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Today's Rundown

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Pfizer passes COVID-19 vaccine safety milestone, reveals 95% efficacy ahead of EUA

Pfizer is preparing to file its COVID-19 vaccine for emergency use authorization (EUA) after passing a key safety milestone. CEO Albert Bourla, Ph.D., said Pfizer now has the median two-month follow-up data needed to secure EUA from the FDA, putting it a step closer to bringing its vaccine to market in the U.S.

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Top Stories

Despite impressive data, FDA's coronavirus vaccine reviews will take weeks, not days, official says

As leading COVID-19 vaccines post positive phase 3 data and near FDA submissions, the agency official in charge of reviewing vaccines is emphasizing transparency and patience during the high-stakes process. Americans should expect reviews to take weeks rather than days, according to Peter Marks, head of the FDA’s Center for Biologics Evaluation and Research.

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Azar expects 40M COVID-19 vaccine doses ready to distribute by end of December

HHS Secretary Alex Azar expects 40 million doses of a COVID-19 vaccine will be ready by the end of the year as Pfizer and Moderna candidates near FDA approval.

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AMA calls for increased COVID-19 prevention in correctional facilities, end to disinformation campaigns

The AMA's House of Delegates held a special meeting this week and voted to support of a handful of new policies, including supporting the compassionate release of some incarcerated individuals amid the pandemic and a measure to prevent bullying in healthcare. Here's what else they voted to support.

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Airlines rally cold-chain supplies to ship Pfizer, Moderna's frigid COVID-19 shots

With positive news on mRNA shots from Pfizer and Moderna tempered by concerns over cold-chain hurdles, airlines are rapidly working to ensure they have the frigid containers and shipping know-how in place to carry out the global rollout of a COVID-19 vaccine, Reuters reports. Meanwhile, container makers are doubling down on efforts to boost supplies, too.

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FDA greenlights first all-in-one home COVID-19 test, with results in 30 minutes

The FDA has authorized its first all-in-one COVID-19 diagnostic that allows people to test themselves within their own home, from a swab to a result in about 30 minutes.

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China's Sinovac sees speedy immune response with COVID-19 shot in early trials

A week after one of its tests in Brazil was stopped amid a safety scare, Chinese biotech Sinovac has published data showing its experimental COVID-19 vaccine can quickly boost an immune response.

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AstraZeneca taps CCT Research for COVID-19 vaccine tests

U.K. Big Pharma AstraZeneca and academic partner the University of Oxford are tapping research services firm CCT Research for their COVID-19 shot tests in Arizona.

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Biopharma roundup: Lucira's all-in-one home COVID-19 test wins OK; AstraZeneca taps CCT Research for trial recruitment

The FDA approved an all-in-one home COVID-19 test developed by Lucira Health. AstraZeneca tapped CCT Research to help recruit trial participants in Arizona. J&J is pledging $100 million to fight health inequities over the next five years. And Americans are feeling slightly more confident about a vaccine, a recent poll found.

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Healthcare roundup: BCBSA estimates 9M vaccine doses could be missed this year

Follow along with the latest COVID-19 news straight from the Fierce Healthcare team.

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Providence posts $214M loss during first 9 months of 2020 due to COVID-19 impact

Providence hospital system posted a $214 million loss for the first nine months of 2020 as the system struggles to recoup major losses caused by COVID-19.

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