The recommendation they voted on was: “The Moderna COVID-19 BLA approved vaccine (Spikevax, 2-dose primary series) is recommended for persons 18 years of age and older.”
Before it was approved by the FDA, the vaccine was available under emergency use authorization, and had previously been recommended on an interim basis.
The CDC’s Advisory Committee on Immunization Practices endorsed the vaccine after hearing details about Moderna’s application to the FDA and the latest safety data. There are no new safety concerns around the Moderna vaccine in adults, but it is linked to rare cases of two types of serious adverse events: anaphylaxis and myocarditis, a type of heart inflammation. The overall risk of myocarditis is low, but risk was greater among adolescent and young adult males and after the second dose, the advisers heard.
“The benefits for the Moderna Covid-19 vaccine far outweigh any possible vaccine-associated risk,” the CDC’s Dr. Sara Oliver told the advisers. CDC research also suggests some people may be more willing to be vaccinated following FDA approval and recommendation of the vaccine, Oliver said.
Following the ACIP vote, CDC Director Dr. Rochelle Walensky will decide whether to sign off on the ACIP recommendation.
More than 200 million doses of the Moderna vaccine have been administered already in the United States. There is no difference between the approved vaccine and the vaccine previously available through emergency use authorization. Boosters of the Moderna vaccine continue to be available under FDA emergency use authorization.
