Washington: The US Food and Drug Administration’s (FDA) advisory panel, comprising external experts, has given an emergency use approval to Moderna COVID-19 vaccine. It is the second COVID-19 vaccine after Pfizer to receive such an authorisation in less than a week.
FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC), made up of independent scientific and public health experts, at its meeting Thursday voted 20-0 with one abstention to recommend emergency use authorization for the Moderna COVID-19 vaccine mRNA-1273.
The FDA allowed last Friday the emergency use of the country’s first COVID-19 vaccine developed by Pfizer and BioNTech. The US is desperately trying to combat the disease that has killed over 310,000 people.
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.
The agency has also notified the US Centres for Disease Control and Prevention and Operation Warp Speed, so they can execute their plans for timely vaccine distribution, he said.
“We were grateful for the opportunity to present the clinical data package for our mRNA vaccine against COVID-19 to the FDA’s advisory committee today. We thank the committee for their review and for their positive recommendation in support of Emergency Use Authorization,” said Stéphane Bancel, CEO of Moderna.
“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. We look forward to getting our vaccine to people in the US to help address this ongoing public health emergency,” Bancel added.
The VRBPAC based its recommendation on the totality of scientific evidence shared by the company, including a data analysis from the pivotal Phase 3 clinical study announced November 30. The primary efficacy analysis conducted on 196 cases indicated a vaccine efficacy rate of 94.1 per cent, it said.
Moderna has expanded the handling guidance for mRNA-1273 to include local transport under controlled conditions in a liquid state at 2-8°C (36° to 46°F). In some cases, this may be the only practical means of distribution from clinics and for remote locations.
This important update will help facilitate distribution to the final site of administration. Recognising that shipping and handling of the product can be a barrier to vaccination, Moderna remains committed to supporting efficient distribution, the company said.
Congressman Ross Spano said that 150 hospitals in Florida are preparing to receive 300,000 to 400,000 doses of the Moderna COVID-19 vaccine, which is set for approval later this week. “This is great news for our community and another victory for Operation Warp Speed,” he said.
The US is the worst-hit country from the pandemic with 17,195,926 COVID-19 cases.
