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Comirnaty COVID-19 Vaccine

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December 6, 2021
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Comirnaty COVID-19 Vaccine (BioNTech - Pfizer; BNT162b2) Description

BioNTech S.E. and Pfizer, Inc. co-developed the BNT162b2 vaccine to prevent severe COVID-19 caused by the SARS-CoV-2 betacoronavirus. The vaccine is based on BioNTech proprietary messenger RNA (mRNA)

Known globally as Comirnaty, the vaccine is a nucleoside-modified RNA formulated in lipid nanoparticles and encodes an optimized SARS-CoV-2 full-length spike protein antigen. 

Comirnaty contains a molecule with instructions for producing a protein from the SARS-CoV-2 virus. However, Comirnaty does not include the coronavirus itself and cannot cause COVID-19, says the European Medicines Agency (EMA). This Vaccine Information Fact Sheet for Recipients and Caregivers comprises the Fact Sheet for the authorized Pfizer-BioNTech COVID-19 Vaccine. The EMA published a Comirnaty vaccine update EMEA/H/C/005735 on September 24, 2021.

John L. Perez, MD, MBA, MA, Pfizer, Vice President Vaccine Clinical Research & Development, presented 'Efficacy & Safety of BNT162b2 booster' - C4591031 2 month interim analysis during the U.S. CDC vaccine advisory meeting on November 19, 2021. On November 17, 2021, the CDC, in consultation with U.S. FDA, issued emergency use instructions to provide information about the use of the vaccine as an additional primary series dose or as a booster dose in certain individuals who completed vaccination with certain non-FDA-authorized or -approved COVID-19 vaccines. The FDA amended EUA to include a single booster dose that was granted to Pfizer Inc.

The Revised Fact Sheet for Providers includes information about the U.S. FDA-licensed vaccine, COMIRNATY. Please see EUA Fact Sheets at www.cvdvaccine-us.com. The Comirnaty (Tozinameran) Drugbank Accession Number: DB15696; ChemIDplus 434370509; CAS number: 2417899-77-3; STN: 125742UKClinicalTrials.gov Identifier - Phase 3 clinical trials: NCT04805125NCT04368728NCT04713553NCT04754594 (additional studies are listed at this link).

Germany-based Biopharmaceutical New Technologies (BioNTech S.E.) is the Marketing Authorization Holder in the U.S., the EU, and the UK, and the holder of emergency use authorizations or equivalents in the U.S. (jointly with Pfizer), Canada, and other countries. Biopharmaceutical New Technologies is an immunotherapy company pioneering novel therapies for cancer and other serious diseases. New York-based Pfizer's corporation information is updated at this link

Comirnaty COVID-19 Vaccine (BioNTech - Pfizer; BNT162b2) Approvals and Authorizations

The Comirnaty vaccine was issued the first U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) to prevent severe COVID-19 in people 16 years of age and older on December 11, 2020. In addition, on December 31, 2020, the World Health Organization (WHO) issued an Emergency Use Listing (EUL) for the Comirnaty vaccine. On May 10, 2021, the FDA expanded the EUA to include people 12 years old.

The FDA Approved the Comirnaty COVID-19 vaccine on August 23, 2021. The vaccine is also available under FDA EUA, including for individuals 12 through 15 years of age and administering the third dose in specific immunocompromised individuals. The FDA Approval was granted to BioNTech Manufacturing GmbH. The FDA Approved the Comirnaty COVID-19 vaccine for additional people, including individuals 12 through 15 years of age, and for administering the third dose in specific immunocompromised individuals on August 23, 2021. Updated Q&As were issued on August 27, 2021. Then, on October 29, 2021, the FDA extended the authorization to include children 5 through 11 years of age. 

The EMA Approved the Comirnaty vaccine for preventing COVID-19 in people aged 12 years and older on July 29, 2021. The EMA updated EMEA/H/C/005735 on October 15, 2021. The U.K.'s Medicines and Healthcare products Regulatory Agency approved the Comirnaty vaccine for use in booster dosing on September 10, 2021. In addition, Canada issued an Approval for Comirnaty on September 16, 2021.

On September 17, 2021, Pfizer, Inc. executives presented data to the U.S. FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) information that confirmed the Comirnaty vaccine's effectiveness is compromised by the SARS-CoV-2 virus variant Delta. As a result, on September 22, 2021, the FDA amended the EUA to allow for the use of a single booster dose for certain people to be administered at least six months after completion of the two-dose primary series. Click here for the Factsheet for Vaccination Providers and here for the Recipients and Caregivers Fact Sheet. The Summary Basis for Regulatory Action 125742/0 was filed with the U.S. on November 8, 2021.

The FDA announced on November 19, 2021, it amended the EUA for Comirnaty authorizing the use of a single booster dose for all individuals 18 years of age and older after completion of primary vaccination with any FDA-authorized or approved COVID-19 vaccine.

Comirnaty COVID-19 Vaccine (BioNTech - Pfizer BNT162b2) History

On July 1, 2020, the manuscript describing the preliminary clinical data for the Comirnaty vaccine became available online for scientific peer-review for potential publication. 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. 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. 

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. In addition, an early release of the CDC's Morbidity and Mortality Weekly Report published on December 13, 2020, stated 'after a detailed, 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, reported the ACIP website.

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.' However, on July 15, 2021, The Lancet published a study: Spike-antibody waning after the second dose of BNT162b2. Our data suggest waning of S-antibody levels in infection-naive individuals over a 3–10-week period after the second dose of BNT162b2. These data are consistent with the decline in Spike-antibody and neutralizing antibody levels observed after infection, although memory B-cell populations appear to be maintained. As such, the clinical implications of waning antibody levels post-vaccination are not yet clear, and it remains crucial to establish S-antibody thresholds associated with protection against clinical outcomes.

