Moderna awarded full FDA approval for COVID-19 vaccine, Spikevax

The U.S. Food and Drug Administration (FDA) awarded full approval to Moderna, Inc’s Spikevax vaccine for COVID-19 last week, greenlighting the mRNA vaccine for use without restriction on adults and making it the second COVID-19 vaccine to earn the measure.

Approval was based on endorsement of the company’s Biologics License Application (BLA). Approximately 807 million doses of the vaccine shipped globally last year, with about a quarter of those earmarked for low and middle-income countries for equitable distribution. With approval from regulators in more than 70 countries and consideration based on data from clinical studies, manufacturing, and facilities, SPIKEVAX has shown high efficacy and safety profiles through about six months after second dose.

“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,” Stéphane Bancel, CEO of Moderna, said. “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. 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.”

What is now the Spikevax vaccine has operated in the United States under an Emergency Use Authorization (EUA) since Dec. 18, 2020. A booster dose was also authorized for emergency use, and a third dose of the vaccine at its normal, 100 µg dose level is allowed for immunocompromised adults.

“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,” Acting FDA Commissioner Janet Woodcock, M.D., said. “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. 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.”

Approval means that the FDA’s medical and scientific experts have thoroughly evaluated data relating to the vaccine, independently verifying analyses submitted to the agency, conducting analyses of its own, and looking into Moderna’s manufacturing processes and facilities, along with its test methods.

The FDA noted that with usage, Spikevax provides an increased risk of myocarditis and pericarditis, along with the potential for mild adverse reactions such as pain at the injection site, fatigue, headache, myalgia, arthralgia, chills, nausea/vomiting, axillary swelling/tenderness, fever, swelling at the injection site, erythema at the injection site and rash. While vaccination is not a guarantee of success for all recipients, the FDA stressed that vaccines remain the most effective way to protect against COVID-19, including its variants.

Spikevax will be administered as a primary series of two doses, one month apart. It can be used interchangeably with the EUA Moderna COVID-19 Vaccine, which remains under EUA as a two-dose primary series for several instances. In addition, Spikevax can be mixed and matched as a booster for adults who have used a different COVID-19 vaccine for their primary vaccination.