US Drug Regulator Advisers to Meet on Moderna, Johnson & Johnson COVID-19 Vaccine Boosters

A Moderna COVID-19 vaccine vial is seen in a file photograph. (Eugene Hoshiko/AP Photo)

A panel that advises the Food and Drug Administration (FDA) is set to meet this month to consider whether to recommend booster shots of the Moderna and Johnson & Johnson COVID-19 vaccines.

The Vaccines and Related Biological Products Advisory Committee will meet on Oct. 14 and 15 to consider whether to recommend the companies’ booster shots for certain groups.

Advisers will hear presentations on both days, including from both companies. Another presentation, from the National Institute of Health’s National Institute of Allergy and Infectious Diseases, will outline data on mixing and matching booster vaccinations or using a different vaccine for the booster shot than that used for the initial regimen, the FDA said in a statement.

The FDA typically takes up recommendations from the panel. The Biden administration announced in September that it supported using booster vaccinations for individuals who have received a vaccine, regardless of their health status or underlying characteristics. However, the FDA has only authorized Pfizer COVID-19 vaccine boosters in some populations, after two top FDA officials announced their resignations, penning a paper on their way out that argued that there was no evidence to support their use.

The authorization only applies to people who have received Pfizer’s initial two-dose regimen. Mixing and matching booster vaccinations isn’t advised at this time.

Tension over vaccine booster shots continued after the FDA agreed with its advisers. The Centers for Disease Control and Prevention advisory board rejected a vote to recommend booster vaccinations for millions of people as young as 18, but was overruled by the agency’s director, Dr. Rochelle Walensky.

Moderna and Johnson & Johnson have said scientific data backs allowing more doses of their vaccines.

Moderna released partial results from a trial in mid-September that it said shows that people benefit from increased protection against infection bestowed by a third dose of its vaccine, even as the company said data show little waning against hospitalization and death.

Johnson & Johnson said about a week later that data from a phase 3 clinical trial show a second shot of its vaccine bolstered protection against symptomatic COVID-19.

Dr. Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, signaled anew ahead of the advisory committee meetings the FDA’s position on boosters.

“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,” he said.