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Yahoo NewsSep 23, 2020
The FDA is reportedly about to make approving a coronavirus vaccine before the election a lot tougher
The Food and Drug Administration is poised to roll out new, rigorous standards for an emergency approval for a coronavirus vaccine, The Washington Post reports.The standards, which appear to be an example of the agency's efforts to increase public trust amid the politicization of vaccine development, could be unveiled as soon as this week and are expected to be much tougher than what was used for the controversial emergency clearances of potential COVID-19 treatments hydroxychloroquine and convalescent plasma, per the Post. Manufacturers will be asked to follow vaccine trial participants for at least two months after they receive their second shot, two individuals familiar with situation told the Post on condition of anonymity. The agency will also reportedly be looking for at least five severe COVID-19 cases in the placebo group for each trial, as well as some cases of the disease in older people to see if the vaccine works. Given the new standards, plus the time it will take companies developing vaccine candidates to apply for an emergency use authorization and for the FDA to review the data, "it's hard to imagine how an EUA could possibly occur before December," Paul Offit, the director of the Vaccine Education Center at Children's Hospital of Philadelphia and FDA vaccine advisory board member, told the Post.That will likely allay at least some fears that the White House will try to pus

CNN Most RecentSep 22, 2020
Begin Covid-19 vaccine trials for children, pediatric specialists say
With the US surpassing 200,000 deaths due to Covid-19, a group of pediatric infectious disease specialists is calling for vaccine trials for children.
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