FDA, CDC consider change to rules for eligible for medical care

The government’s two top health advisers said Thursday that they might need to change the requirements for patients eligible for federal funding for vaccines because they haven’t always provided the required level of protection….

FDA, CDC consider change to rules for eligible for medical care

The government’s two top health advisers said Thursday that they might need to change the requirements for patients eligible for federal funding for vaccines because they haven’t always provided the required level of protection.

In congressional testimony Thursday, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, and Thomas Frieden, the director of the Centers for Disease Control and Prevention, were asked whether they would consider extending the requirement, currently set at 28 days of protection from a vaccine, to 90 days.

“As with anything with science and public health, we’ve got to constantly evaluate and consider the effectiveness, the benefits, the cost, the other side of the coin, and then make adjustments,” Fauci said. “It might be our view that some sort of a real strong progressive shake-up of the requirements might be needed at some point.”

Fauci and Frieden said that while no official decisions had been made, the FDA and CDC were considering updating the criteria for what’s now considered a “fully vaccinated individual” under the National Vaccine Injury Compensation Program, a federal program set up after a 1986 law that compensates victims of vaccine injuries and deaths.

One potential change would give parents the option of getting a second dose of a vaccine if they believed their children’s first one was not enough. Also, children who would be eligible for this option would be identified to ensure they have sufficient protection from the vaccine before the new requirements were implemented.

Vaccination programs are often subject to debate, both because of fears about the safety of vaccines and because they can be very expensive for families. Just two days ago, Vermont Gov. Peter Shumlin, D, said he would do away with an official annual mandatory childhood vaccination.

Fauci said he wasn’t sure that extension would save lives, but it could improve prevention.

“In terms of the safety of vaccines, of course, as you know, vaccines are very safe,” he said. “But looking at all sides of this, there are many parents who feel that those vaccinations only provided 40 days protection rather than the needed 100 days.”

Fauci and Frieden said the FDA and CDC had decided to address the possibility of further changes in a few months, after they had had more time to examine the problem, but a final recommendation would likely not be made before later this year.

Cristian Farias, a spokesman for the FDA, said officials had not discussed any possible new vaccine safety standards.

“At this time, vaccine safety is an FDA responsibility that includes holding manufacturers to responsible standards for potential side effects to vaccine programs,” he said. “When it comes to the agency’s approval criteria for patient requests and program applications to resubmit vaccines in support of products that were accepted, we do not expect any change to our current approval criteria.”

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