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Comirnaty COVID-19 Vaccine

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January 14, 2022
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Pfizer-BioNTech COVID-19 Vaccine Comirnaty (BNT162b2) Description

BioNTech S.E. and Pfizer, Inc. co-developed the Pfizer-BioNTech COVID-19 Vaccine (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 in the U.S. as Pfizer-BioNTech COVID-19 Vaccine and 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).

The Pfizer-BioNTech COVID-19 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. The FDA Approved the Pfizer-BioNTech COVID-19 Vaccine on August 23, 2021. The FDA Approval was granted to BioNTech Manufacturing GmbH. In addition, 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. And the FDA announced an amended EUA for the Pfizer-BioNTech COVID-19 Vaccine on January 3, 2022.

John L. Perez, M.D., 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 specific individuals who completed vaccination with certain non-FDA-authorized or -approved COVID-19 vaccines. In addition, the FDA amended EUA to include a single booster dose granted to Pfizer Inc.

On January 3, 2021, the U.S. FDA published a Supplemental Approval Letter (STN: BL 125742/36) to Pfizer Inc. and reissued emergency use instructions Fact Sheets to provide information about the use of the vaccine. 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

Pfizer-BioNTech COVID-19 Vaccine Comirnaty (BNT162b2) Effectiveness Against Variants (Omicron)

As of January 14, 2022, the U.S. NIH's OpenData Portal reported in vitro Therapeutic Activity against the Omicron variant. But, given the breaking Nature of these releases, Omicron data should be interpreted with caution. In addition, the CDC and Scripps publish SARS-CoV-2 virus variant information.

A study published by the journal Cell on December 23, 2021, found an additional "booster" (3rd or 4th) dose of Pfizer mRNA-based vaccine is needed to provide immunity against the Omicron variant, according to researchers at the Ragon Institute of MGH, MIT, and Harvard.

The companies announced results from an initial laboratory study on December 8, 2021, demonstrating those serum antibodies induced by Comirnaty neutralize the SARS-CoV-2 Omicron variant after three doses. And Pfizer disclosed in its presentation to the U.S. FDA's VRBPAC 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. 

Pfizer-BioNTech COVID-19 Vaccine Comirnaty (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.

Pfizer-BioNTech COVID-19 Vaccine Comirnaty (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.

The Israeli Mistry of Health approved the fourth dose for seniors (60+) and for Medical Teams on January 3, 3022. 

Pfizer-BioNTech COVID-19 Vaccine Comirnaty (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.

On December 16, 2021, the FDA announced its approval to STN: BL 125742/36 to include a new 30 microgram dose formulation (Tris/Sucrose) of COMIRNATY manufactured at the Pfizer Manufacturing Belgium NV, Puurs, Belgium (Pfizer, Puurs) facility.

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.'

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

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. The U.S. CDC's ACIP committee's presentation slides on August 30, 2021, and 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. In addition, the FDA updated its guidance in October 2021.

On October 15, 2021, the peer-review journal Vaccine published an analysis that concluded 'the frequencies of cardiac adverse events were affected by the vaccine, vaccine type, vaccine dose, sex, and age of the vaccinated individuals. Systems biology results suggested a central role of interferongamma in the biological processes leading to cardiac adverse events, by impacting MAPK and JAK-STAT signaling pathways. We suggest that increasing the time interval between vaccine doses minimizes the risks of developing inflammatory adverse reactions. We also propose glucocorticoids as preferred treatments based on system biology evidence.'

On December 9, 2021, the EMA stated the outcome of the review confirms the risk of myocarditis and pericarditis, which is already reflected in the product information for Comirnaty and provides further details on these two conditions. Based on the reviewed data, the EMA's PRAC has determined that the overall risk for both conditions is overall 'very rare', meaning that up to 1 in 10,000. Additionally, the data show that the increased risk of myocarditis after vaccination is highest in younger males. PRAC has recommended updating the product information accordingly. Of note, swollen lymph nodes in the underarm were observed more frequently following the booster dose than after the second dose of a two-dose primary series. 

A very large (42m) non-peer-reviewed study funded by Health Data Research UK confirmed on December 25, 2021, Myocarditis risk was increased during 1-28 days following the third dose of BNT162b2 vaccination (IRR 2.02, 95%CI 1.40, 2.91).

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. In addition, side effects can be reported to Pfizer Inc. at www.pfizersafetyreporting.com or by calling 1-800-438-1985.

Pfizer-BioNTech COVID-19 Vaccine Comirnaty (BNT162b2) Authorization for Children and Adolescents

The CDC's Advisory Committee on Immunization Practices meeting on January 5, 2021, included presentations: Anne M. Hause, Ph.D., MSPH - Safety monitoring of COVID-19 vaccine among children and young adults in v-safe; Nicola Klein, MD, Ph.D. - Vaccine Safety Datalink Rapid Cycle Analyses: Uptake and Safety of COVID-19 Vaccines in 5–11 and 12–17-Year-Olds.

The U.S. FDA announced on January 3, 2022, the expand the use of a single booster dose to include use in individuals 12 through 15 years of age, and allowed for a third primary series dose for certain immunocompromised children 5 through 11 years of age. And the FDA authorized on December 9, 2021, a 3rd dose booster for people 16 years of age and older, following completion of the primary series, which could be 2 or 3 doses. 

