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FDA Announces Next Steps for COVID-19 Boosters

Advisory meeting this month will discuss the latest data ahead of White House’s September 20 booster plan

September 02, 2021

The U.S. Food and Drug Administration (FDA) announced this week that its vaccine advisers will meet September 17 to provide recommendations about COVID-19 booster doses.

The advisory meeting will provide an independent evaluation about the need for additional doses of the available COVID-19 vaccines, FDA officials said. The meeting comes three days ahead of the White House’s September 20 plan to make Pfizer-BioNTech and Moderna COVID-19 booster doses available.

“A transparent, thorough, and objective review of the data by the FDA is critical so that the medical community and the public continue to have confidence in the safety and effectiveness of COVID-19 vaccines,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Research and Evaluation. “The FDA will review the supplemental application as expeditiously as possible, while still doing so in a thorough and science-based manner.”

Here’s what you need to know about the next steps for the White House’s booster plan:

  • What the panel will evaluate:  The FDA advisory committee plans to review data pertaining to safety and effectiveness of booster doses. Pfizer-BioNTech submitted its application to federal regulators last month, and Moderna submitted its application on Wednesday
  • Why it matters:  The advisory panel will provide an in independent evaluation and determination of the safety and effectiveness of additional vaccine doses
  • Rationale for boosters:  The COVID-19 vaccines continue to provide outstanding protection against severe disease, but public health officials are worried that protection against infection, severe disease, and death may decrease over time, particularly among older adults
  • Timing:  Pending the panel’s approval, boosters of the Pfizer-BioNTech and Moderna vaccines would be available starting September 20. The boosters would occur eight months after people receive the second dose. The initial recommendation would not apply to the Johnson & Johnson vaccine, as regulators await additional data

The White House’s booster plan accompanies an ongoing effort to encourage people who have not received the COVID-19 vaccine to make an appointment. The spread of the Delta variant has made it even more important to increase vaccination rates, with all Pennsylvania counties reporting “high” or “substantial” spread of the virus.

Information about the COVID-19 vaccine is available online.

HAP will continue to monitor COVID-19 public health developments and provide updates to members. For more information, contact Robert Shipp III, PhD, BSN, RN, NEA-BC, HAP’s vice president, population health and clinical affairs.