• COVID-19 Vaccine

    Updated October 21, 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 219 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: Moderna and Janssen (J&J) Booster Doses and Heterologous (Mixed) Boosting

    On Oct. 20, the FDA authorized the following uses:

    • A single Moderna COVID-19 vaccine booster dose may be administered at least 6 months after completion of the primary series to individuals who are:
      • 65 years of age and older
      • 18 through 64 years of age at high risk of severe COVID-19
      • 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2
    • A single Janssen (Johnson and Johnson) COVID-19 vaccine booster dose may be administered at least 2 months after completion of the single-dose primary regimen to individuals 18 years of age and older.
    • Each of the available COVID-19 vaccines can be used as a heterologous (or “mix and match”) booster dose in eligible individuals following completion of primary vaccination with a different COVID-19 vaccine.

    These amendments to the authorizations for use of the COVID-19 vaccines come after votes by the FDA’s VRBPAC recommending booster doses for Moderna and Janssen vaccines in the populations indicated above. The committee reviewed data for heterologous boosting but did not take a vote. More detail is available in the FDA press release.

    What’s next:  The CDC’s ACIP will discuss potential recommendations for provision of a booster doses at a virtual meeting on Oct. 21. Any recommendations will be reviewed by AAFP for approval once ratified by the CDC. AAFP staff will continue to update the website and resources with new information as it becomes available. 

    COVID-19 Vaccination for Pregnant People Health Alert

    In August, the CDC reported the highest number of COVID-19-related deaths in pregnant people since the pandemic began. Evidence suggests that about 97% of pregnant people hospitalized with SARS-CoV-2 infection were unvaccinated. The CDC and AAFP strongly recommends that all people who are pregnant, recently pregnant, are trying to get pregnant or might become pregnant get vaccinated now. 

    CDC Issues Recommendations for Pfizer-BioNTech Booster Doses

    On Sept. 24, the CDC approved the ACIP recommendation for a booster shot of the Pfizer-BioNTech COVID-19 vaccine in certain populations and also recommended a booster dose for those in high risk occupational and institutional settings. The use of the terms “should” and “may” are based on the level of evidence and the differences in the balance of benefits and harms for different populations. The CDC issued the following recommendations

    • people 65 years and older and residents in long-term care settings should receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer-BioNTech primary series,
    • people aged 50–64 years with underlying medical conditions should receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer-BioNTech primary series,
    • people aged 18–49 years with underlying medical conditions may receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer-BioNTech primary series, based on their individual benefits and risks, and
    • people aged 18-64 years who are at increased risk for COVID-19 exposure and transmission because of occupational or institutional setting may receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer-BioNTech primary series, based on their individual benefits and risks.
       

    The AAFP has approved the recommendations and has updated resources for our members, including the COVID-19 Vaccine FAQs and COVID-19 Vaccine Booster FAQs. All recommendations are issued under the parameters of the Emergency Use Authorization and only apply to those who have completed a primary series of the Pfizer-BioNTech vaccine. The CDC and FDA are committed to reviewing data related to boosters from other manufacturers as soon as it is available. 

    FDA Authorizes Pfizer-BioNTech Vaccine Booster Doses for Certain Populations 

    On Sept. 22, the FDA amended the EUA for the Pfizer-BioNTech COVID-19 Vaccine to allow for use of a single booster dose in the following populations:

    • individuals 65 years of age and older;
    • individuals 18 through 64 years of age at high risk of severe COVID-19; and 
    • individuals 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19.

    These doses would be administered at least six months after completion of the primary series.

    Off-Label Use of Vaccine

    Pfizer-BioNTech vaccine is 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 or are eligible for a booster dose under the amended EUA as outlined by the FDA. Unlike most FDA-licensed medications, off-label use in younger individuals or as a booster dose in immunocompetent individuals who received a non-Pfizer-BioNTech vaccine is strongly discouraged. 

    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.