Moderna's Spikevax Vaccine Gets Full FDA Approval

Moderna's Covid-19 vaccine received full approval from the US Food and Drug Administration (FDA) on Monday.

The vaccine, named Spikevax, is now fully approved for use in people ages 18 and older. However, it is not approved or authorized for use in younger inpiduals.

There's no difference between the approved vaccine and the vaccine previously available through emergency use authorization.

Moderna is the second Covid-19 vaccine to receive full approval from the FDA after Pfizer's Covid-19 vaccine had the approval in August.

In the same vein, Moderna revealed that the FDA based its decision on scientific evidence shared by Moderna in its submission package to the agency.

The scientific reports included six-month follow-up data from a Phase 3 clinical trial study as well as FDA-required manufacturing and facilities data.

"This is a momentous milestone in Moderna's history as it is our first product to achieve licensure in the U.S.," Moderna CEO Stéphane Bancel said in the release.

"The full licensure of Spikevax in the U.S. now joins that in Canada, Japan, the European Union, the UK, Israel, and other countries, where the adolescent indication is also approved. We are grateful to the U.S. FDA for their thorough review of our application. We are humbled by the role that Spikevax is playing to help end this pandemic."

On her part, Dr. Janet Woodcoc, the FDA's acting commissioner, called the approval a "significant 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 of any vaccine approved for use in the United States," Woodcock said in a statement.