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New York City’s New Health Commissioner Is Worried About a Coronavirus Resurgence

October 14, 2020

When Dave A. Chokshi was appointed commissioner in August of the New York City Department of Health and Mental Hygiene, the percentage of New York City residents testing positive for the coronavirus was at one of its lowest points, a promising moment that put the worst days of the pandemic in the rearview mirror.

But only 10 weeks into his tenure, Dr. Chokshi, a primary care physician, has pressing worries.

With a resurgence of cases in Brooklyn and Queens—which have now required new lockdowns in several neighborhoods, including the one where he lives with his wife and toddler daughter—Dr. Chokshi is concerned about controlling hot spots. He is worried that misinformation about herd immunity and the seriousness of the illness, as well as testing, has played a role in the spread of the virus in Brooklyn and Queens.

“I’m worried that what we’re seeing with respect to the increase in

FDA Commissioner Shares Requirements for COVID-19 Vaccine Approval

October 8, 2020

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Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center.

FDA experts evaluate three main areas for all vaccines, including for COVID-19: safety, effectiveness, and manufacturing quality.
Before a COVID-19 vaccine is approved, the FDA will review safety and effectiveness data from at least one well-designed and -performed clinical trial that shows data that are “clear and compelling.”
The FDA is looking for a COVID-19 vaccine that has a minimum of 50% efficacy but is hoping for higher.
The FDA is requiring a “very robust” program to continue to look at safety data after a COVID-19 vaccine is approved, as well as an “aggressive” postmarketing assessment program.

This transcript has been edited for clarity.

John Whyte, MD, MPH: You’re watching Coronavirus in Context. I’m Dr John Whyte, chief medical officer at WebMD. Today I am joined by Dr Stephen Hahn. He’s the commissioner of the US Food

Former FDA commissioner clarifies debate over agency’s coronavirus vaccine guidance

September 27, 2020

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White House Chief of Staff Mark Meadows on Sunday, during an appearance on CBS News’ Face the Nation, addressed reports about how he demanded the Food and Drug Administration justify, in detail, its reasoning for preparing to unveil new standards for a coronavirus vaccine.

Meadows told host Margaret Brennan that he wants to know “why would that new guidance come out after we’ve already spent $30 billion” on vaccine development. “And my challenge to the FDA is just to make sure it’s based on science,” rather than politics, he said.

But former FDA Commissioner Scott Gottlieb, who appeared on Face the Nation after Meadows, suggested the whole debate has been misinterpreted on all sides. Gottlieb said the agency’s guidance as discussed in the press isn’t technically new, but “an articulation of the principles and standards the FDA has been using for a long time.” As Gottlieb put it, the companies

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New York City’s New Health Commissioner Is Worried About a Coronavirus Resurgence

FDA Commissioner Shares Requirements for COVID-19 Vaccine Approval

Former FDA commissioner clarifies debate over agency’s coronavirus vaccine guidance