Health care providers who administer a COVID-19 vaccine "off-label" face legal liability, the Centers for Disease Control and Prevention warns. Luis Alvarez/Getty Images
Some Americans are already lining up for COVID-19 booster shots, but the Centers for Disease Control and Prevention is warning that administering doses of the vaccine in ways that aren't OK'd by the federal government could put health care providers at risk of lawsuits and leave patients with unexpected bills.
These so-called "off-label" uses include giving the vaccine out as a booster shot to people who are not immunocompromised, or using it to vaccinate children under the age of 12 for whom the shot is not yet authorized.
In fact, more than 1.1 million people have already received unauthorized shots of a COVID-19 vaccine, according to numbers provided by the CDC in mid-August.
On Aug. 23, the Food and Drug Administration approved the Pfizer vaccine for use in adults and teens ages 16 and over. It's a move that health experts hope will lead to more vaccine uptake among the hesitant; many also worry it will lead to more off-label use among the eager.
The FDA approval of the vaccine has led some doctors and other health care providers to assume the Pfizer shots can now be administered off-label. That's when a medical product is prescribed in a way that deviates from how it's officially been approved to be used. (Get it? The use is not on the label.) But federal health officials say vaccine providers are taking a risk when they go outside the official guidelines for the COVID-19 vaccine.
A stern warning about off-label use
The Biden Administration announced a tentative plan on Aug. 18 to start rolling out boosters for the general population beginning on Sept. 20. Patients would be eligible for their third shot eight months after receiving their second dose of Pfizer or Moderna, the administration said.
But that decision isn't actually final yet. The FDA and the CDC's Advisory Committee on Immunization Practices (ACIP) first need to OK the move, and that hasn't happened.
Until then, administering these extra doses would be considered off-label.
And at an ACIP meeting Aug. 30, Dr. Demetre Daskalakis, a senior CDC official, warned that administering the shot off-label could be a dangerous decision for health care providers in the event that something goes wrong.
"Providers may not have immunity from [legal] claims," Daskalakis said.
Health care providers administering the vaccine off-label may not be granted liability protection under the Public Readiness and Emergency Preparedness Act, the agency says. That means providers could be sued by patients in the event of injury, or if something else goes wrong — legal actions they are protected from as long as they're administering shots in accordance with federal rules. They would also be violating the provider agreement they signed with the CDC to be able to give out COVID-19 vaccines, which means they could be kicked out of the program.
And even patients could run into trouble.
Although the cost of administering the vaccines has been free to patients, insurers wouldn't necessarily be required to cover an off-label shot. NPR reached out to the health insurance trade group, America's Health Insurance Plans, to see how its members were handling off-label COVID-19 shots, but the trade group did not respond.
What's more, patients are eligible for certain benefits through the Countermeasures Injury Compensation Program if they're one of the rare few who experience a serious injury as a result of a vaccine. But if patients receive a dose off-label, they may no longer be eligible for that sort of compensation, the CDC says.
For now, states are telling providers to wait until boosters are officially OK'd by the federal government before administering them. (Some people whose immune systems have been suppressed by certain illnesses or their treatment are already formally eligible for third doses of Moderna or Pfizer shots.)
Erin Fox runs COVID-19 vaccine clinics for the University of Utah Health hospitals. She and her colleagues are preparing to offer booster shots in a few weeks, but are holding off for now.
"We don't want to risk not being able to access vaccines," Fox says. The state controls the supply and has issued clear communication to wait for the federal government's full blessing before administering boosters, she says.
"The state is going to know how we're using it because we report in with every dose," she says. "It goes straight to their database. So it's fairly easy for them to see when a patient has had three doses or four doses."
A "vague" legal threat? CDC warning rattles some doctors
Dr. Helen "Keipp" Talbot, an infectious disease doctor at Vanderbilt University Medical Center, says some providers have been administering boosters anyway — especially in areas of the South hit hard by the Delta variant.
"Many, many, many hospitals have already started vaccinating healthcare workers with third doses — and [vaccinating] patients," says Talbot.
Health systems in San Francisco and Colorado have also announced that they're giving additional shots to specific groups — for example, people who got the Johnson & Johnson shot — beyond what is currently recommended by the FDA and CDC.
The CDC's warning against off-label boosters prompted Talbot to speak up at the CDC's vaccine advisory committee meeting earlier this week: "That is very frightening to me that health care providers are trying to do the best job that they can and now have put themselves at risk."
Experts in health care law told NPR that the CDC's threats are vague, and it's not clear that they would hold up in court. "Off-label prescribing [for other drugs] happens every single day," says Ana Santos Rutschman, assistant professor at the Saint Louis University School of Law. "Probably a fifth to a quarter of drugs being administered go through that pathway." This approach to prescribing is common with some adult medicines given to children, or with people who are pregnant if they were not included in clinical trials.
"At the end of the day, this might be less of a legal problem and more of a policy problem," with the CDC trying to dissuade people from getting unauthorized vaccines en masse, now that the Pfizer vaccine is fully approved, she says.
Govind Persad, assistant professor at the University of Denver Sturm College of Law, says since people are getting the vaccine off-label anyway, he would like to see more guidance.
"I think one danger — when you just say 'don't do this' in terms of harm reduction — is that you don't always give a pathway toward saying, you know, 'if you do this, here's how to do it in a way that is safer, or sort of does better in terms of a risk-benefit balance,' " he says.
A reason to wait for science before vaccinating young children
There are more than just legal reasons not to rush out for an off-label shot — particularly when it comes to kids.
Parents are eager to vaccinate their children under 12, who are not yet eligible for the shot. But Fox at the University of Utah says it's smart to wait until the scientific community can agree on specific pediatric dosing.
"They're not little adults," she says. "Thinking about other vaccines that we have. In some cases, the pediatric dose is actually larger than the adult dose, which is a little bit counterintuitive. In some cases, it's the same. In some cases, it's smaller. So it's not an exact linear prediction."
Dr. Yvonne Maldonado, a pediatrician at Stanford who's running a COVID-19 vaccine clinical trial for children, echoed this danger.
"The vaccine is a much higher dose than the vaccines that we're using in the trials for children under 11 — at least for the Pfizer vaccine" she says. "So I would worry that higher doses might create more [side effects] in younger kids."
For now, Fox tells people to be patient.
She and her colleagues will use the next few weeks to focus on getting immunocompromised people their third shots, which were authorized on Aug. 12, and to vaccinate others who haven't yet received their first or second shots.
The FDA announced Wednesday that its committee will hold a meeting Sept. 17 to review the data underpinning the safety and effectiveness of giving a third Pfizer shot as a booster to adults and teens ages 16 and over. (Moderna also announced this week that it is submitting data to the FDA to support the use of its vaccine as a booster shot).
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