A federal advisory panel voted 2/19 on Tuesday to reformulate COVID-19 booster shots for the fall to more directly target the ommicron viral variant.
Food and Drug Administration advisory panel members supported targeting ommicron’s BA.4 and BA.5 sub-variants, which now account for about half of the COVID-19 cases in the US and have been reported in recent weeks. increased as other subvariants fade.
Committee members also largely supported the idea of using both the strain of omicron and the original in a single vaccine, which the companies said they could provide.
Panelists said they had far less data on the new boosters than they wanted. But they said they were confident the changes would be safe and felt compelled to try and prevent as many serious illnesses as possible by further targeting the vaccine.
The number of cases is expected to increase again towards the end of this year, as well as at the end of 2020 and the end of 2021.
Vaccine makers have tested new versions of their vaccines against the BA.1 version of omicron, but not against these more recent subvariants. But officials said it made sense to match the new boosters as closely as possible to circulating strains of the SARS-CoV-2 virus.
Only about half of Americans have received at least one booster dose, and even those who have received additional injections have less protection over time, said Dr. Peter Marks, chief of the Food and Drug Administration department responsible for regulating of vaccines.
“That combination of declining immunity, combined with the potential emergence of new variants, at a time this winter when people are moving in as a population, increases our risk of a major COVID-19 outbreak,” Marks said, opening the statement. day-long hearing. “That’s why we need to seriously think about a booster campaign this fall to help protect us.”
Vaccine makers will take time to produce a new vaccine formula, Marks said, so a decision had to be made now to make it available by the end of October.
The current vaccines and their booster dose were developed to target the spike protein of the original SARS-CoV-2 virus, which began to spread around the world in late 2019 and early 2020. But the virus has evolved since then — via major variants called alpha. , beta, delta and now versions of ommicron.
Pfizer-BioNTech, Moderna and Novavax have developed and tested new vaccine formulations in a small number of people targeting the omicron subvariant BA.1, which circulated last winter and which caused the largest outbreak of the two-and-a-half-year pandemic. BA.1 has since been replaced by other ommicron sub-variants.
Not all committee members agreed that a change was necessary.
Two of the 21 voting members voted against changing the shots because current vaccines are sufficiently protective. The companies lacked evidence, they said, that targeting ommicron would make a real difference in preventing serious infections or saving lives.
dr. Paul Offit, a vaccine expert at the Children’s Hospital of Philadelphia who voted against the change, said he thinks some people, especially those who are older or have weakened immune systems, will need boosters this fall.
But he wasn’t convinced that ommicron should be part of that vaccine.
“When you ask people to get a vaccine, the benefit should be obvious because there is always a risk,” he said after the meeting. “I just don’t think the benefits were obvious.”
Data from the companies suggests that boosters of all varieties are “about equally good at reactivating our memory cells,” said John Moore, a vaccine and virology expert at Weill Cornell Medicine in New York City, who is not a committee member. “Therefore, the variant boosters are not noticeably different from the (original vaccine booster), because they all do the same thing.”
Moore said he was concerned that FDA officials were pushing panelists toward a decision without adequate information.
“That’s not a good scenario when making a multi-billion dollar decision that could potentially affect tens of millions of people,” he said via email during the meeting.
In a statement released shortly after the vote, Pfizer said it specifically chose mRNA technology for its COVID-19 vaccine because it can be easily modified to address new viral variants.
“The data presented and discussed at today’s meeting underlines that we can quickly set up a program and validate the process,” the statement said. “We believe we have identified potential solutions as we move into this next chapter of the pandemic and will continue to share our available data with health experts and regulators to bring an ommicron-adapted booster to the world as soon as possible.”
The Advisory Committee on Vaccines and Related Biological Products has not discussed the cost of changing the vaccine’s composition, but it will cost both the companies and the federal government.
Congress has so far refused to provide funding that the government has requested to pay for COVID-19 vaccines, treatments, testing and support. Money will run out later this year and the government has been unable to negotiate with vaccine makers for fall supplies, potentially leaving the US short of vaccine doses to bolster protection against the winter season.
“We need (additional) funding to ensure that any American who wants a bivalent vaccine, should it be approved by the FDA, has the opportunity to do so,” said Dr. Ashish Jha, the White House’s Coronavirus Response Coordinator, in a Thursday press conference.
Contact Karen Weintraub at [email protected]
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