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Why do you believe that the FDA is holding them back? So far the process appears to be approval after the minimum of safety and effectiveness testing. This mea
by Moto7451 6y ago
Why do you believe that the FDA is holding them back?
So far the process appears to be approval after the minimum of safety and effectiveness testing. This means that people won’t waste time or be harmed by a failed vaccine candidate. I don’t work in medicine and am just a bystander like most. Is there something I am missing?
- alexhutcheson 6y agoThe AstraZeneca vaccine has been approved for use in the UK since December, but the FDA isn't currently scheduled to approve it in the US until April.
- bluGill 6y agoThe FDA isn't scheduled for anything. They told AZ long ago that their trail wouldn't meet FDA standards, and so AZ started a new trail that would. Everyone assumes the approval will happen in April, but that is just an educated guess.
- alexhutcheson 6y agoThat’s just semantics around the word “scheduled”. The FDA insisted on a course of action that makes it unlikely the AZ vaccine will receive an EUA before April. They did this despite the fact that pretty much no one with vaccine expertise doubts that it will meet the safety standards or the (relatively low) efficacy standards required to grant that EUA. No one disputes that AZ screwed up their trial, but it doesn’t make sense to prevent people from accessing a safe and reasonably effective vaccine just to make a point about that. That’s why the UK and EU have approved it and are moving forward with distribution, while the US waits months for absolutely perfect data before doing anything.
- JamesBarney 6y agoBecause they care 6 orders of magnitude more about people who die from taking the vaccine than people who die from them witholding the vaccine.
- deleted 6y ago[deleted]
- mchusma 6y agoThe FDA has banned it I'm the US, it's holding them back.