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.
27 thoughts on “Pfizer Announces that it will Seek Full FDA Approval By the End of the Month, So guess what’s coming?”
Wow. We went back in time to East Germany.
I’ve seen the UC campus exemption/opt out form, wonder if that can be leveraged somehow?? Wow, zoom in isolation again or move.
If told take the shot or lose your job, and a person says, “Ok, I will take the shot but I will not sign away my rights be signing a waiver of liability.” At that point most if not all Dr’s wil refuse to provide the shot. Now the person has agreed to the mandate and the issue now becomes the liability waiver which to my knowledge cannot be forced.
This would pose an interesting dilemma
not really. Everyone in the vaccine chain is immune from liability as a matter of law. It doesn’t matter what you reserve or claim not to waive. You take it or you don’t. If you don’t you’re not in compliance. I think it’s pretty simply
What about these reports of side effects from just having contact with vaccinated people? How do you see that playing out? Any legal recourse?
Do you have a link for that?
Marilyn, I’ve tried replying to you three times, and don’t know why my comments haven’t gone through. Maybe Richard can help.
Here are a couple of links:
“Unvaccinated Women Report Miscarriages After Interactions with Vaccinated People”
Dr Pavelsky on “spike proteins” shedding (VIDEO, 15 min)
thx. good information, but I’m sceptical of the miscarriage connection to the vaccine. So what’s the hypothesized connection vaccine shedding plus an analogue to the clotting problem found in a very small number of cases, so if it doesn’t cause clotting problems in the recipient, it causes some kind of excessive blood problem in a female who came in contact with that person, miscarriage could be a blood problem I suppose (though I don’t know anything about what all or any of the causes are). I go back to the 100 million fully vaccinated people in the US alone. Any problem that is manifest in only a handful a cases to me seems like background rate/random
First, it’s not a “handful” — it’s thousands of cases of interference with menstrual cycles, even in post-menopausal women, also swelling of testes in men, bleeding from legs, and other blood-related symptoms. Even if you meant “a handful in comparison to the number of people vaccinated,” I don’t think serious side effects of medical treatments should ever be dismissed, even if only one person experiences them. But also, I believe there is science behind the potential for interference with reproductive function, and problems with pregnancy were anticipated because of a particular ingredient that could interfere with adhesion of the placenta. I’ve seen info on these things, and can root around for links if you want.
Second, these incidents are being reported soon after contact with vaccinated people. This is a whole different ball game. To choose not to be vaccinated and be subjected to serious side effects anyway? This is unacceptable to me. I find it hard to believe that these kinds of symptoms have been experienced all along at the same rate, although you make a crucial point. I would be very interested in seeing a studied comparison, which I hope can be done, and done soon.
there have been several to many hundreds of millions of doses given. close temporal connection or not, that kind of number might cause a lot of things in background. Probably 500 or more people died within 12 hours of visiting someone who got the vaccine. How many miscarriages occur every day around the world. 10k, 50k? just a guess
Again, you could be right, but data/research is needed, not guesses. Do you have any thoughts about the other points I’ve made?
I don’t see that going anywhere. First, go prove it. Second, it’s second level, one step removed. If you can’t sue for vaccine injury if you get the shot, I don’t see how someone who didn’t get the shot can sue because of a claim that he was injured by someone who got the shot. It’s not really a negligence claim because of lack of foreseeability and there has to be some kind of statute for a products liability claim and there isn’t; just one saying no suits. But that is not to say someone won’t file such a suit, to make a point or raise the issue, hmmmm.
I’m wondering about foreseeability. I believe at least Pfizer collected reports of exposure to vaccinated people during the trials and had people fill out VAERS reports in advance, just in case there were SAEs. Curious about what the data show in that regard.
I haven’t checked the statute recently but I think it’s blanket absolute immunity that no one in the vaccine delivery system is liable for any vaccine injury caused or alleged to be caused by the vaccine. No liability means no liability is my off-the-cuff response.
Yeah, there’s def no liability from what I’ve seen. There is a govt compensation system, but it’s even worse than the usual “vaccine court.” Reward amount is capped really low.
