December 14, 2020, 11:14 am News Staff -- On Dec. 12, the CDC officially approved the recommendation of the agency’s Advisory Committee on Immunization Practices to use BNT162b2, a COVID-19 vaccine candidate developed by Pfizer Inc. and BioNTech SE, in individuals 16 and older in the United States. The agency’s approval followed the committee’s 11-0 vote (with three abstentions), held earlier in the day, to recommend the vaccine’s use.
The committee’s full interim recommendation was published as a Morbidity and Mortality Weekly Report Early Release on Dec. 13.
“Today we celebrate new hope for an end to this pandemic as the first COVID-19 vaccine enters the market,” remarked AAFP President Ada Stewart, M.D. “The American Academy of Family Physicians commends the researchers and scientists who have worked determinedly to develop safe and effective vaccines that will decrease COVID-related illness and suffering in the U.S. and around the world.”
The ACIP’s vote followed an emergency use authorization issued by the FDA on Dec. 11 for the vaccine, the first of its kind to receive an EUA in the United States.
The decisions by FDA and CDC mean that, depending on availability, health care professionals and others identified by the ACIP to receive the first distribution may be able to start receiving the vaccine as early as the beginning of this week. Family physicians can visit the Academy’s COVID-19 Vaccine Distribution page to find their specific state and jurisdiction vaccine distribution plans.
The AAFP reviews all ACIP recommendations for approval through the Commission on Health of the Public and Science. As the vaccine will be distributed and administered to health care workers as early as this week, an expedited review process was undertaken by members of the commission’s executive committee. The Board chair approved the executive committee’s recommendation for supporting ACIP’s 2020 interim recommendation.
While the efficacy and safety data were sufficient to determine that the potential benefits outweigh the harms, there are still a number of unknowns regarding the vaccine. As highlighted by ACIP and others, there is lack of data in children under 16 years of age and in individuals who are pregnant or lactating. While persons who are pregnant or lactating may receive the vaccine, a full understanding of the potential benefits and risks associated with receiving the vaccine will be important. Individuals considering the vaccine should discuss it with their primary care physician.
Additionally, caution has been issued by the CDC for individuals with a history of anaphylaxis in response to a vaccine or other injectable medication. This caution does not apply to individuals with food allergies or reactions to oral medications. As with other vaccines, any individual who has a known allergy to any of the components in the vaccine should not be immunized. The AAFP has created a COVID-19 Vaccine FAQ document to help answer questions. The FDA has published additional information regarding vaccine storage, preparation and contraindications.
The CDC is expected to release more detailed guidance on the vaccine soon. As these and other resources become available, they will be posted on the AAFP COVID-19 Vaccine web page and communicated to members.
Stewart commended the FDA and ACIP for applying due diligence while evaluating the science, efficacy and safety of the new vaccine candidate. She also emphasized the role family physicians will play in administering the vaccine and in educating patients on the importance of all vaccines, not just those for COVID-19.
“While broad distribution plans and timing are being determined, family physicians stand ready to serve as partners in vaccine education, distribution and administration,” said Stewart. “We will work to ensure all people in the U.S. can be vaccinated, especially those populations who have been disproportionately affected by COVID-19.”
“Vaccines are safe, effective, and they save lives,” Stewart continued. “That is why the AAFP has long been committed to reducing vaccine hesitancy through highlighting that immunizations are a selfless act of prevention that help the broader community. Family physicians trust the science of vaccines, and we encourage our patients to learn more about vaccines and how getting vaccinated builds a community of immunity at familydoctor.org/vaccines."
The Academy is also taking steps to keep its members apprised of the latest information related to COVID-19.
On Dec. 16, the AAFP will host a Virtual Town Hall devoted entirely to issues related to the approval and distribution of COVID-19 vaccines.
The Academy also continues to regularly update its COVID-19 page, which debuted on AAFP.org in March 2020, as well as the COVID-19 Vaccine page.