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FDA Panel OKs Moderna Booster for High-Risk Groups

5 takeaways from today’s FDA Advisory Panel on Moderna boosters

October 14, 2021

The U.S. Food and Drug Administration’s (FDA) advisory panel recommended approving a half-dose booster of Moderna’s COVID-19 vaccine for older Americans, health care workers, and other high-risk groups.

The panel’s unanimous recommendation mirrors its guidance for those who received the Pfizer-BioNTech vaccine. The advisory panel said it had enough available data to support the safety and effectiveness of Moderna’s COVID-19 vaccine as a booster dose for the following groups at least six months after their two-dose series:

  • Individuals 65 and older
  • Individuals between 18 and 64 at high risk of severe COVID-19
  • Individuals between 18 and 64 whose frequent institutional or occupational exposure puts them at high risk of serious complications and severe COVID-19

The meeting is the latest in a series from the nation’s infectious disease experts evaluating the safety, effectiveness, and need for booster doses of the available COVID-19 vaccines. The FDA’s discussion is just a part of the process. Experts from the Centers for Disease Control and Prevention also will discuss booster doses during meetings next week before a final recommendation is approved.

Here are five takeaways from today’s meeting:

  1. Rationale for a smaller booster dose:  Moderna officials said a 50 microgram booster dose returned antibody levels, or titers, to levels seen after the second dose of the two-shot series
  2. Side effects:  Pain at the injection site was the most common side effect. Headache, fatigue, and muscle pain were the most commonly reported adverse reactions, and most were mild to moderate. FDA staff provided information about rare reports of myocarditis/pericarditis, which were highest in men between 18 and 25
  3. Workforce concerns:  The FDA’s committee expressed the importance of ensuring health care workers and others at risk of occupational exposure have access to booster doses
  4. Israel data:  Panelists again reviewed data from Israel’s COVID-19 booster campaign and its effectiveness in breaking the curve of new cases and preventing severe disease. The country has primarily relied on the Pfizer-BioNTech vaccine for its vaccine campaign, so it was not a direct comparison, panelists noted
  5. Clear priorities:  The panel stressed that vaccinating the unvaccinated remains the top priority. The panelists expressed reluctance for a broader booster campaign, because the vaccines continue to provide strong protection against severe disease

HAP will continue to monitor public health developments and provide updates to members. Today’s meeting and presentations are available online.

Tomorrow’s FDA booster meeting about the Johnson & Johnson vaccine and mixing and matching vaccine brands also will be available to watch live.