And the committee was momentarily sidelined when the final vote was confused with last week’s question about the vaccine from Pfizer / BioNTech, which already has an EUA.
The Advisory Committee on Vaccines and Related Biological Products (VRBPAC) voted 20-0 with one abstention to recommend 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 it would recommend EUA.
“I have no doubt that the data – it appears that the benefits outweigh the risks, as I have seen,” said committee member Dr. Steven Pergam of the University of Washington and Fred Hutchinson Cancer Research Center previously. the voice.
However, that didn’t stop the rally of academics, doctors, public health experts, and others from engaging in a lengthy discussion about whether Moderna should offer the vaccine to people who have received saline injections – something that could have the effect that it is long-term data on how well and safely the vaccine protects people against infection.
“Academics have a way of getting involved in details, and what we’ve been doing for the past eight or nine hours is going through the details,” said Dr. Arnold Monto, an infectious disease specialist and professor of epidemiology at the University of Michigan. who chairs the panel, said after the vote.
He noted that the vote this time was more one-sided than last week’s vote to recommend the Pfizer / BioNTech vaccine, which dropped 17 in favor, 4 against, and 1 abstinence.
And some people took the issues last week – especially those involving the different age groups, the 16- and 17-year-olds – to make the decision that they made, which was clearly made based on that issue and not on the basis of the overwhelming evidence that risk is less than benefit – clear benefit – for these vaccines. ”
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 outside of the coronavirus, which in turn trigger an immune response that protects against infection.
Each vaccine is approximately 95% effective in the prevention of symptomatic diseases with few side effects.
When the vote began, a committee member noted that they had been presented with a visual slide containing the text of last week’s vote on the vaccine from Pfizer and its partner BioNTech – one already being distributed under the FDA’s EUA. Monto, clearly amused, got the slide changed and the vote went on with proper language about Moderna’s vaccine.
Only one adviser abstained, saying he did so because he wanted a more limited recommendation.
Dr. Michael Kurilla, who is director of the Clinical Innovation Division of the National Center for Advancing Translational Sciences, abstained from Thursday to recommend EUA.
“I abstained because I feel very uncomfortable with the language. I think that in the midst of a pandemic and with limited vaccine supplies available, general explanations for people 18 and older are just too broad,” Kurilla said after the vote, which came 20-0 with only his abstention.
“I am not convinced that for all those age groups the benefits actually outweigh the risks, and I would prefer it to be more focused on people at high risk for serious and life-threatening Covid disease,” added Kurilla. institute is part of the National Institutes of Health. The committee was not given that option.
“I would have preferred an emergency authorization route – a comprehensive access program. I think it would have given us a lot more options to continue collecting the data,” he added.
Dr. Oveta Fuller, associate professor of microbiology at the University of Michigan Medical School, who voted against the Pfizer / BioNTech EUA, agreed with Kurilla, but voted to recommend Moderna’s shot.
“I didn’t think an EUA was the right choice, but since the train has left the station, I appreciate that Moderna has given us a very transparent and thorough study that even seemed to be very well organized from the start,” said Fuller . .
Dr. James Hildreth, president of Meharry Medical College, pointed out the historic nature of the two voices that are rapidly coming together for brand new vaccines to fight a pandemic.
“What a remarkable scientific achievement this is,” said Hildreth. “Going from having a virus sequence in January to having two vaccines available in December, that’s a remarkable achievement.”
Moderna says it will continue to collect safety data on the vaccine.
“We look forward to getting our vaccine in humans in the US to help address this ongoing public health emergency,” said Stéphane Bancel, Moderna’s chief executive officer, in a statement.
CNN’s Samira Said contributed to this story.