Updated October 20, 2020
As new information is available, this page will be updated to help members effectively prepare practices, counsel patients and administer the vaccine.
To date, no COVID-19 vaccine candidates have been approved by the FDA. All of the candidates are going through clinical trials, with only a few options moving into phase III trials. Currently there is not a vaccine approved or authorized by the FDA; worldwide, there are 46 vaccine candidates in phase 1-3 trials. Four vaccine candidates are in phase III trials for potential use in the U.S: two candidates are using viral vectors as a vehicle for the SARS-CoV-2 proteins while the other two candidates candidates are using SARS-CoV-2 mRNA, which have cold-chain requirements. Only one candidate does not require a booster.
View a list of vaccine candidates and phase of development in a World Health Organization report.
The FDA has released guidance for manufacturers to request approval for Emergency Use Authorization (EUA) of a COVID-19 vaccine. The standards for EUA for the vaccine will be stricter than those for other products and vaccine candidates must meet prespecified efficacy and safety data with at least two months of follow up. Additionally, under an EUA, the FDA will continue to collect safety and efficacy data as the vaccine is made available to the public. All data will be reviewed by experts in vaccinology and the CDC’s Advisory Committee in Immunization Practices.
The CDC and agencies are working on a distribution plan to roll out the vaccine in the U.S. Initially, there will be limited quantities of the vaccine available so priority will be given for certain populations like front line healthcare workers and those at greatest risk of morbidity and mortality from COVID-19.
As the amount of vaccine and supplies ramp up, the vaccine will be distributed more broadly. AAFP and other organizations are actively providing input into this process and advocating strongly for equitable distribution.
The Virtual Town Hall Updates FPs on COVID-19 Vaccine Work article highlights key points about vaccines in development, concerns about vaccine safety, effectiveness and access, health disparities and patient concerns.
The CDC has added vaccine-specific content to its extensive COVID-19 website. These resources include information on vaccination planning, how vaccine safety is being ensured, and frequently asked questions. They clarify how COVID-19 vaccine recommendations will made and how the vaccines will be monitored for safety, to build trust and confidence in future COVID-19 vaccines.
Expect frequent updates to this website, plus CDC’s Vaccination and Immunization website, as more information is available and vaccines become authorized/approved and recommended for use in the U.S. We are committed to ensuring jurisdictions and federal entities that will be receiving vaccine have information and guidance to implement an effective COVID-19 vaccination program.
The AAFP and other primary care organizations work with the CDC’s Advisory Committee on Immunization Practices to develop recommendations for the routine use of immunizations. This work is aided through AAFP members serving on the committee as well as its work group. The immunization schedules are reviewed and approved by the AAFP each year.
Similarly, any recommendations for a COVID-19 vaccine will receive input from family physicians and will be reviewed by the AAFP. The AAFP has issued several statements calling for a transparent review and approval process that adheres to a scientifically rigorous standards to ensure safety and effectiveness of the vaccine.