total number of doses to the EU to 300 million.
December 28, 2020 - The U.S. FDA posted an updated letter of authorization, health care provider fact sheet, and frequently asked questions regarding the number of Pfizer-BioNTech doses in a vial.
December 24, 2020 - After the European Medicines Agency's granting and its validation by the European Commission of a conditional marketing authorization for the Comirnaty® mRNA vaccine, the HAS confirms the vaccine strategy against Covid-19 and determine the place of this vaccine in this strategy. At the same time, it publishes recommendations intended for general practitioners to guide them in conducting a pre-vaccination consultation.
December 23, 2020 - The US Secretary of Health announced that the administration would purchase an additional 100 million doses of the Comirnaty vaccine on Twitter.
December 21, 2020 - Pfizer Inc. and BioNTech SE announced that the European Commission had granted a conditional marketing authorization (CMA) for COMIRNATY® (also known as BNT162b2) for active immunization to prevent COVID-19 caused by SARS-CoV-2 virus in individuals 16 years of age and older. This follows the European Medicines Agency’s Committee for Medicinal Products for Human Use positive opinion to authorize the vaccine earlier today. The CMA is valid in all 27 member states of the European Union.
December 21, 2020 - The European Medicines Agency (EMA) held a virtual press briefing on the outcome of the EMA’s human medicines committee meeting, which discussed the COVID-19 vaccine from BioNTech / Pfizer. The EMA has recommended granting conditional marketing authorization for the vaccine Comirnaty, developed by BioNTech and Pfizer, to prevent coronavirus disease 2019 (COVID-19) in people from 16 years. EMA’s scientific opinion paves the way for the first marketing authorization of a COVID-19 vaccine in the EU by the European Commission, with all the safeguards, controls, and obligations this entails.
December 20, 2020 - The U.S. CDC published information about 1:00 PM ET indicating 556,208 doses of the Pfizer COVID-19 Vaccine have been administered in the USA.
December 19, 2020 - Pfizer AG and BioNTech SE announced that Swissmedic in Switzerland had granted a Conditional Marketing Authorization for their COVID-19 mRNA vaccine COMIRNATY® (BNT162b2), the brand name under which the vaccine will be marketed in Switzerland. The distribution of the vaccine in Switzerland will be prioritized by the Federal Office of Public Health, according to the populations identified in guidance from the Federal Vaccination Commission.
December 19, 2020 - The Saudi Health Ministry announced the start of registration for the COVID-19 vaccine for all citizens and expatriates in the kingdom through the smart app “Sehhaty” by visiting http://onelink.to/yjc3nj. “There is interest in registering for taking the vaccine as the number of those who have registered via Sehaty has surpassed 300,000 in three days,” Undersecretary of the Saudi Health Ministry for Public Health Dr. Hani Jokhdar said.
December 18, 2020 - The journal BMG published a response by Charles J Egmont, Barrister-at-Law Retired, Oxford: 'In the case of the UK adverse reactions, a vaccine component Polyethylene Glycol (PEG) was considered to be the primary cause. Apparently, PEG has been well cited in the medical literature as a pharmaceutical composition that causes severe allergies.'
December 17, 2020 - Pfizer Inc. released the following statement to address public comments that allege there are issues in the production and distribution of the company’s COVID-19 vaccine: “Pfizer is not having any production issues with our COVID-19 vaccine, and no shipments containing the vaccine are on hold or delayed. This week, we successfully shipped all 2.9 million doses that we were asked to ship by the U.S. Government to the locations specified by them. We have millions of more doses sitting in our warehouse, but, as of now, we have not received any shipping instructions for additional doses."
