Pfizer-BioNTech COVID-19 Vaccine (Comirnaty) Description
BioNTech SE and Pfizer, Inc. co-developed the Pfizer-BioNTech COVID-19 (Comirnaty) (BNT162b2) vaccine to prevent severe COVID-19 disease caused by the SARS-CoV-2 coronavirus. The vaccine is based on BioNTech proprietary mRNA technology and was co-developed by BioNTech and Pfizer.
The BNT162b2 vaccine is a nucleoside-modified RNA formulated in lipid nanoparticles and encodes an optimized SARS-CoV-2 full-length spike protein antigen.
The Pfizer-BioNTech COVID-19 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 U.S. CDC updated its 'Pfizer-BioNTech COVID-19 Vaccine Overview and Safety on April 5, 2021.
The Pfizer-BioNTech COVID-19 vaccine (Comirnaty) (Tozinameran) (BNT162b2): Drugbank Accession Number: DB15696; ChemIDplus 434370509; CAS number: 2417899-77-3
Pfizer-BioNTech COVID-19 Vaccine 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.
New York-based Pfizer's corporation information is updated at this link.
Global Information About Pfizer‑BioNTech (Comirnaty) COVID‑19 Vaccine
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. The European Medicines Agency issued marketing authorization for Comiranty to BioNTech Manufacturing GmbH on December 21, 2020.
Pfizer-BioNTech COVID-19 Vaccine For Children
Adolescents: Pfizer Inc. and BioNTech SE announced on March 31, 2021, that, in a Phase 3 trial in 2,260 adolescents 12 to 15 years of age with or without prior evidence of SARS-CoV-2 infection, the Pfizer-BioNTech COVID-19 vaccine BNT162b2 demonstrated 100% efficacy and robust antibody responses, exceeding those recorded earlier in vaccinated participants aged 16 to 25 years old, and was well tolerated. On April 9, 2021, Pfizer requested that the current emergency-use authorization for its COVID-19 vaccine be amended to include teens between the ages of 12 and 15. Pfizer's statement indicated a Phase 3 clinical trial for this age group found that the vaccine is 100% efficacious and had a similar side-effect profile as those between the ages of 16 and 25.
Children: Pfizer confirmed on March 25, 2021, they have dosed the first healthy children in a global Phase 1/2/3 continuous study to evaluate further the safety, tolerability, and immunogenicity of the Pfizer-BioNTech COVID-19 vaccine in 4,644 children between the ages of 11 years to 6 months.
Pfizer-BioNTech COVID-19 Vaccine Indication For Women
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 women and lactating patients.
In February 2021, Pfizer and BioNTech dosed the first participant in a global Phase 2/3 study to evaluate further the safety, tolerability, and immunogenicity of the Pfizer-BioNTech COVID-19 vaccine in preventing COVID-19 in healthy pregnant women 18 years of age and older.
Data are not available to assess Pfizer-BioNTech COVID-19 Vaccine's effects on the breastfed infant or milk production/excretion.
Pfizer-BioNTech COVID-19 Vaccine 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, says the U.S. FDA.
The U.S. CDC published Possible Side Effects of COVID-19 vaccines on March 5, 2021. And, the CDC published '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 March 4, 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. Diarrhea and vomiting after vaccination have been identified as new side effects.
In this prospective cohort of health care employees published by The JAMA on March 8, 2021, 98% of vaccinated individuals did not have any symptoms of an allergic reaction after receiving an mRNA COVID-19 vaccine. The remaining 2% reported some allergic symptoms; however, severe reactions consistent with anaphylaxis occurred at a rate of 2.47 per 10 000 vaccinations. All individuals with anaphylaxis cases recovered without shock or endotracheal intubation. Most of the vaccine recipients with anaphylaxis had allergy histories, with 31% having prior anaphylaxis.
Pfizer-BioNTech COVID-19 Vaccine 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 COVID-19 Vaccine 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 COVID-19 Vaccine Distribution
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.
The US government issued distribution authorization on December 11, 2020. On December 23, 2020, the U.S. government announced it would purchase an additional 100 million doses of the Pfizer/BioNTech COVID-19 vaccine.
As of December 20, 2020, the companies stated, 'the vaccine has been authorized or approved for emergency use in more than 15 countries.'
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 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.
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 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.
