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The Food and Drug Administration has asked a group of advisers to set aside three days in early December for potential meetings to discuss Covid-19 vaccines – a key step in the agency’s clearance process, according to two people familiar with the plans .
The advisory group could be asked to weigh in on the vaccines from Pfizer and Moderna, said the people, who asked not to be named because the plans are not yet public.
The meetings, tentatively scheduled for December 8-10, are said to take place just weeks after the two companies reported data from their phase three trials showing their vaccines are around 95% effective in preventing Covid-19 cases. .
On Wednesday morning, Pfizer and its partner BioNTech reported the final efficacy results of their study, saying they had reached the safety milestone required by the FDA and planned to submit their request for emergency vaccine use by now. A few days.
Moderna is also expected to take this security milestone imminently. The FDA requires two months of safety follow-up after half of the trial participants have been fully vaccinated – receiving two injections of the vaccine a few weeks apart. The company said Monday that it plans to seek FDA clearance within weeks.
The regulator should quickly decide on vaccines after meetings of the group, known as VRBPAC, for vaccines and related biologics. If it gives the green light to vaccines, an advisory committee from the Centers for Disease Control and Prevention would make recommendations on prioritization.
An FDA spokeswoman declined to comment on the meetings.
CDC’s group, the Advisory Committee on Immunization Practices, or ACIP, has scheduled a meeting for November 23. This should be a pre-approval meeting for the Covid-19 vaccines.
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