On October 26, 2021, the U.S. FDA vaccine committee met in an open session to discuss a request to amend Pfizer-BioNTech's EUA to administer their COVID-19 mRNA vaccine to children 5 through 11 years old. The docket number is FDA-2021-N-1088. On October 22, 2021, Pfizer published its presentation to the FDA vaccine committee. 

Comirnaty COVID-19 Vaccine (BioNTech - Pfizer; BNT162b2) Dosage

The Comirnaty Vaccine is offered in various dose regimens, subject to country-based authorizations. After preparation, a single dose is 0.3 mL is recommended for adults and smaller doses for adolescents and children. The Companies disclosed on October 28, 2021, for children 5 to <12 years of age, the pediatric dosage strength is (10 µg) and differs from the (30 µg) dosage strength for individuals 12 years and older. For the pediatric age group (5-11), the CDC authorized the 10-µg dose level in a two-dose regimen administered 21 days apart.

On October 4, 2021, the EMA's human medicines committee (CHMP) concluded that an extra dose of Comirnaty may be given to people with severely weakened immune systems at least 28 days after their second dose. However, there is no direct evidence that is producing antibodies in these patients protected against COVID-19. Therefore, the CHMP also concluded that booster doses (3rd) might be considered at least six months after the second dose for people aged 18 years and older.

The U.K.'s JCVI confirmed on September 14, 2021, 'the JCVI advises a preference for the Pfizer-BioNTech Comirnaty vaccine to be offered as the third booster dose irrespective of which product was used in the primary schedule. And, the JCVI advises that the booster vaccine dose is offered no earlier than six months after completion of the primary 2-dose vaccine course.'

On August 12, 2021, the U.S. FDA amended the EUAs for the Pfizer-BioNTech COVID-19 Vaccine to allow for the use of an additional dose in specific immunocompromised individuals. The CDC's Sara Oliver M.D., MSPH, presented at the ACIP Meeting on August 13, 2021, Considering booster doses of COVID-19 vaccines. Participants in a phase 1 study received a 30-µg booster dose of BNT162b2 8 to 9 months after receiving the second dose. Results from this participant group show that the third dose elicited significantly higher neutralizing antibodies against the initial SARS-CoV-2 coronavirus compared to the levels observed after the two-dose primary series and against the Beta variant and the highly infectious Delta variant. On September 24, 2021, the CDC Director approved delivering a third dose of Comirnaty to most people. The FDA authorized the third dose in October 2021. 

The UK's Joint Committee on Vaccination and Immunisation advised on November 15, 2021, that most people over 16 years should be offered an mRNA booster, 6 months after their second dose, irrespective of the vaccines given for the first and second doses.

On November 30, 2021, a peer-reviewed study funded by the government of Canada found that a longer second dosing interval (42–49 days) resulted in higher spike, receptor binding domain, and spike N terminal domain antibody concentrations.

Comirnaty COVID-19 Vaccine (BioNTech - Pfizer; BNT162b2) Ingredients

The Pfizer-BioNTech COVID-19 Vaccine contains a nucleoside-modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2. Doses may also include 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. In addition, the vial stoppers are not made with natural rubber latex. The U.S. CDC publishes 'Common Ingredients in U.S. Licensed Vaccines.'

Comirnaty COVID-19 Vaccine (BioNTech - Pfizer; BNT162b2) Side Effects

The U.S. CDC's ACIP committee's presentation slides on August 30, 2021, were published. And again on October 21, 2021, presenting heart-health risks. Hui-Lee Wong, Ph.D., MSc, presented Surveillance Updates of Myocarditis/Pericarditis and mRNA COVID-19 Vaccination in the FDA BEST System during the U.S. FDA's VRBPAC meeting on October 14, 2021. And the CDC meeting on October 21, 2021.

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.' In addition, on July 6, 2021, the CDC published Use of mRNA COVID-19 Vaccine After Reports of Myocarditis Among Vaccine Recipients: Update from the Advisory Committee on Immunization Practices — United States, June 2021. In addition, the FDA updated its guidance in October 2021.

The journal Rheumatology published a study on April 13, 2021, that concluded by saying, 'Epidemiologic studies on the safety of the mRNA-based COVID-19 vaccines in patients with autoimmune inflammatory rheumatic diseases are needed to clarify the association between the BNT162b2 mRNA vaccination and reactivation of zoster.'

On December 3, 2021, the EMA stated a recent French study shows that, in a period of seven days after the second dose, there were about 0.26 extra cases of myocarditis in 12- to 29-year-old males per 10,000 compared to unexposed persons. In the Nordic study, in a period of 28 days after the second dose, there were 0.57 extra cases of myocarditis in 16- to 24-year-old males per 10,000 compared to unexposed persons. Furthermore, there is currently insufficient evidence of a possible link between Comirnaty and very rare cases of multisystem inflammatory syndrome.

Report an Adverse Event using the VAERS online form or the download. Anyone can submit a report to VAERS, including parents and patients. In addition, healthcare providers in the USA are required by law to report to VAERS.

Comirnaty COVID-19 Vaccine (BioNTech - Pfizer; BNT162b2) SARS-CoV-2 Coronavirus Variants

BioNTech confirmed on November 9, 2021, studies are underway evaluating variant-specific versions of the vaccine to generate data to inform BioNTech and Pfizer’s strategy to address emerging SARS-CoV-2 variants. While to date, there is no clinical data suggesting the need for a variant-specific version of the vaccine, the companies are establishing a preemptive prototype approach to evaluate the development, manufacturing, and regulatory processes for variant-specific vaccines. This prototype approach is aimed to be substantiated by broad clinical data that are being prepared for submission to regulatory authorities.