The approval decision by the New Zealand medicines regulator Medsafe to provisionally approve the Pfizer/BioNTech vaccine (Comirnaty) was announced on February 3, 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 COVID-19 Vaccine Cold Storage
The U.S. FDA announced on February 25, 2021, that it allows undiluted frozen vials of the Pfizer-BioNTech COVID-19 Vaccine to be transported and stored at conventional temperatures found in pharmaceutical freezers for a period of up to two weeks. This reflects an alternative to the undiluted vials' preferred storage 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).
On March 26, 2021, the companies announced, 'New stability data show vaccine can be stored at -25°C to -15°C for a total of two weeks and support decentralized distribution plans for vaccination at EU general practitioners offices.'
Other countries may 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 COVID-19 Vaccine Indication
BNT162b2 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.
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.
Pfizer-BioNTech COVID-19 Vaccine 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 limited data 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 COVID-19 Vaccine CPT Code
The American Medical Association helps identify the appropriate CPT code combination (91300) for the type and dose of the COVID-19 vaccine provided to patients.
Pfizer-BioNTech COVID-19 Vaccine News
April 9, 2021 - Pfizer Inc. and BioNTech SE announced they requested amendments to the U.S. EUA of the Pfizer-BioNTech Vaccine (BNT162b2) to expand the use in adolescents 12 to 15 years of age. These requests are based on data from the pivotal Phase 3 trial in adolescents 12 to 15 years of age with or without prior evidence of SARS-CoV-2 infection, which demonstrated 100% efficacy and robust antibody response after vaccination with the COVID-19 Vaccine.
April 5, 2021 - The U.S. CDC published an update to its Pfizer-BioNTech COVID-19 Vaccine Overview and Safety overview.
April 2, 2021 - The U.S. CDC published: Interim Estimates of Vaccine Effectiveness of BNT162b2 COVID-19 Vaccines in Preventing SARS-CoV-2 Infection Among Health Care Personnel, First Responders, and Other Essential and Frontline Workers — Eight U.S. Locations, December 2020–March 2021. Prospective cohorts of 3,950 health care personnel, first responders, and other essential and frontline workers completed weekly SARS-CoV-2 testing for 13 consecutive weeks. Under real-world conditions, mRNA vaccine effectiveness of full immunization (≥14 days after the second dose) was 90% against SARS-CoV-2 infections regardless of symptom status; vaccine effectiveness of partial immunization (≥14 days after the first dose but before the second dose) was 80%.
April 1, 2021 - The companies announced updated topline results from analysis of 927 confirmed symptomatic cases of COVID-19 observed in their pivotal Phase 3 study through March 13, 2021, showing the Pfizer-BioNTech COVID-19 vaccine, BNT162b2, was 91.3% effective against COVID-19. These results were measured seven days through up to six months after the second dose. Furthermore, the experimental vaccine was 100% effective against severe COVID-19 as defined by the US government.
March 31, 2021 - The companies announced in a press release, 'In 2,260 participants aged 12-15 years old, BNT162b2 demonstrated 100% efficacy and robust antibody responses, exceeding those reported in the phase 3 trial of vaccinated 16-25-year-old participants in an earlier analysis, and was well tolerated. The companies plan to submit these data to the U.S. Food and Drug Administration and the European Medicines Agency as soon as possible to request expansion of the Emergency Use Authorization and EU Conditional Marketing Authorization for BNT162b2.
March 26, 2021 - BioNTech SE announced that the European Medicines Agency (EMA) approved the manufacturing of the COVID-19 vaccine drug product at the facility in Marburg. The approvals make BioNTech’s Marburg manufacturing site one of the largest mRNA vaccine manufacturing sites in Europe and worldwide, with an annual production capacity of up to one billion doses of our COVID-19 vaccine, once fully operational. Due to optimized operational efficiencies that were initiated last year, BioNTech has increased the expected annual manufacturing capacity by 250 million doses.
March 25, 2021 - The Pfizer website revealed details of a new phase 3 study with the Pfizer-BioNTech COVID-19 vaccine focused on infants older than six months up to children 11 years of age. These study participants will evaluate the safety, tolerability, and immunogenicity of the Pfizer-BioNTech COVID-19 vaccine on a two-dose schedule (approximately 21 days apart) in three age groups. Children younger than 6 months of age may subsequently be evaluated once an acceptable safety profile has been established.