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. 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 effectiveness data to support the FDA's EUA in adolescents in this age group is based on immunogenicity and analysis of COVID-19 cases. The immune response to the vaccine in 190 participants 12 through 15 years of age was compared to the immune response of 170 participants 16 through 25 years of age. In this analysis, the immune response of adolescents was non-inferior to (at least as good as) the immune response of the older participants. The most commonly reported side effects in the adolescent clinical trial participants, which typically lasted 1-3 days, were pain at the injection site, tiredness, headache, chills, muscle pain, fever, and joint pain. 

The UK's Medicines and Healthcare products Regulatory Agency announced on December 22, 2021, approval for a 2-dose formulation specially designed for 5-11-year-olds given at a lower dose compared to that used in individuals aged 12 and above (10 micrograms compared with 30 micrograms). 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.

On November 25, 2021, Pfizer Inc. and BioNTech SE announced that the Committee for Medicinal Products for Human Use of the EMA 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. 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.

Pfizer-BioNTech COVID-19 Vaccine Comirnaty Indication For Pregnant or Breastfeeding Women 

The U.S. FDA says 'while there have been no specific studies in these groups, there is no contraindication to receipt of the vaccine for pregnant or breastfeeding women. Pregnant or breastfeeding women should discuss the potential benefits and risks of vaccination with their healthcare providers. On January 5, 2022, the Department of Obstetrics and Gynecology, Oregon Health & Science University published Original Research that concluded: after 2-doses of a COVID-19 vaccine, a small change in menstrual cycle length was determined, but not menses length.'

Pfizer-BioNTech COVID-19 Vaccine Comirnaty CoAdministration With PREVNAR 20

On January 12, 2022, Pfizer announced positive top-line results from a Phase 3 study (B74710126) describing the safety and immunogenicity of PREVNAR 20™ (Pneumococcal 20-valent Conjugate Vaccine) in 570 senior adults in the U.S. when administered at the same time as the Pfizer-BioNTech COVID-19 Vaccine or when each vaccine was given with placebo.

Pfizer-BioNTech COVID-19 Vaccine Comirnaty 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.

Pfizer-BioNTech COVID-19 Vaccine Comirnaty 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.

Pfizer-BioNTech COVID-19 Vaccine Comirnaty 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.

Since its marketing authorization in the European Union on December 21, 2020, until December 2021, almost 479 million doses of Comirnaty have been administered in the EU/EEA. On December 20, 2021, the companies announced an agreement with the European Commission and its member states to exercise an option to purchase more than 200 million additional doses of COMIRNATY. These 200 million optional doses are in addition to the 450 million doses already planned to be delivered in 2022.

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.

Pfizer-BioNTech COVID-19 Vaccine Comirnaty 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.

Pfizer-BioNTech COVID-19 Vaccine Comirnaty 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. And CMS has released a set of toolkits for providers, states, and insurers to help the health care system prepare and assist in swiftly administering these products once they become available. 

Comirnaty Vaccine Revenues and Company Financial News

December 10, 2021 - Pfizer Inc. announced an increase in the quarterly cash dividend on the company's common stock to $0.40 for the first-quarter 2022 dividend, payable March 4, 2022, to holders of the Common Stock of record at the close of business on January 28, 2022.

November 2, 2021 - The Company expects revenues of approximately $36 Billion for Comirnaty, Reflecting 2.3 Billion Doses Expected to be Delivered in Fiscal 2021.

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

January 10, 2022 - Pfizer Inc. and Acuitas Therapeutice announced they have entered into a Development and Option agreement under which Pfizer will have the option to license, on a non-exclusive basis, Acuitas' lipid nanoparticle technology for up to 10 targets for mRNA vaccine or therapeutic development. Acuitas' LNP technology is used in the COMIRNATY Pfizer-BioNTech COVID-19 vaccine.

January 4, 2022 - A study published by the journal Cell found that neutralization capacity against the Delta VoC is significantly increased in sera of ChAdOx1 nCoV-19/BNT162b2 vaccinated participants.

January 3, 2022 - The U.S. FDA announced various changes to the Pfizer-BioNTech COVID-19 Vaccine Comirnaty EUA.

December 17, 2021 - The companies announced the clinical study evaluating vaccination options for children 6 months to under 5 years of age will now include evaluating a third dose of 3 µg at least two months after the second dose of the two-dose series.

December 14, 2021 - Italy confirmed it will offer Comirnaty vaccines to children aged 5-11 beginning mid-December. Italy's AIFA approved the Comirnaty vaccine on December 1, 2021, following Authorization by the EMA.

December 9, 2021 - The U.S. FDA amended Pfizer Inc.'s EUA for the Pfizer-BioNTech COVID-19 Vaccine, authorizing the use of a single booster dose for administration to individuals 16 and 17 years of age at least six months after completion of primary vaccination (2-doses) with the Pfizer-BioNTech COVID-19 Vaccine.  

December 8, 2021 - Pfizer Inc. and BioNTech SE announced results from an initial laboratory study demonstrating those serum antibodies induced by BNT162b2 neutralize the SARS-CoV-2 Omicron variant after three doses. Sera obtained from vaccinees one month after receiving the booster vaccination (third dose) neutralized the Omicron variant to levels that are comparable to those observed for the wild-type SARS-CoV-2 spike protein after two doses.

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, 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.

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

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 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.

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.

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.

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 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.'

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 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 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 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.

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.

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.

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