New York State's Off Label COVID Vaccine Policy Raises Physician Fear and Ethics Concerns

Fearful of speaking out, an anonymous doctor says, "It just feels like an internalized hypocrisy that we have to recommend these vaccines when most of us aren't getting them."

9 minute read

New York’s department of public health released a series of odd guidances to pharmacists and physicians on Friday to promote COVID vaccines to children and adults for “off label” use, meaning in conflict with FDA’s official label. Signed by Governor Kathy Hochul, New York’s executive order 52 declares a “disaster in the state of New York due to federal actions related to vaccine access.”

“A friend of mine said they’re contacting the nurse’s union,” a New York City nurse texted me, shortly after New York released their new COVID vaccine guidance. “They don’t know wtf to do with that!”

A New York physician sent me documents the state’s health department sent to physicians and pharmacists, called “providers” in healthcare lingo. She and the majority of her colleagues no longer get COVID boosters, and she’s worried that the new guidance for “off label” use makes no sense, does not fully inform patients, and might be illegal.

Pfizer pled guilty to criminal charges and paid a record $2.3 billion fine for illegal, off label promotion of multiple drugs in 2009. As previously reported here, Biden’s FDA Commissioner and CDC Director both promoted COVID vaccines for uses that the FDA admitted were off label. No evidence exists that pharmaceutical companies helped to shape New York’s off label policy, but CNBC reported in 2021 that Governor Hochul’s daughter-in-law is a top lobbyist at a pharma firm that has sought to influence NY lawmakers.

According to a recent biography at BIO, Christina Hochul is now a lobbyist at Alexion, a subsidiary of AstraZeneca.

In one unsettling example of New York’s emergency guidance, officials allege that “physical activity” places people at risk of COVID.

Because she works in both New Jersey and New York, this physician requested to go by the name “Michelle” to protect her license and possible job reprisals. “The states that I practice in are particularly regressive and hostile,” Michelle said. “They have pursued suspending and revoking licenses for providers that asked questions that in any other situation would be normal to ask.”

Over the weekend, I spoke at length with Michelle, probing her to explain what is going on in healthcare right now and what she and other physicians plan to do about New York’s emergency declaration. At times, the conversation veered into the horrors she’s experienced in modern American healthcare. When a wave of illegal immigrant children came to New York a couple years back, many of them she treated had been sexually abused and trafficked during their migration from places as far away as Honduras. She also consulted for a hospital where boys who identified as “trans girls” were placed in a female psychiatric ward and then sexually abused the girls, crimes which were likely never reported to police, and handled internally by staff.

This interview has been edited and condensed for brevity and clarity. “I have never worked in healthcare like this,” Michelle said. “I can’t even ask the state department questions about some of this because that might flag me to a licensing board.”

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THACKER: Tell people what's been going on with prescribing in your part of the country, and what happened when these new statements came down from the Department of Health in New York.

MICHELLE: There’s an undercurrent in healthcare right now … if you look at the uptake of COVID vaccinations, it's plummeted, right? Even in healthcare workers. And many hospitals have dropped their COVID vaccine requirements.

I also work at a private university. And this is an ongoing conversation for students. Are students going to be required to get these vaccines when they are not required by employees? It's a constantly changing conversation. And some hospitals are requiring students get COVID vaccination, even when they don't require it for their employees.

So what I see... privately and personally in my colleagues is … no one's getting boosters. No one's getting them anymore. They're uncomfortable getting them, and they're not required to.

It just feels like an internalized hypocrisy that we have to recommend these vaccines when most of us aren't getting them. And it's not like a minority of my peers. I would say the vast majority, even people that were previously receiving multiple boosters.

THACKER: Why are they not getting the boosters? Excess mortality dipped below zero in January 2023. Do they think the risk benefit doesn't make any sense, so there's no point in getting them? Or are they worried about potential side effects now?

MICHELLE: In practice you can see the risk benefit doesn't make any sense. There are populations that still get COVID, but it's very treatable for the vast majority of people.

The data is skewed from the beginning, because we are looking at hospital numbers for COVID rates of infection. I would say about 30 to 40 percent of people test at home. So we don't even know the reality of how many people are getting infected. The vast majority of people are recovering from this at home.

THACKER: So the true number COVID infected people are never accounted for, which increases the percentage of people we think are getting seriously ill or dying.

MICHELLE: People with comorbidities may get ill, and certainly older people, but this is not a time where our hospitals are struggling. This is three years out from the height of COVID. RSV and flu were a lot more severe than COVID last year.

States have dropped their COVID trackers. There weren’t COVID trackers last year, I checked everywhere. I feel like that's a conflict, where our states aren't even tracking disease statistics, but then recommending vaccination for the disease that you're not tracking.

