When would you start distribution of Moderna's vaccine?
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(CNN) -
Vaccine advisers from the U.S. Food and Drug Administration (FDA) voted easily and quickly to recommend that the agency grant an Emergency Use Authorization (EUA) to the Moderna's coronavirus vaccine.
Just hours later, high-level FDA officials said they planned to move quickly with the US.
FDA advisory panel recommends authorization for emergency use of Moderna vaccine
“Following the positive outcome of today's advisory commission meeting regarding Moderna's covid-19 vaccine, the US Food and Drug Administration has informed the sponsor that it will work quickly to finalize and issue a emergency use authorization, "said Dr. Stephen Hahn, FDA Commissioner, and Dr. Peter Marks, director of the FDA's Center for Biological Research and Evaluation, in a statement.
"The agency has also notified the US Centers for Disease Control and Prevention and Operation Warp Speed so that they can execute their plans for the timely distribution of the vaccine."
5 facts you should know about Moderna's vaccine 0:39
The Vaccine and Related Biological Products Advisory Commission (VRBPAC) voted 20-0, with one abstention, to recommend an EUA for the Moderna vaccine, which is very similar in design, composition, safety and efficacy to the Pfizer / BioNTech vaccine.
That was the only question the committee faced: whether or not to recommend the EUA.
"I have no doubt that the data ... it seems that the benefits outweigh the risks, from what I've seen," said commission member Dr. Steven Pergam of the University of Washington and Cancer Research Center. Fred Hutchinson, before the vote.
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However, that didn't stop the group of academics, physicians, public health specialists and others from getting into a lengthy discussion about whether Moderna should offer the vaccine to people who received saline injections, something that could have the effect of reducing long-term data on the efficacy and safety of the vaccine in protecting people from infection.
"Academics have a way of getting involved in the details, and what we've been doing for the last eight or nine hours is going over the details," said Dr. Arnold Monto, infectious disease specialist and professor of epidemiology at Dr. Arnold Monto after the vote. the University of Michigan, who chairs the panel.
He noted that this time the vote was more one-sided than last week to recommend the Pfizer / BioNTech vaccine, which obtained 17 votes in favor, 4 against and one abstention.
“And some people took up the issues last week, especially those involving the different age groups, the 16 and 17 year olds, to drive the decision they made, which was clearly based on that issue and not the overwhelming evidence. that the risk is less than a benefit, a clear benefit, of these vaccines.
What we know about Moderna's coronavirus vaccine and how it differs from Pfizer and BioNTech
The Moderna vaccine uses technology very similar to that of Pfizer / BioNTech: messenger RNA or mRNA.
The genetic material prompts the body to produce compounds that look like the exterior of the coronavirus, and in turn, that triggers an immune response that protects against infection.
Each vaccine is approximately 95% effective in preventing symptomatic disease, with few side effects.
When the voting began, a committee member noted that they had been offered a visual slide with the wording of the vote from the last few weeks on the vaccine made by Pfizer and its partner BioNTech, which is already being distributed under an FDA EUA. .
Monto, clearly amused, changed the slide and the vote proceeded with the proper language regarding Moderna's vaccine.
Only one advisor abstained and said he did so because he wanted a more limited recommendation.
Dr. Michael Kurilla, who is director of the Division of Clinical Innovation at the National Center for the Advancement of Translational Sciences, abstained in Thursday's vote to recommend the EUA.
Pfizer and Moderna could obtain US $ 32,000 million from the sale of vaccines against covid-19 (only in 2021)
«I abstained because I feel very uncomfortable with the language.
I think that in the midst of a pandemic, and with a limited supply of vaccines available, the general statements for people 18 years of age or older are too broad, ”Kurilla said after the vote, which ended 20-0 with only his abstention.
"I am not convinced that for all those age groups, the benefits outweigh the risks, and I would rather see it more targeted at people at high risk of severe and life-threatening covid disease," added Kurilla, whose institute is part of the National Institutes of Health. Health.
The commission was not given that option.
“I would have preferred to see, instead of an emergency use authorization path, an extended access program.
I think it would have given us many more opportunities to continue collecting the data, "he added.
Differences between Moderna and Pfizer vaccine 1:49
Dr. Oveta Fuller, an associate professor of microbiology at the University of Michigan School of Medicine, who had voted against the Pfizer / BioNTech USA, agreed with Kurilla but voted to recommend the Moderna injection.
"I didn't think that an AUS was the way to go, but since the train left the station, I am grateful that Moderna has provided us with a very transparent and comprehensive study that even from the beginning seemed to be very well organized," Fuller said.
Dr. James Hildreth, president of Meharry Medical College, highlighted the historic nature of the two votes in rapid succession for new vaccines to fight a pandemic.
"What a remarkable scientific achievement this is," said Hildreth.
"Going from having one sequence of a virus in January to having two vaccines available in December is a remarkable achievement."
Moderna says it will continue to collect safety data on the vaccine.
"We look forward to bringing our vaccine to people in the US to help address this ongoing public health emergency," Stéphane Bancel, Moderna's CEO, said in a statement.
CNN's Samira Said contributed to this story.
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