March 16, 2021 - The President of the EU Commission, Ursula von der Leyen, announced an agreement with @BioNTech_Group and @pfizer to accelerate the delivery of 10 million doses for the second quarter. This will bring the total deliveries of this vaccine to 200 million doses for that quarter.
March 15, 2021 - The JAMA published a new study: Immunogenicity of a Single Dose of SARS-CoV-2 Messenger RNA Vaccine in Solid Organ Transplant Recipients. Transplant recipients receiving anti–metabolite maintenance immunosuppression therapy were less likely to develop an antibody response than those not receiving such immunosuppression therapy (37% vs. 63%, respectively; adjusted incidence rate ratio [IRR], 0.22 [95% CI, 0.15-0.34], P < .001).
March 10, 2021 - The European Commission reached an agreement with BioNTech-Pfizer to supply four million more doses of COVID-19 vaccines for Member States in the next two weeks to address coronavirus hotspots and to facilitate free border movement.
March 9, 2021 - People previously infected with the SARS-CoV-2 virus may produce levels of antibodies against COVID-19 after one dose of the Pfizer–BioNTech COVID-19 vaccine that is equal to or higher than people not previously infected have after two doses, found researchers from NYU Grossman School of Medicine. In the new study, most people that previously had a COVID-19 infection and who received a single dose of mRNA vaccine produced high levels of “neutralizing” antibodies—those capable of defending cells from the virus and of blocking its biological effects—at 6 to 14 days after the shot that were similar to, or higher than, those in SARS-CoV-2–naive people who had received 2 doses. “Our findings support a hypothesis that SARS-CoV-2–experienced people may require only a single dose of mRNA vaccine,” says Mark J. Mulligan, MD, director of the Division of Infectious Diseases and Immunology and director of the Vaccine Center.
March 8, 2021 - The NEJM published Neutralizing Activity of BNT162b2-Elicited Serum follow-up article. These researchers (with industry conflicts) found various levels of neutralizing antibodies (geometric mean titers (GMT)) were generated against all of the SARS-CoV-2 variants. The GMT was highest against the original variant and against the B.1.1.7 variant first detected in the UK; slightly lower against the P.1 variant, and lower still against the B.1351 variant first identified in South Africa.
March 7, 2021 - New Zealand's Prime Minister Jacinda Ardern and Covid-19 Response Minister Chris Hipkins announced the purchase of 8.5 million doses of the Pfizer-BioNTech Covid vaccine, reported local media. "This purchase marks a significant milestone in New Zealand's fight against Covid-19. We can all take heart that we have now secured one of the strongest and more effective tools in the Covid-19 toolkit," Ardern said. These vaccines are expected to arrive during the second half of 2021.
March 4, 2021 - The EMA announced the latest safety data for this vaccine are in line with the known benefit-risk profile; the outcomes of the related assessments are presented in this update. Diarrhea and vomiting after vaccination have been identified as new side effects. The benefits of Comirnaty in preventing COVID19 continue to outweigh any risks, and there are no recommended changes regarding the use of this vaccine. Safety updates provide the outcomes of the assessment of emerging data since marketing authorization for COVID-19 vaccines. The assessments are carried out by EMA’s safety committee (Pharmacovigilance Risk Assessment Committee) based on all available data.
March 3, 2021 - Pfizer Inc. and BioNTech SE, in partnership with UNICEF, announced the arrival of the first doses of their COVID-19 vaccine in Rwanda through the COVAX Facility.
February 25, 2021 - Pfizer Inc. and Germany-based BioNTech SE announced they had 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 18, 2021 - Pfizer Inc. and BioNTech SE announced they would be commencing a global clinical trial to evaluate the COVID-19 vaccine in pregnant women. This phase 2/3 study will evaluate the vaccine's safety, tolerability, and immunogenicity in preventing COVID-19 in healthy pregnant women 18 years and older. The clinical trial NCT04754594 is currently recruiting in 44 locations around the U.S. If interested, contact Pfizer at 1-800-718-1021 or email [email protected].
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 15, 2020 - Presented by the Orthodox Union and the Rabbinical Council of America: the conclusion of our poskim is that, pursuant to the advice of your personal health care provider, the Torah obligation to preserve our lives and the lives of others requires us to vaccinate for COVID-19 as soon as a vaccine becomes available.
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 previous 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 previous 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 of 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.
Pfizer-BioNTech COVID-19 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.