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 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
Pence says in his 'heart' he knows administration 'saved hundreds of thousands' of lives
Trump supporters boo Ohio's GOP lieutenant governor for encouraging mask use
tinyurlis.gdu.nuclck.ruulvis.netshrtco.de
مقالات مشابه
- چین و هند فقط مبارزه عجیب و غریب, نبرد خونین در 14,000 ، چرا ؟
- خرید جم کلش رویال ، قیمت الماس بازی Clash Royale - آسان جم
- جهانی COVID-19 تلفات عبور 650,000 به عنوان موج جدید منجر به محدودیت
- حکم زندان برای 'داغ جیب اری برنده زن به تاخیر افتاد میان coronavirus
- شرکت صادرات و واردات کالاهای مختلف از جمله کاشی و سرامیک و ارائه دهنده خدمات ترانزیت و بارگیری دریایی و ریلی و ترخیص کالا برای کشورهای مختلف از جمله روسیه و کشورهای حوزه cis و سایر نقاط جهان - بازرگانی علی قانعی
- 'لطفا, من نمی توانم نفس بکشم': ما افسر پلیس فیلم برداری با زانو بر گردن بی حرکت مرد که بعد از درگذشت
- 90 Day Fiance’s Colt Says Eric ‘Ghosted’ Him After Trying to Become Friends
- این است جنبه بیش از حد مواد شیمیایی به ندرت دیده میشود، اما این چرا لازم است
- شرکت صادرات و واردات کالاهای مختلف از جمله کاشی و سرامیک و ارائه دهنده خدمات ترانزیت و بارگیری دریایی و ریلی و ترخیص کالا برای کشورهای مختلف از جمله روسیه و کشورهای حوزه cis و سایر نقاط جهان - بازرگانی علی قانعی
- شرکت صادرات و واردات کالاهای مختلف از جمله کاشی و سرامیک و ارائه دهنده خدمات ترانزیت و بارگیری دریایی و ریلی و ترخیص کالا برای کشورهای مختلف از جمله روسیه و کشورهای حوزه cis و سایر نقاط جهان - بازرگانی علی قانعی