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Who decides when vaccine studies are done? Internal documents show that Fauci plays a key role

This story was originally published by ProPublica.

WASHINGTON – Dr. Anthony Fauci, the best government official on infectious diseases, will oversee most of the ongoing attempts to vaccinate against COVID-19 in the United States, but not that of the current favorite made by Pfizer, according to documents received from ProPublica .

According to a draft charter that outlines how most of the advanced attempts at vaccines against COVID-19 will be observed, Fauci is the “appointed senior representative” of the US government, who will be part of the first look at the results. This puts Fauci in the room with companies – including Moderna, Johnson & Johnson and AstraZeneca ̵

1; in deciding whether vaccines are ready to seek approval from the Food and Drug Administration.

Fauci’s role, which was not previously reported and confirmed to ProPublica by the National Institutes of Health, could provide some reassurance in the face of widespread fears that President Donald Trump wants to embark on an unproven vaccine. As Senator Kamala Harris, the Democratic nominee for vice president, said in last week’s debate: “If public health professionals, if Dr. Fauci, if doctors tell us we should take it, I will be the first in line. to take it. “

But there is a big warning. Fauci does not have the same practical role for the vaccine that seems ready to show results sooner: Pfizer’s. This is because Pfizer chose not to accept government funding and to participate in the federal program to develop a coronavirus vaccine known as Operation Warp Speed. (The government has struck a deal with Pfizer for nearly $ 2 billion to order up to 600 million doses of the company’s vaccine, but that’s not as conducive to vaccine development as it is for other companies.)

“(We) offered opportunities to work with Pfizer,” said a spokesman for the National Institute of Allergy and Infectious Diseases, a branch of the NIH. “Pfizer has chosen to conduct its Phase 3 study without Warp Speed ​​operation or NIH support.”

Pfizer CEO Albert Burla said on Friday that the earliest time his company would be ready to apply for a permit would be the third week of November. While Pfizer may know by the end of October whether its vaccine is effective, it will need additional time to gather enough safety data to submit to the FDA, Burla said in an open letter on the company’s website.

Fauci’s role in overseeing the companies involved in Operation Warp Speed ​​stems from a unique arrangement the government has set up to monitor the processes. Typically, clinical trials establish their own independent teams of scientists, known as the Data Safety Oversight Board or DSMB, to look out for safety concerns or early signs of success. But all attempts at vaccines in Operation Warp Speed ​​share a common DSMB, whose members are selected by Fauci’s agency, NIAID. They also share a network of clinical trial sites where some volunteers are recruited for the trials.

The DSMB is responsible for making recommendations, such as stopping the test if there are safety concerns, or notifying the manufacturer that there is sufficient evidence to apply to the FDA. Usually the DSMB recommendation refers to the company that manages the process. In that case, the US government – which has two representatives, one from NIAID and one from the Biomedical Research and Development Authority – will also have a seat at the table to decide what to do next.

“Once the DSMB has made a decision, the DSMB provides a recommendation not only to the study’s sponsor, but also to the ‘US government, whose appointed senior representative’ is Fauci,” NIAID confirmed in an email. Fauci declined to be interviewed.

This is not the same as saying that Fauci has the last word. The company and the government must reach a consensus, the agency said. But if not everyone can agree, the final decision belongs to the company.

Still, it would be an incredibly brazen move for a company to move forward on Fauci’s objection, given its public growth, experts said. “These are the most important tests in medical history, this is the best fish,” said Dr. Eric Topol, director of the Scripps Research Translational Institute. “I don’t think any sponsor would dare oppose the DSMB’s recommendation.”

Although the mechanics of DSMB may be unfamiliar to most members of the public, people probably know and trust Fauci, according to Amy Pisani, executive director of the national nonprofit Vaccine Your Family. “(He) is the nation’s favorite right now,” Pisani said. “I think people have faith in Anthony Foki.”

“The presence of Fauci with supervision is great,” Topol added. “The more people look at it, the better. You can’t be careful enough.”

Other members of the DSMB for COVID-19 vaccines, although less well known as Fauci, are also widely respected in their fields. DSMB members are usually kept confidential to protect them from outside influence, but ProPublica has been able to identify several members. The charter, obtained from ProPublica, describes the group, which has about a dozen members, as having experience in “biostatistics, clinical trials, infectious diseases, vaccine development and ethics.”

