FDA Puts All Hands on Deck to Review Pfizer-BioNTech Covid Shot
Source: MSN/Bloomberg
(Bloomberg) -- U.S. drug regulators are taking an all-hands-on-deck approach to reviewing Pfizer Inc. and BioNTech SEs Covid-19 shot for full approval in an effort to persuade as many as possible to get immunized.
The Food and Drug Adminstration is identifying additional resources such as personnel and technological resources from across the agency and opportunities to reprioritize other activities, in order to complete our review to help combat this pandemic surge, agency spokesperson Abby Capobianco said. Acting Director Janet Woodcock has offered all agency resources to the team to make this happen, she said.
Pfizer and BioNTechs vaccine gained emergency use authorization in December, but many people are waiting for the vaccine to undergo a full review before getting it. The Biden administration is working to vaccinate as many as possible as the highly transmissible delta variant spreads across the U.S., threatening Americans return to normal activities.
We recognize that for some, the FDA approval of Covid-19 vaccines may bring additional confidence and encourage them to get vaccinated, Capobianco said in the statement. FDA staff will conduct a thorough review process, while balancing the incredible sense of urgency necessary, both of which are needed to ensure that any vaccine that is authorized or approved meets our rigorous standards for safety, effectiveness, and quality....
Read more: https://www.msn.com/en-us/news/us/fda-puts-all-hands-on-deck-to-review-pfizer-biontech-covid-shot/ar-AAML5z4
BumRushDaShow
(128,527 posts)I expect it has been designated "HIGH PRIORITY" across the board for this to probably try to get everything done maybe by October.
I just saw that yesterday they released the list of approved flu vaccines for this year - https://www.fda.gov/vaccines-blood-biologics/lot-release/influenza-vaccine-2021-2022-season
yaesu
(8,020 posts)groundloop
(11,514 posts)I get so damned sick of beating my head against the wall talking to my anti-vaxxer relatives...... 120,000 killed by the vaccine; it makes women infertile; it gives you covid; blah blah blah blah. My head is going to explode listening to the lies.
BadgerKid
(4,549 posts)To soften a resurgence. Lets be honest. Too many thick skulls has put everyone at risk.
IronLionZion
(45,380 posts)since that one was developed with the NIH as a partner