December 14, 2020 - Pfizer Inc. and BioNTech SE announced additional data on neutralizing antibody and T cell responses from the Phase 1/2 trial with BNT162b2 conducted in Germany. The study results demonstrate that BNT162b2 elicits a combined adaptive humoral and cellular immune response against SARS-CoV-2 and provide insights into the composite nature of BNT162b2-induced T cell immunity. The results were published on the preprint server MedRxiv and are available here. BNT162b2 is an investigational COVID-19 vaccine developed by Pfizer-BioNTech. It has been authorized for emergency use for individuals 16 years of age and older in several countries worldwide.
December 12, 2020 - The U.S. CDC's ACIP voted (11 yes, to 3 recuse) to recommend the experimental Pfizer - BioNTech COVID-19 Vaccine for people age 16+ USA, under U.S. FDA's Emergency Use Authorization, which was issued on December 11, 2020.
December 11, 2020 - The U.S. FDA issued the first emergency use authorization for a vaccine to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus in individuals 16 years of age and older. The emergency use authorization allows the Pfizer-BioNTech COVID-19 Vaccine to be distributed in the U.S.
December 11, 2020 - The Commissioner of US Food and Drug Administration issued the following statement: 'Following yesterday’s positive advisory committee meeting outcome regarding the experimental Pfizer-BioNTech COVID-19 vaccine (BNT162b2), the U.S. FDA has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization.'
December 10, 2020 - The U.S. FDA's Vaccines and Related Biological Products Advisory Committee voted to affirm the Emergency Use Authorization of the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) for the prevention of COVID-19 in individuals 16 years of age and older.
December 10, 2020 - The British Medical Journal (BMJ) reported the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) is currently investigating (2) cases of anaphylactoid reactions in NHS staff who received the experimental vaccine BNT162b2 on December 8, 2020. Both people had a history of severe allergic reactions and carried adrenaline auto-injectors. The MHRA has informed people running BNT162b2 vaccination sites in the UK to report any suspected adverse reactions and to ensure that they have appropriate resuscitation facilities available,
December 10, 2020 - The Kingdom of Saudi Arabia’s Food and Drug Agency has registered the Pfizer-BioNTech COVID-19 vaccine for import and use in the country, state news agency SPA reported. The Authority said that based on the approval issued today, concerned health authorities would start importing procedures according to concerned standards and requirements.
December 9, 2020 - BioNTech was informed by the European Medicines Agency (EMA) that the agency has been subject to a cyber attack and that some documents relating to the regulatory submission for Pfizer and BioNTech’s COVID-19 vaccine candidate, BNT162b2, which has been stored on an EMA server, had been unlawfully accessed. It is important to note that no BioNTech or Pfizer systems have been breached in connection with this incident. We are unaware that any study participants have been identified through the accessed data. At this time, we await further information about EMA’s investigation and respond appropriately and according to EU law. EMA has assured us that the cyber attack will have no impact on its review timeline.
December 9, 2020 - National Health Service medical director Stephen Powis is reported to say: 'the advice had been changed after two NHS workers reported anaphylactoid reactions associated with receiving the vaccine. They were among the thousands who received the vaccination on December 8th. “As is common with new vaccines, the MHRA (regulator) have advised on a precautionary basis that people with a significant history of allergic reactions do not receive this vaccination.' The MHRA said it would seek further information and was investigating as a matter of priority, and Pfizer and BioNTech said they were supporting the MHRA’s investigation.
December 9, 2020 - Pfizer Canada and BioNTech SE announced that Health Canada had granted Authorization under Interim Order for the emergency use of their mRNA COVID-19 vaccine (BNT162b2). BioNTech will hold the regulatory approval in Canada, while Pfizer Canada will have the commercialization rights.
December 8, 2020 - The U.S. FDA's Vaccines and Related Biological Products Advisory Committee Meeting scheduled for December 10, 2020, has released the Briefing Document for the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) discussion. Safety data from approximately 38,000 participants ≥16 years of age randomized 1:1 to vaccine or placebo with a median of 2 months of follow up after the second dose suggest a favorable safety profile, with no specific safety concerns identified that would preclude the issuance of a EUA. The committee will also discuss what the vaccine manufacturer should conduct additional studies following the issuance of the EUA to gather further data on the safety and effectiveness of this vaccine.
