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.
On Oct. 20, the FDA authorized the following uses:
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.
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.
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:
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.
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:
These doses would be administered at least six months after completion of the primary series.
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.
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 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
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.
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.
The American Medical Association continues publishing COVID-19 vaccine and administration codes. Their unique structure allows for tracking and accommodating multiple COVID-19 vaccines.
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.