By Julie Steenhuysen and Chad Terhune
(Reuters) -U.S. government lawyers attempted to block a vaccine skeptic appointed by Health Secretary Robert F. Kennedy, Jr. from assuming new powers at the Centers for Disease Control and Prevention that could be used to restrict access to COVID-19 shots, two sources familiar with the matter told Reuters.
Retsef Levi, a professor of operations management at the Massachusetts Institute of Technology, serves as an outside adviser to the government on vaccines. He
was elevated to the head of a work group with CDC on COVID immunization in August.
At the same time, new rules published by CDC would allow him to appoint other panel members, set the work priorities and shape recommendations on who should receive COVID-19 vaccines.
Lawyers at the Department of Health and Human Services "expressed legal concerns" about the widened scope and Levi’s outsized role in the group and proposed that government officials narrow its purview to topics "that are within the scope of the CDC mission," according to an August 25 email to federal health officials that was read to Reuters.
The lawyers feared that Levi’s mandate would violate the Federal Advisory Committee Act, which governs how advisory panels operate within the federal government. Under that federal law, the lawyers wrote, the CDC "maintains responsibility to define agendas, scope of topics addressed and membership," not the work group chair, who is Levi in this case.
LAWYERS CHALLENGE KENNEDY ADVISER
Levi has publicly claimed government lawyers tried to narrow his work to prevent the group from addressing topics such as vaccine-related injuries.
"I could not accept that," he said in an August 31 interview on the journalist Maryanne Demasi’s Substack. "As it turns out, they were wrong, because it is in our scope, and now we intend on examining these issues."
In the end, the HHS legal counsel’s concerns were not addressed, and federal lawyers did not approve the final rules that were posted Aug. 20, according to an email exchange between the lawyers and federal health officials on August 25 that was read to Reuters.
Levi referred a request for comment to HHS. In a statement to Reuters, HHS spokesman Andrew Nixon said all legal concerns were addressed.
"The COVID-19 workgroup is advisory only, and CDC/HHS officials retain responsibility for scope, membership, and agendas. We are confident our process is legally sound," Nixon said.
The objection of HHS lawyers to Levi’s role and the scope of his work group have not been previously reported.
CONCERNS ABOUT VACCINE ACCESS
The move is the latest example of Kennedy’s upending of vaccine policies since taking office this year that critics say will make it harder for Americans to get protective immunization against major illnesses.
The CDC was thrown into chaos after Director Susan Monarez was ousted in August, prompting three top CDC officials to resign over what they described as threats to the agency’s scientific independence.
Levi shares Kennedy’s views that the mRNA vaccines used widely during the COVID pandemic can cause serious harm and death and has called for their removal from the market. Their stance runs counter to scientific studies showing the shots reduced deaths and complications from COVID, while instances of serious harm were exceedingly rare.
Levi was first named in June as a member of an external advisory board to the CDC that provides recommendations on how vaccines should be administered to Americans. Then in August, Levi was chosen to lead the vaccine board's work group on COVID immunizations.
The COVID work group rules described an ambitious set of topics for Levi to explore. They include investigating theories, often promoted by COVID vaccine skeptics, that mRNA shots could contain contaminated DNA or allow the coronavirus’s spike protein to linger in the body of a vaccinated person.
POTENTIAL LEGAL CHALLENGES
Health experts say such questions related to vaccine safety are supposed to be taken up by the Food and Drug Administration, which is responsible for evaluating vaccine safety and efficacy, and deciding which shots are approved for the U.S. market.
"What they've done is disrupt the process and procedures … that have worked well and that have been traditionally used – all in support of predetermined ideologies," said Dr. Gregory Poland, a vaccine expert who has served on previous CDC vaccine advisory panels.
Outside legal experts say the failure to heed advice of HHS counsel could lead to court challenges and undermine recommendations made by the vaccine board, which is scheduled to meet this week to consider COVID shots.
"You want to ensure that you’re setting agendas and making decisions in a manner that’s compliant with the statute. It subjects you to legal risk if you go against the law," said Richard Hughes, a partner at law firm Epstein Becker Green in Washington, D.C.
Hughes is lead counsel in a lawsuit filed in July challenging Kennedy’s decision to remove the COVID vaccine from the CDC’s immunization schedule for children and pregnant women.
(Reporting by Julie Steenhuysen in Chicago and Chad Terhune in Los Angeles; Editing by Michele Gershberg and Michael Learmonth)