December 7, 2020 - The Honourable Anita Anand, Minister of Public Services and Procurement, said: “The Government of Canada continues to do everything possible to protect Canadians from COVID-19. This includes securing the world’s most extensive portfolio of vaccines and taking all necessary measures to ready the country to receive doses once they are authorized for use.”
December 6, 2020 - Media is reporting Pfizer India has become the first pharmaceutical firm to approach the Drugs Controller General of India seeking emergency authorization for its COVID-19 vaccine in India.
December 4, 2020 - The Company's presentation: Next Generation Immunotherapy was published.
December 4, 2020 - The Kingdom of Bahrain announced it had granted emergency use authorization for the BioNTech developed COVID-19 vaccine, BNT162b2, becoming the second country after Britain to approve it. Dr. Mariam Al-Jalahma, CEO of Bahrain’s National Health Regulatory Authority, said in a statement: 'The vaccine will be made available to groups at greater risk of contracting complications from the coronavirus, including the elderly, people with chronic diseases, and other groups identified by the health ministry as vulnerable.'
December 2, 2020 - Pfizer Inc. and BioNTech SE announced the Medicines & Healthcare Products Regulatory Agency (MHRA) in the U.K. had granted a temporary authorization for emergency use for their COVID-19 mRNA vaccine (BNT162b2) against COVID-19. The MHRA’s decision is based on a rolling submission, including data from the Phase 3 clinical study, which demonstrated a vaccine efficacy rate of 95% in participants without prior SARS-CoV-2 infection and also in participants with and without prior SARS-CoV-2 infection, in each case measured from 7-days after the second dose.
December 1, 2020 - The EMA announced it had received an application for conditional marketing authorization (CMA) for BNT162b2, a COVID‑19 mRNA vaccine developed by BioNTech and Pfizer. The assessment of BNT162b2 will proceed under an accelerated timeline. An opinion on the marketing authorization could be issued within weeks, depending on whether the data submitted are sufficiently robust and complete to show the vaccine's quality, safety, and effectiveness.
November 25, 2020 - BioNTech SE and Shanghai Fosun Pharmaceutical Co., Ltd. jointly announced that their lead mRNA COVID-19 vaccine candidate BNT162b2 would be evaluated in Phase 2 clinical trial Taizhou and Lianshui, Jiangsu Province, China.
November 23, 2020 - Between 200,000 and 500,000 doses of the SARS-CoV-2 coronavirus vaccine from Pfizer Pharmaceuticals will arrive in Israel during December 2020, assuming regulators clear the substance for use, according to a report broadcast by Israel’s Channel 12 news.
November 20, 2020 - The U.S. Food and Drug Administration (FDA) has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee on December 10, 2020, to discuss the request for emergency use authorization of a COVID-19 vaccine from Pfizer, Inc. in partnership with BioNTech Manufacturing GmbH. FDA Commissioner Stephen M. Hahn, M.D., added in a press statement: “The FDA has been preparing for the review of EUAs for COVID-19 vaccines for several months and stands ready to do so as soon as a request is submitted. While we cannot predict how long the FDA’s review will take, the FDA will review the request as expeditiously as possible while still doing so in a thorough and science-based manner so that we can help make available a vaccine that the American people deserve as soon as possible."
November 18, 2020 - Pfizer Inc. and BioNTech SE announced that, after conducting the final efficacy analysis in their ongoing Phase 3 study, their mRNA-based COVID-19 vaccine candidate, BNT162b2, met all of the study’s primary efficacy endpoints. Analysis of the data indicates a vaccine efficacy rate of 95% (p<0.0001) in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from 7-days after the second dose. Vaccine Efficacy was consistent across age, gender, race, and ethnicity demographics.
