Another COVID Vaccine Garners Full FDA Approval

Moderna’s COVID-19 vaccine (Spikevax) has been fully approved by the FDA for adults ages 18 and up, the agency said on Monday.

The two-dose 100 μg primary series has been available under emergency use authorization (EUA) since late December 2020. FDA noted that an EUA remains in effect for a third 100 μg dose of Moderna’s vaccine for certain immunocompromised adults, as well as a 50 μg booster dose for adults at least 5 months after completing a primary series with any authorized or approved COVID vaccine.

“The FDA’s medical and scientific experts conducted a thorough evaluation of the scientific data and information included in the application pertaining to the safety, effectiveness, and manufacturing quality of Spikevax,” Peter Marks, MD, PhD, director of the agency’s Center for Biologics Evaluation and Research, said in a statement.

He added that this assessment included “independent verification of analyses submitted by the company, our own analyses of the data, along with a detailed assessment of the manufacturing processes, test methods and manufacturing facilities.”

FDA granted full approval to the Moderna vaccine based on long-term safety data from the phase III trial that backed its initial EUA. Among 14,287 vaccine and 14,164 placebo recipients, Moderna’s vaccine was 93% effective against symptomatic COVID-19 prior to the Omicron variant (55 cases in vaccine group vs 744 in the placebo group), and 98% effective at preventing severe disease, the agency said.

Safety data included 15,184 vaccine recipients and 15,162 placebo recipients, more than half of which were followed for at least 4 months after the second dose. FDA added that 7,500 participants in the vaccine group completed safety follow-up for at least 6 months.

Common systemic reactions were fatigue, headache, muscle or joint pain, chills, nausea/vomiting, swollen lymph nodes under the arm and fever, the agency said.

FDA also noted an increased risk of vaccine-associated myocarditis within 7 days after the second dose, with men ages 18 to 24 at the highest risk. Short-term follow-up suggests symptoms resolved for most individuals, though some required intensive care, and there is no information yet available on potential long-term health outcomes. Based on its own risk-benefit assessment, the agency said the benefits outweigh the risks in adults ages 18 and up.

Moderna’s vaccine is the second to receive full FDA approval, joining Pfizer’s COVID vaccine (Comirnaty), which was approved in August 2021.