The NEJM published an ORIGINAL ARTICLE on July 28, 2021, Covid-19 Breakthrough Infections in Vaccinated Health Care Workers. This study based in Israeli found a 2.6% COVID breakthrough reinfection rate of the Alpha variant in health care staff. On August 19, 2021, Oxford University published a study that concluded by saying 'SARS-CoV-2 vaccination still reduces new infections, but the vaccine's effectiveness and attenuation of peak viral burden are reduced with SARS-CoV-2 Delta virus variant.'

Pfizer disclosed in its presentation to the U.S. FDA on September 17, 2021, 'A retrospective cohort study conducted at Kaiser Permanente Southern California suggests that the observed erosion in Cominraty vaccine effectiveness is likely primarily due to waning effectiveness rather than due to Delta variant escaping vaccine protection.

Comirnaty COVID-19 Vaccine (BioNTech - Pfizer BNT162b2) For Children

On November 25, 2021, Pfizer Inc. and BioNTech SE announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion on the administration of the COMIRNATY vaccine in children 5 to under 12 years of age. 

The updated findings from the companies’ pivotal Phase 3 trial published on November 22, 2021, show that a two-dose series of the Comirnaty Vaccine (30-µg per dose) was 100% effective against COVID-19, measured seven days through over four months after the second dose.

Isreal's Ministry of Health's Director-General, Prof. Nachman Ash, accepted the recommendation by the Pandemic Response Team on November 15, 2021, and the COVID-19 Vaccination Advisory Board, to vaccinate children aged 5-11.

U.S. CDC Director Rochelle P. Walensky, M.D., M.P.H., endorsed the Advisory Committee on Immunization Practices’ recommendation that children 5 to 11 years old be vaccinated against COVID-19 with the Pfizer-BioNTech pediatric vaccine on November 2, 2021. The CDC's ACIP unanimously voted to support vaccinating children between 5 and 11 years of age on November 2, 2021. 

The FDA's VRBPAC meeting on October 26, 2021, discussed a request to amend Pfizer-BioNTech's EUA for the administration of their COVID-19 mRNA vaccine to children 5 through 11 years of age. Pfizer's presentation was distributed on October 22, 2021. The FDA advisory committee voted in favor of this request. On October 29, 2021, the FDA authorized this EUA extension.

The U.S. CDC reported on October 19, 2021, among hospitalized U.S. patients aged 12–18 years, vaccine effectiveness of 2 doses of Comirnaty vaccine against COVID-19 hospitalization during June–September 2021, was 93% (95% confidence interval = 83%–97%).

On August 4, 2021, the U.K.'s Joint Committee on Vaccination and Immunisation issued an advisory that all 16 and 17-year-olds should receive their first dose of the Pfizer-BioNTech vaccine.

The EMA’s human medicines committee recommended on November 25, 2021, granting an extension of indication for the COVID-19 vaccine Comirnaty to include use in children aged 5 to 11.

Comirnaty COVID-19 Vaccine (BioNTech - Pfizer; BNT162b2) Indication For Women 

The journal Nature Medicines published results from a new study on September 7, 2021: Effectiveness of the BNT162b2 mRNA COVID-19 vaccine in pregnancy. In summary, the BNT162b2 mRNA vaccine was estimated to have high vaccine effectiveness in pregnant women, similar to the general population's effectiveness.

Comirnaty COVID-19 Vaccine (BioNTech - Pfizer; BNT162b2) Indication For Cancer Patients

The National Comprehensive Cancer Network® (NCCN®) announced on August 30, 2021, enhancements to the NCCN: Cancer and COVID-19 Vaccination guidance. The fourth version incorporates the latest data and recent FDA and CDC approvals regarding a third mRNA vaccine dose for immunocompromised people.

On July 8, 2021, the JAMA Oncology published: Serologic Status and Toxic Effects of the SARS-CoV-2 BNT162b2 Vaccine in Patients Undergoing Treatment for Cancer. Conclusions and Relevance - In this cohort study, the SARS-CoV-2 BNT162b2 vaccine appeared safe and achieved satisfactory serologic status in patients with cancer. There was a pronounced lag in antibody production compared with the rate in noncancer controls. However, seroconversion occurred in most patients after the second dose. Future real-world data are warranted to determine the long-term efficacy of the vaccine concerning the type of anticancer treatment.

Comirnaty COVID-19 Vaccine (BioNTech - Pfizer; BNT162b2) Indication For Multiple Sclerosis Patients

In this study published by the JAMA Network on September 23, 2021, the humoral response against SARS-CoV-2 at one month after mRNA vaccination was appropriate under treatment with cladribine and teriflunomide and diminished/absent under treatment with anti-CD20 therapies and S1P modulators. Delaying anti-CD20 infusions by 3 to 6 months before vaccination could, however, increase the probability of developing appropriate humoral responses, especially in selected clinically and radiologically stable patients. Future studies should aim at investigating antibody dynamics over time, if and how T cell-mediated responses after vaccination are influenced by DMTs, and whether these biological measures actually reflect vaccine efficacy in terms of preventing severe SARS-CoV-2 infection.

Comirnaty COVID-19 Vaccine (BioNTech - Pfizer; BNT162b2) Distribution

BioNTech and Pfizer have delivered an aggregate of over 2 billion doses of BNT162b2 vaccine around the world as of November 2, 2021. BioNTech and Pfizer expect to manufacture 2.7 billion to 3 billion doses by the end of 2021 and anticipate capacity to manufacture up to four billion doses in 2022. Separately, Pfizer and BioNTech have agreed to provide a total of 1 billion doses to the U.S. government at a not-for-profit price for donation to low- and lower-middle-income countries. As of November 13, 2021, the Comirnaty COVID-19 Vaccine is available in about 152 countries including the USA, BrazilCanadaEurope, IcelandIsraelItalyQatar, Finland, the U.K.

