Pfizer and BioNTech Receive Positive CHMP Opinion for Omicron BA.1-Adapted Bivalent COVID-19 Vaccine Booster in European Union

  • CHMP recommendation based on safety, tolerability, and immunogenicity data from a Phase 2/3 trial of the Omicron BA.1-adapted bivalent vaccine
  • The Omicron BA.1-adapted bivalent COVID-19 vaccine combines 15 µg of mRNA encoding the SARS-CoV-2 wild-type spike protein which is also in the Original Pfizer-BioNTech COVID-19 Vaccine with 15 µg of mRNA encoding the spike protein of the Omicron BA.1 variant
  • Omicron BA.1-adapted bivalent vaccine is available to ship immediately to support the start of European vaccination campaigns within the coming days

NEW YORK, NY, USA and MAINZ, Germany I September 1, 2022 I Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced a 30 µg booster dose of their Omicron BA.1- Bivalent COVID-19 Vaccine (COMIRNATY® Original/Omicron BA.1 15/15 µg) has been recommended for conditional marketing authorization (cMA) by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for individuals 12 years and older. The European Commission will review the CHMP recommendation and is expected to make a final decision soon.

The Omicron BA.1-adapted bivalent vaccine contains 15 µg of mRNA encoding the wild-type spike protein of SARS-CoV-2, which is present in the Original Pfizer-BioNTech COVID-19 Vaccine, and 15 µg of mRNA encoding the spike protein of the Omicron BA.1 subvariant. Apart from the addition of the mRNA sequence of the BA.1 spike protein, all other components of the vaccine remain unchanged. 

“As we face another autumn living with COVID-19, our Omicron BA.1-adapted bivalent vaccine presents EU residents, care providers and public health authorities with an immediate avenue to begin boosting immunity against Omicron, pending authorization,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “This BA.1-adapted bivalent vaccine was clinically shown to have a favorable safety profile with immunogenicity against both wild-type and Omicron strains and may serve as a key component of vaccination strategies for the coming months.”

“Today’s positive opinion by the committee confirms that immunogenicity and safety goals of variant-adapted mRNA vaccines can be met. Compared to a booster dose of our COVID-19 vaccine, which is currently approved for use in the EU, the bivalent vaccine with mRNA encoding the wild-type and the BA.1 spike proteins provides higher neutralizing antibody titers against the Omicron BA.1 and BA.4/BA.5 sublineages,” said Prof. Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “In addition, a booster dose of our Omicron BA.1-adapted bivalent vaccine is anticipated to preserve and expand the breadth of B and T-cell responses with the aim to provide broader immunity against COVID-19 caused by SARS-CoV-2, including Omicron sublineages.”

Today’s recommendation follows guidance from the EMA, World Health Organization (WHO) and International Coalition of Medicines Regulatory Authorities (ICMRA) to advance a bivalent vaccine candidate, with the goal of making an Omicron-adapted vaccine available to European Union (EU) member states as soon as possible. 

The CHMP recommendation is based on previously announced safety, tolerability and immunogenicity data from a Phase 2/3 trial of participants 56 years of age and older who received a 30-µg booster dose of the Omicron BA.1-adapted bivalent vaccine. In this study, a booster dose of the Omicron BA.1-adapted bivalent vaccine (n=178) elicited a superior immune response against Omicron BA.1 subvariant compared to the companies’ original COVID-19 vaccine (n=163) as demonstrated by an approximately 9-fold improvement in neutralizing titers. In additional analyses of a SARS-CoV-2 live virus neutralization assay tested on sera from participants in this trial, neutralization titers improved by approximately 4-fold for BA.4/BA.5 (n=100). The BA.1-adapted bivalent vaccine was well-tolerated with a favorable safety profile. 

If an authorization is granted, COMIRNATY® Original/Omicron BA.1 doses will be available within the coming days to all 27 EU member states supporting the start of the European vaccination campaigns. Local supply may vary based on individual country government requests.

The companies have also filed an application to the EMA for a booster dose of an Omicron BA.4/BA.5-adapted COVID-19 bivalent vaccine to allow for flexible vaccination strategies. This application is currently under review. An Omicron-adapted vaccine based on the BA.4/BA.5 subvariant was authorized by the U.S. Food and Drug Administration as a booster for ages 12 and older on August 31, 2022.  

