Summary:
An FDA advisory panel unanimously agreed that upcoming COVID-19 vaccines should target the XBB variants of the SARS-CoV-2 virus circulating in the United States. However, the panel questioned whether booster shots are necessary and how often they should be given. The FDA staff recommended a monovalent vaccine of the XBB lineage for the 2023-2024 vaccination campaign, replacing the current bivalent vaccine. The change aligns with the World Health Organization and European regulators. The FDA is likely to act on the panel’s recommendations, as vaccine companies need the recommendation to start making vaccines in the fall. The panel also raised concerns about tying COVID vaccines to the annual flu shot model and advocated for an increased focus on the T-cell response after vaccination. Some manufacturers are already working on experimental products intended to protect against both the flu and SARS-CoV-2. Panel members expressed concerns about routine annual vaccinations against SARS-CoV-2 variants, as it is unclear if the virus will become seasonal. Manufacturers are already honing in on the XBB 1.5 variant for updated COVID vaccines. The FDA’s director stressed the need to better convey the benefits of vaccination to the public and highlighted the importance of follow-up shots. The timing for additional COVID vaccines is still being determined to maximize protection. Many Americans have yet to receive the bivalent dose and are a year or more away from getting the monovalent dose, leaving them with little protection.
Additional Piece:
In the ongoing battle against COVID-19, the focus has shifted towards targeting specific variants of the SARS-CoV-2 virus. The recent recommendation by the FDA advisory panel to target the XBB variants is a step in the right direction. By tailoring vaccines to the specific strains circulating in the United States, we can increase effectiveness and ultimately curb the spread of the virus.
However, the panel rightly raised concerns about the need for booster shots and the frequency with which they should be given. While booster shots can provide an additional layer of protection, it is crucial to strike the right balance. We must consider the long-term durability of the immune response and focus on other aspects like T-cell response.
The T-cell response, often referred to as the “unsung hero” of the pandemic, plays a vital role in long-lasting immune protection. Unlike antibodies, which decline over time, T cells are long-lived and can provide protection against serious disease for years, if not decades. Therefore, it is crucial to prioritize research and development in this area to optimize vaccine effectiveness.
Another point of contention raised by the panel was the comparison between COVID and flu vaccination practices. While annual flu shots have become the norm, it is premature to assume that COVID will follow the same pattern. The unpredictable nature of the virus and its variants makes it difficult to establish a fixed vaccination schedule. Flexibility and adaptability will be key in determining the future of COVID vaccination.
As we move forward, it is essential to maintain open communication with the public and address any concerns or misconceptions. Clear and concise messaging about the benefits of vaccination is crucial to increasing vaccine uptake. Additionally, ongoing research and data collection will help inform policy decisions and ensure that we are on the right track in the fight against COVID-19.
In conclusion, the FDA advisory panel’s recommendation to target the XBB variants in upcoming COVID-19 vaccines is a significant step forward. However, important considerations remain regarding booster shots and the long-term management of the virus. By prioritizing research on T-cell response and maintaining flexibility in vaccination strategies, we can optimize the effectiveness of vaccines and ultimately control the spread of COVID-19.
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June 15, 2023 – An FDA advisory panel today unanimously agreed that upcoming COVID-19 vaccines should target the XBB variants of the SARS-CoV-2 virus now circulating in the United States, but questioned whether the population needs booster shots and how often they should be given.
The FDA’s Advisory Committee on Vaccines and Related Biological Products voted 21-0 in favor of the recommendation on the strain to be used in the next vaccine crop.
In it informative document For the meeting, FDA staff said available evidence suggests that a monovalent (single strain) vaccine of the XBB lineage “is warranted” for the 2023-2024 vaccination campaign and would replace the current bivalent vaccine, which targets the original version of the virus. and two strains of the Omicron variant.
The FDA staff also noted how that change would be in line with the World Health Organization to target the XBB family of subvariants. European regulators have too..
The FDA is not required to act on the panel’s recommendations. But the agency often does, and most likely will in this case. Vaccine companies will need the FDA’s recommendation to start making vaccines in the fall.
New shot every year?
The FDA asked its panel of experts to vote only on the question of the composition of future vaccines in terms of which strain to include.
But the panelists also raised other questions during the meeting, including concerns about moves to tie COVID vaccines into the annual flu shot model.
Paul Offit, MD, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, advocated for an increased focus on the T-cell response after vaccination, even in light of the already recognized decline in antibody protection.
in a recent Substack article, Offit called T cells the “unsung hero” of the pandemic. They take longer to develop after infection or vaccination than the antibodies that first attack the virus, but immune memory cells called B and T cells “are long-lived” and their “protection against serious disease often lasts for years and sometimes , decades”.
