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New FDA Covid vaccine coverage raises entry, transparency questions


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Helen Branswell covers points broadly associated to infectious ailments, together with outbreaks, preparedness, analysis, and vaccine improvement. Comply with her on Mastodon and Bluesky. You may attain Helen on Sign at hbranswell.01.

WASHINGTON — Meals and Drug Administration Commissioner Marty Makary promised stakeholders final week that the company’s new Covid-19 vaccine framework would reply all of their questions. 

However the framework has maybe created as a lot confusion as readability. Broadly, the FDA stated it would restrict approval of Covid-19 vaccines to individuals 65 and older and to these in danger for extreme Covid outcomes, and would require vaccine makers to conduct scientific trials investigating whether or not the pictures profit wholesome adults and youngsters. 

At a public webinar on Tuesday, high vaccine regulator Vinay Prasad described the strategy as a “compromise” permitting Covid-19 vaccine entry for tens of millions of People whereas nonetheless producing proof. He answered some questions, requested by Makary, about his rationale. 

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