| As the U.K. started Covid-19 vaccinations across the country on Tuesday, this week could also mark an early turning point in the U.S. battle against the coronavirus. An advisory panel made of up of top medical experts will help the Food and Drug Administration gain outside perspective in reviewing a shot by Pfizer and BioNTech before any final ruling is made on whether its use can be authorized on an emergency basis. The meeting is set for Thursday. Here are some key points to help clarify the approval process: 1) Why are they meeting?FDA Commissioner Stephen Hahn pledged earlier this year to hold public advisory committee meetings for each Covid-19 vaccine that seeks emergency authorization. That vow came after trust in the agency, as well as in any vaccine that might be made available, waned following President Donald Trump's push for a vaccine to be approved ahead of the presidential election in early November. 2) What's the timeline?On Tuesday, the advisers and the public will get their first hint of the agency's view of the clinical trial data with the release of extensive briefing documents and comments from the FDA staff. The briefing documents are also likely to include questions the FDA wants its advisers to answer as well as specific wording for any final vote. Typically, advisory committees vote at the end of a meeting to indicate whether they think the FDA should approve the product under review, but not always. 3) Must the FDA accept the recommendations?No. The agency often is in agreement with an advisory committee, but there have been instances where it takes the opposite stance.  A Pfizer facility in Puurs, Belgium. U.S. regulators are meeting this week to review the drugmaker's coronavirus vaccine for emergency use. Photographer: Geert Vanden Wijngaert/Bloomberg 4) What happens after the advisers are done?Hahn and Marks have given estimates for FDA authorization that range from a few days to a few weeks following the meeting—depending on how straightforward the clinical trial data is. Pfizer has said the vaccine appears to be safe and 95% effective, though the company hasn't gone into great detail. Any complications within the data could extend the time as the FDA staff seeks to determine who the vaccine is best suited for, based on age or other factors including whether certain groups were found to have side effects or were not studied widely enough. Operation Warp Speed officials expect to start distributing the vaccine within 24 hours of FDA authorization, with as many as 6.4 million doses immediately available. A separate advisory panel for the Centers for Disease Control and Prevention has recommended that the first doses go to health-care workers and long-term care residents, though states get the ultimate say. 5) Is that it?Not by a long shot. The FDA wants vaccine makers that gain emergency authorization to seek full approval as soon as possible. The agency is granting emergency clearance based on two months of safety follow-up after trial participants received the last shot in a two-dose regimen. Full approval requires six months. This may prove difficult as vaccines become more available and people drop out of trials if they think they're getting a placebo. Meanwhile, other U.S. programs will be tracking potential adverse effects in the public that weren't seen in the clinical trials.—Anna Edney | 
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