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Who decides when vaccine studies will be conducted? Internal documents show that Fauci plays a key role

This story was originally published by ProPublica.

WASHINGTON – Dr. Anthony Fauci, the nation’s leading infectious disease officer, will oversee most of the ongoing COVID-19 vaccine trials in the US, but not those of Pfizer’s current front runner, ProPublica documents show.

According to a draft charter outlining how most advanced COVID-19 vaccine trials will be monitored, Fauci is the US government’s “senior designate” who will be part of the first look at the results. This will allow Fauci to work with the companies – including Moderna, Johnson & Johnson and AstraZeneca – to decide whether the vaccines are ready to seek approval from the Food and Drug Administration.

The role of Fauci, previously unreported and confirmed by the National Institutes of Health for ProPublica, could offer some reassurance amid widespread concern that President Donald Trump is about to overturn an unproven vaccine. As Senator Kamala Harris, Democratic nominee for vice president, said in last week̵

7;s debate, “When the health professionals, when Dr. Fauci, the doctors tell us to take it, I’ll be first.” Line to take it. “

But there is one major caveat. Fauci doesn’t have the same practical role for the vaccine that seems to be showing results soon: Pfizers. That’s 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 signed a nearly $ 2 billion contract with Pfizer to pre-order up to 600 million doses of the company’s vaccine, but they are not contributing to the development of the vaccine like other companies do.)

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

Pfizer CEO Albert Bourla said Friday that his company would not be ready to apply for approval until the third week of November at the earliest. While Pfizer may know if its vaccine is effective by the end of October, it would take additional time to gather sufficient safety data to submit to the FDA, Bourla said in an open letter posted on the company’s website.

Fauci’s role in overseeing the companies participating in Operation Warp Speed ​​stems from a unique agreement the government made to oversee the trials. Typically, clinical trials use their own independent panels of scientists, known as the Data Safety Monitoring Board or DSMB, to look for safety concerns or early signs of success. However, all vaccine trials in Operation Warp Speed ​​share a common DSMB, the members of which were selected by Fauci’s agency, NIAID. They also share a network of clinical trial sites where some volunteers are recruited for the trials.

A DSMB is responsible for making recommendations, e.g. For example, stop the attempt if there are safety concerns, or inform the manufacturer that there is enough evidence to file an application with the FDA. Usually a DSMB’s recommendation goes to the company conducting the study. In this case, the US government, which has two representatives, one from the NIAID and one from the Biomedical Advanced Research and Development Authority, will also have a seat at the table to decide what to do next.

“As soon as the DSMB makes a decision, the DSMB will not only forward the recommendation to the study sponsor, but also to the” US government, whose “designated senior representative” is Fauci, the NIAID confirmed in an email. Fauci declined to be interviewed.

It’s not the same as saying that Fauci has the final say. The company and the government should reach a consensus, the agency said. However, if everyone does not agree, the final decision rests with the company.

Even so, it would be unlikely for a company to get over Fauci’s objections given its public position, experts said. “These are the most important studies in medical history, this is the ultimate goldfish bowl,” said Dr. Eric Topol, director of the Scripps Research Translational Institute. “I don’t think a sponsor would dare to contradict the DSMB’s recommendation.”

While the mechanics of a DSMB may be unknown to most members of the public, people likely know and trust Fauci, according to Amy Pisani, executive director of the national nonprofit Vaccinate Your Family. “(He is) the nation’s treasure right now,” said Pisani. “I think people believe in Anthony Fauci.”

“It’s great to have Fauci under control,” added Topol. “The more people are experts, the better. You can’t be too careful.”

Other members of the DSMB for the COVID-19 vaccines, although not as well known as Fauci, are also widely recognized in their field. DSMB members are normally treated confidentially to protect them from outside influences. However, ProPublica was able to identify some members. In the charter received from ProPublica, the group of around a dozen members was described as experts in “biostatistics, clinical studies, infectious diseases, vaccine development and ethics”.