BioNTech - Fosun Pharma

BioNTech is also collaborating with Fosun Pharma to develop the BNT162 vaccine 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. Furthermore, on May 9, 2021, BioNTech agreed to Fosun Pharma's heads to establish a 50/50 Joint Venture to manufacture about 1 billion COVID-19 vaccines in China.

Comirnaty COVID-19 Vaccine (BioNTech - Pfizer; BNT162b2) Cold Storage

On February 25, 2021, the U.S. FDA announced that it allows undiluted frozen vials of the Comirnaty Vaccine to be transported and stored at conventional temperatures found in pharmaceutical freezers period of up to two weeks.

Comirnaty COVID-19 Vaccine (BioNTech - Pfizer; BNT162b2) Co-Administration

On October 28, 2021, the companies confirmed 'data on the administration of this vaccine at the same time as other vaccines have not yet been submitted to the U.S. FDA. Individuals considering receiving this vaccine with other vaccines should discuss their options with their healthcare provider.'

Comirnaty COVID-19 Vaccine (BioNTech - Pfizer BNT162b2) 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. The American Medical Association has updated the CPT code to reflect the booster/third dose, 0003A.

Comirnaty Vaccine Revenues

Pfizer Inc. reported on November 2, 2021, it expects revenues of approximately $36 Billion for Comirnaty, Reflecting 2.3 Billion Doses Expected to be Delivered in Fiscal 2021.

Comirnaty COVID-19 Vaccine (BioNTech - Pfizer BNT162b2) News

December 5, 2021 - A non-peer-reviewed study found data demonstrated that both heterologous Ad26.COV2.S and homologous BNT162b2 increased antibody responses in individuals who were vaccinated at least 6 months previously with BNT162b2. Ad26.COV2.S and BNT162b2 led to similar antibody titers by week 4 following the boost immunization but exhibited different immune kinetics. Ad26.COV2.S led to greater increases in CD8+ T cell responses than BNT162b2. However, the durability of these immune responses remains to be determined. These data suggest different immune phenotypes following heterologous compared with homologous boost strategies.

November 25, 2021 - The EMA recommended the Comirnty vaccine for most children. The European Commission, which will issue a final decision.

November 22, 2021 - Pfizer Inc. and BioNTech SE announced topline results from a longer-term analysis of the safety and efficacy of their COVID-19 vaccine in individuals 12 through 15 years of age.

November 19, 2021 - Pfizer Inc. and BioNTech SE announced that the U.S. FDA had expanded the emergency use authorization of a booster dose of the Pfizer-BioNTech COVID-19 Vaccine to include individuals 18 years of age and older. The booster dose is to be administered at least six months after completion of the primary series and is the same dosage strength as the doses in the primary series.

November 15, 2021 - The UK Health Security Agency announced results from the first UK real-world study by UKHSA show that two weeks after receiving a booster dose, protection against symptomatic infection in adults aged 50 years and over was 93.1% in those with AstraZeneca vaccine as their primary course and 94.0% for Pfizer-BioNTech Comirnaty vaccine.

November 12, 2021 - Australia's ATAGI noted that the TGA is investigating 1713 reports of suspected myocarditis and/or pericarditis following Pfizer and in particular 511 suspected myocarditis reports. Of these suspected cases, 288 cases of myocarditis or myopericarditis have been assessed as meeting the U.S. CDC case definition (level 1, 2, or 3), of which 178 cases occurred following the second dose.

November 10, 2021 - Local media reported Taiwan's Central Epidemic Command Center head Chen Shih-chung confirmed a panel of experts decided to suspend administering second doses of the Pfizer-BioNTech Comirnaty vaccine to children 12-17 years old for two weeks amid concerns it may increase the risk of myocarditis.

November 9, 2021 - BioNTech SE reported total revenues were estimated to be €6,087.3 million1 for the three months ended September 30, 2021, compared to €67.5 million for the three months ended September 30, 2020. For the nine months ended September 30, 2021, total revenues were estimated to be €13,444.2 million1 compared to €136.9 million for the comparative prior-year period. 

November 9, 2021 - Health Canada confirmed it has authorized the use of the Comirnaty COVID-19 vaccine as a booster shot. The booster is authorized for adults 18 years of age and older, to be used at least six months after an individual has completed their primary vaccine series. The Comirnaty booster is a full dose of the regular vaccine (30 mcg).

November 2, 2021 - The U.S. CDC vaccine advisory committee unanimously voted to support offering vaccinations for the 5 to 11-year-old group.

November 2, 2021 - Pfizer Inc. announced the Comirnaty vaccine would generate approximately $36 billion (previously approximately $33.5 billion) in revenues.

October 28, 2021 - Pfizer and BioNTech announced that the U.S. government has purchased 50 million additional doses of the companies’ COVID-19 vaccine. The U.S. will receive these additional doses to continue to support preparedness for pediatric vaccinations, including securing vaccines for children under 5 years of age.

October 27, 2021 - The WHO published 'COVID-19 subcommittee of the WHO Global Advisory Committee on Vaccine Safety: updated statement regarding myocarditis and pericarditis reported with COVID-19 mRNA vaccines.'

October 27, 2021 - The NEJM published an ORIGINAL ARTICLE: Waning Immunity after the BNT162b2 Vaccine in Israel. These findings indicate that immunity against the delta variant of SARS-CoV-2 waned in all age groups a few months after receipt of the second dose of vaccine.

