FDA plans stricter vaccine approval rules

FDA plans stricter vaccine approval rules

The FDA plans to tighten vaccine approval standards, requiring more evidence of safety and efficacy. Georgia doctors warn the move could discourage vaccination and reduce vaccine development. The changes come amid shifts in federal health leadership and CDC language on autism and vaccines.

The Food and Drug Administration is preparing to toughen the vaccine approval process, requiring manufacturers to provide more evidence that their shots are safe and effective before they can reach the market.

What we know:

The move comes as top federal officials question the safety of COVID-19 vaccines for children, according to multiple reports.

NPR reports that the FDA’s top vaccine regulator, Dr. Vinay Prasad, told staff in an internal memo the agency plans to overhaul its long-standing flu vaccine framework and update vaccine labels to be "honest."

According to the NPR report, the FDA would no longer authorize vaccines for pregnant women without stricter safety data and pneumonia vaccine makers would need to prove their shots reduce disease, not just show they trigger an antibody response.

Dr. Cecil Bennett, medical director of Newnan Family Medicine Associates and a member of Gov. Brian Kemp’s Healthcare Workforce Assessment Board, cautioned that while research should continue, delaying vaccinations could put people at risk.

"What we cannot do is not vaccinate people, waiting on additional research when we pretty much know the efficacy of vaccines already," he said.

These changes follow several others the Trump administration made surrounding vaccines. 

What they're saying:

Dr. Robert Wiskind, past president of the Georgia Chapter of the American Academy of Pediatrics, criticized the changes.

"This is yet another example of the Trump Administration putting politics above child health," Wiskind said.

"It’s misguided. I think it’s not science-based… Parents have questions, and they’re not getting good, science-based evidence from our nation’s health leaders."

Dr. Bennett also criticized recent federal policy shifts.

"The Department of Health and Human Services has been on a vendetta to completely change vaccination guidelines based on quack medicine."

Dr. Wiskind warned that stricter rules could push vaccine makers out of the market.

"The more hurdles that are placed before vaccine manufacturers, the less incentive they have to stay in the market… and develop new vaccines."

Some Georgia doctors worry the new policy could discourage patients from getting vaccinated.

Dr. Bennett said vaccines have been rigorously tested for decades.

"I don’t think one can argue with the need that there should always be additional research," Dr. Bennett said. "Vaccines have clearly been one of the most significant medical breakthroughs we’ve had over the last hundred years. Diseases like smallpox, diseases like polio, diseases like measles are all eliminated because of vaccines."

As for concerns that health insurers may stop covering vaccines, Dr. Bennett said that is unlikely.

He explained that insurers base coverage decisions on their own data, not directly on federal guidance.

The other side:

FOX 5 has reached out to HHS and is awaiting a response.