White House COVID-19 Booster Shot Plan Still Subject to FDA, CDC Evaluation

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On Aug.18, the White House COVID-19 Response Team and public health and medical experts from the U.S. Department of Health and Human Services announced that they are prepared to offer COVID-19 booster shots to fully vaccinated adults ages 18 and older. According to this announcement, these individuals would be eligible for their booster shot eight months after receiving their second dose of the Pfizer or Moderna mRNA vaccines. According to the initial announcement, this booster vaccine program would start the week of Sept. 20, but subsequent news reports indicate that senior administration health officials are delaying that deadline, instead rolling shots out gradually when data are ready. As of now, there is no information about the time frame for a revised roll out.

Importantly, the availability of booster vaccines under this plan is subject to both (1) the Food and Drug Administration (FDA) conducting an independent evaluation of the safety and effectiveness of a third dose of the Pfizer and Moderna vaccines and (2) the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices issuing booster dose recommendations based on a thorough review of the evidence. Neither of these preconditions has happened yet. An FDA advisory committee will meet on Sept. 17 to discuss Pfizer’s application for administration of a third, booster dose.

There has been no announcement to date of a plan for a booster shot for those who received the Johnson & Johnson/Janssen vaccine, which was first administered several months after the Pfizer and Moderna vaccines. Johnson & Johnson/Janssen has not yet filed an application to offer a second, booster shot.

This proposed booster vaccine is separate and independent from the FDA’s earlier authorization of an additional dose of the Pfizer or Moderna vaccine for certain immunocompromised individuals.