FDA Advisors Recommend Emergency Use Authorisation of Moderna COVID-19 Vaccine

Washington: The US Food and Drug Administration's advisory panel, comprising external experts, has given an emergency use approval to Moderna COVID-19 vaccine, making it the second drug 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 on Thursday voted 20-0 with one abstention to recommend emergency use authorisation (EUA) for the Moderna COVID-19 vaccine mRNA-1273.

The FDA on Friday 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.

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 Centers 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 authorisation," said Stephane 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, he said.

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 on 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.

Dr Michael Kurilla, director of the Division of Clinical Innovation at the National Center for Advancing Translational Sciences, was the only expert who abstained from the voting process.

"I abstained because I'm very uncomfortable with the language. I think in the midst of a pandemic, and with limited vaccine supply available, that blanket statements for individuals 18 years of age and older is just too broad," he said in a statement.

"I'm not convinced that for all of those age groups, the benefits do actually outweigh the risks, and I would prefer to see it more targeted towards people at high risk of serious and life-threatening COVID disease," he said.

"I would have preferred to have seen, rather than an emergency use authorisation route -- an expanded access programme. I think it would have given us a lot more opportunities to continue to collect the data," Kurilla 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.

(PTI)

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