Summary of recent changes (last updated October 6, 2021):
- New section on Considerations for use of a Pfizer-BioNTech COVID-19 vaccine booster dose after completion of a Pfizer-BioNTech primary vaccine series
- COVID-19 vaccination is recommended for everyone aged 12 years and older in the United States for the prevention of coronavirus disease 2019 (COVID-19).
- COVID-19 vaccines currently approved or authorized by FDA are highly effective in preventing serious outcomes of COVID-19, including severe disease, hospitalization, and death.
- Available evidence suggests vaccines offer protection against known variants, including the Delta variant (B.1.617.2), particularly against hospitalization and death. The Delta variant, currently the predominant SARS-CoV-2 variant in the United States, is associated with increased transmissibility.
- Efforts to maximize the proportion of people in the United States who are fully vaccinated against COVID-19 remain critical to ending the COVID-19 pandemic.
- ACIP has recommended the FDA-approved Pfizer-BioNTech (COMIRNATY) COVID-19 Vaccine for use in persons aged ≥16 years.
- ACIP has issued interim recommendations under Emergency Use Authorization (EUA) for the use of:
- These clinical considerations provide additional information to healthcare professionals and public health officials on use of COVID-19 vaccines.
Interim recommendation for use of a single Pfizer-BioNTech COVID-19 vaccine booster dose after completion of a Pfizer-BioNTech primary vaccine series
On September 22, 2021, the U.S. Food and Drug Administration (FDA) amended the emergency use authorizationexternal icon (EUA) for the Pfizer-BioNTech COVID-19 vaccine to allow for use of a single booster dose, to be administered at least 6 months after completion of the primary series in specific populations. The EUA applies only to the Pfizer-BioNTech COVID-19 vaccine.
On September 23, 2021, CDC’s independent Advisory Committee on Immunization Practices (ACIP) recommended certain populations receive a booster dose of Pfizer-BioNTech’s COVID-19 vaccine at least six months after the completion of their Pfizer-BioNTech primary vaccine series. On September 24, 2021 CDC released interim booster recommendations.
CDC recommends that the following groups should receive a booster dose of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after completing their Pfizer-BioNTech primary vaccine series:
- People aged 65 years and older
- Residents aged 18 years and older in long-term care settingsexternal icon
- People aged 50–64 years with underlying medical conditions
CDC recommends that a booster dose of Pfizer-BioNTech’s COVID-19 vaccine should be made available so that the following groups may receive a booster dose of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after completing their Pfizer-BioNTech primary vaccine series, based on their individual benefits and risks:
- People aged 18–49 years with underlying medical conditions
- People aged 18–64 years at increased risk for SARS-CoV-2 exposure and transmission because of occupational or institutional setting
During its discussions, ACIP highlighted the following:
- High and equitable COVID-19 vaccination coverage with a COVID-19 primary vaccine series remains the highest priority and is fundamental to reducing COVID-related morbidity and mortality.
- COVID-19 vaccines currently approved or authorized in the United States remain effective against severe disease, hospitalization, and death. Fully vaccinated persons of all ages are much less likely than unvaccinated persons to become infected with SARS-CoV-2 and to require hospitalization.
- COVID-19 vaccine recommendations may be updated, as needed, to reflect changes in U.S. COVID-19 disease trends, new information on COVID-19 vaccine effectiveness and safety, and updated benefit-risk analyses.
- There is urgency to provide guidance on the use of a booster dose for people who received a primary vaccine series with Moderna and Janssen COVID-19 vaccines.