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). The U.S. FDA Approved the Pfizer-BioNTech COVID-19 Vaccine on Aug. 23, 2021.
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 and cannot cause COVID-19, says the European Medicines Agency (EMA).
The EMA Committee for Medicinal Products for Human Use (CHMP) recommended on September 16, 2022, converting the conditional Marketing Authorization (cMA) for COMIRNATY® [COVID-19 Vaccine (nucleoside modified)] to standard (also referred to as “full”) Marketing Authorization (MA) for all authorized indications and formulations. The European Commission (EC) will review the CHMP recommendation and is soon expected to make a final decision.
The recommendation to convert the cMA to full MA is based on the totality of available efficacy and safety data provided by Pfizer and BioNTech, which confirm the benefits of the vaccine continue to outweigh its potential risks. The conversion, if approved by the EC, applies to all existing COMIRNATY indications and formulations authorized in the EU, including Pfizer and BioNTech’s bivalent vaccines (COMIRNATY Original/Omicron BA.1 and COMIRNATY Original/Omicron BA.4-5) as booster doses for individuals aged 12 and older in the EU.
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 comparative effectiveness of the fourth dose against infection appears to wane sooner than the third dose (10 weeks, 22% VE).
The Comirnaty (Tozinameran) Drugbank Accession Number: DB15696; ChemIDplus 434370509; CAS number: 2417899-77-3; STN: 125742, UK. ClinicalTrials.gov Identifier - Phase 3 clinical trials: NCT04805125; NCT04368728; NCT04713553; NCT04754594 (additional studies are listed at this link). Please see EUA Fact Sheets at www.cvdvaccine-us.com. The EMA published updated Clinical Data on July 6, 2022.
Germany-based Biopharmaceutical New Technologies (BioNTech.E.) is the Marketing Authorization Holder in the USA, Europe, 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 BA.x Variants
As of September 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.
Comirnaty Side Effects
Swissmedic evaluated 15,781 reports on suspected adverse drug reactions (ADRs) as of August 24, 2022, finding 6,006 suspected cases (38.1%) were classified as serious. The majority of the reports involved more than one reaction. As of July 4, 2022, the EMA reported the EC's EudraVigilance identified Comirnaty had a total of 848,204 cases of suspected side effects spontaneously reported from EU/EEA countries; 8,032 of these reported a fatal outcome. By July 2022, about 649 million doses of Comirnaty had been given to people in the EU/EEA.
The companies confirmed on June 29, 2022, that people should not receive the Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY if the vaccine recipient had a severe allergic reaction to any of its ingredients or had a severe allergic reaction to a previous dose of Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY.
Comirnaty Heart Risk
During the U.S. CDC ACIP meeting in July 2022, Tom Shimabukuro, M.D., MPH, MBA, CDC COVID-19 Vaccine Coordination Unit, presented: Most (81.7%) healthcare providers who completed surveys indicated the patient was fully recovered or probably fully recovered from Myocarditis, and follow-up and evaluation of myocarditis cases in children ages 5–11 years are ongoing.
Pfizer disclosed on June 29, 2022, Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received the vaccine, more commonly in adolescent males and adult males under 40 years of age than among females and older males. In most of these people, symptoms began within a few days following receipt of the second dose of the vaccine. The chance of having this occur is very low.
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.
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.
Comirnaty Fertility Impairment
Science Advances.org published on July 15, 2022: Investigating trends in those who experience menstrual bleeding changes after mRNA COVID-19 vaccination. In this sample, 42% of women with regular menstrual cycles bled more heavily than usual, while 44% reported no change after being vaccinated. Among respondents who typically do not menstruate, 66% of postmenopausal people reported breakthrough bleeding.
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.
The Comirnaty Vaccine is offered in various dose regimens, subject to country-based authorizations.
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.'
Comirnaty Adolescents and Children
The EMA's CHMP also recommended approval for COMIRNATY as a 10-µg booster (third) dose given at least six months after completion of a primary series for children 5 through 11 years of age on September 16, 2022. COMIRNATY 10-µg was authorized in the EU in November 2021 as a two-dose primary series for children 5 through 11 years of age. Today’s recommendation is based on Phase 2/3 clinical data from participants 5 through 11 years of age who received a 10-µg booster dose of COMIRNATY approximately 6 months after completing the two-dose primary series. The third dose was well tolerated with a favorable safety profile and generated neutralizing antibodies against both Omicron and the original wild-type virus, regardless of prior COVID-19 diagnosis. The EC will review the CHMP opinion, and if MA is granted, the decision will be immediately applicable to all 27 European Union member states.
