The United States Food and Drug Administration’s advisory panel on Thursday gave emergency use approval to Covid-19 vaccine developed by Biotechnology company Moderna, reported BBC. This makes it the second vaccine after Pfizer/BioNTech to receive such an authorisation in the US in less than a week.
FDA’s Vaccines and Related Biological Products Advisory Committee, which includes independent scientific and public health experts, voted 20-0 to recommend emergency use authorisation for the Moderna Covid-19 vaccine mRNA-1273. There was one member who abstained from voting.
Dr Michael Kurilla, director of the Division of Clinical Innovation at the National Center for Advancing Translational Sciences, who abstained from voting, said that she felt the blanket authorization for those 18 and older was too broad. “I would have preferred to have seen, rather than an emergency use authorisation route – an expanded access programme,” Kurilla said. “I think it would have given us a lot more opportunities to continue to collect the data.”
An emergency use authorisation means that the US drug regulator will allow the vaccine to be used for emergency cases, but is short of a full approval.
Commissioner of Food and Drugs Stephen Hahn said that the FDA has informed Moderna that it will rapidly work towards finalising and issuing an emergency use authorisation for its vaccine candidate.
“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.
Moderna Chief Executive Officer Stephane Bancel said the company was thankful for FDA’s positive recommendation for the emergency use authorisation of the vaccine candidate. “We have been working with the US Centers for Disease Control and Prevention and Operation Warp Speed to prepare for the distribution of mRNA-1273, if the FDA chooses to grant an Emergency Use Authorization,” Bancel said. “We look forward to getting our vaccine to people in the US to help address this ongoing public health emergency.”
The Vaccines and Related Biological Products Advisory Committee, or 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, according to Reuters. The FDA had on December 11 approved granted emergency use approval to the coronavirus vaccine developed by pharmaceutical company Pfizer and its German partner BioNTech.
The news comes when the toll in the United States has surpassed the 3,00,000 mark and reported 16,973,376 coronavirus infections so far, according to John Hopkins University data. The inoculation process, however, will take months to roll out.