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The U. S. Food and Drug Administration’s (FDA) independent vaccine expert committee. UU. se met Thursday to discuss the long-term COVID-19 injections. The assembly seemed to be in a position for an explosive debate. company through its concept that COVID vaccines will be compatible with the mold of annual flu vaccines, with reformulations in the early part of each year, followed by launches in the fall in anticipation of winter waves.
But outside experts, plus some members of the FDA’s advisory committee, have questioned nearly every facet of this plan, from the dubious seasonality of COVID-19 so far, to the futility of looking for immediate (or subvariate) variants. , as would possibly be the case). ). Some have even questioned whether it is necessary to encourage other young, healthy people so that when existing vaccines offer coverage against serious diseases, but only short-lived coverage against infections.
A sincere member of the FDA committee, Paul Offit, a pediatrician and infectious disease expert at the Children’s Hospital of Philadelphia, publicly attacked the bivalent recall and wrote an observation in the New England Journal of Medicine earlier this month titled: Bivalent COVID-19 Vaccines. – A cautionary tale. (The FDA’s advisory committee voted 19-2 in favor of bivalent reinforcements last year, and Offit was one of two votes against. )
However, despite the charged context of yesterday’s assembly, the sparks of the war of words died out in a quiet discussion. The nine-hour assembly concluded with the committee’s unanimous vote to “harmonize” long-term COVID-19 vaccine formulations so that the number one series and boosters are varied formulations. For example, the number one series vaccines would fit the updated bivalent boosters, which lately target the original SARS-CoV-2 strain that emerged from Wuhan, China, as well as the omicron BA. 4/5 subvariants.
The FDA gave the impression of melting the waters with questions and talking about issues related to “harmonization” and simplification of COVID vaccines. After the individual vote, the firm asked the committee to talk about “simplifying the vaccination schedule” before addressing the most dangerous ones. , still mild, topic of conversation about contemplating “periodic updates of the composition of the COVID-19 vaccine”.
Overall, committee members promoted streamlining vaccines when possible, ensuring number one series vaccines fit booster doses and potentially reducing treatment regimens to one dose for adults and two for youth and high-risk adults.
“There’s so much confusion about those other formulations that I think anything we can do to alleviate that confusion and simplify things, it’s going to be a smart thing to do,” said Archana Chatterjee, dean of the Chicago School of Medicine and a voting committee member. . at the end of yesterday’s meeting. ” I agree with my other colleagues that there is still a need for these vaccines and that we are doing everything we can to get our hands on them. Having vaccines is not enough, we want to get them used. . . It’s a step in the right direction to get us there. “
However, the most important steps for long-term vaccines — deciding which formulas deserve to be used next, who deserves to receive them, and when — remained elephant-sized questions in the boardroom. And even among the placid comments, it became clear that arguments bubbled beneath the surface.
Prior to the committee’s vote and debate, the advisers heard a series of presentations from vaccine manufacturers, the FDA, and the Centers for Disease Control and Prevention, all of which update COVID-19’s prestige and vaccine functionality so far.
Although Offit and others criticized bivalent reinforcements for not being better than previous reinforcements, the data presented at the assembly argued otherwise. Real-world observational data show merit to other people strengthened with bivalent booster over the original (monovalent) vaccine, even opposites. to the maximum of recent subvariants. The data presented at the assembly show that it has surpassed the original vaccine in terms of coverage against symptomatic infection, emergency room visits or urgent care and hospitalization.
In a CDC study published Wednesday, for example, researchers found that the relative effectiveness of bivalent booster vaccine against symptomatic infection with an OMICRON sublineage related to BA. 5 (which includes BQ. 1 and BQ. 1. 1) is 52 percent in other people ages 18 to 49. In other words, other people in this age organization had 52% more coverage against infection with BA. 5-related strains than other people who gained the initial booster. For people aged 50 to 64 years, relative effectiveness against BA. 5-related infections 43% and 37% for those over 65 years.
Compared with newer XBB/XBB. 1. 5-like omicron subvariants, relative efficacy against infection was 49% in the elderly aged 18 to 49 years, 40% in the elderly aged 50 to 64 years, and 43% in the 65-year-old. and older.
Numerous serological studies have also been conducted to compare the antibody responses of the bivalent withdrawal with those of the original recall with respect to the diversity of omicron subvariants circulating lately. The effects are combined and, in some cases, difficult to compare due to differences in vaccination intervals, the number of other people involved, and the types of tests used. But overall, the FDA argued that it suggests the bivalent booster provides greater neutralizing antibody responses compared to recently and recently circulating omicron subvariants than the original vaccine.
“What’s vital is that all the effects are moving in the same direction,” Jerry Weir, director of the FDA’s division of viral products, said Thursday at the meeting. “In other words, with all those studies, like the manufacturers’ ones, there is a stepwise variant neutralization after the management of the bivalent BA. 4/5 vaccine compared to the monovalent . . . I find it remarkable to see this point of uniformity. “
For example, one of the most recently published studies, published Wednesday in the New England Journal of Medicine, found that a bivalent supplement resulted in an approximately threefold buildup in neutralizing antibody levels compared to XBB. 1 compared to other people. seasoned with the original seasoned. This accumulation is almost the same (3. 6 times and 2. 7 times) in other people without and with previous SARS-CoV-2 infection, respectively.
Despite complaints from Offit and others before the meeting, committee members were comfortable with the bivalent data and accepted the FDA’s pink retrospective.
“I am totally convinced that the bivalent vaccine is the number one series and its boosters,” said David Kim, a committee member and infectious disease expert at the Department of Health and Human Services.
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