November 13, 2020 - Prime Minister Benjamin Netanyahu announced Friday that Israel had signed an agreement with Pfizer Inc. and Germany's BioNTech SE to supply its coronavirus vaccine in 2021. In televised remarks, Netanyahu said the agreement marked “a great day for Israel” and added: “The goal is for the vaccine supply to start in January and increase in the months thereafter.”
November 12, 2020 - China’s regulatory authority accepts the Fosun Pharma clinical trial application of the mRNA vaccine candidate. The Shanghai-based conglomerate will maintain close communication with regulatory and licensing authorities and hopes ongoing research and testing will show the vaccine complies with Chinese laws and will be available as quickly as possible, wrote Guo. In March 2020, Fosun Pharmaceutical Industrial was granted a German company BioNTech to develop and commercialize its vaccine products exclusively developed based on BioNTech's proprietary mRNA technology platform targeting COVID-19 in China.
November 10, 2020 - BioNTech SE and Pfizer announced that they had reached an agreement with the European Commission to supply 200 million doses of their investigational BNT162b2 mRNA-based vaccine candidate against COVID-19 to European Union Member States, with an option for the European Commission to request an additional 100 million doses. "We aim to develop a safe and effective vaccine to contribute to bringing this pandemic to an end. Only through joint efforts will we be able to do so,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech.
November 9, 2020 - Pfizer Inc. and BioNTech SE announced their mRNA-based vaccine candidate, BNT162b2, against SARS-CoV-2 had demonstrated evidence of efficacy against COVID-19 in participants without prior evidence of SARS-CoV-2 infection, based on the first interim efficacy analysis conducted on November 8, 2020, by an external, independent Data Monitoring Committee from the Phase 3 clinical study.
November 4, 2020 - New York-based Pfizer 'intends to use its own distribution system to deliver its COVID vaccine directly to healthcare providers,' said Tanya Alcorn, Pfizer's vice president for global supply chain, during a recent webinar. A Pfizer spokesperson confirmed that plan in an email to FiercePharma on November 4, 2020.
October 27, 2020 - A comprehensive update of Pfizer’s development pipeline was published today and is now available at www.pfizer.com/science/drug-product-pipeline. It includes an overview of the BNT162 COVID-19 Vaccine Development Program.
October 21, 2020 - The WSJ reported 'to keep the vaccines safe in transit and to move them fast, Pfizer designed a new reusable container that can keep the vaccine at ultracold temperatures for up to 10 days and hold between 1,000 and 5,000 doses. The suitcase-sized boxes, which are packed with dry ice and tracked by GPS, will enable Pfizer to avoid the larger, temperature-controlling containers used in transportation, giving it more flexibility to ship the vaccines faster since planes and trucks won’t have to wait for the standard refrigerated metal boxes.'
October 20, 2020 - Pfizer and BioNTech SE announced launching a combined Phase I and Phase II clinical trials in Japan of their mRNA vaccine candidate against the coronavirus.
October 16, 2020 - Pfizer Inc.’s Chief Executive Officer Albert Bourla noted in an open letter posted on the company's website that Pfizer expects to have the safety data from its SARS-CoV-2 coronavirus vaccine candidate BNT162 in the third week of November 2020. All the data in our U.S. application would be reviewed by the FDA’s own scientists and an external panel of independent experts at a publicly held meeting convened by the agency.
October 14, 2020 - Australia’s Therapeutic Goods Administration announced Pfizer Australia Pty Ltd. had received provisional 'determination' for its COVID-19 vaccine candidate, BNT162b2. The next step is that Pfizer may now apply for provisional 'approval.'
October 13, 2020 - Pfizer Inc. expanded its Phase 3 clinical trial for the BNT162b2 vaccine candidate has received permission from the U.S. FDA to enroll children aged 12 and older.
October 12, 2020 - Pfizer's updated website stated: 'We are grateful to each of the more than 120 clinical trial investigators and their study teams who are partnering with us in this effort and to all of the participants who have volunteered, and will volunteer, to help make a difference for society.'
