Pfizer-BioNTech Comirnaty Vaccine (BNT162b2) - PrecisionVaccinations

Pfizer-BioNTech Comirnaty Vaccine (BNT162b2) Description

BioNTech SE and Pfizer, Inc. 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 vaccine, which is based on BioNTech proprietary mRNA technology, was co-developed by BioNTech and Pfizer.

The Pfizer-BioNTech Comirnaty (BNT162b2) (Tozinameran) mRNA vaccine was issued the first U.S. Food and Drug Administration (FDA) emergency use authorization for a vaccine to prevent COVID-19 individuals 16 years of age and older on December 11, 2020. However, the experimental Pfizer-BioNTech COVID-19 vaccine has not been Approved or Licensed by the U.S. FDA.

The U.S. CDC issued Interim Clinical Considerations for the use of mRNA COVID-19 Vaccines Currently Authorized in the United States on January 21, 2021.

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 February 11, 2021, the U.S. CDC vaccine committee issued Interim Clinical Considerations for the use of mRNA COVID-19 Vaccines Currently Authorized in the United States.

The Pfizer-BioNTech Comirnaty COVID-19 vaccine (Tozinameran, INN), also known as BNT162b2, Drugbank Accession Number: DB15696; ChemIDplus 434370509; CAS number: 2417899-77-3

Pfizer-BioNTech Comirnaty Vaccine (BNT162b2) History

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.

A study published by The Lancet on February 22, 2021, concluded by saying, 'this study demonstrates that the BNT162b2 vaccine effectively prevents both symptomatic and asymptomatic infection in working-age adults. And this cohort was vaccinated when the dominant variant in circulation was B1.1.7 and demonstrated effectiveness against this variant.'

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.

Global Information About Pfizer‑BioNTech Comirnaty COVID‑19 Vaccine (BNT162b2)

The approval status of the Pfizer‑BioNTech COVID‑19 Vaccine varies worldwide. In countries where the relevant regulatory authority has not approved the vaccine, it is an investigational drug, and its safety and efficacy have not been established. 

Pfizer-BioNTech 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 expected 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.

The European Medicines Agency safety update issued on January 28, 2021, reflects data collected and assessed since Comirnaty's authorization, including data from EudraVigilance (the EU's centralized database of suspected side effects) and data received from other sources, including the company's monthly safety report required for COVID-19 vaccines.

Pfizer-BioNTech 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.

Pfizer-BioNTech 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.'

Pfizer-BioNTech Comirnaty Vaccine (BNT162b2) Distribution

The Australian Therapeutic Goods Administration granted provisional approval on January 25, 2021, to Pfizer Australia Pty Ltd for its COVID-19 vaccine, COMIRNATY, making it the first COVID-19 vaccine to receive regulatory approval in Australia.

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.

On January 22, 2021, Pfizer and BioNTech SE announced an advance purchase agreement with COVAX for up to 40 million doses of the Pfizer-BioNTech COVID-19 Vaccine. The doses will be delivered throughout 2021.

The Honourable Anita Anand, Minister of Public Services and Procurement, announced on February 12, 2021, that Canada has negotiated an accelerated delivery schedule for Pfizer-BioNTech's COVID-19 vaccine and will receive all 40 million of its secured doses from Pfizer-BioNTech by the end of September 2021.

Pfizer Inc. and BioNTech SE announced on February 12, 2021, that the U.S. government had exercised its option for an additional 100 million doses of the Pfizer-BioNTech COVID-19 vaccine. This brings the total number of doses to be supplied by the companies to the U.S. government to 300 million. Consistent with the agreements for the prior 200 million doses, the U.S. government will pay $1.95 billion for the additional 100 million doses. 

Pfizer-BioNTech Comirnaty Vaccine (BNT162b2) Cold Storage

The U.S. FDA announced on February 25, 2021, that it is allowing undiluted frozen vials of the Pfizer-BioNTech COVID-19 Vaccine to be transported and stored at conventional temperatures commonly found in pharmaceutical freezers for a period of up to two weeks. This reflects an alternative to the preferred storage of the undiluted vials in an ultra-low temperature freezer between -80ºC to -60ºC (-112ºF to -76ºF).

The change is being reflected in updates to the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers).

Other countries require the BNT162b2 vaccine 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.

Pfizer-BioNTech 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.

Pfizer-BioNTech 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. After dilution, one vial contains 6 doses of 0.3 mL. Vial labels and cartons may state that a vial contains 5 doses of 0.3 mL after dilution. The information in this January 2021 FDA Fact Sheet regarding the number of doses per vial after dilution supersedes the number of doses stated on vial labels and cartons.

