The FDA is reportedly about to make approving a coronavirus vaccine before the election a lot tougher

The FDA is reportedly about to make approving a coronavirus vaccine before the election a lot tougherThe 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 push a vac­cine out before the Novem­ber elec­tion, although there are some peo­ple who think the FDA should­n’t grant an EUA for a vac­cine at all since there’d still be less safe­ty data required for approval than under nor­mal cir­cum­stances. Read more at The Wash­ing­ton Post.More sto­ries from theweek.com Democ­rats have a bet­ter option than court pack­ing Trump sup­port­ers boo Ohio’s GOP lieu­tenant gov­er­nor for encour­ag­ing mask use Pennsylvania’s 2‑envelope mail-in bal­lot rule prompts fears of dis­card­ed ’naked’ bal­lots, pre­ventable ‘chaos’


(Vis­it­ed 1 times, 1 vis­its today)



Tags: design TT Mod­ell­bahn TT H0 N schal­ten mod­elleisen­bahn bahn spiele­max preise 

Ein Reichsmarschall von Adolf Hitler hatte auch Märklin Modelleisenbahn Modelle > read more