For those who largely follow the progression of Covid-19 vaccines, Thursday is a date.
Nothing ordinary deserves to happen when a committee of external experts, known as the Advisory Committee on Vaccines and Related Biological Products, or VRBPAC, meets for the first time to review Covid-19 vaccines.
But the mere convening of the assembly is a reassuring sign that the Food and Drug Administration, which relies on VRBPAC’s advice, is considering doing what it does: making decisions that are not based on political calendars but on knowledge that shows whether new vaccines are safe. . and effective.
“This is how the FDA makes its decisions,” said Jason Schwartz, an assistant professor of physical fitness policy and control at Yale School of Public Health.
“It is not the Blanca. No House that drives the train, however it is those processes, those very technical and dry processes that will drive the review of vaccines in the coming months,” said Schwartz, who is not on the committee. .
Most federal advisory committees are precisely well known. But VRBPAC, which is pronounced VER-Pack, can be a bit dark, even through those standards. So here’s some data to stay in the brain, as the committee holds its first in what will be a series of meetings on the Covid-19 vaccine over the next few months.
Who are these people?
The “A” in VRBPAC is a clue.
“They are advisors, decision makers,” said Bruce Gellin, president of global immunization at the Sabin Institute. Gellin is a former director of the Office of the National Vaccine Program of the Department of Health and Human Services.
The 15 committee members are largely academics and specialty physicians who help assess whether a new vaccine deserves to be authorized. There are experts in infectious diseases (adults and pediatrics) and biostatistics. People like Paul Offit, a well-known professor of pediatrics and vaccines, advocate at Children’s Hospital of Philadelphia, and Andrea Shane, professor of pediatrics at Emory University School of Medicine.
There is a representative of the pharmaceutical industry on the panel, but that user, lately Paula Annunziato, Merck’s vice president of clinical vaccine studies, cannot vote when the committee makes decisions. Occasionally there is also a public representative on the committee.
Conflict of interest regulations apply strictly. While some federal advisory committees are only experts before being appointed to office, VRBPAC members are subject to conflict-of-interest review prior to each meeting, said Geeta Swamy, a member of the committee that is scheduled to leave Covid-19 meetings because Duke University, where she is associate vice president of research, is a clinical trial site for The Pfizer-BioNTech and AstraZeneca vaccines.
Swamy doesn’t have to stray from discussions about Covid-19 VRBPAC. Paul Spearman of Cincinnati Children’s Hospital, who is also a clinical trial site for the Covid vaccine, joins her on the sidelines this time, as is VRBPAC President Hana El Sahly, who is investigating the Covid-19 Covid-19 Modern Vaccine Trial.
The FDA has the ability to upload ad hoc members to VRBPAC to expand rows when this happens. Thursday assembly documents published in the FDA reveal that Arnold Monto, professor of epidemiology at the University of Michigan, has been appointed interim president of VRBPAC. James Hildreth, immunologist and president of Meharry Medical College, and Jeannette Lee, biostatistics at the University of Arkansas for Medical Sciences and director of the Statistical Center for the Consortium of Clinical Trials of Malignant Diseases of AIDS, were included as members with a transitional vote.
What will VRBPAC do this week?What will VRBPAC do later?
Thursday is the first of those for this organization on Covid vaccines. “A preview of the attractions to come,” said Ruth Karron, PRESIDENT of VRBPAC from 2006 to 2008.
Committee members have been informed in the past that they may only have up to 3 meetings in November and 3 in December, Offit said. These meetings will be convened when vaccine brands have sufficient knowledge of their Phase 3 clinical trials to apply for emergency use authorizations, or the USS.
Overall, VRBPAC serves a variety of purposes, said Karron, who is the director of the Immunization Research Center at the Johns Hopkins Bloomberg School of Public Health.
The first is that this gives the FDA the ability to seek the recommendation of outdoor experts on urgent issues. An example imaginable: when a vaccine gets an AAU, it deserves to be told to other people that they have been randomized for a placebo. Have you not been vaccinated and are presented with the opportunity to be vaccinated?Vaccinating them at this early level would restrict what can be learned by comparing the vaccine arm to the placebo arm.