I’m very interested in joining any groups who care about this invasion of our privacy and dissolution of our right to dominion over our own bodies.
Any thoughts about North Carolina’s likelihood to adopt mandates?
Good question to clarify something. The post was basically about school and employment COVID mandates because they are decisions by institutions public and private. I didn’t specifically address mandates at the state of local government level (other than the discussion of Jacobson).
Government mandates for all adults will require legislative action, and of course, that will be vigorously opposed by the 25 to 40% of people who are opposed to mandates. That is a completely different story, because of the political issue though the legal judicial issues are the same.
Hey, thanks for the comments. I’ve updated to post to clarify that I don’t think there will be a general state or local government mandate now, because that would take legislation/local ordinances. It’s really about schools and employers, including government employees. The change is at the beginning of the last heading about the practicalities.
As someone stated before, if mandated for work, take it or loose your job. If mandated for school , take it or home school on zoom indefinitely or move to another state and find a college to accept you.
Why no students are up rising like at UC Berkeley on their Freedom of choice is besides me.
Wonder how companies will enforce via HR employees who say no, especially ones from other countries who have to have some religious beliefs against it.
Guess we need a class action and lock it up in courts somehow.
Where are the red state governors against this tyranny?
I think the red states for sure won’t do general mandates, but they have no control over private employers or private schools. Public schools are local controlled, and public universities are not directly controlled by the governor.
As I said in my post, I am sure there will be lawsuits but the judges, especially in the blue states are not the friends of those with concerns about vaccines.
I just heard and read about the VAERS data of over 3000 deaths associated to this one vaccine? More than the combination of all other vaccines given?? Wow. How about using that data Mr Jaffee?
FYI: while I do have a point of view, in this blog I try to stick with my view of the law and how facts play into and might effect the law, as opposed to just promoting one side of the issue. The deaths associated with the covid vaccine issue is something I have been thinking about in terms of the public policy implications and the law, but I suspect you and many others won’t love what I have to say about it, some will though. But you have prompted me to address it. Thx
Please address it and apply law. The numbers are factual numbers we can get away from. If this VAERS database the Federal gov uses says there have been more Covid deaths than from all the other combined ones, why wouldn’t a court press pause. We need to stop the bleeding and families from no choice but move or zoom hell!
IF we only had a diff Governor and/or one to reconsider these archaic medical laws.
Public schools are horrible anyway and union controlled like the mafia. Sad many will have to resort to moving to different states to find peace for their families.
I wonder if any other attorneys will step up and speak up or are afraid to be in the spotlight and be called out by the media and cancel culture.
You are ignoring the fact that the “vaccines” do not confer immunity.
They claim to mitigate immune response when the virus is encountered, by altering your own cells to cause then to make spike proteins, (so that you can have an immune response), thus trigging your body to create antibodies.
In young healthy people the spike protein reaction from the shot is MUCH greater than to the virus.
These shots are doing the OPPOSITE of what they are marketed for, causing people who would NOT have a huge spike protein surge (from the virus) to have an extended ones (from the shots).
This is criminal malpractice, and a money making fraud- period.
Also- the entire extent of the outbreak was fraudulently reported and massively overblown from the start. They literally practiced this panic creation exercise in 2019 at Johns Hopkins. The purpose was to by-pass the long approval process for a drug that had bad long-term results in animal trials (DuckDuckGo Simone Golds talk on it)
Wake up, roll up your sleeves and take action to halt the long term harm being inflicted on the young whose immune systems are being tinkered with FOR NO BENEFIT TO ANYONE but the Big Pharma investors bottom lines.
you are certainly entitled to your opinion, and I have no problem with allowing you to do so on my blog. You are using a lot of loaded words which don’t make any legal sense (“criminal malpractice”) and the whole Johns Hopkins as part of some conspiracy thing is a joke or would be if it wasn’t been so misused. As for the rest, I do litigate cases, mostly on behalf of doctors being attacked by the government, and I do file some lawsuits and probably will file something at some point in the covid world, if I find the right case and the right backing, but it won’t be based on the things you are saying.