The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder for BNT162b2 (COMIRNATY®) in the United States, the European Union, the United Kingdom, Canada and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned. 

IMPORTANT SAFETY INFORMATION:

  • Events of anaphylaxis have been reported. Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic reaction following the administration of the vaccine.
  • There is an increased, but very rare risk (<1/10,000 cases) of myocarditis and pericarditis following vaccination with COMIRNATY. These conditions can develop within just a few days after vaccination and have primarily occurred within 14 days. They have been observed more often after the second vaccination, and more often in younger males. Available data suggest that the course of myocarditis and pericarditis following vaccination is not different from myocarditis or pericarditis in general. The risk of myocarditis after a third dose of COMIRNATY has not yet been characterized.
  • Rare cases of acute peripheral facial paralysis; uncommon incidence of insomnia, hyperhidrosis and night sweats; and unknown incidence of paraesthesia, hypoaesthesia and erythema multiforme have been identified in post-marketing experience.
  • Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stressā€related reactions (e. g. dizziness, palpitations, increases in heart rate, alterations in blood pressure, tingling sensations and sweating) may occur in association with the vaccination process itself. Stress-related reactions are temporary and resolve on their own. Individuals should be advised to bring symptoms to the attention of the vaccination provider for evaluation. It is important that precautions are in place to avoid injury from fainting.
  • Vaccination should be postponed in individuals suffering from acute severe febrile illness or acute infection. The presence of a minor infection and/or low-grade fever should not delay vaccination.
  • As with other intramuscular injections, the vaccine should be given with caution in individuals receiving anticoagulant therapy or those with thrombocytopenia or any coagulation disorder (such as haemophilia) because bleeding or bruising may occur following an intramuscular administration in these individuals.
  • The efficacy, safety and immunogenicity of the vaccine has not been assessed in immunocompromised individuals, including those receiving immunosuppressant therapy. The efficacy of COMIRNATY may be lower in immunosuppressed individuals.
  • As with any vaccine, vaccination with COMIRNATY may not protect all vaccine recipients. Individuals may not be fully protected until 7 days after their second dose of vaccine.
  • In clinical studies, adverse reactions in participants 16 years of age and older that received two doses were injection site pain (> 80%), fatigue (> 60%), headache (> 50%), myalgia and chills (> 30%), arthralgia (> 20%), pyrexia and injection site swelling (> 10%) and were usually mild or moderate in intensity and resolved within a few days after vaccination. A slightly lower frequency of reactogenicity events was associated with greater age.
  • The overall safety profile of COMIRNATY in participants 5 to 15 years of age that received two doses was similar to that seen in participants 16 years of age and older. The most frequent adverse reactions in children 5 to 11 years of age were injection site pain (>80%), fatigue (>50%), headache (>30%), injection site redness and swelling (>20%), myalgia and chills (>10%).
  • A large amount of observational data from pregnant women vaccinated with COMIRNATY during the second and third trimester have not shown an increase in adverse pregnancy outcomes. While data on pregnancy outcomes following vaccination during the first trimester are presently limited, no increased risk for miscarriage has been seen. COMIRNATY can be used during pregnancy. No effects on the breast-fed newborn/infant are anticipated since the systemic exposure of breast-feeding woman to COMIRNATY is negligible. Observational data from women who were breast-feeding after vaccination have not shown a risk for adverse effects in breast-fed newborns/infants. COMIRNATY can be used during breast-feeding.
  • Interactions with other medicinal products or concomitant administration of COMIRNATY with other vaccines has not been studied.
  • Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
  • For complete information on the safety of COMIRNATY, always make reference to the approved Summary of Product Characteristics and Package Leaflet available in all the languages of the European Union on the EMA website.

The black equilateral triangle denotes that additional monitoring is required to capture any adverse reactions. This will allow quick identification of new safety information. Individuals can help by reporting any side effects they may get. Side effects can be reported to EudraVigilanceThis email address is being protected from spambots. You need JavaScript enabled to view it.www.biontech.com or directly to BioNTech using email, telephone +49 6131 9084 0, or via the website.

About Pfizer: Breakthroughs That Change Patients’ Lives
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer NewsLinkedInYouTube and like us on Facebook at Facebook.com/Pfizer.

About BioNTech
Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bispecific immune checkpoint modulators, targeted cancer antibodies and small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer. For more information, please visit www.BioNTech.com.

SOURCE: Pfizer

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