Previously, the U.S. FDA announced its authorization for a version of Comirnaty for infants and young children. On August 23, 2022, Pfizer Inc. and BioNTech SE announced updated efficacy results from a Phase 2/3 trial evaluating a three 3-µg dose series of the Pfizer-BioNTech COVID-19 Vaccine in children six months through 4 years of age after about two months from the last dose.
Bivalent COVID-19 Vaccine BNT162b5
Pfizer's bivalent COVID-19 vaccine candidate, BNT162b5, consists of RNAs encoding enhanced prefusion spike proteins for the SARS-CoV-2 ancestral strain (wild-type) and an Omicron variant. The enhanced spike protein encoded from the mRNAs in BNT162b5 has been modified with the aim of increasing the magnitude and breadth of the immune response that could better protect against COVID-19.
Comirnaty 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.
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.
The companies announced on June 29, 2022, that the U.S. government would pay $3.2 billion upon receipt of 105 million vaccine doses. Under a new purchase agreement, the U.S. government has the option to purchase up to 195 million additional doses, bringing the total number of potential doses to 300 million. As of September 2022, the Comirnaty COVID-19 Vaccine was available in over 150 countries, including Germany, the USA, Brazil, Canada, Europe, Iceland, Israel, Italy, Qatar, Finland, Pakistan, the U.K., Mongolia, and Nepal.
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, for children six months to under five years of age.
July 28, 2022 - Pfizer Inc. reported Comirnaty revenues of approximately $32 billion, which reflects favorable operational updates compared to prior guidance, offset by unfavorable incremental impacts from foreign exchange. This guidance includes doses expected to be delivered in fiscal 2022, primarily under contracts signed as of mid-July 2022.
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.
Comirnaty News For 2020 - 2022
September 19, 2022 - The U.S. government representatives and the Government of Pakistan confirmed a nationwide campaign to vaccinate children with the first batch of 8 million Pfizer COVID-19 pediatric vaccine doses donated by the USA.
September 16, 2022 - The companies announced the EMA standard marketing authorization recommendation applies to all indications and formulations in the EU, including COMIRNATY® Original/Omicron BA.4-5 and COMIRNATY® Original/Omicron BA.1 bivalent vaccines. And the CHMP separately recommends approval of a booster dose of COMIRNATY® in children 5 through 11 years of age in the EU.
August 22, 2022 - Prof. Ugur Sahin, M.D., CEO and Co-founder of BioNTech, stated, “In less than three months after the FDA provided its guidance for adapted vaccines in the U.S., we are ready to ship the first doses of our Omicron BA.4/BA.5-adapted bivalent vaccine, pending regulatory authorization, to provide people in the U.S. with the possibility to get a booster adapted to the currently most dominant strain of the virus.”
August 8, 2022 - The Lancet published: Vaccine effectiveness of two-dose BNT162b2 against symptomatic and severe COVID-19 among adolescents in Brazil and Scotland over time: a test-negative case-control study. We found waning vaccine protection of BNT162b2 against symptomatic COVID-19 infection among adolescents in Brazil and Scotland from 27 days after the second dose.
July 8, 2022 - Pfizer Inc. and BioNTech SE announced the U.S. FDA Approved the companies' supplemental Biologics License Application for COMIRNATY® to include individuals 12 through 15 years of age.
June 29, 2022 - "As the virus evolves, this new agreement (with the USA) will help ensure people across the country have access to vaccines that may provide protection against current and future variants," said Albert Bourla, Chairman and Chief Executive Officer, Pfizer.
June 25, 2022 - Pfizer and BioNTech reported pivotal data demonstrating the safety, tolerability, and immunogenicity of two Omicron-adapted mRNA vaccine candidates.
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."
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.
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.
January 21, 2022 - Japan's health ministry approved the Comirnaty vaccine for children aged between 5 and 11.
December 14, 2021 - Italy confirmed it would offer Comirnaty vaccines to children aged 5-11 beginning mid-December 2021.
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.
November 9, 2021 - Health Canada confirmed it had authorized the use of the Comirnaty COVID-19 vaccine as a (30 mcg) booster shot.
November 2, 2021 - The U.S. CDC vaccine advisory committee unanimously voted to support offering vaccinations for the 5 to 11-year-old group.
October 28, 2021 - Pfizer and BioNTech announced that the U.S. government had purchased 50 million additional doses of the companies' COVID-19 vaccine.
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 the '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). The FDA vaccine committee voted affirmingly to expand access to a 3rd booster dose for seniors and certain people.
August 23, 2021 - The U.S. FDA issued its Approval for the Comirnaty Vaccine to BioNTech Manufacturing GmbH.
May 12, 2021 - The U.S. CDC's ACIP emergency meeting agenda and presentation slides were posted. 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.
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®.
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.
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.