FDA fully approves Moderna’s COVID-19 vaccine

Moderna (NSDQ:MRNA) announced today that it received full FDA approval of the biologics license application for its COVID-19 vaccine.

FDA’s approval for the company’s Spikevax mRNA COVID-19 vaccine covers the prevention of the virus in individuals aged 18 years or older. Moderna submitted for full FDA approval back in June 2021 and becomes the second fully FDA-approved COVID-19 vaccine after the Pfizer-BioNTech vaccine received approval in August 2021.

“The FDA’s approval of Spikevax is a significant step in the fight against the COVID-19 pandemic, marking the second vaccine approved to prevent 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,” Acting FDA Commissioner Dr. Janet Woodcock said in an FDA release. “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 instill additional confidence in making the decision to get vaccinated.”

Full approval enables doctors to prescribe the vaccine for off-label use, but the government’s role in distributing COVID-19 vaccines could limit that practice. Providers administering COVID-19 vaccines must agree to use them based on federal guidance.

As Woodcock emphasized, the approval could sway those who are skeptical of the vaccine because of the emergency tag toward receiving Spikevax as full approval can instill confidence.

Cambridge, Massachusetts-based Moderna said in a news release that the FDA’s decision was based on the totality of scientific evidence shared by the company in its submission package, which included follow-up data from the Phase 3 COVE study showing high efficacy and favorable safety at approximately six months following the second dose.

Spikevax has now received approval from regulators in more than 70 countries. It was available in the U.S. under FDA emergency use authorization (EUA) from Dec. 18, 2020. Spikevax has the same formulation as the Moderna vaccine that was available under EUA. It’s administered in two doses set one month apart.

A booster dose remains authorized for emergency use in adults 18 years old and up, while a third dose remains authorized for emergency use in immunocompromised individuals 18 years of age or older in the U.S. who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.

“Our COVID-19 vaccine has been administered to hundreds of millions of people around the world, protecting people from COVID-19 infection, hospitalization and death. The totality of real-world data and the full BLA for Spikevax in the United States reaffirms the importance of vaccination against this virus. 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. “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.”