Last updated on August 31st, 2021 at 12:55 pm
This article about how “cures” should prevent a COVID-19 vaccine emergency use authorization (EUA) was written by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), who is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy, and the law.
Professor Reiss writes extensively in law journals about the social and legal policies of vaccination. Additionally, Reiss is also a member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable disease. She is also a member of the Vaccines Working Group on Ethics and Policy.
I have seen this myth around but haven’t had a chance to respond to it, so I will do it quickly here. No, there is no conspiracy to hide the benefits of things like hydroxychloroquine (HCQ) and vitamin D, and no, if they were shown effective, it would not prevent a COVID-19 vaccine EUA.
COVID-19 vaccine EUA myth
An anti-vaccine activist alleged on Twitter:
The only way the FDA can authorize an EUA for a vaccine is if it can be proven that there is no other treatment or cure for the illness. Now, do you understand why hydroxychloroquine, Ivermectin, Zinc, Vitamin D, Azithromycin et al have all been dismissed as viable treatments?
That is just untrue. This discussion is based on a Twitter thread with the very talented Alexander Gaffney from Politico.
Even then, FDA treats therapeutics and vaccines super differently. A vaccine isn't a substitute for treatment for a person with active COVID-19.
And there are active EUAs for COVID-19 treatments and vaccines despite FDA's *approval* of Veklury (remdesivir), so…
— Alexander Gaffney (@AlecGaffney) December 24, 2020
According to the FDA:
The [FDA] Commissioner may issue a EUA to allow an MCM (medical countermeasure) to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by a CBRN agent when there are no adequate, approved, and available alternatives.
There are two parts to the issuance of a EUA:
- Serious or life-threatening disease or condition.
- No “adequate, approved, and available alternatives.”
(There are additional conditions related to the effectiveness and safety of the product).
As Mr. Gaffney pointed out:
If there’s a shortage of an approved product, FDA can issue an EUA. If the approved product isn’t effective in all populations, it can issue an EUA. If the original approved product isn’t effective at all, it can issue an EUA.
The last part is important.
If there's a shortage of an approved product, FDA can issue an EUA.
If the approved product isn't effective in all populations, it can issue an EUA.
If the original approved product isn't effective at all, it can issue an EUA.
— Alexander Gaffney (@AlecGaffney) December 24, 2020
In other words, there was no barrier to, for example, accepting hydroxychloroquine as a treatment and still approving a vaccine EUA if it was not effective, say, in those with severe diseases. But HCQ was not effective.
There would have been no barrier to a EUA for COVID-19 vaccines unless such treatment was clearly a magic cure for COVID-19 – there is no such treatment. So even if you subscribe to the belief that FDA scientists would hide a cure for a disease killing 2000-3000 people each day, the explanation does not hold.
And note that the is exactly what the anti-vaccine activist is claiming – FDA scientists and the many other experts that have commented on these treatments are all intentionally lying to hide a cure while thousands of people are dying each day. Yes, anti-vaccine activists are willing to believe something as extreme and unrealistic as that.
Further, vaccines are not treated as equivalent to or substitute for treatments. Prevention is different – and often better – than a cure. And biologics are regulated differently. FDA could issue a EUA to a vaccine even if a treatment existed. In fact, a COVID-19 treatment does exist – FDA approved Remdesivir for COVID-19, and still issued EUAs to both treatments and vaccines for COVID-19, as Mr. Gaffney pointed out.
Even then, FDA treats therapeutics and vaccines super differently. A vaccine isn't a substitute for treatment for a person with active COVID-19.
And there are active EUAs for COVID-19 treatments and vaccines despite FDA's *approval* of Veklury (remdesivir), so…
— Alexander Gaffney (@AlecGaffney) December 24, 2020
Finally, Mr. Gaffney pointed out that zinc and vitamin D are regulated as supplements and not approved for medical use, so they would not prevent a EUA either – they don’t meet the ‘approved’ prong of an “adequate, approved and available” product.
And while I'm raging against that Tweet, ANOTHER thing:
Zinc and Vitamin D are regulated as supplements. Those aren't "approved" for medical use, and therefore fail the three-part test of "adequate, approved AND available."
So they have no bearing on any of this, either.
— Alexander Gaffney (@AlecGaffney) December 24, 2020
In short, like other anti-vaccine claims, this claim by the anti-vaccine activist is incorrect.
I will go back to the starting point, which is the assumption that everyone – scientists, regulators, and doctors – are so committed to vaccines, and vaccines alone, that they are willing to let people die in large numbers to promote that vaccine.
For doctors, apparently, that includes a willingness to commit suicide, since rates of harm and death among doctors from COVID-19 are disproportionally high. That is pretty obviously unrealistic, with such a large number of people, many of whom directly work with COVID-19 patients or have paid a personal price during the pandemic. It merely reflects the dark conspiracy anti-vaccine activists have to convince themselves exists to hold onto their beliefs in the face of the evidence.
We all wish there was a good treatment for COVID-19 – and it would not remove the need for vaccines to prevent it. Right now, we don’t have it. The vaccines are our best hope.
Professor Reiss writes extensively in law journals about the social and legal policies of vaccination. Additionally, Reiss is also member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable disease.
