AANP Updates on COVID-19 Vaccine Boosters

Federal Agencies Approve COVID-19 Vaccine Booster Doses for Certain Individuals

On September 22, 2021, the United States Food and Drug Administration (FDA) announced that the agency amended the Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to allow a single booster dose, after the completion of the primary series, to be administered for individuals 65 years of age and older, as well as in populations at high risk due to underlying medical conditions or due to institutional or occupational exposure, including health care professionals.

United States Department of Health and Human Services (HHS) Secretary Xavier Becerra has also issued a directive, effective September 25, authorizing all Centers for Disease Control and Prevention (CDC) COVID-19 Vaccination Program providers to make available and administer Pfizer-BioNTech booster doses to all people who are eligible. The language of the directive is available on the HHS announcement.

Following the FDA’s EUA, CDC announced updated interim guidance for use of the booster shots. Further information on the agency actions is available in the FDA announcement as well as the CDC statement. The CDC recommendations include:

• 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 six 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 six 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 six months after their Pfizer-BioNTech primary series, based on their individual benefits and risks.
• 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 six months after their Pfizer-BioNTech primary series, based on their individual benefits and risks.

The CDC will be hosting a Clinician Outreach and Communication Activity (COCA) webinar “What Clinicians Need to Know About the Latest CDC Recommendations for Pfizer-BioNTech COVID-19 Booster Vaccination” on September 28, from 2 p.m. to 3 p.m. ET. Information on accessing the webinar is available on the CDC COCA webpage.

Centers for Medicare and Medicaid Services (CMS) Announces Coverage of COVID-19 Booster Shots

CMS announced that the agency will cover booster doses without cost sharing. Beneficiaries with Medicare will not pay for COVID-19 vaccines or their administration, and there is no applicable copayment, coinsurance or deductible. In addition, nearly all Medicaid and Children’s Health Insurance Program beneficiaries must receive coverage of COVID-19 vaccines and their administration, without cost-sharing. COVID-19 vaccines and their administration, including boosters, will also be covered without cost-sharing for eligible consumers of most issuers of health insurance in the commercial market. Further information on coverage of booster doses is available on the CMS announcement.