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Who decides when vaccine studies are done?




Dr Anthony Fauci, the country’s chief infectious disease officer, will oversee most of the ongoing COVID-19 vaccine trials in the United States, but not that of the current leader carried out by Pfizer, according to documents obtained by ProPublica.

According to a draft charter outlining how most advanced COVID-19 vaccine trials will be monitored, Fauci is the US government’s “designated principal representative” who will be part of the first review of the results. That puts Fauci in the room with companies – including Moderna, Johnson & Johnson, and AstraZeneca – to decide whether the vaccines are ready to seek Food and Drug Administration approval.

Fauci’s role, which has not been previously reported and has been confirmed for ProPublica by the National Institutes of Health, may offer some reassurance in the face of widespread concerns that President Donald Trump wants to rush to an unproven vaccine . As Senator Kamala Harris, Democratic Vice Presidential candidate, said in her recent 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 caveat. Fauci does not have the same practical role for the vaccine that looks set to work the earliest: that of Pfizer. This is because Pfizer has chosen not to accept government funding and to participate in the federal coronavirus vaccine development program, known as Operation Warp Speed. (The government has reached an almost $ 2 billion deal with Pfizer to pre-order up to 600 million doses of the company’s vaccine, but it is not contributing to vaccine development as others are. companies.)

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

Pfizer CEO Albert Bourla said on Friday that the earliest his company would be ready to apply for a clearance would be the third week of November. While Pfizer could know by the end of October whether its vaccine is effective, it would take longer to gather enough safety data to present to the FDA, Bourla said in an open letter on the company’s website. .

Fauci’s role in overseeing the companies participating in Operation Warp Speed ​​stems from a unique arrangement the government has put in place to monitor the trials. Typically, clinical trials set up their own groups of independent scientists, known as the Data Security Oversight Board, or DSMB, to watch for security issues or the first signs of success. But all of Operation Warp Speed’s vaccine trials share a common DSMB whose members were selected by Fauci’s agency, NIAID. They also share a network of clinical trial sites where volunteers are recruited for the studies.

A DSMB is responsible for making recommendations such as stopping the trial if there is a safety concern or letting the manufacturer know that there is sufficient evidence to submit an application to the FDA. Normally, the recommendation of a DSMB is made to the company performing the test. In this case, the US government – which receives two representatives, one from NIAID and one from the Biomedical Advanced Research and Development Authority – will also have a seat at the table to decide how to proceed.

“Once the DSMB makes a decision, the DSMB provides the recommendation not only to the study sponsor, but also to the ‘US government, whose’ designated principal representative ‘is Fauci, NIAID confirmed in an email. Fauci declined to be interviewed.

This is not the same as saying that Fauci has the final say. The company and the government are supposed to reach a consensus, the agency said. But if they don’t all agree, the final decision is up to the company.

Still, it would be an unlikely bold move for a company to move forward on Fauci’s objection, given his public stature, experts said. “These are the most important trials in medical history, this is the ultimate fish bowl,” said Dr Eric Topol, director of the Scripps Research Translational Institute. “I don’t think any sponsor would dare challenge the recommendation of the DSMB.”

While the mechanics of a DSMB may not be familiar 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 darling of the nation right now,” Pisani said. “I think people trust Anthony Fauci.”

“Having Fauci under surveillance is great,” Topol added. “The more people who are experts looking at it, the better.

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

The chairman of the group 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 it, although the webpage was later removed.

His leadership offers another level of comfort in the reliability of trials to those who know him. “He’s not only brilliant, he’s also independent and outspoken,” 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, professor of biostatistics at the University of Pennsylvania and former director of the FDA, told ProPublica in an interview that many people, including herself, feared that the NIH was “being pushed by the political leaders of the HHS. to publish data “from premature trials, which could undermine the integrity of a trial. HHS, the US Department of Health and Human Services, is the parent agency of NIH. She was concerned that political leaders would not understand the scientific arguments for not stopping trials when they wanted to have data “so that they could act quickly in an urgent situation,” she said.

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

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

The common DSMB appears to be unprecedented, if only because there have not previously been multiple vaccines in development for the same disease at the same time. Experts said the arrangement offered benefits such as strengthening the available evidence to show that each hit is safe and effective.

According to Schaffner of Vanderbilt, standardization of test measurements should make it easier to compare vaccines directly, which can be useful in knowing whether one is better or worse than another in certain subgroups, such as the elderly. or people with weakened immune systems.

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

There may also be advantages from a security point of view.

If a potential safety issue emerges in one trial, having a common data security oversight committee for multiple trials means the board knows it needs to monitor that same issue in all trials, said Moderna Chief Medical Officer, Dr Tal Zaks. “When AstraZeneca had an unwanted side effect, we have a DSMB reviewing our trial – the fact that it’s the same DSMB means there isn’t one DSMB that needs to go educate another DSMB,” Zaks said. . (ProPublica Chairman of the Board, Paul Sagan, is a member of Moderna’s board and a shareholder in the company.)

AstraZeneca’s trial has been put on hold in the United States while the company and the FDA investigate what happened with a participant who had a bad reaction. It is not yet known 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 quickly as possible,” the company said in a statement.

AstraZeneca added that another benefit of joining the government consortium was that its vast 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 it and the other companies risk missing out on some of the benefits of pooling resources. “It’s at least unfortunate and not very sporty, as the British would say,” Schaffner said.

At the same time, there might be some advantages to going solo at Pfizer. “One of the greatest risks to this process is the perception of political influence and, in this regard, having parallel efforts, especially efforts seen as independent of each other and / or independent of perceived sources of political influence, is a good thing “. said Mani Foroohar, analyst at SVB Leerink investment bank.

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

Whether it’s Pfizer or one 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 panel of external experts at 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 any vaccine. The agency has also committed to holding advisory committee meetings to review data for each candidate vaccine.

Between independent trial security oversight committees and public advisory committee meetings, “any kind of handkerchief that people worry about will (go through) multiple checkpoints,” Fauci said in an interview with Dr. Howard Bachner on the JAMA Network Podcast September 25. “The big elephant in the room is, is anyone going to try to run a political race to interfere with the process? … If you look at the standard process of how these things work, I think you can be sure it’s really unlikely that will happen. “

• ProPublica is a non-profit newsroom that investigates abuse of power. Sign up to receive our greatest stories as soon as they are published.

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