US should consider national mask mandate for the winter, former FDA commissioner writes in op-ed

As the US reports its second-highest day of new Covid-19 cases amid the continuing fall surge, a former commissioner of the US Food and Drug Administration says it may be time for a national mask mandate.



Alice Arnold wearing a hat: Salt Lake County Health Department public health nurses look on during coronavirus testing outside the Salt Lake County Health Department Friday, Oct. 23, 2020, in Salt Lake City, Utah. (Rick Bowmer/AP)


© Rick Bowmer/AP
Salt Lake County Health Department public health nurses look on during coronavirus testing outside the Salt Lake County Health Department Friday, Oct. 23, 2020, in Salt Lake City, Utah. (Rick Bowmer/AP)

In an op-ed for The Wall Street Journal, Dr. Scott Gottlieb wrote the mandate could be “limited and temporary.”

“A mandate can be expressly limited to the next two months,” Gottlieb wrote, adding that it’s easier to wear a mask in the winter than the summer. “The inconvenience would allow the country to preserve health-care capacity and keep more schools and businesses open.”

With deaths expected to rise this winter, policymakers will have to make moves to slow the spread, Gottlieb wrote. There already is no support for reinstating the stay-at-home orders from the spring.

If 95% of Americans wore masks in public, more than 100,000 lives could be saved in the United States through February, according to data released Friday by the Institute for Health Metrics and Evaluation at the University of Washington.

“If people are not wearing masks, then maybe we should be mandating it,” Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told CNN’s Erin Burnett on Friday.

Gottlieb wrote the concern about needing fines to enforce the mandate leading to confrontations with police isn’t necessarily true.

“States should be able to choose how to enforce a mandate, but the goal should be to make masks a social and cultural norm, not a political statement,” he wrote. “Mandating masks has become divisive only because it was framed that way by some politicians and commentators.”

Gottlieb was appointed FDA commissioner by President Trump and served from May 2017 to May 2019. He is now a resident fellow at the American Enterprise Institute, a think tank in Washington, DC.

Saturday saw 83,718 new Covid-19 cases, just 39 cases shy of the all-time record that was reported Friday. Already, national cases total more than 8.6 million and 225,212 people have died, according to Johns Hopkins.

“We’re at a dangerous tipping point right now,” Gottlieb told Margaret Brennan Sunday on CBS’s “Face the Nation.” “We’re entering what’s going to be the steep slope of the curve, of the epidemic curve.”

Social gatherings and family events moving indoors to avoid the colder weather is largely to blame for the high rates of spread, officials said over the weekend.

In Maryland, the governor said this week family gatherings were the No. 1 source of transmission in the state, followed by house parties. In North Carolina, health officials reported its highest daily case count Friday and said they continue to see clusters “from social and religious gatherings.”

At least 35 states report rise in cases

The Florida Department of Health on Sunday reported 2,385 additional coronavirus cases and

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FDA Commissioner Stephen Hahn on COVID Vaccine Safety


And then, finally, we’ve been working with the manufacturers around the quality of their manufacturing, the consistency of it. So that if a vaccine were to be authorized or approved, we could immediately know that quality manufacturing is in place. And again, that process normally takes months.

The last thing to mention is that there’s been manufacturing done at risk, meaning that companies have started manufacturing their vaccines [before the trials are complete], so that if an authorization or approval occurs, the vaccine is ready to go. And as you can see, this really shrinks the development time. But all the steps necessary to ensure safety and efficacy have taken place. And of course, that’s the next thing that we need to see — the data from the phase 3 clinical trials — before any consideration of authorization or approval takes place.

What happens after you see this data? Can you talk about the approval process and what the FDA will be looking for in the phase 3 trial results?

We have made every attempt to be transparent about this, and will continue to do so, so that all Americans understand what we’re doing from a regulatory point of view.

These phase 3 clinical trials are large trials with 30,000 or more participants, and they compare the active vaccine with a placebo to determine whether an infection occurs in a person participating in the trial — because what you’re looking for is a vaccine to prevent infection [with the coronavirus, SARS-CoV-2]. That’s the effectiveness side of things, and in our guidance for vaccine manufacturers [posted to the FDA’s website in June], we were very clear about the criteria: We said the floor for effectiveness would be 50 percent. [This means that the vaccine should be effective at preventing a coronavirus infection or decreasing its severity in at least 50 percent of vaccine recipients. For comparison, the influenza vaccine is between 40 percent and 60 percent effective.]

We also said that safety would be of the utmost importance to us, and on the safety side of things, we’re looking for side effects. Most recently in our guidance for emergency use authorization, we said that we need to see at least two months of follow-up for 50 percent of the participants after they get the final dose of the vaccine. Looking back at other vaccines, our scientists determined that two-month window was when the overwhelming majority of side effects would be seen.

What’s the difference between standard FDA approval and an emergency use authorization when it comes to a vaccine?

When the developers of the vaccine are in their clinical trials, they determine when their data are mature, and there’s an independent board, called a data safety monitoring board, that helps the manufacturers look at the data and determine whether they reached specified criteria. Then, they’ll apply to the FDA for either emergency use authorization (EUA) or a biological license application (BLA), which is the typical process for vaccine approval. Normally, it

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