CDC vaccine advisers vote to recommend FDA-approved Moderna COVID-19 vaccine for adults
By Jamie Gumbrecht and Carma Hassan, CNN
Vaccine advisers to the US Centers for Disease Control and Prevention voted 13-0 Friday to support recommending the two-dose Moderna COVID-19 vaccine, which received full approval from the US Food and Drug Administration this week for use in adults.
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 on a biologics license application or BLA, the vaccine was available under emergency use authorization and had 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 that some people may be more willing to be vaccinated after FDA approval and recommendation of the vaccine, Oliver said.
After the ACIP vote, CDC Director Dr. Rochelle Walensky will decide whether to sign off on the recommendation.
More than 200 million doses of the Moderna vaccine have been administered 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.
This is the second FDA-approved vaccine available in the United States. The Pfizer/BioNTech COVID-19 vaccine was approved for people 16 and older in August.
“I still have a sense of wonder on what’s been accomplished here. That, and a deep sense of gratitude,” Dr. Matthew Daley, senior investigator for the Institute for Health Research at Kaiser Permanente Colorado, said at Friday’s meeting. “These vaccines were authorized and then licensed along a rapid timeline while still following all the well-established regulatory processes in place before the pandemic.
“An estimated 1.1 million deaths have been averted through vaccination in the US and countless more globally. … I don’t think we can take this for granted.”
Still, the vaccine advisers acknowledged that there’s more work ahead against COVID-19, especially to continue to push for vaccination and boosters.
About 64% of the total US population is fully vaccinated against COVID-19 with at least their initial series, according to the CDC. More than a quarter of the US population is fully vaccinated and boosted.
The CDC says everyone 12 and older should should get a booster dose after the last dose in their primary series.
“I would just like to reinforce the importance of the booster dose,” Dr. Jeffrey Duchin, health officer for Public Health-Seattle and King County, said during Friday’s meeting. “There are many people in our community and many communities throughout the country who have received that primary series and … who are eligible but yet have not received the booster dose.
“It’s critical to understand how necessary that booster doses to receive the full protection that these vaccines can offer against serious disease, including hospitalization and death.”
The-CNN-Wire
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