Advisors to the US Food and Drug Administration (FDA) voted in favour to recommend that the agency must give Emergency Use Authorisation (EUA) to Moderna's COVID-19 vaccine.
According to a report by Reuters, FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC), made up of independent scientific and public health experts, at its meeting on Thursday voted 20-0 with one abstention to recommend Emergency Use Authorization for the Moderna COVID-19 vaccine mRNA-1273.
Commissioner of Food and Drugs Stephen Hahn said that following the positive advisory committee meeting outcome about the Moderna COVID-19 vaccine, the FDA has informed the company that it will rapidly work toward finalisation and issuance of an emergency use authorisation, reported Reuters.
“The agency has also notified the US Centers for Disease Control and Prevention and Operation Warp Speed, so they can execute their plans for timely vaccine distribution,” Hahn said. Operation Warp Speed refers to a public-private partnership to facilitate and accelerate the development, manufacturing, and distribution of Covid-19 vaccines.
If Moderna's vaccine is approved by the FDA, it will become the second shot to be greenlighted in America.
The VRBPAC made the recommendation on the basis of the scientific evidence shared by Moderna, including a data analysis from the Phase 3 clinical study announced on November 30. The primary efficacy analysis conducted on 196 cases indicated a vaccine efficacy rate of 94.1%, the committee said.
“To go from having a [genetic] sequence of a virus in January to having two vaccines available in December is a remarkable achievement,” said Dr James Hildreth, chief executive officer of Meharry Medical College and a member of the committee, told Reuters.
The FDA on December 11 allowed the emergency use of the country's first COVID-19 vaccine developed by American pharmaceutical giant Pfizer and its German partner BioNTech to combat the disease that has killed over 310,000 people in the country.