You track flu, but we stopped tracking COVID statistics. I think that is meaningful, don't you?

THACKER: Your department of health put out this notice to pharmacists and it actually says that while federal actions may restrict eligibility with no underlying conditions, meaning comorbidities, providers may administer the vaccines “off-label.”

And then it provides step by step instruction for off label use for “patients age 3 and older,” which I thought was really odd. That a department of health would be recommending, “Hey, here's how you can do something off label.”

MICHELLE: I was stunned. I couldn't believe that. I've never seen that. I went to my colleagues, I asked peers, “Have you ever seen any department of health recommend off-label use?” No, never. People that I've known—that have been practicing for 25, 30 years—had never seen that before.

And I am like, “Wait a minute, you can't do that.” Departments of health deliver guidance from regulatory bodies; they send federal information, regulatory information to providers. So that made me pause.

But the off-label thing, I still can't wrap my head around.

THACKER: A lot of these COVID vaccines are given by pharmacists. You're not getting a prescription from your doctor. You just show up at like CVS and say, “Hey, I want this.”

Now you can say, “Hey I want this, and I want to get it off label.”

MICHELLE: Absolutely. But I just want to note that a pharmacist can prescribe vaccines only. This is the one thing they can do at point of care. Let's say your kid goes to a school where they require the flu shot, or you have to get an update on varicella. If you go to the CVS, they can now upsell you on COVID vaccine because they have this guidance for off label.

If you're an informed consumer, you might go, “Oh my gosh, look at the federal guidance on COVID and I'm 45. I shouldn’t get this. What am I gonna do? Oh, I can get it off label.”

You might be an informed customer that wants the COVID-19 shot, and you should have that right. But I've never seen this before where you're having a department of health encouraging people to ignore the FDA.

THACKER: I’m not sure I’ve ever heard of this.

MICHELLE: At the top of the new guidance to physicians, it says, “We recommend vaccination..” It’s only on the bottom of the page that it says “federal actions may restrict eligibility.” That wording is very complicated and avoids stating, “The FDA recommends vaccination only for people over 64 etc…” By not naming the FDA or the FDA’s guidance, someone glancing over this could incorrectly believe that this is recommended by the FDA as well.

My concern is for the people with kids who go to the pharmacy and don't know about the research and FDA guidance.

Is the pharmacist gonna give them actual informed consent and say, “Well, I'm writing this for you off label because the state says I can.”

Are you gonna really say that? I highly doubt it.

THACKER: It’s highly unlikely they're gonna inform parents that federal guidance says healthy kids don't need this, but I'm gonna give it to you anyway.

MICHELLE: Are they going to be pleasant, “Hey, do you also want to get a COVID shot for your kiddo?”

I can't speak to if there are incentives for that, for pharmacists. Perhaps. Who knows? There's certainly incentives for MDs, if you maintain a certain percent of your patient population with current vaccinations. That's a known incentive.

There's so many questions at play here, because off label use of medication is tricky.

THACKER: So you can walk into your CVS, Walgreens, Rite Aid and get it off-label for kids, three years and older. Now for medical doctors like yourself, PAs, RNs, it tells you 19 years and over. So it's completely a different age bracket that they're recommending for prescribers.

MICHELLE: Well, let me clarify that, because there are multiple updates. That's the COVID recommendations for adults. There were two other missives that went out, pregnant women and children.

THACKER: It says there is no concern about getting vaccinated at any stage of pregnancy, “in any trimester.” Wow, this is simply not true. There’s real concern here in the medical literature.

Can I just correct you on one thing. It says, “pregnant people.”

Oh, God. We’re doing that again. Can you explain “pregnant people” to readers. I live in Spain and this political vernacular hasn’t worked its way into the Spanish language. When I tell physicians in Spain about “pregnant people” they don’t’ understand.

I then explain it to them and they start cracking up.

MICHELLE: This is the most politicizied term to sanitize a polical agenda. It’s an attempt to include trans langauge into the basics of healthcare, at its foundation. This language didn’t exist from the NY state department of health a few years ago.

THACKER: So let’s look at what NY recommends for children.

MICHELLE: For children, the thing that I noticed right away that was concerning: well, on all of these documents, they hide that FDA is not recommending this. They don’t tell you up top, in a first bullet point. It's way further down. I’m still going through all the new advice we’ve been given.

But the first bullet point states that all children age six to 23 months should be vaccinated. The second says children and adolescents ages two to 18 years who fall in these subgroups can be vaccinated

THACKER: And by “subgroups” they mean these are kids with comorbidities, increased risk for disease.

