And the committee stepped aside briefly when the final vote mingled with last week’s question about the Pfizer / BioNTech vaccine, which the U.S. already has.
The Advisory Committee on Vaccines and Related Biological Products (VRBPAC) voted 20-0 with an abstention to recommend the US for the Modern Vaccine, which is very similar in design, composition, safety, and efficacy to the Pfizer / BioNTech vaccine. That was the only question posed to the committee: whether it would recommend the US.
“There’s no doubt in my mind that the data, it looks like the benefits outweigh the risks, from what I’ve seen,” committee member Dr. Steven Pergam, of the University of Washington and the Fred Hutchinson Cancer Research Center, the vote.
This did not prevent, however, the collection of academics, doctors, public health specialists and others from understanding a long discussion about whether Moderna should offer the vaccine to people receiving saline vaccines, which could have the effect of long – term data on the safety and protection of people against infection.
“Scholars have a way of getting involved in the details and what we’ve done over the last eight or nine hours has been to review 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 unilateral than last week’s vote to recommend the Pfizer / BioNTech vaccine, which fell 17 in favor, 4 against and one abstention.
“And some people took the issues last week, especially those related to the different age groups, the 16 and 17 year olds, to push the decision they made, which was clearly made based on that issue. and not overwhelming evidence of risk is less than the benefit (clear benefit) of these vaccines. “
The Modern vaccine uses a technology very similar to that of Pfizer / BioNTech: messenger RNA or mRNA. The genetic material causes the body to produce compounds that resemble the outside of the coronavirus and in turn cause an immune response that protects it from infection.
Each vaccine is 95% effective in preventing symptomatic disease, with few side effects.
When voting began, a committee member noted that they had been offered a visual slide containing the wording of last week’s vote on the vaccine made by Pfizer and its partner BioNTech, one that is already being distributed. under the US FDA. Monto, clearly amused, changed the slide and voting continued with the proper language about 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 Clinical Innovation Division of the National Center for the Advancement of Translation Sciences, abstained from Thursday’s vote to recommend the U.S.
“I abstained because I feel very uncomfortable with the language. I think, in the midst of a pandemic and with a limited supply of vaccines, the general statements for people 18 and older are too broad,” Kurilla said after the vote, which fell 20-0 with only his abstention.
“I am not convinced that, for all these age groups, the benefits outweigh the risks and I would prefer to see it more aimed at people at high risk of suffering from a serious and life-threatening covida disease,” added Kurilla, institute form part of the National Institutes of Health. The committee was not given that option.
“I would have preferred to have seen, rather than an emergency use authorization route, an expanded access program. I think it would have given us many more opportunities to continue collecting the data,” he added.
Dr. Oveta Fuller, an associate professor of microbiology at the University of Michigan School of Medicine, who had voted against the U.S. Pfizer / BioNTech, agreed with Kurilla but voted to recommend Moderna’s shot.
“I didn’t think a US was the way to go, but since the train left the station, I’m grateful that Moderna has given us a very transparent and comprehensive study that even from the beginning seemed to be very well organized,” he said. dir Fuller. .
Dr. James Hildreth, president of Meharry Medical College, noted the historic nature of the two votes in quick succession for new vaccines to combat a pandemic.
“What remarkable scientific success,” Hildreth said. “Going from having a virus sequence in January to having two vaccines available in December is a remarkable success.”
Modern says it will continue to collect safety data about the vaccine.
“We look forward to getting our vaccine to people in the U.S. to help address this ongoing public health emergency,” Stéphane Bancel, CEO of Moderna, said in a statement.
CNN’s Samira Said contributed to this story.