There is another reason why this isn't (yet) done in the USA. It's a legal reason, not medical or scientific.
When approving the Pfizer, Moderna, and J&J vaccines for use, The FDA granted an Emergency Use Authorization (EUA). An EUA has less hoops to jump through than a full authorization. It's quicker, and the national health emergency certainly justified the EUA. However, the EUA is temporary, until enough long-term safety and efficacy data is collected. For vaccines, I don't know how long that must be, but it might be for another year or two. As a result, the FDA's EUA rules require giving the vaccines exactly as they were tested in the clinical trials. You can't skip a second dose unless the clinical trial never included one. Once enough long-term data is in, there will be some loosening of those rules.
I personally don't believe all those rules should apply so rigidly. However, I know the FDA well enough to be quite certain that it will not violate the very rules that it created. I also know those working in the FDA do take these regulations very seriously. As a front-line intensive care clinican, TLS Guy has a very different view. He takes the well-being of an individual patient very seriously, as opposed to the well-being of the entire public's health. From the FDA's point of view, that would be playing dangerously fast & loose with the public's trust. I can see both point's of view. But in the USA, the FDA's ruling have the power of federal law.
That makes sense. My self-imposed homework assignment is to figure out what the limits of federal law are in this situation.
The following Federal Register Notice seems to cover the basics. I'm curious what the significance of the "if available" modifier is. At first glance it seems to suggest that clinical trials are not absolutely required in every case (i.e. why is this modifier there if clinical trials are required in every case?).
I'm not sure to what extent existing CFR rules apply as well. Agencies are obviously limited in their ability to change the CFR.
>>>FDA may issue an EUA only if, after consultation with the HHS Assistant Secretary for Preparedness and Response, the Director of the National Institutes of Health, and the Director of the Centers for Disease Control and Prevention (to the extent feasible and appropriate given the applicable circumstances), FDA [
2] concludes: (1) That an agent referred to in a declaration of emergency or threat can cause a serious or life-threatening disease or condition; (2) that, based on the totality of scientific evidence available to FDA, including data from adequate and well-controlled clinical trials,
if available, it is reasonable to believe that: (A) The product may be effective in diagnosing, treating, or preventing (i) such disease or condition; or (ii) a serious or life-threatening disease or condition caused by a product authorized under section 564, approved or cleared under the FD&C Act, or licensed under section 351 of the PHS Act, for diagnosing, treating, or preventing such a disease or condition caused by such an agent; and (B) the known and potential benefits of the product, when used to diagnose, prevent, or treat such disease or condition, outweigh the known and potential risks of the product, taking into consideration the material threat posed by the agent or agents identified in a declaration under section 564(b)(1)(D) of the FD&C Act, if applicable; (3) that there is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating such disease or condition; (4) in the case of a determination described in section 564(b)(1)(B)(ii), that the request for emergency use is made by the Secretary of Defense; and (5) that such other criteria as may be prescribed by regulation are satisfied.
No other criteria for issuance have been prescribed by regulation under section 564(c)(4) of the FD&C Act.<<<(emphasis added)
The Food and Drug Administration (FDA) is announcing the issuance of two Emergency Use Authorizations (EUAs) (the Authorizations) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) for biological products for use during the COVID-19 pandemic. FDA issued one Authorization for a...
www.federalregister.gov
