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Comirnaty COVID-19 Vaccine

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May 24, 2022
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Pfizer-BioNTech COVID-19 Vaccine Comirnaty (BNT162b2) Description For 2022

BioNTech S.E. and Pfizer, Inc. co-developed the U.S. FDA Approved Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) vaccine to prevent severe COVID-19 caused by the SARS-CoV-2 beta coronavirus. 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 as the first U.S. 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 Aug. 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 Aug. 23, 2021. And the FDA amended EUA for the Pfizer-BioNTech COVID-19 Vaccine on Jan. 3, 2022. On March 29, 2022, the U.S. FDA authorized a second booster dose (5th overall) for certain people. The U.S. CDC's Advisory Committee on Immunization Practices Meeting on May 19, 2022, presented updated presentations to Interim Clinical Considerations for the use of COVID19 Vaccines for adolescents and children.

On May 24, 2022, the peer-review journal BMJ published the results from a new study conducted in Israel: A fourth dose of the BNT162b2 vaccine appears to have provided additional protection against both SARS-CoV-2 infection and severe covid-19 disease relative to three vaccine doses. However, the relative effectiveness of the fourth dose against infection appears to wane sooner than that of the third dose (10 weeks, 22% VE).

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). Please see EUA Fact Sheets at www.cvdvaccine-us.com.

Germany-based Biopharmaceutical New Technologies (BioNTech.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) Effectiveness Against SARS-CoV-2 Virus Variants

The peer-review journal JAMA Network Open published a Research Letter on May 13, 2022, which found a rapid decline in Omicron-specific serum neutralizing antibody titers only a few weeks after the second and third doses of BNT162b2. Taken together, vaccine-induced protective antibody responses following a second and third dose of BNT162b2 are transient, and additional booster doses may be necessary, particularly in older people.

As of May 13, 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, the Omicron data should be interpreted with caution. In addition, the CDC and Scripps publish SARS-CoV-2 virus variant information.

An Original Article funded by the U.K. Health Security Agency and published by The NEJM on March 2, 2022, concluded by stating: Primary immunization with two doses of BNT162b2 vaccine provided limited protection against symptomatic disease caused by the omicron variant. And a BNT162b2 booster after the BNT162b2 primary course substantially increased protection, but that protection waned over time.'

Previously, a Pfizer-funded, non-peer-reviewed study published on January 22, 2022, found data supporting a three-dose vaccine strategy that provides short-term neutralization durability against Omicron. At four months post-dose-3, the neutralization GMTs decreased to 820 and 171, suggesting neutralization decay kinetics. 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.

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

On April 18, 2022, the JAMA Network published a Research Letter that 'Most of the respondents (67.8%) reported that their general feeling after the booster vaccination (3rd) was similar to the feeling after the second dose; 18.7% and 11.1% reported a milder or worse response, respectively. About 1.2% sought medical attention owing to an Adverse Event (AE). The proportion of females who reported systemic reactions was nearly double that of males (22.9% vs 11.4%). Individuals aged 60 to 69 years were more likely to report systemic AEs than were individuals 70 years or older (20.5% vs 13.6%).

The EMA announced as of April 28, 2022, a total of 743,735 cases of suspected side effects spontaneously reported from EU/EEA countries; 7,765 of these reported a fatal outcome (by 24 April 2022, about 627 million doses of Comirnaty had been given to people in the EU/EEA.

A meta-review of adverse events following vaccination against COVID-19 with mRNA vaccines in the USA published in The Lancet Infectious Diseases journal on March 7, 2022, confirms that most side effects were mild and decreased substantially after one day. The new study suggests that for more than 298 million vaccine doses administered between December 2020 and June 2021, 92% of reported adverse events were not serious, and less than 1% of v-safe participants reported seeking any medical care following vaccination.

The Annals of Internal Medicine published Original Research on January 25, 2022: Carditis After COVID-19 Vaccination With a Messenger RNA Vaccine and an Inactivated Virus Vaccine. This Case-Control study found 'Despite a low absolute risk, there is an increased risk for carditis associated with BNT162b2 vaccination.'

Myocarditis and Pericarditis Risk

The JAMA Network published a Research Letter on March 17, 2022: Myocarditis Following a Third BNT162b2 Vaccination Dose in Military Recruits in Israel - findings include - only 8 cases of myocarditis among 126,029 people boostered for an incidence rate of 3.17 per 100,000 people vaccinated one week following receipt of the shot and incidence rate of 5.55 per 100,000 people vaccinated two weeks following a third vaccine dose. And the cause of the lower incidence of myocarditis following the third dose compared to the incidence after the second dose requires future research. Additionally, the data show that the increased risk of myocarditis after vaccination is highest in younger males.