This is a delicate resolution that requires a balance between the ethics of studies and the desire to collect as much data as imaginable about these vaccines. “These issues need to be addressed,” said Jesse Goodman, a leading former FDA scientist who recently directored Georgetown University’s Center for Access, Safety, and Medical Product Management. “If not, we will end up with many gaps in our knowledge. “
Gellin said the committee may also raise its own concerns, or be offering reflections on the FDA’s recommendation to brands on the bars their vaccines would like to meet to qualify for an A. S. A.
The merit of the assembly moment is that it allows the public to raise their concerns, Karron said. VRBPAC assemblies are open and members of the public have the right to ask to deal with the committee (if there are more requests than deadlines allow, public comment spaces are allocated by lottery).
Karron called the “two-way street. “
When VRBPAC makes recommendations, will they be made by the FDA?
The regulatory firm is not obliged to adhere to the recommendation of its advisers, but this is the case.
Offit and others learn about the last time VRBPAC met to discuss a new vaccine logo, when the FDA asked for feedback on Sanofi’s problematic Dengvaxia vaccine.
The world urgently needs effective dengue vaccines. But it has become clear that Sanofi can only be used safely in others who have had at least one dengue infection. Dengue can infrequently cause life-threatening and even fatal infections; This occurs to the fullest during the episode of the disease. There was a concern, and then it was felt to be true, that other people who had never had dengue before being vaccinated are at increased threat of serious illness if they then get the disease.
VRBPAC members expressed serious considerations about the vaccine, recommending that it be authorized only for others over the age of nine to 16, and even in this case, only for those who had already had an infection and lived in a component of the United States where dengue fever is endemic This only means Puerto Rico and some other territories and offshore protectorates , a small prospective market.
Sanofi had asked for the vaccine to be authorized in others between the ages of nine and 45. The FDA accepted the advisory committee when it approved Dengvaxia two months later.
If VRBPAC is a component of vaccine approval, why are experts so pleased that it complies with Covid-19 vaccines?
For months, public health and vaccine experts have been involved in President Trump, in an effort to increase his chances of re-election, forcing the FDA to allow Covid-19 vaccines before they prove effective enough. Offit and Ezekiel Emanuel, an ethics expert at the University of Pennsylvania, warned against this option in a New York Times editorial in early June (Emanuel is also an adviser to Democratic presidential candidate Joe Biden).
Trump has said he needs a vaccine before Election Day, but Peter Marks, who runs the FDA’s Center for Biological Assessment and Research, and Moncef Slaoui, co-chair of Operation Warp Speed, the government’s effort to boost Covid’s vaccines, drugs and diagnoses. , have publicly stated that they will surrender if Trump forces him to pass vaccines without sufficient evidence of protection and effectiveness.
As the politicization of Covid vaccines has warmed, public interest in vaccines has cooled. A series of surveys, adding one published Monday through STAT and The Harris Poll, show that the number of others claiming to be willing to settle for a Covid vaccine is declining, even as infection rates in the country rise. Several states have indicated that they will not propose vaccination on the exclusive recommendation of the federal government. Andrew Cuomo of New York has established his own panel of experts to influence vaccines as they go. Available.
Experts see VRBPAC as a buffer, a way to ensure to the public that accelerated vaccines with Operation Warp Speed are evaluated with the same rigour as any other vaccine.
He didn’t feel any political pressure. “We are independent,” heArray
Cody Meissner, director of pediatric infectious diseases at Tufts University School of Medicine, also doesn’t feel political tension, but he knows that the optics around Covid vaccine approvals are incredible for acceptance and use.
“We will have the possibility to introduce a vaccine,” Meissner said. And if this goes wrong, it will be a long time before we get the Covid-19 vaccine. “
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Do we know if knowledge of power will be made public?Will we see the numbers in the category, for the vaccine and placebo: an infected/infected number (asymptomatic/mild/moderate/severe/death)?
1. Only the FDA knows. Different regulators review the same knowledge and make other decisions (for example, the maximum example identified is tydomid, approved only in Europe and not in the United States).
2. Fauci is the NIH. You will have no formality with the FDA to approve it or not.
I would possibly talk to an FDA panel, but it won’t have a vote and, in fact, it won’t contribute to the FDA’s internal debate.
I would be interested to know whether this committee will review the recent report of the National Academies entitled “Fair allocation of the COVID vaccine”, especially since NIH and CDC commissioned this report and drafted and studied it through a similar panel of experts. Can you tell us if this report will tell you the paintings of this new committee?
This committee probably won’t be guilty at all. The FDA makes the decision whether or not to approve and write a very express “label” for a new product.
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