And the World Health Organization said people should receive two doses of the Pfizer and BioNTech vaccine within 21-28 days.

Persons should not be scheduled to receive the second dose earlier than recommended (i.e., 3 weeks [Pfizer-BioNTech] or 1 month [Moderna]). However, second doses administered within a grace period of 4 days earlier than the second dose's recommended date are still considered valid. Doses inadvertently administered earlier than the grace period should not be repeated.

The second vaccine dose should be administered as close to the recommended interval as possible. However, if it is not feasible to adhere to the recommended interval, the second dose of Pfizer-BioNTech and Moderna COVID-19 vaccines may be scheduled for administration up to 6 weeks (42 days) after the first dose. There is currently limited data on the efficacy of mRNA COVID-19 vaccines administered beyond this window. If the second dose is administered beyond these intervals, there is no need to restart the series.

There is no data available on the Pfizer-BioNTech COVID-19 Vaccine interchangeability with other COVID-19 vaccines to complete the vaccination series. 

The CDC said on January 22, 2021, in exceptional situations in which the first-dose vaccine product cannot be determined or is no longer available, any available mRNA COVID-19 vaccine may be administered at a minimum interval of 28 days between doses to complete the mRNA COVID-19 vaccination series. If two doses of different mRNA COVID-19 vaccine products are administered in these situations (or inadvertently), no additional doses of either product are recommended at this time.

Given the lack of data on the safety and efficacy of mRNA COVID-19 vaccines administered simultaneously with other vaccines, the vaccine series should routinely be administered alone, with a minimum interval of 14 days before or after administration with any other vaccine. However, mRNA COVID-19 and other vaccines may be administered within a shorter period in situations where the benefits of vaccination are deemed to outweigh the potential unknown risks of vaccine coadministration (e.g., tetanus toxoid-containing vaccination as part of wound management, measles or hepatitis A vaccination during an outbreak) or to avoid barriers or delays to mRNA COVID-19 vaccination (e.g., in long-term care facility residents or healthcare personnel who received influenza or other vaccinations before/upon admission or onboarding).

If mRNA COVID-19 vaccines are administered within 14 days of another vaccine, doses do not need to be repeated for either vaccine, says the CDC.

Pfizer-BioNTech Comirnaty Vaccine (BNT162b2) CPT Code

To ensure accurate coding and reporting of COVID-19 vaccines and immunization services, the American Medical Association offers a new resource to help identify the appropriate CPT code combination for the type and dose of COVID-19 vaccine provided to each patient.

Pfizer-BioNTech Comirnaty Vaccine (BNT162b2) News

February 25, 2021 - Pfizer Inc. and Germany-based BioNTech SE announced they have begun an evaluation of the safety and immunogenicity of a third dose of the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) to understand the effect of a booster on immunity against COVID-19 caused by the circulating and potential newly emerging SARS-CoV-2 variants. The study will draw upon participants from the Phase 1 study in the USA who will be offered the opportunity to receive a 30 µg booster of the current vaccine 6 to 12 months after receiving their initial two-dose regimen. The study is part of the Companies' clinical development strategy to determine the effectiveness of the third dose against evolving variants.

February 22, 2021 - Data analyzed by Public Health England (PHE) shows the Pfizer-BioNTech vaccine provides high levels of protection against infection and symptomatic disease from the first dose. Early data from PHE's SIREN study shows a promising impact on infection in healthcare workers aged under 65. Healthcare workers in the study are tested for COVID-19 every 2 weeks – whether or not they have symptoms. Data show one dose reduces the risk of catching infection by more than 70%, rising to 85% after the second dose. This suggests the vaccine may also help to interrupt virus transmission, as you cannot spread the virus if you do not have an infection.

February 19, 2021 -  Pfizer Inc. and BioNTech SE announced the submission of new data to the U.S. Food and Drug Administration (FDA) demonstrating the stability of their COVID-19 vaccine when stored at -25°C to -15°C (-13°F to 5°F), temperatures more commonly found in pharmaceutical freezers and refrigerators. The data have been submitted to the FDA to support a proposed update to the U.S. Emergency Use Authorization Prescribing Information, which would allow for vaccine vials to be stored at these temperatures for a total of two weeks as an alternative or complement to storage in an ultra-low temperature freezer.

February 17, 2021 - The NEJM published a Letter to the Editor by Canadian researchers, Danute Skowronski, with the British Columbia Centre for Disease Control, and Gaston De Serres, with the Institut National de Sante Publique du Quebec, noting that using the same data submitted to the U.S. FDA, they calculated that before the second dose, the vComirnaty vaccine was still "highly efficacious," with an efficacy of 92.6%.