On Feb. 22, 2022, the CDC noted that even though the absolute risk for myopericarditis following mRNA COVID-19 vaccination is small, the relative risk is higher for particular groups, including males 12-39 years of age. And the Journal of Pediatrics published on March 25, 2022, a case series reporting the evolution of CMR imaging compared with initial, acute phase CMR in a cohort of patients with myopericarditis post-COVID-19 mRNA vaccine. In a cohort of adolescents with COVID-19 mRNA vaccine-related myopericarditis, a large portion had persistent (3+ months) late gadolinium enhancement abnormalities, raising concerns for potential longer-term effects. 

An Original Article published by Wiley Online on February 14, 2022, strongly supports individualized pediatric COVID-19 vaccination strategies, which weigh protection against severe disease vs. risks of vaccine-associated myocarditis /pericarditis. On February 4, 2022, the ACIP committee reviewed various presentations focused on post-mRNA vaccination heart health side effects. The U.S. CDC published an Original Investigation in the JAMA Network on January 25, 2022, that found 1,991 cases of myocarditis (0.00004%) were reported to the Vaccine Adverse Event Reporting System, with 1,626 (0.000008%) meeting the case definition. Of all patients with myocarditis, the median age was 21 years, 82% were male, with a median time to symptom onset was two days, generally after a second mRNA dose. Furthermore, this heart health risk should be considered in the context of the benefits of COVID-19 vaccination.

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) 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 that 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. 

Pfizer-BioNTech COVID-19 Vaccine (Comirnaty) Dosage

The Comirnaty Vaccine is offered in various dose regimens, subject to country-based authorizations. In the U.S., the U.S. CDC's recommendation for certain people is to receive a 3-dose mRNA vaccine primary series followed by a second booster dose for five total doses. On Feb. 22, 2022, the CDC added considerations for an 8-week interval between the first and second doses of a primary mRNA vaccine schedule for young males and to shorten the interval between completion of the mRNA vaccine primary series and the booster doses to at least four months (instead of 5 months).

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

The U.S. FDA amended the EUA for the Pfizer-BioNTech COVID-19 Vaccine on May 17, 2022, authorizing the use of a single booster dose for administration to individuals 5 through 11 years of age at least five months after completion of a primary series with the Pfizer-BioNTech COVID-19 Vaccine. Antibody responses were evaluated in 67 study participants who received a booster dose 7 to 9 months after completing a two-dose primary series of the Pfizer-BioNTech COVID-19 Vaccine. The antibody level against the SARS-CoV-2 virus one month after the booster dose was increased compared to before the booster dose.

On January 3, the FDA authorized the use of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine for administration to individuals 12 through 15 years of age. A new study by the U.S. CDC and Abt Associates shows that the Pfizer-BioNTech COVID-19 vaccine was moderately effective against the Omicron variant for children ages 5-15. 

Japan's health ministry approved the Comirnaty vaccine for about 8 million children aged between 5 and 11 on January 21, 2022. South Korea issued its authorization on February 22, 2022. 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 than that used in individuals aged 12 and above (10 micrograms compared with 30 micrograms).

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

The companies announced on May 23, 2022, based on topline data, that three doses of the Pfizer-BioNTech COVID-19 Vaccine met all immunobridging criteria required for Emergency Use Authorization. The third 3-µg dose was well-tolerated among 1,678 children under 5 years of age with a safety profile similar to placebo. Vaccine efficacy of 80.3% was observed in the descriptive analysis of three doses during a time when Omicron was the predominant variant. And the 3-µg dose level, which is one-tenth of the dose for adults, was selected for children under 5 years of age based on safety, tolerability, and immunogenicity.

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 receiving the vaccine for pregnant or breastfeeding women. Pregnant or breastfeeding women should discuss vaccination's potential benefits and risks with their healthcare providers. As of mid-February 2022, the CDC reported about 60% of women were vaccinated before pregnancy. As of early March 2022, 293 deaths of pregnant women related to COVID-19 were confirmed. 

