As I’ve discussed previously, the FDA may use its Emergency Use Authorization (EUA) powers to push the Trump coronavirus vaccine out on the citizens of the USA before it’s been fully tested. Using Vladimir Putin’s example of pushing out a vaccine before it’s fully tested, Donald Trump keeps insisting that we’ll get a new COVID-19 vaccine soon, well before phase 3 clinical trials are done.
All vaccines currently on the market have been tested thoroughly. And the science that these current vaccines are very safe and very effective is settled. I am thoroughly convinced of the evidence that we have excellent vaccines, so it is clear that I am thoroughly pro-vaccine – I do not have to convince anyone of that.
However, for the Trump coronavirus vaccine, I am anti-vaccine. But it is a very narrow, very unique situation.
I have been troubled by the speed of the coronavirus vaccine research. I think it can lead to a bad vaccine on the market. Recently, Astra-Zeneca had to put a hold further testing of the so-called University of Oxford vaccine, because of a suspected serious adverse event in one individual. Astra-Zeneca will investigate the adverse event to determine if the vaccine caused it.
This is not uncommon in clinical trials – there is an abundance of caution while investigating new drugs, despite what people believe about how clinical trials are managed. That’s why vaccine research is difficult and not a slam dunk.
On the other hand, there will be serious consequences to a rushed Trump coronavirus vaccine, because we might not get these safety signals that can appear in large clinical trials. And if we do this wrong by avoiding large phase 3 clinical trials, people who may be on the fence about vaccines become convinced by anti-vaxxers that this awful process was used by all other vaccines. It wasn’t.
Dr. Peter Hotez, MD Ph.D., one of the leading vaccine scientists in the world, posted a Twitter thread where he discussed his concerns about a potential Trump coronavirus vaccine.
— Prof Peter Hotez MD PhD (@PeterHotez) September 2, 2020
I want to review each of the 12 concerns he posted along with my own opinions on each.
- 0.1 1 – This would be unprecedented
- 0.2 2 – Substandard review process
- 0.3 3 – EAUs for devices makes sense
- 0.4 4 – Transparent review of data
- 0.5 5 – mRNA vaccines
- 0.6 6 – Published data
- 0.7 7 – More data
- 0.8 8 – Bad messaging
- 0.9 9 – Irresponsible science
- 0.10 10 – Trump has abused the EUA process
- 0.11 11– Misinformation from the White House
- 0.12 12 – Lack of transparency
- 0.13 The Trump coronavirus vaccine summary
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1 – This would be unprecedented
Dr. Hotez wrote:
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.
I need to remind everyone over and over – this would be an unprecedented maneuver by Trump to get his vaccine on the market before thorough testing. It has never been done before, and it is why all current vaccines are very safe and very effective, something that we cannot establish with the Trump coronavirus vaccine.
2 – Substandard review process
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?
Despite the claims of the anti-vaccine crowd, all vaccines undergo thorough reviews at the FDA. Final approval requires a final review by the Vaccines and Related Biological Products Advisory Committee (VRBPAC), which is made up of leading scientists who frequently require further testing or could even reject an application for a vaccine.
3 – EAUs for devices makes sense
I understand EUAs for ventilators, or PPE, etc, but not for a widely administered vaccine
Not much to add here, other than I agree
4 – Transparent review of data
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 VRBPAC, ACIP.
As I mentioned above, more reviews would be extremely helpful if the FDA wants to use its powers to get a Trump coronavirus vaccine approved. The Advisory Committee for Immunization Practices (ACIP) recently began the process of reviewing the evidence supporting the coronavirus vaccine. But they are not even close to recommending any of the vaccines.
Many vaccines fail in clinical trials because of the standard of review and scrutiny by the sponsors, the FDA, and CDC means that vaccines that don’t work or are not very effective don’t get approval.
And EUA for political expediency means that thorough review doesn’t happen.
5 – mRNA vaccines
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.
Although the mRNA vaccines look like they can be a great technology, they are new. There are no mRNA vaccines on the market, and Moderna, who has been pushing their Trump coronavirus vaccine hard, has 10 mRNA vaccines – none of them have gotten through phase 2 clinical trials except for the coronavirus version.
These vaccines must undergo an even more thorough review compared to vaccines that use known methodologies.
6 – Published data
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.
We don’t have robust data on anything yet. That’s why phase 3 clinical trials are called “pivotal trials” because that’s where the real data can be analyzed for safety and effectiveness.
7 – More data
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?
This is a real concern. Vaccine experts need to see the data to recommend a COVID-19 vaccine. Will a physician give a vaccine if they don’t know if it really works or is really safe? Will a state health department do the same?
8 – Bad messaging
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.
This is what is very troubling. A lot of information is coming from dueling press releases from pharmaceutical companies. As opposed to many of the other readers here, Big Pharma isn’t made up of unethical humans trying to suppress science. However, their press releases tend to cherry-pick information and boost stock prices. Moderna has been especially guilty of this issue.
And Operation Warp Speed is a terrible idea.
9 – Irresponsible science
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”
I agree. It is a nightmare.
10 – Trump has abused the EUA process
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.
The hydroxychloroquine disaster that got an EUA had to be revoked because it didn’t work and it caused harm. What’s worse is that scientists knew that it would not work, and there was no data to support the EUA. This is what we all fear from an EUA for the Trump coronavirus vaccine.
11– Misinformation from the White House
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.
Dr. Scott Atlas is the new science advisor to Trump. Unfortunately, his views on science reflect Trump’s anti-science beliefs and not reality.
12 – Lack of transparency
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.
Absolutely. We cannot vaccinate millions of Americans based on what Trump and his lackeys say. As scientists, we need solid, robust, repeated, transparent, and published (peer-reviewed) data that shows us that any or all of these vaccines are safe and effective. We aren’t getting any of that right now.
It is incredible, but nine pharmaceutical companies themselves have issued a statement that they stand with science. Although the companies did not rule out an EUA for their vaccines, they promised that any potential coronavirus vaccine would only be release based on “large, high-quality clinical trials” and that these companies would follow the guidance of all regulatory agencies across the world.
Even though I am troubled by the speed of developing this vaccine, which is taking far less than an average of five years to get a vaccine approved, I would get the vaccine if it met the exacting standards of vaccine experts across the world. If Dr. Hotez says that the data looks good, then I’d get it.
As former FDA director Dr. Tom Frieden posted:
To be clear: Licensing a vaccine requires that it be proven safe and effective. That's a reasonable standard. If reached, I also would feel comfortable getting a vaccine and recommending to my family. An Emergency Use Authorization, in contrast, is a much lower standard. https://t.co/RzUn8Nhmmm
— Dr. Tom Frieden (@DrTomFrieden) September 2, 2020
Kamala Harris, the Democratic Vice Presidential Candidate, recently stated that she would not get the vaccine if approved by an FDA EUA. Then, Trump accused Senator Harris of being an anti-vaxxer. Well, that’s ironic since Trump has been pushing false claims about vaccines for years and is himself an official vaccine denier. He’s even good buddies with the cunning fraud, Andrew Wakefield.
So yes, I’m an anti-vaxxer. But only in a very very narrow sense of the word – it’s all about a Trump coronavirus vaccine that comes to market under an Emergency Use Authorization. I won’t get that one.