The public release of the documents marks another instance of health departments and the White House butting heads during the pandemic, with the Centers for Disease Control and Prevention being the center to much of the chaos.
"Pfizer has never discussed @US_FDA’s #COVID19 vaccine guidelines with the White House and will never do so as it could undermine the agency’s independence," tweeted the company's CEO Albert Bourla. Pfizer has estimated it would know if the vaccine is effective by the end of October.
Vaccines typically take 10 years to develop, approve and distribute. The new FDA guidelines are meant to ensure a Covid-19 vaccine is free of severe side effects and gives ample immunity for an extended period of time. One of the frontrunners, Moderna recently said it would likely be able to apply for an emergency use authorization by November 25 but wouldn't expect full approval for public use until late first quarter or early second quarter of 2021. Even with approval, vaccines will need to be widely distributed and taken by the public, meaning pre-pandemic levels may not be achieved until 2022. There are 35,622,409 total confirmed cases of the coronavirus and 1,046,153 global deaths.. That's the percentage of Americans who would consider a vaccine available this year to be"rushed through," according to a YouGov poll published in early September.
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.
Ex-Trump FDA chief criticizes White House over coronavirus precautions to protect Trump and staff'The president didn't want to get Covid, from everything I can glean, and thought he was being protected based the testing that was in place around him,' Dr. Scott Gottlieb told CNBC on Monday.
Read more »
Report: White House Blocking More Stringent FDA Guidelines On Covid-19 Vaccine ApprovalThe new guidelines call for tracking volunteers in late-stage clinical trials for around two months after the final dose of the vaccine is administered in order to ensure no severe side-effects and adequate immunity from the virus.
Read more »
Trump White House overrules FDA on updated guidelines for vaccine approvalThe White House has blocked new Food and Drug Administration guidelines on bringing potential vaccines for COVID-19 to market that would almost certainly...
Read more »
House panel investigates political interference by White House over coronavirus at CDC and FDAThe subcommittee is seeking documents and information from the FDA and CDC on agency actions, drafts submitted to the White House and changes made during the review process.
Read more »
FDA discloses vaccine guidelines blocked by White HouseThe FDA posted standards on their web site for makers of COVID-19 vaccines after the White House blocked their formal release. The FDA said vaccine makers should follow trial participants for at least two months, likely precluding a vaccine before Nov. 3.
Read more »
FDA posts vaccine guidelines blocked by White HouseThe Food and Drug Administration laid out updated safety standards Tuesday for makers of Covid-19 vaccines after the White House blocked their formal release.
Read more »