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CDC Backs Moderna Vaccine After Getting U.S. Approval

CDC Backs Moderna Vaccine After Getting U.S. Approval

The Centers for Disease Control and Prevention (CDC) continued its endorsement of Moderna’s COVID-19 vaccine for adults on Friday, saying that U.S. regulators have given the shots their full approval. Before it was approved, the vaccine was available under emergency use authorization and had been recommended on an interim basis.

Tens of millions of Americans have already gotten Moderna shots, following its emergency authorization by the Food and Drug Administration (FDA) more than a year ago. Earlier this week, the FDA gave the product full licensure, following the kind of rigorous, time-consuming review given to other vaccines.

A healthcare worker administers a dose of the Pfizer-BioNTech Covid-19 vaccine to a teenager at West Philadelphia High School in Philadelphia, Pennsylvania, U.S., on Tuesday, August 4, 2021. The White House has called upon??schools, community organizers, and even the Gen Z pop star??Olivia Rodrigo??to double down on pitching the vaccine???s benefits before the??school??year starts. Photographer: Hannah??Beier/Bloomberg

 

While the FDA licenses vaccines, the CDC makes recommendations about how they should be used. So the CDC’s Advisory Committee on Immunization Practices took up the matter on Friday. The panel heard summaries of medical studies that showed the vaccine is working against the coronavirus and there is no evidence of new safety concerns. It voted unanimously to continue to endorse the shots, and the agency’s director later signed off on the recommendation.

The Moderna vaccine, now being marketed under the name Spikevax, is licensed as a two-dose series for people 18 and older. Under earlier emergency use authorizations, additional doses can be given as additional doses for people with weakened immune systems or as half-dose boosters.

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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 the risk was greater among adolescent and young adult males and after the second dose.

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