Recommendation follows yesterday’s FDA authorization for emergency use of the Pfizer-BioNTech COVID-19 vaccine (BNT162b2), to address the crisis
Based on urgent need, Committee recommends Pfizer-BioNTech COVID-19 vaccine for persons 16 years of age and older under U.S. FDA’s Emergency Use Authorization; earlier this month, the Committee recommended a phased allocation of vaccine distribution with Phase 1a to prioritize health care personnel treating patients, and residents in nursing homes and other long-term care facilities Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced today that the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted today to recommend the use of the Pfizer-BioNTech COVID-19 vaccine in people 16 years of age and older under the Emergency Use Authorization (EUA) issued by the U.S. Food and Drug Administration (FDA). This ACIP vote follows the December 1, 2020 ACIP recommendation for a Phase 1a rollout where first priority of COVID-19 vaccines is given to health care personnel treating patients, and residents in nursing homes and other long-term care facilities.
ACIP advises the CDC on the types of populations and circumstances for which vaccines should be used. The advisors based today’s recommendation on the scientific evidence supporting the 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, as well as on interim guidance that ACIP made on December 1, 2020 regarding the allocation of initial vaccine doses. The vaccine was authorized by the FDA on December 11, 2020 under an EUA while Pfizer and BioNTech gather additional data and prepare to file a planned Biologics License Application (BLA) with the FDA for a possible full regulatory approval in 2021.
“Today’s ACIP recommendation marks a momentous step in this historic journey and the beginning of another, as we work jointly with the U.S. government, other vaccine companies and our many partners to execute the largest mass vaccination program in our nation’s history. Collectively, we aim to vaccinate hundreds of millions of Americans by the end of 2021,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “With vaccinations set to begin this week, I feel a sense of tremendous pride at what we have collectively achieved over the past nine months. I now look forward to the day that this devastating and deadly pandemic is finally behind us.”
“We started our project to develop a potential COVID-19 vaccine in January because we felt we had a duty to leverage our mRNA technologies and fast vaccine development competences to help address the pandemic,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “We have the greatest respect for all the healthcare workers and people working day and night in long-term care facilities and hospitals. They have been taking care of so many people who needed help the most. Now, we feel honored to be able to support them by providing this vaccine.”
The first vaccine supplies are being prepared to ship from Pfizer’s Kalamazoo, MI site, and will be distributed by the U.S. Department of Defense in partnership with agencies within the Department of Health and Human Services (HHS), including the CDC, to government-designated facilities across the country.
These ACIP recommendations will be forwarded to the director of the CDC and HHS for review and adoption.
AUTHORIZED USE:
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:
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 ErrorsPlease see Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) including Full EUA Prescribing Information available at https://www.cvdvaccine.com.
For a discussion of these and other risks and uncertainties, see BioNTech’s Quarterly Report for the Three and Nine Months Ended September 30, 2020, filed as Exhibit 99.2 to its Current Report on Form 6-K filed with the SEC on November 10, which is available on the SEC’s website at www.sec.gov.
All information in this press release is as of the date of the release, and BioNTech undertakes no duty to update this information unless required by law.
Jasmina Alatovic, photo BioNTech