The chairman of the committee is Dr. Richard Whitley, Professor of Pediatrics, Microbiology, Medicine and Neurosurgery at the University of Alabama at Birmingham. His role became public when the university announced this, although the website was later removed.

His guidance offers those who know him yet another measure of comfort in the trustworthiness of the trials. “He is not only famously bright, but also famously independent and open,” said Dr. William Schaffner, Professor of Preventive Medicine and Infectious Diseases at Vanderbilt Medicine. “He’ll look at the data and tell you exactly what he’s thinking.”

Whitley declined to comment.

Susan Ellenberg, a professor of biostatistics at the University of Pennsylvania and former director of the FDA, told ProPublica in an interview that many people, including her, feared that the NIH “might be pushed to release data by the political leadership at HHS “premature attempts that could undermine the integrity of an attempt. HHS, the US Department of Health, is the parent agency of the NIH. Her concern was that political leaders may not understand the scientific arguments so as not to disrupt processes when they want data “to act quickly in an urgent situation,” she said.

At the time of the interview, Ellenberg had not identified herself as a member of the NIH’s DSMB, but later recognized that she was a member.

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

The joint DSMB seems unprecedented, if only because multiple vaccines for the same disease have not been developed at the same time. Experts said the deal had benefits like strengthening the evidence available to show that every shot is safe and effective.

The standardization of experimental measurements should make it easier for vaccines to compare head-to-head. Vanderbilt’s Schaffner says this can be helpful in determining whether one is better or worse than the other in certain subgroups, such as the elderly or people with compromised immune systems.

“It is better for me when public health has a fairly common view,” said Dr. Gregory Glenn, President of Research and Development at Novavax, who has received $ 1.6 billion from Operation Warp Speed ​​and is hoping to begin its Phase 3 trial in the US this month as part of the Network for Clinicals NIH studies.

There may also be some advantages for security reasons.

If a study has a potential security issue and there is a common data security monitoring body for multiple studies, the panel must look for the same issue in all studies, said Dr. Tal Zaks, Moderna Chief Medical Officer. “When AstraZeneca had an adverse side effect, we have a DSMB looking at our study. The fact that it is the same DSMB means there is no DSMB that needs to train another DSMB,” Zaks said. (ProPublica chairman Paul Sagan is a member of Moderna’s board of directors and a shareholder in the company.)

AstraZeneca trial has been put on hold in the US while the company and the FDA investigate what happened to a participant who had a bad reaction. It is not yet clear whether the reaction was due to the vaccine or not.

“AstraZeneca is committed to working with governments and key partners to ensure that we develop and obtain 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 the large network of trial sites can help reach minority communities that are historically less represented in clinical trials and also more prone to COVID-19.

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

At the same time, Pfizer’s solo advantage could bring benefits. “One of the biggest risks to this process is the perception of political influence. In this regard, it is a good thing to put in parallel efforts, especially efforts that are viewed as independent and / or independent of perceived sources of political influence.” said Mani Foroohar, an analyst at investment bank SVB Leerink.

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

Whether Pfizer or any of the companies involved in Operation Warp Speed, the final say on whether a vaccine is ready for public use rests with the FDA.

The FDA has promised to present the data to an advisory committee of external experts in a public meeting. A preliminary meeting will be held on October 22nd to broadly discuss the standards that the FDA will seek prior to approving a vaccine. The agency has also committed to holding meetings of the advisory board to review the dates of individual vaccine candidates.

Between the independent study safety monitoring bodies and the public advisory board meetings, “any type of handkerchief that people are concerned about will go through multiple checkpoints,” Fauci said in an interview with Dr. Howard Bachner on the JAMA Network Podcast on September 25th. “The big elephant in the room is is anyone going to try to get a political ending to disrupt the process? … If you look at the standard process of how these things work, I think you can feel safe that it really is it is unlikely that this will happen. “

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