Scientists at the Food and Drug Administration (FDA) on Tuesday did not take a stance on whether or not to support booster shots of Moderna's
"Some real world effectiveness studies have suggested declining efficacy of Moderna COVID-19 Vaccine over time against symptomatic infection or against the Delta variant, while others have not," FDA scientists wrote in a 45-page document published on the agency's website. "However, overall, data indicates that current U.S.-licensed or authorized COVID-19 vaccine still afford protection against severe COVID-19 disease and death in the United States."
The scientists' report is meant to brief the agency's independent vaccine panel--Vaccines and Related Biological Products Advisory Committee--which is scheduled to meet Thursday to review Moderna's request to authorize COVID vaccine boosters for American adults. The agency could make a final decision within days of the meeting, leaving the U.S. Centers for Disease Control and Prevention (CDC) and its independent advisory committee--Advisory Committee on Immunization Practices--to make the final decision, likely next week.
FDA scientists also failed to take a stance on Pfizer
Last month, the FDA and the CDC had authorized booster shots of the Pfizer-BioNTech vaccine for more at-risk Americans, including the elderly, adults with underlying medical conditions and those who work or line in high-risk settings such as healthcare and other frontline positions.
Moderna applied for authorization of a third dose with the FDA on September 1. The biotech said its booster shot data is based on a clinical trial of about 170 adults--less than the 318 people who participated in Pfizer-BioNTech's booster shot trial. Moderna found that its booster dose was safe and produced a stronger immune response than seen after the second dose in its late-stage clinical trial.