February 17, 2021 - NEJM Preliminary Report: Neutralizing Activity of BNT162b2-Elicited Serum. 'Our data are also consistent with poorer neutralization of the virus with the full set of B.1.351-spike mutations than SARS-CoV-2 virus with either subset of mutations and suggested that virus with mutant residues in the receptor-binding site (K417N, E484K, and N501Y) is more poorly neutralized than the coronavirus with Δ242-244, which is located in the N-terminal domain of the spike protein.'

February 14, 2021 - FUJIWARA Yasuhiro, M.D., Ph.D. Chief Executive Pharmaceuticals and Medical Devices Agency announced the first COVID-19 vaccine applied by Pfizer Japan Inc. was granted Special Approval for Emergency in Japan. With this Special Approval for Emergency, Japanese citizens can now start vaccination with prioritization to protect themselves against SARS-CoV-2. Special Approval for Emergency is the process under articles 14-3 of the Pharmaceuticals and Medical Devices Act to approve a medical product swiftly in an emergency to protect public health.

February 11, 2021 - Researchers from Bar-Ilan University and Ziv Medical Center now report preliminary evidence that people previously infected with the virus responded very strongly to one dose of the Pfizer vaccine, regardless of when they were infected and whether or not they had detectable antibodies against COVID-19 before receiving the vaccine. Their study, published in the journal Eurosurveillance, was conducted on a cohort of 514 staff members at Ziv Medical Center. A single dose of the BNT162b2 mRNA COVID19 vaccine was immunogenic in the vast majority (92%) of our study cohort 21 days post-vaccination, a result compatible with trial data. Of note, the sample is relatively small and therefore did not allow for adjusted analyses. Also, information on co-morbidities was not available. Since the study population only includes HCWs, it may not be representative of the wider population: elderly individuals, in particular, are under-represented. The researchers continue to follow healthcare workers after their second dose to understand better how long the vaccine will protect against COVID-19 in different groups of people.

February 10, 2021 - BioNTech SE announced an Update on vaccine production at BioNTech's manufacturing site in Marburg, Germany. The company started the Marburg facility's manufacturing process by executing the first step: mRNA production of the active pharmaceutical ingredient of the Pfizer-BioNTech COVID-19 vaccine. A single mRNA batch of the current scale is sufficient to produce around eight million vaccine doses. BioNTech plans to start manufacturing the drug substance based on the latest manufacturing license granted from the Darmstadt Regional Administrative Council for Marburg's amended facility.

February 8, 2021 - BioNTech SE and Pfizer announced the publication in Nature Medicine of data from in vitro studies that demonstrate that sera from individuals vaccinated with the Pfizer-BioNTech COVID-19 vaccine neutralize SARS-CoV-2 with key mutations present in the United Kingdom and South African variants. These data are based on Pfizer and the University of Texas Medical Branch studies. Neutralization geometric mean titers (GMTs) of 20 BTN162b2 vaccine-elicited human sera against the three mutant viruses were 0.81- to 1.46-fold of the GMTs against the parental virus, indicating minor effects of these mutations on neutralization by sera elicited by two BNT162b2 doses.

February 4, 2021 - The University of Oxford announced it is leading a study to explore alternating different COVID-19 vaccines, explore the potential for flexibility in delivery, and look for clues about increasing the breadth of protection against new virus strains. The study, run by the National Immunisation Schedule Evaluation Consortium, will evaluate the feasibility of using a different vaccine for the initial 'prime' vaccination to the follow-up 'booster' vaccination.

February 2, 2021 - Pfizer announced its financial results, including information regarding the Comirnaty vaccine. As of January 31, 2021, Pfizer supplied 65M doses globally, of which 29M doses were supplied to the U.S. Government. Furthermore, Pfizer indicated it could deliver ~2B doses by the end of 2021 based on the updated 6-dose label, expansion at our current facilities, and contingent upon adding more suppliers and contract manufacturers.

February 1, 2021 - A total of 320,000 Comirnaty vaccine doses reach Poland. "This week, we will send 308,000 vaccines for the second doses to vaccination sites as well as about 180,000 vaccines for the first doses for the vaccination of seniors," stated Kuczmierowski.

January 29, 2021 - Report published by Science: Neutralization of SARS-CoV-2 lineage B.1.1.7 pseudovirus by BNT162b2 vaccine-elicited human sera. These data indicate that the B.1.1.7 lineage will not escape BNT162b2-mediated protection.