October 26, 2021 - The U.S. FDA Vaccines and Related Biological Products Advisory Committee 170th meeting posted its agenda and presentation materials. The VRBPAC committee voted in favor of offering Comirnaty vaccines to children.

October 22, 2021 - Pfizer Inc. published its presentation regarding FDA authorization to vaccinate children.

October 21, 2021 - Pfizer Inc. and BioNTech SE announced topline results from a Phase 3 randomized, controlled trial evaluating the efficacy and safety of a 30-µg booster dose of the Pfizer-BioNTech COVID-19 Vaccine in more than 10,000 individuals 16 years of age and older. In the trial, a booster dose administered to individuals who previously received the Pfizer-BioNTech primary two-dose series restored vaccine protection against COVID-19 to the high levels achieved after the second dose, showing a relative vaccine efficacy of 95.6% when compared to those who did not receive a booster. These are the first efficacy results from any randomized, controlled COVID-19 vaccine booster trial.

October 8, 2021 - In recent days, there has been data from Nordic countries on the increased incidence of myocarditis and pericarditis after vaccination with Moderna vaccine in addition to vaccination with Pfizer / BioNTech (Comirnaty). Regional epidemiologists have decided that the Moderna vaccine will not be used in Iceland.

October 7, 2021 - A non-peer-reviewed study assessed SARS-CoV-2-Spike (S)-targeted antibody and functional T cell responses at around 6 months after complete vaccination. Findings: Almost all residents displayed detectable SARS-CoV-2-S-reactive antibodies and T cell responses, respectively, by around 6 months after complete vaccination with Comirnaty® COVID-19 vaccine, albeit generally waning in magnitude over time.

October 7, 2021 - Finland's National Institute for Health and Welfare instructed municipalities to administer the Comirnaty vaccine to men under the age of 30.

October 6, 2021 - The journal NEJM published an ORIGINAL ARTICLE: Waning of BNT162b2 Vaccine Protection against SARS-CoV-2 Infection in Qatar. CONCLUSIONS - BNT162b2-induced protection against SARS-COV-2 infection appeared to wane rapidly following its peak after the second dose. And protection against hospitalization and death persisted at a robust level for 6 months after the second dose. Funded by Weill Cornell Medicine–Qatar and others.

October 4, 2021 - A Pfizer-funded retrospective cohort study reported a significant reduction in vaccine effectiveness against SARS-CoV-2 infections over time (6 months) is probably primarily due to waning immunity with time rather than the delta variant escaping vaccine protection.

October 4, 2021 - The EMA's human medicines committee concluded that an extra dose of the COVID-19 vaccines Comirnaty (BioNTech/Pfizer) may be given to people with severely weakened immune systems, at least 28 days after their second dose. Although there is no direct evidence that the ability to produce antibodies in these patients protected against COVID-19, it is expected that the extra dose would increase protection at least in some patients. 

September 24, 2021 - The U.S. CDC Director Rochelle P. Walensky, M.D., M.P.H., endorsed the CDC's Advisory Committee on Immunization Practices' recommendation for a booster shot of the Pfizer-BioNTech COVID-19 vaccine in certain populations and also recommended a booster dose for those in high risk occupational and institutional settings.

September 23, 2021 - The U.S. CDC's vaccine committee reviewed various risks and benefits regarding a 3rd booster dose of the Comirnaty vaccine for certain populations. Sara Oliver, M.D., MSPH, presented 'Evidence to Recommendation Framework.'

September 20, 2021 - The Companies reported a Phase 2/3 study that enrolled children 6 months to 11 years of age, and for 2,268 participants who were 5 to 11 years of age, who received a 10 µg dose level in a two-dose regimen. In the trial, the SARS-CoV-2–neutralizing antibody geometric mean titer (GMT) was 1,197.6 (95% confidence interval [CI, 1106.1, 1296.6]), demonstrating a strong immune response in this cohort of children one month after the second dose. This compares well (was non-inferior) to the GMT of 1146.5 (95% CI: 1045.5, 1257.2) from participants ages 16 to 25 years old, used as the control group for this analysis and who were administered a two-dose regimen of 30 µg. Further, the COVID-19 vaccine was well tolerated, with side effects generally comparable to those observed in participants 16 to 25 years of age.

September 17, 2021 - Pfizer and BioNTech had received reports in Japanese cities that white to off-white opaque amorphous particles have been found in vials of "Comirnaty" manufactured by BioNTech. We have conducted a full investigation of the reports from Kamakura-city, Sagamihara-city, and Sakai-city related to white / off-white opaque amorphous particles found in vials. We confirm that there is no safety issue regarding the presence of these particles found in these vials (Lot #. FF5357). These particles have been determined to be an intrinsic component of the vaccine and are not attributable to a product quality issue.

September 17, 2021 - Pfizer and BioNTech published a presentation for the U.S. FDA vaccine committee review meeting. Dr. Oliver's presentation indicates the Delta coronavirus variant has significantly reduced protection against infection (including asymptomatic or mild infections) from the 380 million COVID-19 vaccines administered in the USA during the June-July timeframe. And, data from the Israel Israeli MOH, Weizmann Institute of Science, Gertner Institute, Hebrew University & Technion, was presented: Booster protection against confirmed infections and severe disease. The FDA vaccine committee vote affirmingly to expand access for a 3rd booster dose for seniors and certain people.

September 17, 2021 - The U.S. CDC issued an MMWR: Comparative Effectiveness of Moderna, Pfizer-BioNTech, and Janssen Vaccines in Preventing COVID-19 Hospitalizations Among Adults Without Immunocompromising Conditions. Among U.S. adults without immunocompromising conditions, vaccine effectiveness against COVID-19 hospitalization during March 11–August 15, 2021, was higher for the Moderna vaccine (93%) than the Pfizer-BioNTech vaccine (88%) and the Janssen vaccine (71%).

