FDA ‘Approval’ of Rona Vax: Money Talks, Science Walks
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Tag: Delta Variant
Does the FDA think these data justify full approval of Covid Vaxx?
Does the FDA think these data justify full approval of Covid Vaxx?
Prior to the preprint, my view, along with a group of around 30 clinicians, scientists, and patient advocates, was that there were simply too many open questions about all covid-19 vaccines to support approving any this year. The preprint has, unfortunately, addressed very few of those open questions, and has raised some new ones.
Unfortunately, it was just given full approval by the FDA.
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Pfizer CEO to Public: Just ‘Trust’ Us on the Covid Booster
Pfizer CEO to Public: Just Trust Us on the Covid Booster
Pfizer announced its global phase 3 trial on a third dose in mid-July. That trial’s completion date is in 2022. Phase 3 results generally are required before regulatory approval.
“We are confident in this vaccine and the third dose, but you have to remember the vaccine efficacy study is still going on, so we need all the evidence to back up that,” Jerica Pitts, Pfizer’s director of global media relations, said Monday. The financial stakes are enormous: Pfizer announced in July that it expects $33.5 billion in covid-19 vaccine revenue this year.
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The White House has added to the mixed messaging: Spokesperson Jen Psaki confirmed that the U.S. will buy an additional 200 million doses of the Pfizer-BioNTech vaccine for inoculating children under 12 and for possible boosters.
Ms. Cat’s Chronicles 
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