FDA Approves Moderna's Spikevax COVID-19 Vaccine

The approval of the Spikevax vaccine was based on safety and efficacy data approximately 6 months after the second dose.

Today, the Food and Drug Administration (FDA) approved Spikevax, a COVID-19 vaccine produced by Moderna. The vaccine had been approved by regulators in more than 70 countries including Canada, Japan, the United Kingdom, and Israel.

With this new approval, Spikevax will be indicated for individuals 18 years and older

The company announced last week that it had begun dosing for its vaccine against the Omicron variant. This phase 2 clinical trial is an extension of an earlier study that will evaluate the immunogenicity, safety, and reactogenicity of this vaccine as a single booster dose in adults aged 18 years and older.

According to Moderna, the Omicron-specific booster candidate included data from 2 cohorts including 1 featuring participants who received the 2-dose primary series of mRNA-1273 and a second group featuring participants who received the 2-dose primary series and a 50 µg booster dose of mRNA-1273.

Moderna CEO Stéphane Bancel said the company was “reassured by the antibody persistence against Omicron at 6 months after the currently authorized 50 µg booster of mRNA-1273,” and noted that the company will be advancing their Omicron-specific variant vaccine booster candidate.

"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, 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.”