The FDA Advisory Committee recommends emergency accreditation for Pfizer’s Govt vaccine


The U.S. Food and Drug Administration (FDA) advisory board voted late on Thursday, with Pfizer (NYSE: PFE) and Biotech (Nostock: PNTX) Govt-19 Recommended that the vaccine be granted Emergency Use Authorization (EUA) for PND162b2. The FDA does not have to go with the panel’s recommendation, but it is widely expected that both Canada and the UK will do so after the vaccine is approved for emergency use. The Vaccines and Related Biological Products Advisory Committee (VRPPAC) consists of independent professional immunization experts. Members of the committee discussed Pfizer and Bioentech’s EUA filing for PNT162B2 on Thursday. In particular, the team focused on the safety profile of the vaccine. Image Source: Getty Images. In the end, it all came down to a question posed to members of the VRPPAC team. They were asked, “Based on the available scientific evidence, are the benefits of the Pfizer-BioTech Covit-19 vaccine greater than the risks of use for individuals 16 years of age and older?” The answer to that question was “yes” with a vote of 17 to four. The positive vote is not surprising. Earlier this week, the FDA released brief documents for an advisory panel to review the performance and safety profile of PNT162b2. These documents revealed that the Pfizer and Bioentech vaccine reached 52.4% efficacy after the first dose. Now, the ball is in the FDA court. Alex Azhar, secretary of the Department of Health and Human Services, has publicly stated that the company will make its decision “within a few days” after the recommendation of the advisory board. The world is waiting.

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