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Ex-FDA Chief On How Coronavirus Vaccine OK Could Come In Stages

September 4, 2020

The Trump administration is urging individual states to start working on a strategy to distribute a coronavirus vaccine by Nov. 1, but some experts are skeptical of the quick timeline, as it comes just weeks after interim study results.

Early Vaccine Data Within Weeks: U.K.-based AstraZeneca plc AZN 1.03% is expected to release data in mid-September that could confirm that its vaccine can prevent people from contracting the disease.

Prior to a scheduled U.S. Food and Drug Administration meeting Oct. 22, similar readouts are expected from Moderna Inc MRNA 3.45% and BioNTech’s collaboration with Pfizer Inc. PFE 0.05%.

These readouts will merely be interim results, and a final readout will likely be released sometime from the middle of November through the end of the year, Rasmus Bech Hansen, CEO of the drug trial analytics company Airfinity, told Bloomberg TV in an interview. It remains unclear if regulatory authorities in the U.S. and elsewhere will approve a vaccine based merely on interim results, he said. 

The FDA will likely make a decision in late October based solely on the interim results that have been released, he said, adding that doing so is “not unusual,” especially if the interim results are “super successful.”

“It’s one of the reasons why you do the interim read-outs,” he said.

Gottlieb On A Staged Approval Timeline: The FDA will likely follow a “staged approval” strategy, with the vaccine first being made available under an emergency use authorization, former FDA Commissioner Dr. Scott Gottlieb said on CNBC’s “Squawk Box.”

An EUA isn’t a “low standard,” Gottlieb said, adding that it allows the FDA to start distributing a vaccine to high-risk groups while simultaneously collecting post-market safety and efficacy data.

High-risk individuals will likely be defined as front-line health care workers or older people with comorbidities, he said.

Additional groups will be brought on as time passes, but expectations are that mass availability is “clearly” a 2021 event, Gottlieb said.

The Abbott Test: Some confusion exists around the recent announcements of at-home COVID-19 detection kits, Dr. Michael Mina, an epidemiologist at Harvard T.H. Chan School of Public Health, told Fox News. The tests are accurate in detecting whether a person is infected and contagious, he said. 

The kit developed by Abbott Laboratories ABT 1.3%, for example, is 97% accurate in detecting the presence of the disease within the first week of the development of symptoms, the doctor said.

Even if 50% of people chose not to use a kit and another 10% of samples are improperly administered, the prevalence of the virus will still diminish, he said.

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