October 7, 2020 - Rentschler Biopharma SE announced an agreement to serve as a CDMO partner for BioNTech. As an initial project, Rentschler Biopharma will be responsible for key aspects of cGMP drug substance manufacturing of BNT162b2, the mRNA-based vaccine against SARS-CoV-2 developed by Pfizer and BioNTech.
October 6, 2020 - Pfizer Inc. and BioNTech SE announced the initiation of a rolling submission to the European Medicines Agency for BNT162b2, the lead candidate from the companies’ vaccine development program against COVID-19.
September 17, 2020 - BioNTech SE announced the signing of a share purchase agreement with Novartis AG to acquire its GMP certified manufacturing facility in Marburg, Germany. The manufacturing site will expand BioNTech’s COVID-19 vaccine production capacity by up to 750 million doses per year, or over 60 million doses per month, once fully operational. The transaction is expected to close in the fourth quarter of 2020. The Company plans to produce up to 250 million doses of BNT162b2 in the first half of 2021.
September 15, 2020 - Pfizer Inc. provided an extensive overview, including new data on the BNT162b2 vaccine candidate being developed in collaboration with BioNTech SE. Submission of an amended protocol to the FDA for the Phase 3 pivotal trial to expand recruitment to approximately 44,000 participants allows for new populations' enrollment. Enrollment in the trial has been proceeding as planned, with current enrollment at more than 29,000. Based on current infection rates, the companies continue to expect that a conclusive readout on efficacy is likely by the end of October 2020.
September 15, 2020 - BioNTech SE announced that it would receive a grant of up to 375 million euros from an initiative by the German Federal Ministry of Education and Research (BMBF) to support the accelerated development SARS-CoV-2 vaccines. BioNTech will use the milestone-based BMBF funding to support its contribution to the Company’s mRNA vaccine program BNT162 that is being co-developed with its partners Pfizer Inc. and Fosun Pharma, respectively. The initiative aims to expand vaccine development and manufacturing capabilities in Germany and expand the number of late-stage clinical trials. The BNT162 vaccine program is one of three programs supported by the BMBF initiative, which will provide up to 750 million euros to its funding recipients.
September 12, 2020 - Pfizer Inc. and BioNTech SE announced they had submitted an amended protocol to the U.S. FDA to expand the enrollment of their Phase 3 pivotal COVID-19 vaccine trial to up to approximately 44,000 participants, which also allows for the enrollment of new populations.
September 9, 2020 - Pfizer and BioNTech SE announced that they had concluded talks with the European Commission for a proposed supply of 200 million doses of their investigational BNT162 mRNA-based vaccine candidate against SARS-CoV-2 to European Union Member States, with an option for a further 100 million doses. Vaccine deliveries would be starting by the end of 2020, subject to clinical success and regulatory authorization.
September 3, 2020 - Pfizer CEO confirms late-stage coronavirus vaccine trial may have study results in October 2020.
August 27, 2020 - “This announcement is the first one to potentially supply the Chinese market with a BioNTech vaccine together with our partner Fosun Pharma. It further demonstrates our commitment to provide our vaccine candidate as broadly as possible globally to help end the SARS-CoV-2 pandemic,” said Sean Marett, Chief Business and Chief Commercial Officer at BioNTech.
August 20, 2020 - A non-peer-reviewed study's conclusion supports selecting the BNT162b2 vaccine candidate for Phase 2/3 large-scale safety and efficacy evaluation.
August 17, 2020 - The Yale School of Medicine and Yale-New Haven Hospital announced the start of Phase 3 study of the BioNTech SE - Pfizer BNT162 vaccine candidate at the hospital. In Phases 1 and 2 of the trial, this novel vaccine has proven safe and effective in generating an appropriate immune response. This third phase hopes to show that it can prevent infection.
