The Impact of Growing Demand For Unauthorized Covid Vaccine Booster Shots

The combination of the fast spread of the Covid Delta variant, Pfizer's push for official approval of boosters - which may or may not be tied to its profit projections - on top of news that Israel and Germany are providing them  is causing a growing number of Americans to seek boosters. 

While there are plenty of vaccines doses now, it may not be the case in the near future if, as expected, children under 12 are approved for inoculation. The more doses kept in the US, the fewer there are to share with countries whose vaccine deficit is having a negative affect on the global economy. JL

Rachel Cohrs reports in Stat:

The buzz around booster shots for Covid-19 vaccines has intensified in recent weeks as Pfizer has sought approval for a third shot of its vaccine regimen, and Israel, the United Kingdom, and Germany have greenlit additional shots. Some anxious US patients are trying to get them either by asking a health care provider willing to prescribe an extra shot, or by lying about their earlier vaccination. Some states don’t require providers administering the shots check beforehand. Because vaccine supplies have been so plentiful, ensuring patients aren’t overloading on vaccines hasn't been top of mind

WASHINGTON — The entire U.S. health care system has been single-mindedly focused on getting Covid-19 vaccine shots in arms, but as the Delta variant spreads, the country’s decentralized vaccination campaign is presenting a different challenge — how to police people seeking unauthorized booster shots.

The buzz around booster shots for Covid-19 vaccines has intensified in recent weeks as Pfizer has sought approval for a third shot of its vaccine regimen, and Israel, the United Kingdom, and Germany have greenlit additional shots. Federal officials in the United States say that booster shots are not needed yet. But some anxious patients are nonetheless trying to get them — either by asking a health care provider willing to prescribe an extra shot, or by lying about their earlier vaccination.

That puts the onus on hospital systems to make prescribing policies, on vaccination sites to check people’s vaccine records, and insurers to decide whether they will cover vaccines outside of the Food and Drug Administration’s authorization.

The Centers for Disease Control and Prevention is just starting to track data about unauthorized booster shots, Director Rochelle Walensky said Monday. She said the government can discern the difference between second and third shots, and is encouraging people to report safety outcomes if they receive boosters, though they are not recommended.

“We have the capacity and are looking at those data right now,” Walensky said. The data are not yet public.

Those at Walgreens and CVS, have explicit policies not to give additional shots to people who have been fully vaccinated. But they may not always be checking to ensure that that’s the case.

When patients arrive at vaccination sites, they usually have to fill out a consent form that asks whether they have been vaccinated before. In an ideal world, vaccinators would check the information on those forms against state vaccine registries to validate that patients are telling the truth.

“For this idea of boosters, it’s going to be hard to control. You just have to rely on local public health departments and local providers to prevent that from happening,” said Ajay Sethi, an associate professor of population health sciences at the University of Wisconsin-Madison.

In reality, some states don’t require that providers administering the shots check beforehand, and the Covid-19 vaccination mobilization brought in many new providers who may be doing the bare minimum, said Rebecca Coyle, executive director of the American Immunization Registry Association.

Because vaccine supplies have been so plentiful in recent weeks, ensuring patients aren’t overloading on vaccines hasn’t necessarily been top of mind for providers, Coyle said.

“Reviewing a person’s history before administration has been the best practice for many years,” Coyle said. “It’s time for a conversation about, ‘Maybe I should do that,’ as it hasn’t been on everyone’s minds yet.”

If pharmacists don’t check immunization records and a patient receives an unauthorized shot, that could leave providers without payment if insurers deny the claim.

“They don’t have any incentive to say, ‘Hey, come get your third dose,’” said Kurt Proctor, senior vice president of strategic initiatives at the National Community Pharmacists Association.

Kristine Grow, a spokesperson for AHIP, the biggest health insurance lobby, said the group has had no indication that anyone is having trouble getting a third shot covered when it is recommended by a physician.

However, Aetna said that based on current guidelines from the CDC, the insurer does not cover additional Covid-19 shots for fully vaccinated patients.

Health insurer Anthem is monitoring the situation closely, a spokesperson said, and is watching for guidance as to whether additional shots are advisable or necessary.

“That said, any claims for COVID shots that we receive would be paid with no cost sharing for the member, just as they have been since the vaccine became available,” said Michelle Vanstory, Anthem’s vice president for external communications.

The American Medical Association on Friday unveiled a billing code for a Pfizer booster shot that could help insurers track them, but the code will not be active unless the FDA authorizes the third shot.

If providers do catch patients trying to get booster shots, it could be an opportunity for a conversation about current recommendations as opposed to a situation that would escalate.

“People are frightened, and they are not sure what to do,” Coyle said. “There are so many reasons why someone would be motivated to seek an additional shot and it’s hard to catch all of those, so registries can be leveraged to ask questions.”

Aside from just presenting at a vaccination site, patients can have conversations with their doctor about prescribing a third shot outside of the FDA’s authorization. That’s leading hospital systems to develop policies on whether they will allow physicians to prescribe boosters.

Mount Sinai Health System said it does not endorse prescribing booster shots, and said any providers administering extra doses will receive a notice and will have to fill out extra paperwork to help collect safety data.

“The current surge in numbers of individuals with Covid-19 is directly related to individuals declining to be vaccinated, not the need for more vaccines to those who already have been vaccinated,” Mount Sinai Chief of the Division of Infectious Diseases Judith Aberg and George Baehr, a professor of clinical medicine at Mount Sinai’s medical school, said in an email.

The Mayo Clinic, University of Washington Medicine, and Wellforce Health System are also not providing booster shots, spokespeople said. AMA President Gerald Harmon said in an email that the group supports the FDA and CDC position as well.

Associations of specialty physicians who serve immunocompromised patients are also working on guidance, as their patients may be good candidates for boosters in the future. Ted Okon, the executive director of the Community Oncology Alliance, said the group’s leadership is tracking the issue and working to develop guidance. The American Society of Transplantation advised members that there isn’t enough evidence to recommend booster shots, or guidance on when they should be given.

Beyond effectiveness, Deepali Kumar, the president-elect of the American Society of Transplantation, said the organization is keenly aware of the health equity concerns if some patients have more resources to track down unauthorized shots or travel to vaccine sites than others.

“It plays a big role, when we make recommendations for anything, that we want to make sure that all the patients have equal access,” Kumar said.