Christ Yoder
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The U.S. Food and Drug Administration’s advisory board of outside experts has granted emergency use authorization to the Moderna COVID-19 vaccine, making it the second drug after Pfizer to receive such an emergency use authorization. authorization in less than a week.
The FDA’s Vaccines and Related Biologicals Advisory Committee (VRBPAC), made up of independent scientific and public health experts, at its meeting on Thursday voted 20 to 0 with one abstention to recommend approval of the vaccine. emergency use for Moderna COVID-19 vaccine mRNA-1273.
The FDA on Friday authorized the emergency use of the country’s first COVID-19 vaccine developed by U.S. pharmaceutical giant Pfizer and its German partner BioNTech to fight the disease that has killed more than 310,000 people in the country.
Food and Drugs Commissioner Stephen Hahn said following the positive outcome of the Moderna COVID-19 Vaccine Advisory Committee meeting, the FDA has informed the company that it will work quickly to finalize and issuance of an emergency use authorization.
The agency has also notified the US Centers for Disease Control and Prevention and Operation Warp Speed, so they can execute their vaccine distribution plans in a timely manner, he said.
We are grateful to have had the opportunity to present the clinical data package of our mRNA COVID-19 vaccine to the FDA Advisory Board today. We thank the committee for their review and positive recommendation for emergency use authorization, said Stephane Bancel, CEO of Moderna.
We have worked with the US Centers for Disease Control and Prevention and Operation Warp Speed to prepare for distribution of mRNA-1273, should the FDA choose to grant emergency use authorization. We look forward to getting our vaccine to people in the United States to help deal with this ongoing public health emergency, he said.
The VRBPAC based its recommendation on the full scientific evidence shared by the company, including an analysis of data 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%, it said.
Moderna has expanded the handling guidelines for mRNA-1273 to include local transport under controlled liquid state conditions at 2-8C (36-46F). In some cases, this may be the only practical means of distribution from clinics and for remote sites.
This important update will help facilitate distribution to the final administration site. Recognizing that product shipping and handling can be a barrier to vaccination, Moderna remains committed to supporting effective 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 to abstain during the voting process.
“I abstained because I’m very uncomfortable with the language. I think in the midst of a pandemic, and with a limited supply of vaccines, these general statements for people 18 and older are just too wide,” he said in a statement.
I’m not convinced that for all of these age groups the benefits actually outweigh the risks, and I would prefer to see it more targeted to those at high risk of severe and life-threatening COVID disease,” he said. he declares.
“I would have preferred to see, rather than an emergency use authorization pathway – an expanded access program. I think that would have given us a lot more opportunity to continue collecting the data,” said said Kurilla.
Congressman Ross Spano said 150 Florida hospitals are preparing to receive 300,000 to 400,000 doses of the Moderna COVID-19 vaccine, which is expected to be approved later this week.
This is great news for our community and another win for Operation Warp Speed, he said.
The United States is the country most affected by the pandemic with 17,195,926 cases of COVID-19.
(Only the title and image of this report may have been edited by Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)