August 12, 2020 - Nature article: Phase 1/2 study of COVID-19 RNA vaccine BNT162b1 in adults. These results support further evaluation of this mRNA vaccine candidate.
August 5, 2020 - Pfizer Canada and BioNTech SE announced an agreement with the Government of Canada to supply their BNT162 mRNA-based vaccine candidate against SARS-CoV2, subject to clinical success and Health Canada approval.
July 31, 2020 - Pfizer and BioNTech SE announced an agreement with the Ministry of Health, Labour, and Welfare in Japan to supply 120 million doses of their BNT162 mRNA-based vaccine candidate against SARS-CoV-2, subject to clinical success and regulatory approval, beginning in 2021.
July 27, 2020 - Pfizer Inc. and BioNTech SE announced the start of a global, except for China, Phase 2/3 safety and efficacy clinical study to evaluate a single nucleoside-modified messenger RNA (modRNA) candidate from their BNT162 mRNA-based vaccine program against SARS-CoV-2.
July 22, 2020 - Pfizer and BioNTech SE announced the execution of an agreement with the U.S. government to meet the Operation Warp Speed program's goal to begin delivering 300 million doses of a vaccine for COVID-19 in 2021. Under the agreement, the U.S. government will receive 100 million doses of BNT162, the COVID-19 vaccine, after Pfizer successfully manufactures and obtains approval or emergency use authorization from the US Food and Drug Administration. The government also has an option to acquire an additional 500 million doses of BNT162.
July 20, 2020 - Pfizer and BioNTech announced an agreement with the United Kingdom to supply 30 million doses of their BNT162 mRNA-based vaccine candidate against SARS-CoV-2, currently in development.
July 13, 2020 - Pfizer Inc. and BioNTech SE announced that 2 of the companies’ 4 investigational vaccine candidates from their BNT162 mRNA-based vaccine program (BNT162b1 and BNT162b2) received Fast Track designation from the U.S. FDA. These vaccine candidates in the BNT162 program are currently being evaluated in ongoing Phase 1/2 clinical studies in the USA and Germany.
July 10, 2020 - BioNTech Chief Executive Officer Ugur Sahin predicted the company’s vaccine for COVID-19, which is co-developing with Pfizer, could be ready for regulatory approval by the end of the year, with hundreds of millions of doses available for immediate distribution.
July 9, 2020 - A Maryland-based graduate immunology student believes he could be one of the 1st people in the USA to produced coronavirus antibodies in response to being vaccinated in a phase 2 clinical trial conducted at the University of Maryland.
July 1, 2020 - Phase 1/2 Study to Describe the Safety and Immunogenicity of a COVID-19 RNA Vaccine Candidate (BNT162b1) in Adults 18 to 55 Years of Age: Interim Report. Local reactions and systemic events were dose-dependent, generally mild to moderate, and transient. RBD-binding IgG concentrations and SARS-CoV-2 neutralizing titers in sera increased with the dose level and after a second dose. Geometric mean neutralizing titers reached 1.8- to 2.8-fold that of a COVID-19 convalescent human sera panel.
June 29, 2020 - BioNTech SE announced a private investment of USD 250 million by investors.
June 24, 2020 - Cincinnati Children’s vaccine program is one of 4 sites testing for the BNT162 vaccine. It's continuing to enroll participants in the first stage of the study and wants underrepresented populations.
May 30, 2020 - Global pharmaceutical Pfizer CEO Albert Bourla said he believes that a vaccine could be available in the fall of 2020.
May 13, 2020 - SARS‐CoV‐2 immunogenicity at the crossroads. Letter to the editor.
May 12, 2020 - Pfizer CEO and Chairman Albert Bourla told CNBC that the company plans to expand human trials of its experimental coronavirus vaccine to thousands of test patients by September 2020. Pfizer is currently testing four different vaccine variations, Bourla said during CNBC’s Healthy Returns Virtual Summit. If one or two variations indicate success, the company will ramp up trials, and then in September, launch a broad, large-scale study with thousands of participants if a vaccine proves to be successful.