January 29, 2021 - The European Medicines Agency (EMA) released its first safety update on the COVID-19 vaccine Comirnaty. It concludes that safety data collected on Comirnaty use in vaccination campaigns are consistent with the vaccine's known safety profile, and no new side effects were identified. The safety update reflects data collected and assessed since Comirnaty's authorization, including data from EudraVigilance (the EU's centralized database of suspected side effects) and data received from other sources, including the company's monthly safety report required for COVID-19 vaccines. EMA will publish monthly safety updates for all authorized COVID-19 vaccines, in line with exceptional transparency measures for COVID-19.

January 28, 2021 - According to local media reporting, the Comirnaty vaccine shows 92% effectiveness in Israel. Only 31 out of 163,000 Israelis vaccinated by Maccabi Healthcare Services caught coronavirus in their first 10 days of full-strength protection, its top vaccine statistics analyst, Anat Ekka Zohar, told The Times of Israel. In an equivalent sample of unvaccinated Israelis, some 6,437 were diagnosed in the same timeframe.

January 27, 2021 - Sanofi and BioNTech announced they have today entered into an agreement under which Sanofi will support the manufacturing and supply of BioNTech's COVID-19 vaccine, which is being co-developed with Pfizer. Sanofi will provide BioNTech access to its established infrastructure and expertise to produce over 125 million doses of the Comirnaty COVID-19 vaccine in Europe. Initial supplies will originate from Sanofi's production facilities in Frankfurt from the summer of 2021.

January 26, 2021 - Bloomberg reported Pfizer's Chief Executive Officer Albert Bourla announced the drugmaker and its partner would be able to deliver 200 million Comirnaty vaccine doses to the U.S. well before an earlier July 31 deadline due to a change in the vaccine's label that allows healthcare providers to extract an additional dose from each vial.

January 25, 2021 - The Therapeutic Goods Administration (TGA) of Australia has granted provisional approval to Pfizer Australia Pty Ltd for its Comirnaty COVID-19 vaccine, the first COVID-19 vaccine to receive regulatory approval in Australia. Following a thorough and independent review of Pfizer's submission, the TGA has decided that this vaccine meets the high safety, efficacy, and quality standards required for use in Australia.

January 23, 2021 - According to PBS, the British Medical Association urged England's chief medical officer to "urgently review the U.K.'s current position of second vaccine doses after 12 weeks." In a statement, the association said there was "growing concern from the medical profession regarding the delay of the second dose of the Pfizer-BioNTech vaccine."

January 22, 2021 - Pfizer and BioNTech announced they would provide 40 million vaccines to COVAX at a not-for-profit price. "At Pfizer, we believe that every person deserves to be seen, heard, and cared for. That is why from the very beginning of our vaccine development program, Pfizer and BioNTech have been firmly committed to working toward equitable and affordable access of COVID-19 vaccines for people around the world," said Pfizer Chairman and CEO Albert Bourla in a press statement. "We share the mission of COVAX and are proud to work together so that developing countries have the same access as the rest of the world, which will bring us another step closer to ending this global pandemic and proving that science will win for everyone, everywhere."

January 21, 2021 - JAMA Insights - Clinical Update: Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Pfizer-BioNTech COVID-19 Vaccine. From December 14 to 23, 2020, after administering a reported 1,893,360 first doses of Pfizer-BioNTech COVID-19 vaccine, the CDC identified 21 case reports submitted to VAERS that met Brighton Collaboration case definition criteria for anaphylaxis, corresponding to an estimated rate of 11.1 cases per million doses administered. No deaths from anaphylaxis were reported.

January 20, 2021 - Pfizer Inc. and BioNTech SE announced results from an in vitro study that provides additional data on sera's capability from individuals immunized with the Pfizer-BioNTech COVID-19 vaccine BNT162b2 to neutralize the SARS-CoV-2 B.1.1.7 lineage or VOC 202012/01. The results were published on the preprint server bioRxiv and submitted to a peer-reviewed journal. Further data are needed to monitor the Pfizer-BioNTech COVID-19 vaccine's effectiveness in preventing COVID-19 caused by new virus variants. So far, for COVID-19 vaccines, it has not been established what reduction in neutralization might indicate the need for a vaccine strain change. Should a vaccine strain change be required to address virus variants in the future, the Companies believe that BioNTech's proprietary mRNA vaccine platform's flexibility is well suited to enable such adjustment.

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 - The EMA's human medicines committee has recommended updating the product information for Comirnaty to clarify that each vial contains 6 doses of the vaccine.

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 extra 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 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 complete 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 confirmed the vaccine strategy against Covid-19 and determined 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 pla...