Saturday, December 10, 2022

Moderna’s COVID-19 Vaccine Gets Full FDA Approval

Moderna's COVID-19 Vaccine Gets Full FDA Approval

By Naomi Thomas and Ben Tinker | CNN

According to news releases from the FDA and Moderna, Moderna’s COVID-19 vaccine has received full approval from the US Food and Drug Administration.

The vaccine named Spikevax is now approved for use in people 18 years of age and older. It is not approved or authorized for use in young persons. There is no difference between an approved vaccine and a vaccine previously available through an emergency use authorization.

Moderna is the second COVID-19 vaccine to receive full approval from the FDA. Pfizer’s COVID-19 vaccine, Comirnati, was approved in August for use in people 16 years of age and older. The Pfizer vaccine is also authorized for use in individuals 5 to 15 years of age.

Moderna said the FDA based its decision to grant full approval to the agency on the scientific evidence shared by Moderna in its submission package, which includes Phase 3 clinical trial studies as well as FDA-required manufacturing and facilities. Includes six-month follow-up data from K.

“This is an important milestone in Moderna’s history as it is our first product to be licensed in the US,” Moderna CEO Stephane Bunsell said in the release. “The full license of SpikeVax in the US now joins Canada, Japan, the European Union, the UK, Israel and other countries where Juvenile Indications has also been approved. We are grateful to the US FDA for their thorough review of our application. We are overwhelmed by Spikewax’s role in helping to end this pandemic.”

FDA Acting Commissioner Dr. Janet Woodcock called the approval an “important step” in the fight against COVID-19.

“The public can be assured that SpikeVax meets the FDA’s high standards for safety, effectiveness, and manufacturing quality required for any vaccine approved for use in the United States,” Woodcock said in a statement. “While hundreds of millions of doses of Moderna COVID-19 Vaccine have been administered to individuals under emergency use authorization, we understand that for some individuals, FDA approval of this vaccine may create additional confidence in vaccination decision-making.”

The two-dose vaccine is available in the US under the FDA’s emergency use authorization as of December 18, 2020. Since then, more than 204 million doses of Moderna’s COVID-19 vaccine have been administered in the US, about 38% of all. According to data from the US Centers for Disease Control and Prevention, the dosage is given.

About 75 million people have completed their initial series with Moderna Vaccine, and about 38.5 million have received the Moderna booster shot.

Manufacturers of COVID-19 vaccines originally applied for emergency use authorizations because the authorization process takes less than the time required for full approval.

Emergency use authorization is what its name suggests – a medical product, such as a vaccine, that receives special FDA authorization to use during an emergency. When the health emergency ends, “any EUA(s) issued based on that declaration will no longer be in effect,” according to the FDA.

A booster dose of the vaccine at a dose of 50mg is currently available under the EUA for people 18 years of age and older. A third 100mg dose of the vaccine is authorized for use in immunocompromised adults.

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