Offit said he was concerned about using a blanket approach for future COVID vaccine recommendations, following the one now applied for influenza vaccines. the cdc recommend flu shots for everyone over 6 months, with rare exceptions.
“We need to continue to define who those high-risk groups are and not make this a recommendation for everyone every season,” he said.
Offit offered his own experience as an example. Although he had been vaccinated against the first Wuhan strain of the virus, he was still infected, most likely with a variant that emerged later.
“That was a derivative virus. That’s why I had a mild infection but not a severe infection, because presumably I had T cells that prevented that severe infection, which can last for years,” Offit said.
Pfizer and modern, The two companies that make mRNA-based COVID vaccines are working on experimental products intended to protect against the flu and SARS-COv-2 all at once. Novavax, maker of a more traditional protein-based COVID injection, is doing the same.
The idea of these combination products is to make it more convenient for people to protect themselves against both viruses, while giving companies some marketing advantages.
But without referring to these drugmakers’ plans for future combined flu and COVID-19 vaccines, FDA panel members on Thursday objected to the assumption of routine annual vaccinations against SARS-CoV-2 variants. .
Among the panelists who expressed concerns was Henry H. Bernstein, DO, a former member of the CDC’s Advisory Committee on Immunization Practices.
Bernstein questioned the approach of calling these “2023-2024 formulas,” as this approach conveyed a sense of expectation of the need for annual vaccinations, as is the case with the flu.
“It’s still not clear to me if this is a seasonal virus,” 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 today’s FDA panel, suggested that such a pattern could emerge, though he also agreed that it’s too soon to say for sure.
An emeritus professor at the University of Michigan, Monto’s career included pandemic planning and emergency response to virus outbreaks, including the 1968 Hong Kong influenza pandemic, avian influenza, and the original SARS.
“I think it is premature to say that this virus will not become seasonal,” Monto said of SARS-CoV-2. “I agree. We’re not there yet, but we may be.”
At the end of the meeting, Monto summarized the key points of the meeting, noting that there was a general consensus that the XBB.1.5 subvariant would be the best one to use in future COVID vaccines.
He also noted that Novavax, which makes the more traditional protein-based vaccine, along with Pfizer and Moderna, have already honed in on this subvariant, which would allow for rapid development of updated COVID vaccines.
“The fact that most manufacturers are ready to work on an XBB 1.5 [vaccine] it is an additional reason to select this strain or this variant, given the immunological data,” Monto said.
Peter Marks, MD, PhD, director of the FDA’s Center for Biological Research and Evaluation, said the lawsuits involved in vaccine manufacturing lean toward yearly changes.
“Virtually, we’re going to have one update a year unless we make a heroic effort to deal with a strain that comes along that is essentially so different that it requires us to mobilize tremendous resources to address that strain change,” he said.
Marks questioned panelists’ concerns about comparing flu and COVID vaccination practices. The intent of the FDA staff was to try to help the public understand the need for follow-up vaccination, she said.
“I really have trouble understanding the need for that committee to bristle against something that is similar to influenza. People understand an annual flu shot,” Marks said.
And it’s not certain when another major COVID virus change will follow the XBB subvariant, but it likely will, and soon, Marks said.
“It looks like probably by next fall, there will be a bigger deviation from this,” he said.
inform the public
Marks also stressed the need to better convey the benefits of vaccination to people in the US.
CDC data estimates that 70% of the US population completed an initial series of original monovalent vaccinations, and only 17% received bivalent injections. There is even a decline among people 65 and older. The CDC estimates that 94% of this group completed their primary series, but only 43% received the bivalent booster dose.
“We have to do better because today we haven’t done a good job of communicating to the American public what’s going on here,” Marks said.
Researchers are also still trying to determine the best time for people to receive additional COVID vaccines. Finding the “sweet spot” where people can maximize additional protection is tricky, since people are most protected if they are shot near the beginning of a surge in viral spread, said Ruth Link-Gelles, PhD, MPH of the CDC, to the panel during a presentation.
“You’ll get the best incremental benefit if it’s been longer since your last vaccination,” he said. “But of course, if you wait too long after your last vaccination, you are left with very little protection and therefore are at greater risk of becoming seriously ill.”
Like the FDA’s Marks, Link-Gelles stressed the need to persuade more people to get follow-up shots.
“Most Americans, right now, haven’t even gotten the bivalent dose, so they’re a year or more away from getting the monovalent dose, and therefore have relatively little protection left,” he said.
https://www.webmd.com/covid/news/20230615/fda-panel-backs-new-covid-booster-focusing-only-on-variants?src=RSS_PUBLIC
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