FDA to tighten vaccine rules after memo ties COVID-19 shot to child deaths

 The Food and Drug Administration (FDA) is set to implement stricter vaccine approval guidelines after a memo claimed at least 10 children died “after and because of” receiving a COVID-19 shot.

The guidelines, obtained by The New York Times, could also impact vaccinations for other illnesses and viruses, including the FDA’s standards for annual flu shots and if Americans should receive multiple vaccines at a time. The memo also states that shots for pregnant women could be limited, and manufacturers will be required to conduct larger studies before seeking approval for vaccines.

Vinay Prasad, a top vaccine regulator at FDA, said pneumonia vaccine manufacturers must show that their treatments reduce the infection instead of merely developing antibodies to fight it. The new restrictions would also require drug manufacturers to run larger studies that would slow the process of developing vaccines, according to The Washington Post, which also reviewed the memo.

Prasad, who was reinstated to his post in August after being ousted amid conservative criticism, announced other changes that included a requirement for randomized studies to include all subgroups. He also referred to the annual flu shot framework as a “catastrophe of low-quality evidence,” the Times wrote.

“It’s not like these things are being approved without strong scientific evidence,” Jesse Goodman, the FDA’s former chief scientist, told the Post, noting that guidelines are already “quite strict.”

“They’re being approved with strong scientific evidence,” Goodman added.

The memo does not go into detail about the alleged COVID vaccine-related child deaths.

Prasad called the finding “a profound revelation,” according to the Post.

“For the first time, the U.S. FDA will acknowledge that COVID-19 vaccines have killed American children,” he said.

The Hill has reached out to the FDA for comment.

FDA Commissioner Marty Makary told Fox News on Saturday that the data on the vaccine-linked child deaths were “accumulated during the Biden administration,” Reuters reported.

The stricter guidelines fit with Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr.’s skepticism of vaccines. Kennedy earlier this year resurrected the long-defunct task force on the safety of childhood vaccines.

Critics said that bringing the panel back would further undermine public confidence in vaccines.

“It’s another politically-controlled forum that can be used for bad messaging and to make investment in and production of vaccines less viable,” Dorit Reiss, a law professor at University of California Law San Francisco, previously told The Hill. “Secretary Kennedy has worked to undermine vaccines for 20 years; this likely seems to him like another tool to make vaccines less accessible.”

In August, the FDA said it was considering revoking the emergency use authorization of Pfizer’s COVID-19 vaccine for healthy children younger than 5 years old. The agency also approved the use of updated vaccines for “high risk” people.

Routine COVID-19 shots are no longer recommended for healthy children and pregnant women.

https://thehill.com/policy/healthcare/5626374-fda-vaccine-rules-child-covid-deaths/