And on January 26, 2022, the BMJ reported that more than 36,000 reports of menstrual changes or unexpected vaginal bleeding following covid-19 vaccination (55% Comirnaty) have been made to the yellow card surveillance scheme run by the UK Medicine and Healthcare Products Regulatory Agency (MHRA). A similar signal appeared in the U.S. VAERS. On January 5, 2022, the Department of Obstetrics and Gynecology, Oregon Health & Science University, published Original Research that concluded: that 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 Co-Administration 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 enhancements to the NCCN: Cancer and COVID-19 Vaccination guidance on August 30, 2021. The fourth version incorporates the latest data and recent FDA and CDC approvals regarding a third mRNA vaccine dose for immunocompromised people.

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 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. However, delaying anti-CD20 infusions by 3 to 6 months before vaccination could increase the probability of developing appropriate humoral responses, especially in selected clinically and radiologically stable patients. 

Shingles and Pfizer-BioNTech COVID-19 Vaccination

A study published on Feb. 1, 2022, found the incidence of additional herpes zoster (shingles) cases was 7.1 (95% CI: 4.1–11.5) for BNT162b2 per 1,000,000 doses administered. 

Pfizer-BioNTech COVID-19 Vaccine Comirnaty Distribution in 2022

The companies previously announced that they expect to produce four billion doses of the Comirnaty / Pfizer-BioNTech COVID-19 Vaccine in 2022. This capacity is not expected to change if an adapted vaccine is required. As of May 2022, the Comirnaty COVID-19 Vaccine was available in over 150 countries, including Germany, the USA, BrazilCanadaEurope, IcelandIsraelItalyQatar, Finland, Pakistan, and the U.K.

BioNTech - Fosun Pharma

BioNTech collaborates with Fosun Pharma to develop and sell the BNT162 vaccine in China. Fosun Pharma and BioNTech agreed with Fosun Pharma's heads to establish a 50/50 Joint Venture to manufacture about 1 billion COVID-19 vaccines in China. By the end of February 2022, over 20 million doses of BNT162b2 have been administrated in Hong Kong SAR, Macau SAR, and Taiwan region, helping to establish the local COVID-19 immune barrier.

Pfizer-BioNTech COVID-19 Vaccine Comirnaty Storage

On February 25, 2021, the U.S. FDA announced undiluted frozen vials of the Comirnaty Vaccine could be transported and stored at conventional temperatures.

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 AMA has updated the CPT codes to reflect the booster/third dose, 0003A and for children 6 months to under 5 years of age. 

Comirnaty Vaccine Revenues and Company Financial News For 2021 - 2022

May 9, 2022 - BioNTech SE (Nasdaq: BNTX) reported financial results for the three months ended March 31, 2022: revenues of €6.4 billion, Reiterates BioNTech COVID-19 2022 vaccine revenue guidance of €13 billion to €17 billion.

March 17, 2022 - Germany approved procurement of COVID-19 vaccines until 2029. Since the COVID-19 pandemic started, about 196 million doses have been delivered in Germany.

February 8, 2022 - Pfizer Inc. announced Comirnaty contributed $12.5 billion in direct sales and alliance revenues during the fourth quarter of 2021. These revenues do not include revenues for certain Comirnaty-related manufacturing activities performed on behalf of BioNTech, which are included in the Pfizer CentreOne contract development and manufacturing organization. Revenues related to these manufacturing activities totaled $46 million and $320 million for the fourth quarter and full-year 2021, respectively. Pfizer expects to sell $32 billion of its Covid-19 vaccines in 2022.

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. 

Pfizer-BioNTech COVID-19 Vaccine Comirnaty (BNT162b2) News For 2020 - 2022

May 23, 2022 - The companies stated 'Vaccine efficacy, a secondary endpoint in this trial, was 80.3% in children 6 months to under 5 years of age. This descriptive analysis was based on 10 symptomatic COVID-19 cases identified from seven days after the third dose and accrued as of April 29, 2022. The trial protocol specifies a formal analysis will be performed when at least 21 cases have accrued from seven days after the third dose. Final vaccine efficacy data will be shared once available.'

May 19, 2022 - The U.S. CDC Director Dr. Rochelle P. Walensky stated: "Today, I endorsed the ACIP vote to expand eligibility for COVID-19 vaccine booster doses."

May 17, 2022 - U.S. FDA Commissioner Robert M. Califf, M.D., stated: “The FDA is authorizing the use of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age to provide continued protection against COVID-19."

April 14, 2022 - The companies announced data from a subanalysis of 30 sera from a Phase 2/3 clinical trial of children 5 through 11 years of age show a 36-fold increase in SARS-CoV-2 Omicron neutralizing titers following a booster (third) dose of the Pfizer-BioNTech COVID-19 Vaccine.

