HAP's Latest News

FDA Panel to Evaluate Moderna, J&J Booster Doses

Agency also will study evidence to mix-and-match brands for boosters

October 06, 2021

Next week, the U.S. Food and Drug Administration (FDA) will evaluate the next steps for Moderna and Johnson & Johnson’s COVID-19 booster doses, as well as available research about mixing vaccine brands.

On October 14–15, the FDA’s advisory committee will discuss Moderna and Johnson & Johnson’s trial data and requests to authorize booster doses for their respective COVID-19 vaccines. Officials from both companies have said their vaccines provide strong protection against severe COVID-19, but that a third dose would improve protection against infection over time.

The meeting comes after the FDA and the Centers for Disease Control and Prevention (CDC) authorized a third dose of the Pfizer-BioNTech vaccine for certain individuals last month. The booster shot should be given at least six months after the completion of the initial two-dose series.

Here’s what you need to know about the FDA’s upcoming booster meetings:

  • Mixing vaccines:  During the October 15 meeting, the National Institute of Allergy and Infectious Diseases will discuss the possibility of mixing and matching the three authorized vaccines for booster doses
  • Efficacy review:  Johnson & Johnson officials say a booster of the COVID-19 vaccine increases levels of protection to 94 percent. Moderna said last month that a booster dose of its vaccine would help increase antibodies at least six months after the completion of the two-dose series
  • Study group:  The advisory panel will review the benefits and risks of a booster dose for people 18 and older
  • Boosters to date:  About 186 million Americans are fully vaccinated and six million have received a booster dose, according to the CDC
  • Quotable: “The available data make clear that protection against symptomatic COVID-19 in certain populations begins to decrease over time, so it’s important to evaluate the information on the use of booster doses in various populations,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research

The meetings on October 14 and October 15 will be available online.

This week, the Pennsylvania Department of Health issued its advisory for boosters of the Pfizer-BioNTech vaccine. Philadelphia released its recommendations last month.

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