September 16, 2021 - Pfizer Canada ULC and Germany-based BioNTech S.E. confirmed Health Canada granted Approval for COMIRNATY® to prevent COVID-19 in individuals 12 years of age and older.

September 15, 2021 - The NEJM published an ORIGINAL ARTICLE: Protection of BNT162b2 Vaccine Booster against Covid-19 in Israel. CONCLUSIONS - In this study involving participants who were 60 years of age or older and had received two doses of the BNT162b2 vaccine at least five months earlier, we found that the rates of confirmed Covid-19 and severe illness were substantially lower among those who received a booster (third) dose of the BNT162b2 vaccine.

September 14, 2021 - Foreign matter has been found in five unused vials of Pfizer Inc.'s COVID-19 vaccine in two cities near Tokyo and one in Osaka Prefecture, reported Kyodo News. These cities have requested Pfizer to analyze the substances. The vials containing the white floating matter belong to the same lot, FF5357. The Comirnaty vaccine was initially approved in Japan in February 2021.

September 10, 2021 - Dr. June Raine, the U.K.'s MHRA Chief Executive, commented: 'We are committed to getting safe and effective COVID-19 vaccines to the U.K. public. I am pleased to confirm that the COVID-19 vaccines made by Pfizer can be used as safe and effective booster doses.'

September 5, 2021 - The Lancet Regional Health Europe published a new study that concluded by stating, 'The mRNA vaccine induces a strong antibody response to SARS-CoV-2 and five VOCs at 1-week post-vaccination that decreases after that. Although detectable in the majority, T cell responses were lower in individuals with higher T cell immunosenescence. And the deterioration of vaccine response suggests the need to monitor for the potential booster vaccination.'

August 31, 2021 - The Children's Health Defense filed suit in U.S. District Court, Eastern District of Tennessee, against the U.S. Food and Drug Administration and its acting director, Dr. Janet Woodcock, for their allegedly deceptive, rushed licensure of the Comirnaty vaccine.

August 31, 2021 - The JAMA Network published a news study based in Israel that concluded 'a simple algorithm enables immunization of most patients with a history of allergy, while only patients defined as highly allergic should receive vaccination under medical supervision.'

August 30, 2021 - The Smithsonian Magazine published an article: Why the Pfizer-BioNTech Covid-19 Vaccine Is called Comirnaty?

August 25, 2021 - Pfizer Inc. and BioNTech S.E. announced the initiation of a supplemental Biologics License Application (sBLA) to the U.S. FDA to approve a booster dose of COMIRNATY® to prevent COVID-19 in individuals 16 years of age and older. The companies intend to complete the submission of the sBLA by the end of this week.

August 24, 2021 - The U.S. DOD mandated vaccinations (Comirnaty) for the military. The memo states that service members actively participating in COVID-19 clinical trials are exempt from mandatory vaccination until the trial is complete to avoid invalidating clinical trial results.

August 24, 2021 - The EMA approved an additional manufacturing site to produce Comirnaty, the COVID-19 vaccine developed by BioNTech and Pfizer. Located in Saint Rémy sur Avre, France.

August 23, 2021 - The U.S. FDA issued its Approval for the Comirnaty Vaccine to BioNTech Manufacturing GmbH.

August 20, 2021 - A non-peer-reviewed study - Significant reduction in humoral immunity among healthcare workers and nursing home residents 6 months after COVID-19 BNT162b2 mRNA vaccination. Healthcare workers, given their younger age and relatively good health, achieved higher initial antibody levels and better maintained them, yet also experienced significant declines in humoral immunity.

August 18, 2021 - Public health and medical experts from the U.S. Department of Health and Human Services released a statement on the administration's plan for COVID-19 booster shots for the American people.

August 16, 2021 - The Companies announced they submitted Phase 1 data to the U.S. FDA to support evaluating a third dose of the COVID-19 vaccine (BNT162b2) for future licensure.

August 13, 2021 - The CDC's Advisory Committee on Immunization Practices endorsed using an additional dose of COVID-19 vaccine for people with moderately to severely compromised immune systems after an initial two-dose vaccine series.

August 11, 2021 - The EMA published an updated report regarding potential side effects. The PRAC started assessing erythema multiforme (E.M.; a hypersensitivity (allergic) reaction with characteristic round skin lesions, which may also affect mucous membranes in internal body cavities) to establish whether it is a side effect of Comirnaty. And, the PRAC started an assessment of glomerulonephritis (inflammation of tiny filters in the kidneys) and nephrotic syndrome (kidney disorder causing the kidneys to leak too much protein in the urine) to establish whether they may be side effects of Comirnaty. And discussed reported cases of menstrual disorders occurring after vaccination against COVID-19.

August 9, 2021 - Germany-based BioNTech S.E. announced for the six months ended June 30, 2021, total revenues were estimated to be €7,356.9 million compared to €69.4 million for the comparative prior-year period. The increase was mainly due to rapid increases in the supply of COVID-19 vaccines worldwide. As of July 21, 2021, BioNTech and its partner Pfizer, Inc. have shipped approximately one billion doses of BNT162b2 to more than 100 countries or territories worldwide. The companies have signed orders of more than 2.2 billion doses for delivery in 2021 and more than one billion doses for 2022 and beyond as of July 21, 2021. 

July 28, 2021 - Pfizer Inc. revealed the BNT162b2 vaccine contributed $7.8 billion in direct sales and alliance revenues and indicated 2.1 billion vaccine doses are expected to be delivered in 2021. Pfizer presented its expanded mRNA vaccine strategy on slide #22.

