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The FDA plans to toughen coronavirus vaccine standards

The Food and Drug Administration plans to toughen the requirements for a coronavirus vaccine emergency authorization, which would make it more difficult for one to be ready by the election, the Washington Post reported Tuesday.

Why it matters: Public skepticism of an eventual vaccine keeps increasing as President Trump keeps making promises that are at odds with members of his own administration.


  • This skepticism is bad. A rushed, unproven vaccine would be even worse.

Driving the news: The new FDA guidance would be much more rigorous than what was used to provide emergency authorization to hydroxychloroquine or convalescent plasma. Both authorizations were controversial.

  • The agency is expected to ask vaccine manufacturers to monitor late-stage clinical trial participants for a median of at least two months, beginning after the participants receive their second shot.
  • It will also be looking for at least five severe coronavirus cases in each trial's placebo group, along with cases in older people, to further indicate that the vaccine works.

Between the lines: The new standards, combined with other elements of the authorization process, would make it very unlikely than any vaccine will be ready for administration before Nov. 3.

The other side: Some critics say that an emergency authorization — versus a full approval — shouldn't be used at all for a vaccine.

  • "Things are so revved up right now that there is quite a possibility that the American public won't accept a vaccine because of all the things that are going on," Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine, told the Post.

What they're saying: "The FDA has previously noted that the agency intends to issue additional guidance shortly to provide sponsors of requests for Emergency Use Authorization for COVID-19 vaccines with recommendations regarding the data and information needed to support the issuance of an EUA," the agency said in a statement.

North Carolina police pepper-spray protesters marching to polls on final day of early voting

Officers in North Carolina used pepper spray on protesters and arrested eight people at a get-out-the-vote rally at Alamance County’s courthouse Saturday during the final day of early voting, the City of Graham Police Department confirmed.

Driving the news: The peaceful "I Am Change" march to the polls was organized by Rev. Greg Drumwright, from the Citadel Church in Greensboro, N.C., and included a minute's silence for George Floyd. Melanie Mitchell told the News & Observer her daughters, age 5 and 11, were among those pepper-sprayed by police soon after.

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Boris Johnson announces month-long COVID-19 lockdown in U.K.

U.K. Prime Minister Boris Johnson on Saturday outlined his plan for the country's second coronavirus lockdown as the nation topped the 1 million case mark, per Johns Hopkins University data.

Details: Starting Thursday, people in England must stay at home, and bars and restaurants will close except for takeout. All non-essential retail will also be shuttered. Inter-mingling between households and outbound international travel or out-of-home boarding will be prohibited. The new measures will last through at least December 2.

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Trump's legacy is shaped by his narrow interests

President Trump's policy legacy is as much defined by what he's ignored as by what he's involved himself in.

The big picture: Over the past four years, Trump has interested himself in only a slim slice of the government he leads. Outside of trade, immigration, a personal war against the "Deep State" and the hot foreign policy issue of the moment, Trump has left many of his Cabinet secretaries to work without interruption, let alone direction.

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Ipsos poll: COVID trick-or-treat

Data: Axios/Ipsos poll; Note ±3.3% margin of error for the total sample size; Chart: Andrew Witherspoon/Axios

About half of Americans are worried that trick-or-treating will spread coronavirus in their communities, according to this week's installment of the Axios/Ipsos Coronavirus Index.

Why it matters: This may seem like more evidence that the pandemic is curbing our nation's cherished pastimes. But a closer look reveals something more nuanced about Americans' increased acceptance for risk around activities in which they want to participate.

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Dunkin' Brands agrees to $11B Inspire Brands sale

Dunkin' Brands, operator of both Dunkin' Donuts and Baskin-Robbins, agreed on Friday to be taken private for nearly $11.3 billion, including debt, by Inspire Brands, a quick-serve restaurant platform sponsored by Roark Capital.

Why it matters: Buying Dunkin’ will more than double Inspire’s footprint, making it one of the biggest restaurant deals in the past 10 years. This could ultimately set up an IPO for Inspire, which already owns Arby's, Jimmy John's and Buffalo Wild Wings.

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Federal judge halts Trump administration limit on TikTok

A federal judge on Friday issued an injunction preventing the Trump administration from imposing limits on the distribution of TikTok, Bloomberg reports. The injunction request came as part of a suit brought by creators who make a living on the video service.

Why it matters: The administration has been seeking to force a sale of, or block, the Chinese-owned service. It also moved to ban the service from operating in the U.S. as of Nov. 12, a move which was put on hold by Friday's injunction.

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Podcast: How hospitals are prepping for the new COVID-19 surge

Coronavirus cases and hospitalizations are surging, particularly in areas that had been largely spared in the spring. One big question now is if hospitals are better prepared for this new wave, including if they'll be able to continue providing elective services.

Axios Re:Cap digs into what hospitals have, and what they still need, with Lloyd Dean, CEO of CommonSpirit Health, one of America's largest operators of hospitals and health clinics.

Belgium imposes lockdown, citing "health emergency" due to influx of COVID-19 cases

Belgium is enforcing a strict lockdown starting Sunday amid rising coronavirus infections, hospital admissions and a surge of deaths, Prime Minister Alexander De Croo announced on Friday.

Why it matters: De Croo said the government saw no choice but to lock down "to ensure that our health care system does not collapse." Scientists and health officials said deaths have doubled every six days, per the Guardian.

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