I haven’t been a “why won’t the FDA go faster” guy but I really do think a Pfizer BLA, with expansion to ages 12-15, would really be super helpful right now
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Spoke this into existence apparentlyhttps://twitter.com/Zamboni231/status/1380571246564409346 …
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Good news in terms of speed - I believe they can just amend the EUA and that should happen quicklyhttps://twitter.com/megtirrell/status/1380647178713063428 …
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And just one of them will help headlines bc it’s not like these people are following closely
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Agree but hearing it’s not so simple. If one gets approval the others lose EUA status. not sure the validity of this but if true then it might not be so beneficial until all three products can get approval at once
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I don’t believe so - but it does probably mean no additional EUAs can be issued (AZ or Novavax). However I believe this could be remedied by the government though
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Me today, literally: ' "I'm suspicious; that development timeline seems really rushed. Are they even approved?" said no obese middle aged man with erectile dysfunction at the introduction of Viagra. Vaccines on the other hand... .'
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“Experimental”
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Also, wouldn't they be able to stop the 15 minute observation period under formal approval, which would allow sites to vaccinate more people (and might make it more feasible for, eg, doctors offices to offer it)?
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I tend to think we should ditch that anyway, but I don't think that depends on EUA versus BLA. People keep telling me they do this for flu vaccines too, although that has never been my experience.
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