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Critics slam health secretary after FDA memo links COVID vaccine to childhood deaths

The memo represents another escalation of broadsides on vaccines by federal authorities under Kennedy, who has used his position as secretary to repeatedly raise doubts about inoculations and name other sceptics to positions of authority.

Kennedy’s team has issued new policies that are limiting access to the COVID shots to people 65 and older as well as to younger people with underlying medical conditions. He and FDA officials have also called for more studies of existing vaccines that have been considered safe for decades.

Health officials in the first Trump administration, when the vaccines were developed during the pandemic, and in the Biden years, strongly endorsed the COVID shots as lifesaving measures. Public health experts have pointed to the number of lives saved by the COVID vaccine and to the fact that the virus caused more than 1 million deaths among Americans. About 2100 children have died of COVID since the pandemic began, according to the American Academy of Pediatrics.

Robert F. Kennedy has the ear of US President Donald Trump and spearheads the Make America Healthy Again movement.Credit: AP

Prasad’s memo is landing just before next week’s meeting of the Centres for Disease Control and Prevention’s influential vaccine committee. Kennedy’s handpicked panel includes supporters of the so-called medical freedom community, who often reject vaccination and oppose mandates. The committee is expected to discuss the children’s immunisation schedule and the hepatitis B vaccine for newborns.

Michael Osterholm, a critic of Kennedy’s health agency oversight and an infectious disease expert at the University of Minnesota, said he believed the memo was intentionally released before the meeting.

“This is an irresponsible way to deal with a very critical public health issue like vaccination and adverse events,” he said.

Deadly diseases such as measles are on the rise in the US because of growing vaccine hesitancy.

Deadly diseases such as measles are on the rise in the US because of growing vaccine hesitancy.Credit: Getty Images

Among the changes Prasad outlined for oversight and approval were requirements that studies looking at people using a vaccine or a placebo include all subgroups, such as pregnant women. In addition, he described the annual process of updating flu vaccines to match a circulating strain a “catastrophe of low-quality evidence,” and said it would also be reexamined. (The chosen strain is at times a poor match.)

He also said companies would need to do larger studies before promoting vaccines as safe to administer together, such as the flu and COVID vaccines. And vaccine makers would need to conduct large, randomised studies of pneumonia vaccines to prove that they reduce cases of the disease rather than prove that they generate antibodies.

The changes would most likely raise costs for vaccine makers, which submit studies of their products to the FDA for review and approval decisions. Public health experts also warn that high-profile pronouncements suggesting that vaccines are not safe will erode confidence, as measles and whooping cough cases are soaring in the United States.

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Dr Paul Offit, a vaccine expert with the Children’s Hospital of Philadelphia and a critic of Kennedy’s vaccine policies, called the memo an example of science “by press release.”

He said it was missing context such as the number of deaths from the virus itself among vaccinated and unvaccinated children.

The vaccine letter followed Prasad’s recent missive exhorting staff members to refrain from publishing “obviously erroneous work” instead of studies that further the agency’s mission.

Prasad, whose leadership style has rankled some people inside and outside the agency, complained in the latest memo of staff members who disagreed with the vaccine division’s direction and new policies, saying they were leaking information. He then outlined how employees could submit their resignations.

This article originally appeared in The New York Times.

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