Pfizer and BioNTech Receive CHMP Positive Opinion for their COVID-19 Vaccine

  • European Commission decision on conditional marketing authorization expected imminently
  • Positive CHMP opinion follows several emergency use authorizations worldwide; committee reviewed totality of scientific evidence, including Phase 3 efficacy and safety data
  • If authorized, BNT162b2 will be the first COVID-19 vaccine available in the European Union

NEW YORK, NY, USA and MAINZ, Germany I December 21, 2020 I Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion to recommend the conditional marketing authorization (CMA) of the Pfizer-BioNTech COVID-19 vaccine (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. The purpose of a CMA is to allow for medicinal products to be authorized on a conditional basis for seriously debilitating or life-threatening diseases or for use in emergency situations in response to public health threats recognized either by the World Health Organization or the European Union (EU).

“Today is a particularly personal and emotional day for us at BioNTech. Being in the heart of the EU, we are thrilled to be one step closer to potentially delivering the first vaccine in Europe to help combat this devastating pandemic. We are standing by ready to start the delivery of initial vaccine doses across the EU as soon as we get the green light,” said Ugur Sahin, M.D. CEO and Co-founder of BioNTech.

“We are pleased with the Committee’s strong vote of confidence in our data,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “If the European Commission issues an authorization, we are ready to start delivering this vaccine to government-designated sites all across the EU where cases of disease continue to rise and several countries are managing lockdowns.”

The CHMP advisors based their positive opinion on the scientific evidence supporting the Pfizer-BioNTech COVID-19 vaccine, including data from a Phase 3 clinical study announced last month and published in The New England Journal of Medicine on December 10, 2020. The European Commission (EC) will review the CHMP recommendation and is expected to make a final decision on the conditional marketing authorization in the near future. If the EC grants the CMA, the decision will be immediately applicable to all 27 EU member states.

To date, the vaccine has been authorized or approved for emergency or temporary use in more than 15 countries. Regulatory reviews are underway in several countries, with more submissions anticipated.

The Pfizer-BioNTech COVID-19 vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564 (b) (1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. Please see Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering vaccine (Vaccination Providers) including Full EUA Prescribing Information available at www.cvdvaccine.com.

AUTHORIZED USE IN THE U.S.:
The Pfizer-BioNTech COVID-19 vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older. 

IMPORTANT SAFETY INFORMATION FROM U.S. FDA EMERGENCY USE AUTHORIZATION PRESCRIBING INFORMATION:

  • Do not administer Pfizer-BioNTech COVID-19 vaccine to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 vaccine.
  • Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer-BioNTech COVID-19 vaccine.
  • Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 vaccine.
  • The Pfizer-BioNTech COVID-19 vaccine may not protect all vaccine recipients.
  • In clinical studies, adverse reactions in participants 16 years of age and older included pain at the injection site (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), fever (14.2%), injection site swelling (10.5%), injection site redness (9.5%), nausea (1.1%), malaise (0.5%), and lymphadenopathy (0.3%).
  • Severe allergic reactions have been reported following the Pfizer-BioNTech COVID-19 vaccine during mass vaccination outside of clinical trials. Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Pfizer-BioNTech COVID-19 vaccine.
  • Available data on Pfizer-BioNTech COVID-19 vaccine administered to pregnant women are insufficient
  • to inform vaccine-associated risks in pregnancy.
  • Data are not available to assess the effects of Pfizer-BioNTech COVID-19 vaccine on the breastfed infant or on milk production/excretion.
  • There are no data available on the interchangeability of the Pfizer-BioNTech COVID-19 vaccine with other COVID-19 vaccines to complete the vaccination series. Individuals who have received one dose of Pfizer-BioNTech COVID-19 vaccine should receive a second dose of Pfizer-BioNTech COVID-19 vaccine to complete the vaccination series.
  • Vaccination providers must report Adverse Events in accordance with the Fact Sheet to VAERS at https://vaers.hhs.gov/reportevent.html or by calling 1-800-822-7967. The reports should include the words “Pfizer-BioNTech COVID-19 vaccine EUA” in the description section of the report.
  • Vaccination providers should review the Fact Sheet for mandatory requirements and Information to Provide to vaccine Recipients/Caregivers and the Full EUA Prescribing Information for Requirements and Instructions for Reporting Adverse Events and vaccine Administration Errors.

Please see Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering vaccine (Vaccination Providers) including Full EUA Prescribing Information available at www.cvdvaccine.com.

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 150 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 News, LinkedIn, YouTube 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, bi-specific checkpoint immuno-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, Bayer Animal Health, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer. For more information, please visit www.BioNTech.de.

SOURCE: BioNTech

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