Who’s No. 2? After Health Care Workers, A Hot Debate Over Next Group To Get COVID Vaccine
ACIP officials struggle with whether essential workers or high-risk adults should be next in line when there is a limited vaccine supply.
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Most vaccines will be distributed centrally by McKesson, but those with ultra-cold storage requirements will be shipped directly from the manufacturer to the vaccination site. Data exchange system will enable public and private databases to talk to each other and help ensure individuals receive timely revaccination with a second dose of the same vaccine regardless of location.
US FDA officials fear comparator arms would be unwieldy for ongoing trials as they consider alternative methods to measure efficacy if placebo controls can't be maintained for the studies of other candidate vaccines once a product is on the market.
Former FDA Commissioner says agency could grant an EUA for a vaccine, but require it meet the standard for full approval, and then roll it out gradually with postmarket data collection.