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Pfizer Announces that it will Seek Full FDA Approval By the End of the Month, So guess what’s coming?

Pfizer Announces that it will Seek Full FDA Approval By the End of the Month, So guess what’s coming?

It is being reported that Pfizer will seek full FDA approval (a biological license) for its COVID vaccine by the end of the month. That’s surprising in terms of timing because it’s still only what, about one year since the first human subject received the shots. That is going to drive anyone with vaccine concerns nuts. But this isn’t a normal clinical trial process, far from it.

I don’t know the actual numbers of people in the US who have received the Pfizer vaccine, but I have heard that the country now has upwards of 100 million who have been fully vaccinated. Assume 40-50% received the Pfizer shots and the other 50 to 60% received the Moderna shots or the J&J vaccine. But that’s still 40 million people who received both of Pfizer’s shots, plus half of the however many people out there who have received only one dose of either of the two mRNA shots. Call it another 5 mil, or don’t even consider the one shot(ers).

Any way you look at it, 40 million test subjects is a very big number, far bigger than any clinical trial of any drug in the history of clinical trials (This is rank speculation on my part, but I am open to hearing about an investigational drug which was given to more than 40 million people prior to FDA approval/biological licensure.)

Of course, there is the not-so-small problem of no long-term data. I would guess that will be the biggest issue with the FDA and its advisory committee’s review of Pfizer’s application. I will make a prediction:

Despite some handwringing/soul searching/deep concerns about the lack of long-term safety data, my money’s on the fact that the vaccine will be approved and the biological license will be issued, and prior to late August. The reason is simple and consists of two words: vaccine hesitancy. There is a constant drumbeat in the media about vaccine hesitancy. It is been widely and frequently reported that the supply of the vaccine will exceed (voluntary) demand by late May.

Add to that the widely reported recent fear among public health officials that the US may not get to “herd immunity” because of two factors, one of which is, you guessed it, vaccine hesitancy. The other being something that gets less attention driving the discussion which is the variations that reduce the efficacy of the existing vaccines or limit their durability. But of course, there is a tried and true solution to the durability or variation problems, and that of course is the booster, followed by the equally compelling case for an annual shot. And yes, most of you have been thinking and telling your social media contacts that is coming, and you are right, it is.

But getting back to vaccine hesitancy and supply exceeding demand. As all of you know, under federal law, EUA drugs and products can’t be mandated (under federal law at least). A few schools like the UC and CSU have already said that there won’t be a mandate until the vaccines are fully licensed. Many schools, especially private schools, and many private companies have or are considering mandating the vaccine, but there is still is that nagging view that EUA products can’t be mandated.

Obviously, that issue goes away with the full licensure of the vaccine. So if you are a public health official trying to figure out how to combat vaccine hesitancy and help get to herd immunity which is the key to protecting the public, saving lives, and getting the country back to normal, what do you do? Ok, you all know the answer to that one, so let’s move on to the implications of full licensure.

Legally, we are back to Jacobson as interpreted by subsequent cases. Many of you look at Jacobson and focus on the 5 dollar fine as the alternative means of compliance to limit the effect of that decision. (I myself had done that on occasion), but realistically, that really doesn’t fly because cases subsequent to Jacobson starting with Zucht a few years later, used Jacobson to justify full-on school mandates where there was no 5 buck alternative compliance.

Ultimately, Jacobson and its progeny support mandatory vaccination because the public’s right to health and safety are more important than an individual’s personal opinions about bodily integrity. Almost all of these cases deal with what I call mandatory vaccination as opposed to compelled vaccination (where they line you up, roll up your sleeve, and give you the shot). Mandatory vaccination is more like if you want to do X (go to a public or private school, be a teacher, work for my company) you have to take the shot. Fine if you don’t, but you’re out of here. That is what Jacobson and its progeny supports, and more actually since I think a recent NY City case upheld (on appeal) compelled vaccination in a specific community measles hot spot.

Many in the community believe that Jacobson should and will be overturned in favor of a decision that leaves it up to each individual to make the vaccine decision, or maybe requires a higher level of proof that the vaccine concerned think supports licensed vaccines. (Maybe so, but when you bet against the house, you’ll usually walk away lighter, money-wise).

Others focus on religious exemptions because of the Supreme Court’s new conservative majority’s much greater accommodation to first amendment religious rights. Anything is possible. However on the pure vaccination issue, especially if there is a religious accommodation built-in, and based on some of the knocks I and others have received from the courts, regretfully I say that judges are not the friends of the vaccine concerned. But sure, maybe things can change.

So what does that mean practically?

Once the vaccines are fully licensed, look to many employers (and even government employers) and public and private schools to mandate the fully licensed vaccines with some kind of very limited medical accommodation and a vaguely defined religious accommodation with no real guidance about how it applies.

Right now, I am not seeing broad state or local government all-citizen mandates, as that would require state legislation or municipal ordinances with the input of the legislative bodies. I don’t think we are there yet, with the decline in cases and continued albeit slowing progress on vaccination rates.

But the accommodation is likely a mask, which is how it works with the flu vaccine accommodation. I don’t think you will have the option of just not getting the shot and proceed normally (i.e a full-on exemption, and certainly not for religious reasons). How that is enforced is going to be interesting, and I think the likely trade-off for the accommodation is some kind of filed document which might even have to be maintained to prove compliance (ok a vaccine passport, or maybe not, but some kind of written acknowledgment of the accommodation for sure). Based on my past experience, I think that’s how institutions will deal with the mandate and try to satisfy those opposing the mandate.

In the school response/pushback context, it might be nice to see some national student organizations which voice the concerns of the vaccine concerned students.

In this soon-to-be new world of fully licensed COVID vaccines, I see two primary methods of avoiding the shot.

Be the squeaky wheel, and squeak loud and squeak often, and you might get that accommodation, such as it is.

Second, go someplace that does not have the mandate. I think the polarization that this issue is causing will continue and in fact, will increase by a quantum level. I see many more people leaving the states/schools which have these new mandates and moving to places that don’t and won’t (Texas and Florida for sure for the Cali folks, and Idaho).

Sure there will be lawsuits and many of them. However, the courts in the states with the strictest mandates are not likely not to be sympathetic to people who don’t want to take the COVID vaccine.

Such is the way I see this playing out, pending some new big development.

Rick Jaffe, Esq.