The panel is chaired by Dr. Richard Whitley, Professor of Pediatrics, Microbiology, Medicine and Neurosurgery at the University of Alabama at Birmingham. His role went public when the university announced it, although the website was later taken down.

His guidance provides another level of comfort in the reliability of the trials of those who know him. “He is not only extremely bright, but also extremely independent and outspoken,” said Dr. William Schaffner, a professor of preventive medicine and infectious diseases at Vanderbilt Medicine. “He’ll look at the data and tell you exactly what he thinks.”

Whitley declined to comment.

Susan Ellenberg, a professor of biostatistics at the University of Pennsylvania and former director of the FDA, told ProPublica that many people, including herself, are worried that the NIH may be “prompted by HHS political leadership to publish data.” from trials prematurely, which could undermine the integrity of a process. HHS, the U.S. Department of Health and Human Services, is the parent agency of the NIH. Her concern was that political leaders may not understand scientific arguments so as not to disrupt processes when they want to have data, “so they can move quickly in an emergency,” she said.

During the interview, Ellenberg did not identify as a member of the NIH’s DSMB, but later admitted to being a member.

Dr. Malegapuru William McGoba, an immunologist based in South Africa, is one of the few international members of the DSMB. McGoba is well known for his work on public health initiatives around HIV / AIDS, including the South African AIDS Vaccine Initiative. McGoba confirmed his role in the DSMB, but declined to comment further.

The overall DSMB seems unprecedented, if only because multiple vaccines for the same disease have not been developed before. Experts say the agreement offers advantages such as strengthening the available evidence that shows every shot is safe and effective.

Standardization of measurement samples should facilitate the comparison of head-to-head vaccines, which may be useful for knowing whether one is better or worse than another in certain subgroups, such as the elderly or people with impaired immune systems, according to Schaffner. of Vanderbilt.

“It’s better for me to have a fairly general assessment of public health,” said Dr. Gregory Glenn, president of research and development at Novavax, which received $ 1.6 billion from Operation Warp Speed ​​and hopes to launch its Phase 3 trial in the United States this month as part of the NIH Clinical Trials Network.

There may also be some safety benefits.

If a potential safety issue occurs in a single trial, having a common data safety monitoring board for multiple trials means the board knows how to look for the same problem in all trials, said Dr. Tal Sachs, chief medical officer of Moderna. “When AstraZeneca had an adverse side effect, we have a DSMB that looks at our test – the fact that it is the same DSMB means that there is no DSMB that has to go and form another DSMB,” Sachs said. (ProPublica board chairman Paul Sagan is a board member of Moderna and a shareholder in the company.)

The lawsuit against AstraZeneca has been suspended in the United States while the company and the FDA are investigating what happened to a participant who had a bad reaction. It is not yet clear whether the reaction is due to the vaccine or not.

“AstraZeneca is committed to working with governments and key partners to ensure that we develop and receive regulatory approval for an effective vaccine as soon as possible,” the company said in a statement.

AstraZeneca added that another benefit of joining the government consortium is that its large network of trial sites can help reach minority communities that are historically less represented in clinical trials and also more vulnerable to COVID-19.

Pfizer’s decision not to participate means that it and other companies may miss out on some of these resources by pooling resources. “It’s at least pathetic and not very sporty, as the British would say,” Schaffner said.

At the same time, there could be advantages to Pfizer coming out on its own. “One of the biggest risks to this process is the perception of political influence, and in this regard, if there are parallel efforts, especially efforts seen as independent of each other and / or independent of perceived sources of political influence, it is a good thing,” he said. Manny Fourier, analyst at investment bank SVB Leerink.

Pfizer declined to comment on its decision not to join the government’s shared DSMB and test network.

Whether it’s Pfizer or one of the companies involved in Operation Warp Speed, the final word on whether the vaccine is ready for public use belongs to the FDA.

The FDA promised to present the data to an advisory committee of external experts in a public meeting. A preliminary meeting will be held on October 22 to discuss in general the standards that the FDA will seek to see before authorizing a vaccine. The Agency also undertakes to hold meetings of an advisory committee to review the data of individual vaccine applicants.

Between independent test safety monitoring councils and public advisory committee meetings, “any kind of intruder where people are worried will (pass) multiple checkpoints,” Fauci said in an interview with Dr. Howard Bachner Podcast. of the JAMA Network on September 25th. “The big elephant in the room is, will anyone try to make a political end to intervene in the process?” … If you look at the standard process of how these things work, I think you can feel comfortable that this is really unlikely to happen. “

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