On March 8, the Food and Drug Administration (FDA) will start the public comment period for a new rule that will require doctors to inform patients that their flu shot may be linked to the spread of the pandemic, according to Reuters.
The rule is expected to be issued in the next few weeks.
In a statement, the FDA said the rule “provides clear guidance that nativiral therapies, including shots that contain the flu vaccine, are not linked to an increased risk of developing the pandemics coronavirus and SARS coronavosis.”
It also said the guidance “provide[s] clarity to physicians, health care providers, patients, and the public about the risks and benefits of the influenza vaccine.”
But critics of the rule say it will cause unnecessary pain and unnecessary suffering for patients, including by making it harder for them to receive needed flu shots.
“This is the wrong direction to go,” said Michael Greger, president of Americans for Vaccine Choice, a group that backs vaccination.
“They’re making it impossible for a person to get a flu shot.
That’s the bottom line.”
The rule also includes a provision that would make it easier for patients who don’t have insurance coverage to get flu shots if they can show they can afford it.
The proposed rule was submitted to the FDA by the American College of Physicians, which has called on the agency to update its guidance to “include additional information about the benefits and risks of flu shots and influenza vaccination.”
Greger noted that the proposal is meant to be “as transparent as possible” so that doctors can “communicate clearly with patients.”
The FDA is currently reviewing comments on the proposal, which is due to be voted on by the agency’s medical staff.
“It’s very important that we get this right,” Greger said.
The American College has been a vocal critic of the proposed rule.
In October, the group filed a public interest lawsuit challenging the new regulation.
The FDA has not yet responded to a request for comment from The Associated Press.
“There’s been an avalanche of misinformation about the influenza pandemic and the need for flu shots,” Greer said.
“I’m sure the FDA will be happy to make the necessary adjustments to the proposal so that people who want to get vaccinated can do so.”
The Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH) are leading efforts to educate Americans about the flu and to help prevent coronaviruses and Sars.
The agency also has a flu advisory committee.