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1/13: New Thread: A dozen reasons why I'm worried about releasing a #COVID19 #vaccine through an emergency use authorization (EUA)
2/13:
1. We haven't done this before for a #vaccine, or at least a major vaccine released to a large segment of the population. We've done it for technicalities, but nothing like this.
1. We haven't done this before for a #vaccine, or at least a major vaccine released to a large segment of the population. We'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?
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
3. I understand EUAs for ventilators, or PPE, etc, but not for a widely administered vaccine
5/13:
4. With an EUA, it'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
4. With an EUA, it'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'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
5. So why not follow that process? Especially given the vaccines we'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
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'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?
7. It'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've let the pharma companies issue ridiculous or misleading press releases for their sharholders. Or inadequate puzzling interviews or tweets from the HHS agencies
8. Compounding this: Operation Warp Speed has no launched any communication strategy. In its place, they'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've never seen more irresponsible science communications. And we're just supposed to say, "OK an EUA on an unproven technology for millions of Americans? Cool"
9. A public health/science communications nightmare. In my 40 years as a physician-scientist or MD PhD student I've never seen more irresponsible science communications. And we'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'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.
10. Not to mention, that we'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.
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'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
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'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
