Moderna vaccine fails to reach FDA criteria for booster shot

Antibody levels not wide enough after Moderna COVID-19 vaccine booster

Moderna has failed to reach criteria presented by the U.S. Food and Drug Administration (FDA) that would enable its COVID-19 vaccine to be used as a booster shot.  

The FDA said the difference in antibody levels in vaccinated individuals who were given a Moderna booster shot was not large enough, with individuals who already had a large number of antibodies seeing the small difference, reports Reuters. 

“There was boosting, sure. Was it enough boosting? Who knows? There’s no standard amount of boosting that is known to be needed, and nor is it clear how much boosting happened in the study,” John Moore, a New York professor of microbiology and immunology, told Reuters in an email.   

Advisers to the U.S. Centers for Disease Control and Prevention are set to meet this week to discuss the next steps in who should ultimately be eligible to receive booster shots if they are authorized by the FDA.  

A meeting has also been scheduled this week to figure out the dosage levels of any vaccine booster shots given out, reports Reuters.  

Moderna has been looking for approval of a 50-microgram booster dose, reports Reuters. The dosage is half the strength of its original COVID-19 vaccine which is administered in two shots roughly a month apart.  

Moderna is attempting to follow in the path of Pfizer and BioNTech, who have already received authorization for a third shot of their mRNA COVID-19 vaccine for high-risk individuals and those over the age of 65.  

President Joe Biden said earlier this year that his administration wants most adults to be eligible for booster shots, though some scientists from the FDA came out and said there may not be a need for everyone to take one.  

FDA advisers are also set to decide later this week if booster shots for Johnson & Johnson’s single-dose COVID-19 vaccine will be allowed.