The company’s Spikvax vaccine was approved based on its submission that included efficacy and safety data approximately 6 months after second dose.
The Food and Drug Administration (FDA) officially approved Moderna’s COVID-19 vaccine, Spikevax. The approval means the vaccine is indicated for individuals 18 years and older for the prevention of COVID-19.
"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,” Moderna CEO 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.”
Moderna's vaccine has received approval by regulators in more than 70 countries, including Canada, Japan, the European Union, the UK, Israel, according to Moderna.
Previously, the vaccine had been allowed to be administered in the US with an Emergency Use Authorization, which dated back to December 2020.
Last week, the company announced its latest study and had began dosing for its vaccine against the Omicron variant. Moderna’s phase 2 clinical trial for its Omicron-specific booster (mRNA-1273.529) vaccine candidate 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.
The company’s Omicron-specific booster candidate will include 2 cohorts:
"We are reassured by the antibody persistence against Omicron at 6 months after the currently authorized 50 µg booster of mRNA-1273,” Moderna CEO Stéphane Bancel, said then. “Nonetheless, given the long-term threat demonstrated by Omicron's immune escape, we are advancing our Omicron-specific variant vaccine booster candidate and we are pleased to begin this part of our phase 2 study."