Rejection by regulator is good news, but lack of booster sales will hurt company's revenue, profits
Scientists at the U.S. Food and Drug Administration said on Tuesday that Moderna Inc. had not met all of the agency’s criteria to support use of booster doses of its COVID-19 vaccine, possibly because the efficacy of the shot’s first two doses has remained strong, Reuters reported.
FDA staff said in documents that data for Moderna’s vaccine showed that a booster does increase protective antibodies, but the difference in antibody levels before and after the shot was not wide enough, particularly in those whose levels had remained high.
The documents were released ahead of a meeting later this week of the FDA’s outside expert advisers to discuss booster doses of the vaccine.
The FDA typically follows the advice of its experts, but is not bound to do so. A panel of advisers to the U.S. Centers for Disease Control and Prevention (CDC) will meet next week to discuss specific recommendations on who can receive the boosters, if the FDA authorizes them.
“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 professor of microbiology and immunology at Weill Cornell Medical College in New York, said in an email.
Moderna is seeking authorization for a 50-microgram booster dose, half the strength of the original vaccine given in two shots about four weeks apart.
The company has asked regulators to clear a third round of shots for adults aged 65 and over, as well as for high-risk individuals, similar to the authorization gained by rivals Pfizer Inc and German partner BioNTech for their mRNA vaccine.
President Joe Biden’s administration announced plans earlier this year to roll out booster doses for most adults, but some FDA scientists later said in an article in journal The Lancet that there was not enough evidence to support boosters for all.
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