July 23, 2021 - Pfizer Inc. and BioNTech S.E. announced that the U.S. government had purchased an additional 200 million doses of the Pfizer-BioNTech COVID-19 Vaccine. These doses are expected to be delivered from October 2021 through April 2022. 

July 22, 2021 - The University College London announced 'total antibody levels appear to start declining from as early as six weeks after complete vaccination and can reduce by more than 50% over ten weeks,' according to new data from the Virus Watch study.

July 19, 2021 -  BioNTech S.E. and Kite, a Gilead Company (Nasdaq: GILD, "Kite"), announced the two companies have entered into a purchase agreement for BioNTech to acquire Kite's solid tumor neoantigen T cell receptor (TCR) R&D platform and clinical manufacturing facility in Gaithersburg, MD.

July 16, 2021 - Pfizer Inc. and BioNTech S.E. announced that the U.S. Food and Drug Administration granted Priority Review designation for the Biologics License Application for their mRNA vaccine to prevent COVID-19 in individuals 16 years age and older. The Prescription Drug User Fee Act goal date for a decision by the FDA is in January 2022.

July 15, 2021 - A new study, 'Spike-antibody waning after the second dose of BNT162b2', was published by The Lancet.

July 14, 2021 - The EMA reported as of July 4, 2021, a total of 206,668 cases of suspected side effects with Comirnaty were reported to EudraVigilance from EU/EEA countries; 3,848 of these reported a fatal outcome. These figures cannot be extracted directly from the public database of suspected adverse reactions, which groups information per type of side effects. As more than one suspected side effect may have been included in a single case report, the total number of side effects will never match the number of individual cases.

July 12, 2021 - BioNTech S.E. announced that Fosun Industrial Co., Limited had reached advance procurement agreements for the mRNA-based COVID-19 vaccine BNT162b2 with Taiwan Semiconductor Manufacturing Co., Ltd., Hon Hai Precision Industry Co., Ltd., Yonglin Charity Foundation, and Zuellig Pharma, Inc. respectively. Fosun Industrial will sell a total of 10 million doses of COVID-19 mRNA vaccines to Zuellig Pharma entrusted by TSMC, Hon Hai, and Yonglin. In addition, these COVID-19 mRNA vaccines will be donated to the relevant agency of disease control of the Taiwan region for local vaccination.

July 9, 2021 - The United Kingdom Medicines & Healthcare Regulatory Agency announced it had received 450 Yellow Card reports of suspected adverse drug reactions to the Pfizer- BioNTech (Comirnaty) vaccine in which patients died shortly after vaccination.

June 25, 2021 - The U.S. FDA stated 'the warning in the Fact Sheets for Healthcare Providers Administering Vaccines notes that reports of adverse events suggest increased risks of myocarditis and pericarditis, particularly following the second dose with the onset of symptoms within a few days after vaccination. Additionally, the Fact Sheets for Recipients and Caregivers for these vaccines note that vaccine recipients should seek medical attention right away if they have chest pain, shortness of breath, or feelings of having a fast-beating, fluttering, or pounding heart after vaccination.'

June 22, 2021 - The EMA's Committee for human medicines approved additional manufacturing sites to produce Comirnaty, the COVID-19 vaccine developed by BioNTech and Pfizer. One site, located in Reinbek, Germany, is operated by Allergopharma GmbH & Co. K.G. The other in Stein, Switzerland, is operated by Novartis Pharma.

June 14, 2021 - PHE published 'Effectiveness of COVID-19 vaccines against hospital admission with the Delta (B.1.617.2) variant.'

June 10, 2021 - The journal Nature published an early version of a study: BNT162b2-elicited neutralization of B.1.617 and other SARS-CoV-2 variants. 'Geometric mean plaque reduction neutralization titers against the variant viruses, particularly the B.1.617.1 variant, appear lower than the titer against USA-WA1/2020 virus, but all sera tested neutralize the variant viruses at titers of at least 40.'

June 2, 2021 - Following reports of myocarditis cases around the time of vaccination, the Israeli Ministry of Health has appointed an extended epidemiological team to investigate the possible link between these cases and the Pfizer-BioNTech vaccine. In addition, since April 2021, the U.S. CDC says 'there have been increased reports to the Vaccine Adverse Event Reporting System of cases of myocarditis and pericarditis happening after mRNA COVID-19 vaccination (Pfizer-BioNTech and Moderna) in the USA. However, these reports are rare, given the number of vaccine doses administered.

May 28, 2021 - The JAMA published an Original Investigation: Evaluation of Seropositivity Following BNT162b2 Messenger RNA Vaccination for SARS-CoV-2 in Patients Undergoing Treatment for Cancer. The findings of this study suggest that patients with cancer who are receiving active treatment and are at higher risk for severe COVID-19 disease respond well to messenger RNA SARS-CoV-2 vaccines and that vaccination of these patients should be seriously considered.

May 28, 2021 - The EMA's human medicines committee has recommended granting an extension of indication for the COVID-19 vaccine Comirnaty to include use in children aged 12 to 15.

May 27, 2021 - The NEJM published a study that concluded, 'The BNT162b2 vaccine in 12-to-15-year-old recipients had a favorable safety profile, produced a greater immune response than in young adults, and was highly effective against Covid-19.' Across 29 U.S. sites, between October 15, 2020, and January 12, 2021, 1,131 participants received BNT162b2, and there were no vaccine-related serious adverse events and few overall severe adverse events. Among BNT162b2 recipients, severe adverse events were reported in 0.6% of those aged 12 to 15 and 1.7% of those 16 to 25 years of age. No deaths were reported. This report includes safety data through 1 month of follow-up after dose 2 for some participants. Data on longer-term safety and the duration of efficacy and antibody responses in children are not yet available.

