There’s a legitimate way to end coronavirus vaccine trials early, says Fauci

KHN (Kaiser Health News) is a non-profit news service that covers health topics. It is an editorially independent program of KFF (Kaiser Family Foundation) that is not affiliated with Kaiser Permanente.

(Kaiser Health News) – A COVID-19 vaccine could be available sooner than expected if ongoing clinical trials produce overwhelmingly positive results, said Dr. Anthony Fauci, America’s top infectious disease official, in an interview Tuesday with KHN.

Although two ongoing clinical trials of 30,000 volunteers are expected to conclude by the end of the year, Fauci said an independent board has the authority to end the trials weeks earlier if interim results are overwhelmingly positive or negative.

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The Data Security and Monitoring Board (DSMB) might say, “‘The data is so good right now that it can be said to be safe and effective,'” Fauci said. In that case, the researchers would have a “moral obligation” to end the trial early and make the active vaccine available to all study participants, including those who received placebos, and speed up the process of administering the vaccine to millions.

Fauci’s comments come at a time of growing concern over whether political pressure from the Donald Trump administration could sway federal regulators and scientists overseeing the nation’s response to the novel coronavirus pandemic and erode public confidence. in vaccines. Leading vaccine experts have said they fear Trump is pushing for early approval of the vaccine that will help him win re-election.

Fauci, the director of the National Institute of Allergy and Infectious Diseases, said he relies on the independent members of the DSMB, who are not government employees, to keep vaccines to high standards without being politically influenced. The board members are typically experts in vaccine science and biostatistics who teach in major medical schools.

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“If you’re making a decision about the vaccine, you’d better make sure you have very strong evidence that it is safe and effective,” Fauci said. “I’m not worried about political pressure.”

The safety board periodically reviews data from a clinical trial to determine whether it is ethical to continue enrolling volunteers, who are randomly assigned to receive an experimental vaccine or a placebo injection. Neither the volunteers nor the health workers who vaccinate them know what vaccine they are receiving.

Manufacturers are now testing three covid vaccines in large-scale US trials. The first two studies, one led by Moderna and the National Institutes of Health and the other led by Pfizer and BioNTech, began in late July. Each study was designed to enroll 30,000 participants.

Company officials have said both trials have enrolled about half of that total. AstraZeneca, which has been conducting large-scale clinical trials in Britain, Brazil and South Africa, launched another large-scale vaccine study this week in the US, involving 30,000 volunteers. Additional vaccine trials are expected to begin this month.

In trials of this size, researchers will know if a vaccine is effective after just 150 to 175 infections, said Dr. Robert Redfield, director of the Centers for Disease Control and Prevention (CDC, for its acronym in English). ), in a call with reporters on Friday.

“It may be surprising, but the number of events that must occur is relatively small,” said Redfield.

At this time, only the safety board has access to the trial data, said Paul Mango, deputy director of policy staff for the Department of Health and Human Services. As for when the test results will be available, “we cannot determine whether it will be in mid-October or December.”

Safety boards establish “stopping rules” at the beginning of a study, making their criteria for ending a trial very clear, said Dr. Eric Topol, executive vice president of research at Scripps Research in San Diego and an expert on the use of of data in medical research.

Although the safety board may recommend stopping a trial, the final decision to stop a study is made by the scientists conducting the trial, Topol said.

A vaccine manufacturer could apply to the Food and Drug Administration (FDA) for an emergency use authorization (EUA), which can be granted quickly, or continue the regular drug approval process, which requires more time and evidence.

Safety monitors may also stop a trial due to safety concerns, “if it looks like it’s really hurting people on the vaccine arm, because of a lot of adverse events,” Fauci said.

Fauci said that people can trust the process, because all the data that the external monitors used to make their decisions would be made public.

“All of that has to be transparent,” Fauci said. “The only time you worry is if there is any pressure to end the trial before you have enough data on safety and efficacy.”

Topol and other scientists have harshly criticized the FDA in recent weeks, accusing Commissioner Stephen Hahn of giving in to political pressure from the Trump administration, which has pushed the agency to approve covid treatments faster.

Stopping trials early poses a number of risks, such as making a vaccine appear more effective than it actually is, Topol said.

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“If you stop something early, you can get an exaggerated benefit that is not real,” because the less positive evidence only comes out later, Topol said.

Stopping studies early could also prevent researchers from recruiting more minority volunteers. So far, only 1 in 5 trial participants are black or Hispanic. Since blacks and Hispanics have been more affected by the pandemic than other groups, Topol said, it is important that they form a larger part of vaccine trials.

Ending vaccine trials early also carries safety risks, said Dr. Paul Offit, a vaccine developer who is on a National Institutes of Health advisory panel on covid vaccines and treatments.

A smaller, shorter trial might miss major vaccine side effects, which may become apparent only after millions of people have been vaccinated, said Offit, director of the Center for Vaccine Education at Children’s Hospital of Philadelphia.

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Researchers will continue to follow vaccinated volunteers for a full year for long-term side effects, Redfield said.

And Fauci acknowledged that shortening a trial could undermine public confidence in covid vaccines. One in three Americans is unwilling to receive a covid vaccine, according to a recent Gallup poll.

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