The shot's approval appears to contradict the federal government's generally unfavorable view of mRNA vaccines. The U.S. Department of Health and Human Services (HHS) terminated half a billion dollars in funding for mRNA vaccine development, impacting 22 projects. A key vaccine advisory committee was remade to include people who have been vocally opposed to mRNA vaccines. Health Secretary Robert F. Kennedy Jr. has falsely called the mRNA-based COVID-19 shots the "deadliest vaccines ever made" and incorrectly claimed that mRNA vaccines don't work well against upper-respiratory viral infections.
"I don't read this as a shift in the administration's stance on mRNA," Jeff Coller, a distinguished professor of RNA biology and therapeutics at Johns Hopkins University, said in an email. Coller is also a co-founder of the Alliance for mRNA Medicines, an international association aimed at advancing mRNA technology, and he advises several RNA companies.
"What the approval does signal, and I think this is the more useful story: the statutory machinery still works when it is allowed to run," Coller said. "For companies and investors deciding whether to keep building in this space in the United States, that matters more than any statement from HHS."
Reporting by STAT News later found that career FDA scientists had planned to do the review but they had been overruled by Dr. Vinay Prasad, then director of the FDA's Center for Biologics Evaluation and Research (CBER). (Live Science has contacted the FDA for comment.)
"That didn't last long, nor did he last long, after that," Offit added. The denial was reversed within the month, and Prasad left the FDA in April.
Once allowed to do so, the FDA's vaccine advisory committee, called the Vaccines and Related Biological Products Advisory Committee (VRBPAC), met to discuss the shot's safety and effectiveness. The group voted unanimously to recommend approving the vaccine for adults ages 50 and up. The FDA then followed this advice, making the approval official.
Unlike the Advisory Committee on Immunization Practices (ACIP), which advises the Centers for Disease Control and Prevention (CDC), VRBPAC has not seen a major overhaul in its membership since Kennedy's appointment, though it does have a number of open vacancies. However, its remaining members have ample expertise in infectious diseases, immunology, global health and genetics.
mRNA-based vaccines can be made more quickly than conventional flu vaccines can, and trials suggest that the newly approved shot offers more protection, too. (Image credit: Catherine Falls Commercial via Getty Images)Next step for the new mRNA flu vaccine
That's because ACIP is in the midst of a lawsuit, which recently prompted a federal judge to put a freeze on several of the committee's recent changes. Those changes include the appointment of new committee members by Kennedy and a major revision of the childhood immunization schedule. While the litigation plays out, the committee could still issue new vaccine guidance if it appoints enough new members to compensate for the ones who are currently in limbo — but that hasn't happened yet.
"I don't know," Offit said. "Robert F. Kennedy Jr. has ultimate say, and he's a science denialist and an anti-vaccine activist. So I don't know." Offit predicts that Kennedy "will do nothing to encourage vaccination, period, independent of what the vaccine technology is."
It would be useful to have an mRNA vaccine option available this upcoming flu season, Offit said, in part because trials suggest that the shot is more protective than existing options, especially for adults 50 to 64. There's also strong evidence that that's true for adults over 64, but for that age group, more data will be collected in the coming season to see how well mFlusiva stacks up against existing high-dose flu shots for older adults. Offit expects those upcoming results will likely be positive and back up the existing evidence, which involved measuring antibody levels in older adults given either vaccine.
RELATED STORIESOther strengths of mRNA-based flu vaccines are that they can be produced in about half the time that existing flu shots are made and they can be better tailored to match the targeted flu strains, Offit noted.
Looking to the future of mRNA vaccines in the U.S., mFlusiva's approval suggests that vaccine regulatory bodies still have the means and will to review mRNA vaccine trials and approve new products, as Coller said. However, this stand-alone approval doesn't necessarily mark a sea change in the federal government's sentiment toward the technology, he noted.
This article is for informational purposes only and is not meant to offer medical advice.
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