April 3, 2022 - The EMA publishes its monthly vaccine safety report.

March 20, 2022 - The U.K.'s NHS announced 'in line with new advice from the Joint Committee on Vaccination and Immunisation, the NHS COVID-19 vaccination program will contact people when it is their turn to be vaccinated with a booster dose.

March 15, 2022 - Pfizer Inc. and BioNTech SE announced the companies submitted an application to the U.S. FDA for EUA of an additional booster (4th) dose for adults 65 years of age and older who have received an initial (3rd) booster of any of the authorized (Janssen) or approved (Moderns/SpikeVax) COVID-19 vaccines.

March 7, 2022 - A U.S. CDC-funded study of safety data from more than 298 million doses of mRNA COVID-19 vaccine administered in the first six months of the US vaccination program shows that most reported adverse events were mild and short in duration.

February 28, 2022 - A New York-based non-peer-reviewed study found the Comirnaty vaccine was less effective with adolescents during the Omicron variant stage.

February 25, 2022 - MDPI published a study: Intracellular Reverse Transcription of Pfizer BioNTech COVID-19 mRNA Vaccine BNT162b2 In Vitro in Human Liver Cell Line. 'Our results indicate a fast up-take of BNT162b2 into human liver cell line Huh7, leading to changes in LINE-1 expression and distribution. We also show that BNT162b2 mRNA is reverse transcribed intracellularly into DNA in as fast as 6 hours upon BNT162b2 exposure.'

February 22, 2022 - South Korea's Ministry of Food and Drug Safety approved the use of Pfizer’s Comirnaty COVID-19 vaccine for children aged 5 to 11.

February 16, 2022 - Reuters reported BioNTech Chief Executive Ugur Sahin told Germany's Bild 'there is a delay in finalizing an Omnicro-specific vaccine.'

February 15, 2022 - The Annals of Internal Medicine published Original Research - The Incidence of SARS-CoV-2 Reinfection in Persons With Naturally Acquired Immunity With and Without Subsequent Receipt of a Single Dose of BNT162b2 Vaccine - that concluded: Persons previously infected with SARS-CoV-2 gained additional protection against reinfection and COVID-19 from a subsequent single dose of the BNT162b2 vaccine. Nonetheless, even without a subsequent vaccination, reinfection appeared relatively rare.

February 11, 2022 - The Companies announced they expect to have three-dose protection data for the 6-month-old and above study in early April 2022. The independent Data Monitoring Committee for the study supports the continuation of the trial according to the protocol and believes that the data collected to date indicate the vaccine is well tolerated and supports a potential three-dose regimen.

February 1, 2022 - The companies have submitted available data on the safety and efficacy of two 3 µg doses as part of a three-dose primary series for this age group to the U.S. FDA. In a press release, "Our vaccine has already demonstrated a favorable safety, tolerability and efficacy profile in multiple clinical trials and real-world studies for all age groups starting from 5 years old," said Ugur Sahin, M.D., CEO and Co-founder of BioNTech.

January 25, 2022 - In a press statement, "... emerging data indicate vaccine-induced protection against infection and mild to moderate disease wanes more rapidly than was observed with prior strains," said Prof. Ugur Sahin, CEO, and Co-founder of BioNTech. "This (new) study is part of our science-based approach to developing a variant-based vaccine that achieves a similar level of protection against Omicron as it did with earlier variants but with a longer duration of protection."

January 21, 2022 - Japan's health ministry approved the Comirnaty vaccine for children aged between 5 and 11. It is the first COVID-19 vaccine made available in Japan for that age group. About 8 million children will be eligible to receive the vaccine.

January 17, 2022 - The Times of Israel reported "The vaccine, which was very effective against the previous strains, is less effective against the Omicron strain," Prof. Gili Regev-Yochay, a lead researcher in a new experiment said. "We see an increase in antibodies, higher than after the third dose. However, we see many infected (patients) with Omicron who received the fourth dose."

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.

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 15, 2021 - The UK Health Security Agency announced results from the first UK real-world study showing 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 1,713 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 - 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 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 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 - 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. Finland's National Institute for Health and Welfare instructed municipalities not to administer the Comirnaty vaccine to men under the age of 30.

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 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.' The U.S. CDC Director Rochelle P. Walensky, M.D., M.P.H., endorsed the recommendation.

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

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 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