The FDA panel supports a new COVID booster that focuses only on variables

June 15, 2023 – A panel of US Food and Drug Administration advisors unanimously agreed today that the next COVID-19 vaccines should target XBB variants of the SARS-CoV-2 virus now circulating in the United States, but questioned whether the whole population needs booster shots. How often should it be given?

The FDA’s Advisory Committee on Vaccines and Related Biological Products voted 21-0 in favor of recommending which strain to use in the next crop of vaccines.

In the briefing document For the meeting, FDA staff said available evidence indicates that a monovalent (single-strain) XBB vaccine is “justified” for the 2023-2024 vaccination campaign and will replace the current bivalent vaccine, which targets the original version of the virus and two strains of the virus. Omicron variant.

The FDA staff also noted how in line with WHO this shift would be toward targeting the XBB subfamily of variants. European regulators have done so, too.

The Food and Drug Administration is not obligated to act on the committee’s recommendations. But the agency often does and very likely will in this case. Vaccine companies will need a recommendation from the Food and Drug Administration (FDA) to begin making fall vaccines.

A new shot every year?

The FDA asked its panel of experts to vote solely on a question about the makeup of future vaccines in terms of which strain to include.

But committee members also raised other questions during the meeting, including concerns about moves toward tying COVID vaccines to the model for annual flu shots.

Paul Offit, director of the Center for Vaccine Education at the Children’s Hospital of Philadelphia, has advocated for an increased focus on the T-cell response after vaccination, even in light of an already acknowledged diminishment in antibody protection.

in Recent article SubstackOffit called T cells the “unsung hero” of the pandemic. It takes longer for them to develop after infection or vaccination than for antibodies that attack the virus first, but memory immune cells called B and T cells are “long-lived” and their “protection against severe disease often lasts for years, sometimes decades.”

Offit said he was concerned about using a blanket approach for future recommendations for COVID vaccinations, following the approach now applied for flu vaccines. Center for Disease Control He recommends the flu shot For everyone 6 months of age and older, with rare exceptions.

“We need to continue to identify who are those high-risk groups and not make this a recommendation for everyone every season,” he said.

Offit gave his own experience as an example. While he had been vaccinated against the early Wuhan strain of the virus, he was still infected, most likely with a variant that appeared later.

“This was a drifting virus. That’s why I had a mild infection but not a severe infection, presumably because I had the T cells that prevented these severe infections, which could last for years,” Offit said.

Pfizer And moderna, The two companies that make mRNA-based COVID vaccines are working on experimental products intended to protect against influenza and SARS-COv-2 in one shot. Novavax, maker of a traditional protein-based COVID vaccine, He does the same.

The idea of these combination products is to make it more convenient for people to be protected from both viruses, while also offering companies some marketing benefits.

But without indicating these drugmakers’ plans for future shots from the COVID flu, members of the US Food and Drug Administration Thursday raised objections to the assumption of routine annual vaccinations against SARS-CoV-2 variants.

Among the speakers who raised concerns was Henry H. Bernstein, DO, a former member of the Centers for Disease Control and Prevention’s Immunization Practices Advisory Committee.

Bernstein questioned the approach of dubbing these formulas “2023-2024,” as this approach conveys a sense of anticipation that annual vaccinations will be needed, as happens with the flu.

“It’s not clear to me that this is a seasonal virus yet,” said Bernstein, who is also a professor of pediatrics at the Zucker School of Medicine at Hofstra/Northwell in New York.

In response to Bernstein’s point, Arnold Monto, MD, acting chair of the FDA committee today, suggested that such a pattern could emerge, while also agreeing that it was too early to say with certainty.

A professor emeritus at the University of Michigan, Monto’s career has included epidemiological planning and emergency response to virus outbreaks, including the 1968 Hong Kong flu pandemic, avian influenza, and the original SARS.

“I think it’s too early to say that this virus will not become seasonal,” Monto said of SARS-CoV-2. “I agree. We’re not there yet, but we might be.”

At the end of the meeting, Monto summarized the main points of the meeting, noting that there was a general consensus that the XBB.1.5 variant would be the best to use for future COVID shots.

He also noted that Novavax, which manufactures the traditional protein-based vaccine, along with Pfizer and Moderna, has already honed this variant, which will allow the rapid development of updated COVID-19 vaccines.

The fact that most manufacturers are ready to work on XBB 1.5 [vaccine] is an additional reason to choose this strain or this variant, given the immunological data,” Monto said.

Peter Marks, MD, PhD, director of the FDA’s Center for Biologicals Evaluation and Research, said the demands involved in manufacturing vaccines tend toward annual changes.

“In practice, we will have one update a year, except in heroic efforts to deal with stress that manifests itself so differently that it requires us to mobilize enormous resources to address this change in stress,” he said.

Marks questioned panel members’ concerns about the analogy of vaccination practices to influenza and COVID. He said the FDA staff’s intention was to try to help the public understand the need for a follow-up vaccine.

“I find it difficult to understand the need for that committee to have resistance to something similar to influenza. People understand the annual influenza vaccine,” Marks said.

Leave a Reply Cancel reply