The federal government Wednesday announced a plan to offer booster shots for the Pfizer and Moderna COVID-19 vaccines beginning in about a month, subject to the Food and Drug Administration (FDA) “conducting an independent evaluation and determination of the safety and effectiveness” of those third shots.
In a statement, the U.S. Department of Health and Human Services said it was prepared “to offer booster shots for all Americans beginning the week of September 20 and starting eight months after an individual’s second dose.”
“At that time, the individuals who were fully vaccinated earliest in the vaccination rollout, including many health care providers, nursing home residents, and other seniors, will likely be eligible for a booster,” said the statement from leadership in various federal health organizations. The signatories included Rochelle Walensky, MD, director of the Centers for Disease Control and Prevention (CDC); Anthony Fauci, MD, chief medical advisor to President Joe Biden; Janet Woodcock, MD, acting commissioner of FDA; and others.
“The 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,” the medical experts said. “Based on our latest assessment, the current protection against severe disease, hospitalization, and death could diminish in the months ahead, especially among those who are at higher risk or were vaccinated during the earlier phases of the vaccination rollout. For that reason, we conclude that a booster shot will be needed to maximize vaccine-induced protection and prolong its durability.”
The plan is subject not only to the FDA review, but also to CDC's Advisory Committee for Immunization Practices (ACIP) issuing a recommendation for the boosters. ACIP's meeting, originally scheduled to begin on Aug. 24, was pushed back to Monday, Aug. 30, and Tuesday, Aug. 31, from 9 am to 3 pm CT. No registration is required to watch the meeting, which can be viewed via webcast. Also on the CDC website, you can find rules of conduct for ACIP meeting attendees.
In the Wednesday statement, the medical experts also said they anticipated booster shots will eventually be needed for the one-shot Johnson & Johnson (J&J) vaccine.
“Administration of the J&J vaccine did not begin in the U.S. until March 2021, and we expect more data on J&J in the next few weeks. With those data in hand, we will keep the public informed with a timely plan for J&J booster shots as well.”
The statement said the experts will continue to “follow this science on a daily basis, and we are prepared to modify this plan should new data emerge that requires it.” It emphasized the ongoing urgency of vaccinating the unvaccinated both in the U.S. and worldwide.