The coronavirus disease 2019 (Covid-19) vaccine of US biotech firm Moderna is just one step from getting emergency use authorization (EUA) from the country’s Food and Drug Administration (FDA).
The FDA said on Tuesday that a panel of researchers have issued their opinion in a 53-page report ahead of Thursday’s meeting of the agency’s Vaccines and Related Biological Products Advisory Committee, a group of outside medical experts who will advise FDA Commissioner Stephen Hahn on whether to approve emergency use authorization for the Moderna’s vaccine.
“FDA has determined that [Moderna] has provided adequate information to ensure the vaccine’s quality and consistency for authorization of the product under an EUA,” the scientists wrote in their assessment of Moderna’s clinical trial data.
Moderna said last month its two-dose vaccine was more than 94-percent effective in preventing Covid-19 among participants in a 30,000-volunteer clinical trial.Tuesday’s FDA report came on the same day several states are planning to administer their first doses of the Pfizer-BioNTech vaccine. Thousands of additional doses will begin arriving at many US hospitals. SOVEREIGNPH