MICHELLE: Wait so that's the first two points. And then third point states that vaccine may also be provided to children ages 2 to 18 who do not fall into one of the above categories, at the request of their parent or guardian.

So, it's a blanket, it's a catch-all, covering all kids. And when you combine that with the other documents, you see that we're doing everybody.

THACKER: All ages, unless you’re a newborn, less than six months.

MICHELLE: These documents should say very clearly at the top that they don't have the role of the FDA. And maybe that this is a new vaccine from June 2025. Have they reviewed all those studies that the FDA reviewed to approve this newest vaccine? I'm just confused. Who’s taking accountablity for this if some kid is harmed?

Kathy Hochul?

They're taking a regulatory authority they don't have. Did they examine the safety data on these vaccines? The FDA is the one that's supposed to do that. I don't know if they're able to operate in the role of the FDA and give this guidance

Governoer Kathy Hochul released an emergency order to allow this off label use for a month. And I don't see that there either in any guidance, which is also misleading. They’re releasing guidance for the season, but the emergency order only covers this next month.

I don't see anything on there saying this is for the month of September.

THACKER: The other weird thing is on the second page for the adults. It explains the underlying medical conditions that increase the person's risk of severe COVID-19 and it says “physical activity.”

I mean, what the hell? Is this like, “Did you exercise?”

MICHELLE: I know. I'm so curious about that. I'm still pulling everything apart. I want to look at the medical citations. I don't even think that was cited.

So physical activity, that's wild. And I don't understand. I don't understand. Your moderate activity that keeps you healthy, keeps your cholesterol down, your blood pressure down, is what they actually say is putting you at risk for severe COVID.

THACKER: What is all this craziness doing to you and your colleagues?

I'll just let you know, I got a message from a nurse in New York City who told me that her other nurse colleagues are going to their union asking, “What do we do?”

MICHELLE: I think there's like an ethical and moral dilemma going on in healthcare because people—nurses and doctors—are living privately in a different way than they have to practice publicly. And that's the truth.

I mean, look at the uptake rates. Even in the department of health admits that COVID vaccination for small children's is like 3.4%. Wouldn't that indicate that almost 97% of people are not wanting to vaccinate their children for COVID?

THACKER: Who comes to you to get their kids vaccinated for COVID?

MICHELLE: It's a very niche, small group of people. However, there are people that come in to get vaccinations and are told they need to get the COVID vaccine and do it because they're told. They can be convinced into it, but even among that group there is more and more people that aren't.

But this other group are—I would say are separate—that are almost religious in this quest to get vaccinated. It's like a moral belief. “This is the correct thing to do.”

THACKER: What does this do to you as a doctor? You know what the FDA is saying, and you're reading the medical literature. And then you're getting this guidance coming in from New York state telling you what to do.

If a patient said, “I want the COVID vax.” Would tell them what the FDA says? Or do you gotta shut up because you wanna preserve your job?

MICHELLE: It's very, very tricky. It's a very fine line. The core of my practice is patient education and informed consent for every medication. When people ask for medications that I have feelings about or don't agree with, I usually have an exploratory conversation.

“Why do you think you'd like that medication?”

Hear their thoughts and get to the core, the issue. I share information with them as neutrally as possible to help them make the best decision, but it is a tightrope walk. I do not involve politics in any way. I think it's an unhelpful, because my goal is to provide good healthcare. And I think that has to be apolitical.

I don't judge anyone on their politics or beliefs. I don't judge anyone about their choices to get COVID vaccination. I do feel negatively towards healthcare. Agencies and institutions that don't share information with their patients. It's unfair. You're basically using fear-based narratives to sway thinking.

And then again, this is America. If you want to get a shot, you should be able to get a shot. But you have to be told also what your risk-benefit ratio is, just like with any product.

THACKER: Would you feel comfortable if someone came in to get a five-year-old vaccinated for COVID, would you feel uncomfortable telling them, “Well, I just wanna let you know that neither I nor any of my colleagues are getting our children vaccinated for COVID.”

MICHELLE: The states that I practice in are particularly regressive and hostile. They have pursued suspending and revoking licenses for providers that asked questions that in any other situation would be normal to ask.

I've seen colleagues threatened or called racist by hospital administration for suggesting we restrict travel to China at the beginning of the pandemic—when it originated in China. If you look at the swine flu pandemic, that's exactly what they did was restrict travel. That's a normal pandemic measure for centuries.

So this is a very strange, politicized moment in time. And there are many, many providers who will privately practice differently than what they prescribe to their own patients. I have never worked in healthcare like this.

I can’t even ask the state department questions about some of this because that might flag me to a licensing board.