• COVID-19 Vaccine

    Updated September 17, 2021

    All three authorized vaccines are still extremely effective at preventing severe disease, hospitalizations, and death from COVID-19. Vaccination remains one of the best strategies to address the pandemic. Vaccination, masking, and distancing are proven public health measures to reduce the spread of COVID-19.

    Over 211 million people have received at least one dose of COVID-19 vaccine in the U.S., and the Centers for Disease Control (CDC) continues to monitor the safety of COVID-19 vaccines for any health issues after vaccination. 

    As the Delta variant is more infectious than prior strains, the AAFP supports CDC's recommendation that all individuals, including those who are fully vaccinated, should wear a mask in the short-term to help prevent spread. 

     

    The Latest: FDA Reviews Pfizer-BioNTech Vaccine Booster Dose 

    On Sept. 17, the FDA’s Vaccines and Related Biological Products Advisory Committee met to review an application for full approval of a booster dose for Pfizer-BioNTech vaccine in individuals 16 years of age and older. However, this application was not approved based on a paucity of data, especially in the younger age group. View the FDA briefing book.

    The committee discussed and voted unanimously in favor of emergency use authorization for booster doses in certain populations, including: 

    • Individuals 65 years of age and older 
    • Individuals at increased risk for severe COVID-19.

    The booster dose would be given at least 6 months after series completion. 

    What’s next: The FDA will determine if it will grant the EUA for a booster dose for the Pfizer-BioNTech vaccine. If authorized, the CDC’s ACIP will discuss potential recommendations for provision of a booster dose for this vaccine at its upcoming meeting on Sept. 22-23. All are welcome to attend this virtual meeting. AAFP staff will continue to monitor and update the website and resources with new information as it becomes available. 

    Off-Label Use of Vaccine

    It is important to note that the Pfizer-BioNTech vaccine is only authorized or approved for use in individuals over the age of 12. For most individuals, this is a two-dose series unless they have moderate to severe immunosuppression. Unlike most medications that have been licensed by the FDA, off-label use of this vaccine in younger individuals or as a booster dose in immunocompetent individuals is strongly discouraged.

    As outlined by CDC, any off-label use of the COMIRNATY/Pfizer-BioNTech COVID-19 Vaccine is not authorized at this time and may not be covered under the PREP Act or the PREP Act declaration. This means that clinicians providing the vaccine outside of the authorized/approved use may not have immunity from claims. Per CDC, “Individuals who receive a third dose may not be eligible for compensation after a possible adverse event. Such use would be in violation of the CDC COVID-19 Vaccination Program provider agreement and therefore may not be reimbursable, and may impact the ability of a provider to remain in the CDC Program, in addition to other potential sanctions. Administration fees for off-label doses may not be reimbursed by payers.”

    ACIP Recommends Pfizer/BioNTech COVID-19 Vaccine under BLA

    CDC recommends the Pfizer-BioNTech vaccine following FDA approval of the Biologics Licensure Application (BLA) for individuals 16 years and older under the BLA. This means that the vaccine is recommended outside of the public health emergency for this age group. The recommendation was based on extensive data from post authorization safety data and an extended length of follow up compared to the previous recommendation for this vaccine in December 2020. The ACIP recommendations for use in individuals aged 12-15 and for use of an additional dose in immunocompromised individuals are still valid under the conditions of the Emergency Use Authorization. Read more in FDA Gives Full Approval to Pfizer-BioNTech COVID-19 Vaccine.


    COVID-19 Resources

    COVID-19 vaccines have been recommended by the CDC’s Advisory Committee on Immunization Practices, which was reviewed and approved by the AAFP. All three vaccines are recommended by the CDC and AAFP, and are effective at preventing COVID-19 disease, hospitalizations and death. 

     

    Virus mutations are common, and SARS-CoV-2 variants have been detected. The CDC is monitoring these variants and tracking spread across the U.S., as well as the effect on infection and disease. Researchers are also checking vaccine effectiveness against the different variants. 

    Update: The Delta variant is accounting for a growing number of new COVID-19 infections. According to the CDC, it has 

    • Increased transmissibility29
    • Potential reduction in neutralization by some EUA monoclonal antibody treatments 7, 14
    • Potential reduction in neutralization by post-vaccination sera 21

    It is important to note that all the variants appear to have increased efficiency in spreading from person to person so the use of mitigation measures like masks, ventilation, hand washing, physical distancing, and quarantine are paramount. A Variant Classification scheme that defines three classes of SARS-CoV-2 variants has been developed and information for the different variants is provided at the links below:

    The B.1.1.7 (Alpha), B.1.351 (Beta), P.1 (Gamma), B.1.427 (Epsilon), B.1.429 (Epsilon), and B.1.617.2 (Delta) variants circulating in the United States are classified as variants of concern. Use the CDC's map to see where the different variants are found in the U.S.

    COVID-19 vaccines with EUA. Updated May 12.

    See the overview. 

    CDC’s ACIP Recommends Pfizer/BioNTech COVID-19 Vaccine for Adolescents Aged 12-15 

    The committee voted to recommend the vaccine for individuals aged 12 – 15 in the U.S. under the Emergency Use Authorization (EUA). The ACIP recommendation followed the FDA amending its EUA to include individuals 12 to 15 based on safety and efficacy data, which showed 100% effectiveness in the vaccine group (0 cases) compared to the placebo group (16 cases). The EUA Fact Sheets reflect the changes.

    Curious about increased risks of myocarditis and pericarditis? See Myocarditis and Pericarditis after mRNA COVID-19 Vaccination on the News Archive page. 
    • CDC Recommends Pregnant People Be Vaccinated Against COVID-19: Growing evidence about the safety and effectiveness of COVID-19 vaccination during pregnancy demonstrates that the benefits of receiving a COVID-19 vaccine outweigh any known or potential risks. 
    • COVID-19 Vaccines in Pregnancy: With more than 20 health care organizations, the AAFP strongly urges individuals who are pregnant, recently pregnant, planning to become pregnant or lactating to be vaccinated against COVID-19. 

     

     

    Coding and Payment

    The American Medical Association continues publishing COVID-19 vaccine and administration codes. Their unique structure allows for tracking and accommodating multiple COVID-19 vaccines.  

    CDC's COVID-19 Vaccine Resources

    Check out information on the CDC's COVID-19 site, including:


    Expect updates to this site, plus CDC’s Vaccination and Immunization site, as more information is available. It's critical that jurisdictions and federal entities receiving vaccine have information to implement an effective COVID-19 vaccination program.

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