1/13: New Thread: A dozen reasons why I& #39;m worried about releasing a #COVID19 #vaccine through an emergency use authorization (EUA)
2/13:

1. We haven& #39;t done this before for a #vaccine, or at least a major vaccine released to a large segment of the population. We& #39;ve done it for technicalities, but nothing like this.
3/13:

2. And for good reason, EUAs involve substandard or lesser reviews. How can you justify a substandard or lesser review for something that would be injected in tens of millions, maybe hundreds of millions of Americans?
4/13:

3. I understand EUAs for ventilators, or PPE, etc, but not for a widely administered vaccine
5/13:

4. With an EUA, it& #39;s unclear what data will be reviewed or released to the public. I would be willing to take any vaccine that has undergone full FDA review - we have an incredible and rigirous system of review, involving multiple committees including VRBAC, ACIP
6/13:

5. So why not follow that process? Especially given the vaccines we& #39;re talking about are likely mRNA vaccines with a new technology that has never before been licensed. We have no history or experience on such vaccines. Even more reason for a full/comprehensive review
7/13:

6. So far the published data on the two mRNA vaccines is very modest - we know 2 doses will be required and the published data is on only 15 volunteers who received 2 doses of the Moderna vaccine and 12 volunteers the Pfizer vaccine, or 10 the Astra Zeneca vaccine
8/13:

7. It& #39;s really a stretch to go from a 10, 12, 15 to millions, so presumably there are more data by now, but under an EUA who gets to see it?
9/13:

8. Compounding this: Operation Warp Speed has no launched any communication strategy. In its place, they& #39;ve let the pharma companies issue ridiculous or misleading press releases for their sharholders. Or inadequate puzzling interviews or tweets from the HHS agencies
10/13

9. A public health/science communications nightmare. In my 40 years as a physician-scientist or MD PhD student I& #39;ve never seen more irresponsible science communications. And we& #39;re just supposed to say, "OK an EUA on an unproven technology for millions of Americans? Cool"
11/13

10. Not to mention, that we& #39;ve seen how in 2020 the White House has abused the EUA mechanism - remember the EUA for hydroxychloroquine that was revoked? Neither does the White House or Dept. HHS.
12/13

11. And now we have as a lead WH science advisor someone who gives out misinformation and is helping to lead a science disinformation campaign. Believe it or not that does not instill confidence or trust.
13/13

12. Business as usual is not working. The White House + HHS agencies need to communicate to the American people and not speak to us like we& #39;re in 4th grade. We need a full FDA review, even expedited, even using EAPs, or if not we must demand a full accounting/explanation
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