FDA Advisory Board Supports Urgent Approval of Pfizer's New Coronavirus Vaccine, Will It Be Approved Soon?
The U.S. Food and Drug Administration (FDA) Advisory Board (VRPBAC), which considers the use of vaccines and biologics, has recommended an emergency license for the new coronavirus vaccine ' BNT162b2 ' developed by Pfizer, a major U.S. pharmaceutical company. .. Following this recommendation, the FDA is likely to formally approve an emergency license for the vaccine.
Pfizer Shot Gets FDA Advisers' Nod as Agency Decision Nears --Bloomberg
FDA advisory panel recommends approval of Pfizer Covid vaccine for emergency use | Coronavirus | The Guardian
https://www.theguardian.com/world/2020/dec/10/coronavirus-covid-pfizer-biontech-vaccine-fda-panel
The FDA's Advisory Board met on December 10, 2020 to discuss BNT162b2. As a result of voting by 22 members of the committee, 17 votes in favor, 4 votes against, and 1 abstention, judging that 'vaccination over 16 years old has more benefits than risk', urgently urged the FDA Recommended for approval of use. If the FDA accepts the advisory board's recommendations, the emergency use of BNT162b2 will be formally approved.
BNT162b2 is an mRNA vaccine developed by Pfizer and German pharmaceutical venture Biontech, and has already been reported to be 'more than 90% effective' in Phase III trials conducted in the United States, South America and South Africa. It was.
Pfizer announces that 'new corona vaccine with more than 90% preventive effect' has been developed --GIGAZINE
In addition, in a report released on December 10, 2020, a randomized controlled trial of more than 43,000 people showed 95% efficacy. 'The development of BNT162b2 is a scientific victory,' the New England Journal of Medicine, which published the report, said in an editorial .
Emergency use of BNT162b2 was approved by the United Kingdom on December 2, 2020, Bahrain on December 6, and Canada on December 10, 2020. And if the emergency use of BNT162b2 is approved in the United States, where the cumulative number of infected people has exceeded 15 million, this will be the fourth case in the country.
However, in the United Kingdom, BNT162b2 inoculation confirmed severe allergic reactions in two people. Although these allergic reactions are rare in vaccination, the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom recommends that people who have had a serious allergic reaction should not be vaccinated with BNT162b2.
It has also been pointed out that BNT162b2 needs to be stored at an ultra-low temperature of 70 degrees below freezing, which leaves a big problem in vaccine transportation.
Pfizer's new corona vaccine is reported to be a 'logistics nightmare,' and why? --GIGAZINE
The FDA is not obliged to follow the advisory board's recommendations and is concerned about issues such as allergic reactions and logistics challenges, so it is uncertain whether to accept the advisory board's recommendations. However, foreign media Bloomberg said, 'FDA rarely rejects advisory board recommendations and often makes decisions as recommended.'
The FDA's advisory board will meet again on December 17, 2020 to approve the emergency use of the new coronavirus vaccine 'mRNA-1273' developed by Moderna.
Moderna's new coronavirus vaccine, which showed 94.1% efficacy in clinical trials, applied for emergency use permission from the authorities --GIGAZINE
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