May 5, 2020 - Pfizer Inc. and BioNTech SE announced that the first participants had been dosed in the U.S. in the Phase 1/2 clinical trial for the BNT162 vaccine program to prevent COVID-19. The trial is part of a global development program, and the dosing of the first cohort in Germany was completed last week.
April 29, 2020 - BioNTech SE and Pfizer Inc. announced that the first cohort of BioNTech’s Phase 1/2 clinical trial had been dosed. Twelve study participants were dosed with vaccine candidate BNT162 in Germany since dosing began on April 23, 2020.
April 28, 2020 - Pfizer's CEO said the company expects to make safety data available by late May 2020 and move into expanded trials that could allow emergency use or accelerated approval starting in the fall.
April 22, 2020 - Pfizer Inc. and BioNTech SE have entered into a global collaboration agreement to co-develop BioNTech’s potential first-in-class, mRNA-based coronavirus vaccine program to prevent COVID-19 infection. The two companies plan to jointly conduct clinical trials for the COVID-19 vaccine candidates initially in the United States and Europe across multiple research sites. The companies estimate that there is potential to supply millions of vaccine doses by the end of 2020, subject to the technical success of the development program and approval of regulatory authorities, and then rapidly scale up to the capacity to produce hundreds of millions of doses in 2021.
Today, April 9, 2020 - BioNTech SE and Pfizer Inc. (NYSE: PFE) disclosed additional details of their collaboration to advance candidates from BioNTech’s mRNA vaccine program. The collaboration aims to rapidly advance multiple COVID-19 vaccine candidates into human clinical testing based on BioNTech’s proprietary mRNA vaccine platforms to ensure rapid worldwide access to the vaccine is approved. The collaboration will leverage Pfizer’s broad expertise in vaccine research and development, regulatory capabilities, and global manufacturing and distribution network.
March 17, 2020 - BioNTech announced details of its efforts to develop a potential vaccine to induce immunity and prevent COVID-19 infection. BioNTech is working to initiate clinical testing for BNT162, a potential first-in-class mRNA vaccine against COVID-19, in late April 2020.
March 16, 2020 - BioNTech also announced a strategic alliance with Fosun Pharma to develop its COVID-19 vaccine in China. Under the terms of the agreement, the two companies will work together to develop BNT162 in China, conduct clinical trials in China, and leverage Fosun Pharma’s extensive clinical development, regulatory, and commercial capabilities. If approved, Fosun Pharma will commercialize the vaccine in China.
Comirnaty (BNT162b2) Vaccine Clinical Trials
Pfizer's website now displays various clinical trial participant metrics.
Clinical Trial NCT04368728: A PHASE 1/2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF SARS-COV-2 RNA VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY ADULTS - Last Update Posted: January 12, 2021. Estimated Primary Completion Date: July 30, 2021.
Pfizer and BioNTech finalized the Phase 2/3 study protocol in response to global regulators' feedback, including the FDA and the German Paul-Ehrlich-Institut. The Phase 2/3 study is an event-driven trial planned to enroll 30,000 participants between 18 and 85.
The Phase 2/3 trial is designed as a 1:1 vaccine candidate to placebo, randomized, observer-blinded study to obtain safety, immune response, and efficacy data needed for regulatory review. The trial’s primary endpoints will be preventing COVID-19 in those who have not been infected by SARS-CoV-2 before immunization and prevention of COVID-19 regardless of whether SARS-CoV-2 has previously infected participants.
Secondary endpoints include the prevention of severe COVID-19 in those groups. The study also will explore the prevention of infection by SARS-CoV-2, the virus that causes COVID-19. The primary efficacy analysis will be an event-driven analysis based on the number of participants with symptomatic COVID-19 disease. The trial design allows for interim analyses and unblinded reviews by an independent external Data Monitoring Committee.
The NEJM published a study on December 31, 2020.