May 27, 2021 - A study published by the journal Nature confirmed: BNT162b2 elicits an adaptive humoral and poly-specific cellular immune response against epitopes conserved in a broad range of variants at well-tolerated doses.

May 24, 2021 - Pfizer Inc. announced that the first enrolled subjects had received their immunizations as part of a new study in adults ages 65 or older exploring the Company's 20-valent pneumococcal coadministration conjugate vaccine (20vPnC) candidate following a booster dose of the Pfizer-BioNTech COVID-19 Vaccine.

May 21, 2021 - BioNTech S.E. published its first Sustainability Report.

May 20, 2021 - BioNTech Europe GmbH has agreed with Turkey's Ministry of Health to supply 60 million additional doses of the companies' COVID-19 vaccine, with an option of 30 million doses. This second supply agreement brings the total number of doses to Turkey to up to 120 million, delivered in 2021.

May 20, 2021 - Pfizer Inc. and BioNTech S.E. announced a new agreement with the European Commission (E.C.) to supply 900 million doses of COMIRNATY with an option for the E.C. to request up to an additional 900 million doses. Inclusive of all agreements, up to 2.4 billion vaccine doses for the E.C. are planned to be manufactured in the E.U.

May 20, 2021 - The NEJM published a response to a Letter to the Editor. Among persons with three or more coexisting conditions, the estimated vaccine effectiveness was 81% (95% confidence interval [CI], 69 to 90) against documented infection and 88% (95% CI, 79 to 95) against symptomatic infection — findings that support the initial indications of potentially reduced vaccine effectiveness in this subgroup. There were also indications of potentially reduced vaccine effectiveness among persons with certain conditions, such as heart disease, chronic kidney disease, and cerebrovascular disease. The number of control-matched pairs of solid-organ recipients for at least 7 days after receiving the second dose was too small to evaluate vaccine effectiveness.

May 12, 2021 - The U.S. CDC's ACIP emergency meeting agenda and presentation slides were posted. This ACIP focuses on the recently Authorized Safety, immunogenicity, and efficacy of Pfizer - BioNTech COVID-19 Vaccine (BNT162b2) in persons aged 12-15 years. During the afternoon session, the ACIP voted in support of the U.S. FDA's expanded Authorization.

May 11, 2021 - BioNTech S.E. announced today that the U.S. Food and Drug Administration had expanded the Emergency Use Authorization for their COVID-19 vaccine to include individuals 12 to 15 years of age. This is the first COVID-19 vaccine authorized in the U.S. for use in this age group.

May 10, 2021 - The U.S. FDA expanded the EUA for the Pfizer-BioNTech COVID-19 Vaccine to include adolescents 12 through 15 years of age.

May 10, 2021 - BioNTech S.E. announced plans to establish a fully integrated mRNA manufacturing facility in Singapore with support from the Singapore Economic Development Board. The new facility will provide regional and global supply capacity of BioNTech's growing pipeline of mRNA-based product candidates. The Company anticipates that the site could be operational as early as 2023 and will create up to 80 jobs in Singapore.

May 9, 2021 - BioNTech agreed to Fosun Pharma's heads to establish a 50/50 Joint Venture (J.V.) to manufacture the COVID-19 vaccine in Mainland China. The establishment of a J.V. will be conditional on BioNTech receiving approval for its COVID-19 vaccine in Mainland China and agreement with Fosun Pharma on a definitive J.V. agreement, in addition to other conditions. As part of its global supply strategy, BioNTech believes that establishing local manufacturing capacity for the COVID-19 vaccine could substantially increase the Company's ability to supply vaccines to China upon approval.

May 7, 2021 - Pfizer Inc. and BioNTech S.E. announced the initiation of a Biologics License Application with the U.S. FDA to approve their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older.

April 23, 2021 - The Lancet published 'COVID-19 vaccine coverage in England's healthcare workers and effectiveness of BNT162b2 mRNA vaccine against infection (SIREN): a prospective, multicentre, cohort study.' Interpretation: Our findings show that the BNT162b2 vaccine can prevent both symptomatic and asymptomatic infections in working-age adults. This cohort was vaccinated when the dominant variant in circulation was B1.1.7 and showed effectiveness against this variant.

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.

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.

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 were supplied to the U.S. Government.

January 25, 2021 - The Therapeutic Goods Administration of Australia has granted provisional approval to Pfizer Australia Pty Ltd for the Comirnaty COVID-19 vaccine, the first COVID-19 vaccine to receive regulatory approval.

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. 

December 21, 2020 - Pfizer Inc. and BioNTech S.E. announced that the European Commission had granted a conditional marketing authorization 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. 

December 15, 2020 - Presented by the Orthodox Union and the Rabbinical Council of America: our poskim conclude that, according 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 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 10, 2020 - The Kingdom of Saudi Arabia's Food and Drug Agency registered the Pfizer-BioNTech COVID-19 vaccine for import and use.

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.

July 22, 2020 - Pfizer and BioNTech S.E. 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. 

April 22, 2020 - Pfizer Inc. and BioNTech S.E. confirmed they have entered into a global collaboration agreement to co-develop BioNTech's mRNA-based coronavirus vaccine program to prevent COVID-19 infection.

March 16, 2020 - BioNTech also announced a strategic alliance with Fosun Pharma to develop its COVID-19 vaccine in China.

Comirnaty COVID-19 Vaccine (BioNTech - Pfizer BNT162b2) Clinical Trials

Comirnaty has been tested in over 80 clinical trials since the first quarter of 2020. 

Pfizer's website displays various clinical trial participant metrics.

Clinical Trials