A stern warning about off-label use
SHOTS HEALTH NEWS – 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.
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 … READ MORE.