The FDA is expected to issue tougher guidelines for an emergency use authorization of a coronavirus vaccine, according to The Washington Post, likely making approval more difficult and decreasing the chances of approval before Election Day.
“It’s hard to imagine how an [emergency use authorization] could possibly occur before December,” Paul Offit, MD, director of the Vaccine Education Center at Children’s Hospital of Philadelphia and a member of the FDA’s advisory board onThe agency’s move is intended to increase transparency about the safety and efficacy of a potential vaccine. Public trust has dipped in recent weeks as President Donald Trump has repeatedly hinted at an approval by Nov.
Based on the timelines of current late-stage clinical trials, the data won’t likely be ready until mid-November or later, the newspaper reported. Moderna and Pfizer began trials on July 27, took a month to recruit participants, and administered second vaccine doses about a month after that. CNN reported that neither company has given a second dose to half of their trial participants. With a 2-month follow-up period, the companies would need to collect data into November.
United States Latest News, United States Headlines
Similar News:You can also read news stories similar to this one that we have collected from other news sources.
Report: FDA To Announce Tougher Coronavirus Vaccine Standards That May Dash Trump’s Election Day GoalI'm a British-born reporter covering breaking news for Forbes.
Read more »
Report: FDA To Announce Tougher Coronavirus Vaccine Standards That May Dash Trump’s Election Day GoalThe FDA is expected to announce tougher coronavirus vaccine standards that may dash Trump's Election Day goal
Read more »
FDA expected to issue stricter guidelines on vaccine emergency approval, Washington Post reportsThe US Food and Drug Administration is expected to issue new, stricter guidelines for emergency authorization of coronavirus vaccines in a bid to gain more public trust of the vaccine, the Washington Post reported.
Read more »
FDA considering authorization rules that could push coronavirus vaccine past Election DayThe FDA is considering new rules for authorizing a Covid-19 vaccine, sources say — and calculations show these rules would push it beyond Election Day. That would dash the hopes of President Trump, who has said repeatedly the vaccine could be ready by then
Read more »
U.S. FDA reportedly plans to tighten coronavirus vaccine authorization standards ahead of electionThe U.S. Food and Drug Administration is expected to soon announce new, more stringent standards for an emergency authorization of a Covid-19 vaccine, lowering the chances that one might be cleared for use before the Nov. 3 election, the Washington Post reported on Tuesday.
Read more »
Office of the Special Counsel investigating Betsy DeVos over Fox News appearance: reportYet another top Trump administration official is being investigated for potentially violating federal law
Read more »