CDC panel recommends full FDA approval for Moderna COVID-19 vaccine

A key advisory panel for the Centers for Disease Control and Prevention voted to give full approval to Moderna’s COVID-19 vaccine more than a year after it was granted an emergency use authorization.

The CDC’s Advisory Committee on Immunization Practices voted 13-0 to recommend full approval for Moderna’s two-dose vaccine series for ages 18 years and older, marketed as Spikevax, after receiving full approval from the Food and Drug Administration earlier this week, according to CNN.


Full FDA approval is given once enough data show the vaccines are safe and effective for most who received them and once the FDA has reviewed the manufacturing process and facilities, according to Johns Hopkins Medicine.

“The public can be assured that Spikevax meets the FDA’s high standards for safety, effectiveness and manufacturing quality required of any vaccine approved for use in the United States,” acting FDA Commissioner Janet Woodcock said in a statement earlier this week. “We understand that for some individuals, FDA approval of this vaccine may instill additional confidence in making the decision to get vaccinated.”

MODERNA COVID-19 VACCINE RECEIVES FULL FDA APPROVAL FOR ADULTS


Moderna’s two-dose regimen had been granted its EUA on Dec. 18, 2020, by the FDA.

Moderna’s third dose for immunocompromised people and booster doses for adults still remain under EUAs.

After the panel’s vote, it’s left to CDC Director Rochelle Walensky to sign off on the recommendation.


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Pfizer-BioNTech’s mRNA vaccine received full FDA approval for people 16 and older last August.

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