Off-Label COVID Vaccines Can Expose Physicians to Liability
By Emma Freer

The Biden administration’s plan to make booster doses of the COVID-19 vaccines available as soon as Sept. 20 – which came and went on Monday without that availability – has raised questions among physicians about liability for giving the extra shots before they are fully approved.

Although President Joe Biden has said the plan is contingent upon Food and Drug Administration (FDA) approval and eligibility recommendations from the Centers for Disease Control and Prevention (CDC), the announced start date may prompt patients to seek out – and physicians to consider administering – booster doses before those conditions are met, which would be considered off-label use. FDA has authorized a third dose of the COVID-19 vaccine for certain immunocompromised patients by amending the emergency use authorizations for both the Pfizer and the Moderna COVID-19 vaccines on Aug. 12. Less than two weeks later, the federal agency also granted full approval to the Pfizer vaccine for people aged 16 and older, leading to confusion over off-label use, including for unapproved booster shots.

TMA staff point to CDC guidance, which makes clear that off-label use of the Pfizer vaccine remains unauthorized, including boosters for people who don’t meet the immunocompromised criteria.

Physicians who administer such doses may not be covered under the federal Public Readiness and Emergency Preparedness (PREP) Act, which protects physicians and other health care professionals involved in the use, manufacturing, distribution, and administration of certain medical products to combat a public health emergency, according to CDC. As a result, they may not have immunity from legal claims. (As always with legal matters, TMA urges you to contact your own counsel for specific legal advice.)

There are other risks. Administering unauthorized doses violates CDC’s COVID-19 Vaccination Program, which distributes the country’s entire vaccine supply to enrolled health care professionals, facilities, and organizations. Physicians who violate the program requirements may not be paid administration fees and could be kicked out, according to CDC.

During an Aug. 30 meeting of CDC’s Advisory Committee on Immunization Practices (ACIP), members discussed the impact – including potential liability – of the Biden administration’s announced plan, which preempted federal regulators’ endorsement and could cause blowback for physicians.

“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,” said ACIP member Helen Keipp Talbot, MD, an infectious disease specialist at Vanderbilt University.

On Sept. 17, the FDA's Vaccines and Related Biological Products Advisory Committee recommended authorizing Pfizer boosters for people who are 65 or older or at high risk of severe COVID-19 cases. (The panel voted against recommending a Pfizer booster for people 16 and older.) ACIP is scheduled to meet tomorrow and Thursday to discuss booster eligibility recommendations, which will likely focus on certain high-risk populations, such as health care workers and long-term care facility residents.

Last Updated On

September 20, 2021

Originally Published On

September 20, 2021