The U.S. Department of Health and Human Services (HHS) on Aug. 18 announced that booster shots of the Pfizer-BioNTech and Moderna COVID-19 vaccines will be available beginning Sept. 20, starting eight months after an individual's second dose. The availability of the booster shots is subject to a U.S. Food and Drug Administration "independent evaluation and determination of the safety and effectiveness of a third dose" and a recommendation for a third shot the from Centers for Disease Control and Prevention Advisory Committee on Immunization Practices "based on a thorough review of the evidence."

In a statement, HHS said that "available data make very clear that protection against SARS-CoV-2 infection begins to decrease over time following the initial doses of vaccination, and in association with the dominance of the delta variant, we are starting to see evidence of reduced protection against mild and moderate disease." They add that patients at higher risk or those who received a COVID-19 vaccine early in vaccination rollout may have reduced protection against severe disease, hospitalization and death. The reduced protection, along with the delta variant, led the administration to determine that a "booster shot will be needed to maximize vaccine-induced protection and prolong its durability."

Individuals who received the Johnson & Johnson (J&J) vaccine also likely will require a booster shot, and additional data on a J&J booster shot is expected in the coming weeks.

The statement stresses the ongoing importance of COVID-19 vaccinations for those who have not received a vaccine in the U.S. and worldwide. "Nearly all the cases of severe disease, hospitalization, and death continue to occur among those not yet vaccinated at all. We will continue to ramp up efforts to increase vaccinations here at home and to ensure people have accurate information about vaccines from trusted sources," the statement says.

Read the full HHS statement. Access additional guidance, as well as vaccination resources for patients and clinicians on ACC's COVID-19 Hub.

Clinical Topics: COVID-19 Hub, Prevention

Keywords: COVID-19, Advisory Committees, United States Food and Drug Administration, Immunization, Secondary, Vaccination, Vaccines, Centers for Disease Control and Prevention, U.S., Hospitalization, SARS-CoV-2, ACC Advocacy

< Back to Listings