FDA Advisers Fear Coronavirus Vaccines Won't Help Enough

By Jeff Overley
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Law360 (October 22, 2020, 9:55 PM EDT) -- A highly anticipated gathering of U.S. Food and Drug Administration advisers Thursday featured extensive debate over whether the agency is poised to clear coronavirus vaccines that won't do enough to prevent severe cases of COVID-19.

The nearly nine-hour meeting of the FDA's vaccines advisory committee — an 18-member panel of independent experts who offer nonbinding input — primarily focused on agency guidance for proposed coronavirus vaccines. During the virtual meeting streamed on YouTube, multiple panelists fretted that clinical trials are focusing excessively on the prevention of mild COVID-19 cases.

"These efficacy measures that are included in the [guidance] ... really are biased, skewed towards mild disease. And that is a concern," Dr. Luigi Notarangelo, a laboratory chief at the National Institute of Allergy and Infectious Diseases, said Thursday.

Dr. James Hildreth, the CEO of Meharry Medical College, a historically Black institution in Tennessee, voiced similar worries and connected them to the pandemic's disproportionate toll on racial minorities, who tend to get routine vaccinations at relatively low rates.

"Since severe disease and death occur primarily among minorities with this virus, if we put a vaccine out there that does not address that issue, it's just going to perpetuate the perception that exists that [the nonwhite] segment of our population does not matter much in dealing with this challenge," Hildreth said.

Most of the leading vaccine developers are mainly looking for reduced cases of mild COVID-19, as permitted under the FDA's guidance, which says that vaccines should prevent coronavirus infections or reduce COVID-19's severity in at least 50% of inoculated patients. But Johnson & Johnson has said that reductions in moderate and severe cases will be a primary metric for gauging vaccine effectiveness.

Sheldon Toubman, a lawyer who serves as the advisory committee's consumer representative, echoed concerns Thursday that fewer instances of mild illness aren't terribly important when it comes to a pathogen that has killed 223,000 Americans this year.

"We could have a vaccine that seems to do well ... and it's effective in avoiding mild cases, but actually does very little to address what we really care about, which is serious disease and death," Toubman said.

Several speakers made similar observations when the committee heard public comments. As one example, Peter Doshi, an associate professor at the University of Maryland School of Pharmacy, called for "urgent changes" to clinical trials to avoid ending up with "approved vaccines that reduce the risk of a mild infection but do not decrease the risk of hospitalization, ICU use or death."

Some attendees sought to alleviate those concerns. Dr. Arnold Monto, the committee's acting chairperson and an epidemiology professor at the University of Michigan, told his peers that "things that prevent infection ... typically prevent serious disease."

Dr. Philip Krause, deputy director of the FDA's Office of Vaccines Research and Review, suggested at Thursday's meeting that the concerns were unfounded, saying that "there simply does not exist an example in vaccinology of vaccines that are effective against mild disease that are not more effective against severe disease."

Clinical trials of coronavirus vaccines have target enrollments of 30,000 people. Even among such a large pool of patients, severe cases of COVID-19 would likely be relatively rare, arguably making severe cases a poor way to assess vaccine effectiveness.

"If the endpoint of the trials is severe disease, the trials may need to be almost 10 times as big, and those trials would be infeasible, and we would never get a vaccine," Krause said.

Vaccine makers may seek a pre-approval clearance known as Emergency Use Authorization as early as next month, and Pfizer Inc. is on track to be the first applicant. The vaccines advisory committee is expected to convene again to discuss a specific application and offer a recommendation before the FDA grants authorization.

--Editing by Breda Lund.

For a reprint of this article, please contact reprints@law360.com.

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