Short Answer: No one knows yet.
As many of you know or can guess, EUA status does not mean that the safety and efficacy of the drug or biologic has been proven to the FDA’s standards of proof which are normally required for a drug or biologic to be marketed and introduced into interstate commerce. The FDA’s granting EUA status only means that the product”‘may be effective’ to prevent, diagnose, or treat serious or life-threatening diseases.” In case you are interested, here is the FDA’s Guidance Document on EUA which explains this and many other things about the process: EUAGuidance
What about safety? Your quote only references effectiveness, what about safety?
Both EUA pending vaccines (Pfizer and Moderna) are supported by Phase 1/safety clinical trials. Phase 1 clinical trials are relatively small (a couple of hundred participants at most, usually) and give some indication of the short-term safety profile of the study product. More safety data is amassed via Phase 2 and 3 trials. Of course, since the clinical trials only started in July, there is no extensive data on long-term safety, yet. But we are in a pandemic and that’s the difference between EUA and full-on NDA drug approval or a license for a biologic.
FYI: I am (and have been throughout my legal career) one hundred percent in favor of faster access to investigational drugs. So, I am one hundred percent in favor of EUA as a regulatory concept. I am also one hundred percent in favor of EUA for these two vaccines, if the FDA grants EUA to them or any other vaccine which passes through the EUA process, so long as the vaccines are not mandatory.
I’m not even concerned about informed consent, (as heretical as that may sound to many of you). There are basically two kinds of people, neither of which needs informed consent. Based on various polls, somewhere between 50 and 60 percent of people say they are willing to take EUA approved COVID vaccines, just because the government says it is safe and effective (even though, as indicated, the government is not actually saying that). These people don’t need informed consent because they trust the public health authorities.
Somewhere between 40 and 50 percent of people are not willing to take a EUA approved vaccine because they are anti-vaxxers, vaccine concerned, have concerns about the rushed process, don’t want to be guinea pigs for the first-ever mRNA based vaccine or some other reason. There just isn’t enough information available yet to change the minds of these people, (and honestly, for some, I think there is no possible information that could change their minds.) I suspect in six months to a year, if there is still a pandemic, and the media is not reporting deaths or horrible long terms side effects, some portion of this group may get the shots.
So here is the bottom line: The FDA’s EUA authorization doesn’t change the fact that these products are investigational and have not proven to be safe and effective for NDA drug approval or biological licensure, and there is no getting around that fact. That makes the tens or hundreds of millions of people taking these EUA approved products participants in history’s largest clinical trial to answer the question as to whether these products are safe and effective to do whatever they are supposed to do. (And frankly, I am confused about what that is. Is it to stop the vaccine recipient from contracting the disease? probably not. Is it to stop the recipient from transmitting the disease? probably not. Now, the endpoint seems to reduce the risk of death or serious disease).
Let the chips fall where they may
As you all know, health care workers and the aged will be the first to receive the vaccines. I just watched a 90-year-old English woman receive the first Pfizer vaccine shot under a EUA. Like it or not, the choice of recipients will provide very valuable safety and efficacy data.
The data from the aged, who generally have more co-morbidities than the young, will be especially helpful, as callous as that seems. But hey, it’s the regulators who chose them.
Making health care workers the initial recipients makes a lot of sense because of their increased exposure to the disease and people in general, and of course, their critical role in fighting the pandemic. If the people who believe that the vaccine is really dangerous are right, then in the coming months, there should be a detectable number of hospital workers sickened by the vaccine, which should affect hospital staffing.
If the covid vaccinated aged don’t die in increased numbers, and health care worker attendance status does not drop, that would be some indication that the vaccine is not causing more harm than good, in the short term at least. If the vaccination of tens of millions of people in the coming months reduces hospitalizations and deaths during what is expected to be the peak, that would be a big win for the vaccine. And while I hope that turns out to be the case, like many reasonable people, I have my doubts because of the novel nature of the vaccines, the rushed process, and some general skepticism (enough said about that). But again, I hope the vaccines prove to be safe and effective and allow us all to get back to normalcy.
For sure, there will be confounding variables. Will the better numbers come after the expected peak, like in the summer? The authorities are already saying not to expect any big positive results for many months. Also, there is the whole false positive of the PCR testing (which is too complicated to address in this post). Still, with tens or hundreds of millions of people getting the vaccine, I think or at least hope that the data will provide important information that will allow reasonable people to figure out whether the vaccine is doing more harm than good, and whether it is helping resolve the pandemic.
I view the next six to nine months, where hundreds of millions of people will get this novel vaccine, as a decision point on the whole mandatory vaccination issue for biological licensed products. As to mandatory vaccination of these now EUA approved products, well, that happens to be the topic of my next post, so stay tuned.
Rick Jaffe, Esq.