A legal win in vaccine policy fight, but the battle isn’t over

A federal judge has halted some controversial vaccine policy changes put in place by Health Secretary Robert F. Kennedy Jr., but the legal battle is far from over.

The Trump administration is planning to appeal the ruling.

Public health advocates, in addition to working to prevent Kennedy’s changes on vaccine policy, relished the decision by a federal judge this week. They are also engaged in a larger legal battle to block other moves the health department has made relating to vaccine guidance.

Dr. Georges Benjamin, CEO of the American Public Health Association, tells Chief Healthcare Executive® that he’s glad the judge recognized the argument of public health groups.

“We were elated,” Benjamin says. “I mean, we were pretty confident that we were right in our perspectives, but we were glad to see that the judge agreed with us.”

The American Academy of Pediatrics, the American Public Health Association, the American College of Physicians, and other groups filed a lawsuit last July aiming to undo Kennedy’s big changes in vaccine policy. The suit cited changes in vaccine guidance for COVID-19 vaccines and the overhaul of a key panel advising policies on vaccines. That lawsuit was filed months before the health department revised the childhood vaccine schedule.

‘In a great position’

U.S. District Court Judge Brian E. Murphy of the District of Massachusetts issued an injunction Monday temporarily blocking the health department’s changes in recommendations to the childhood vaccine schedule. Many medical societies and healthcare organizations opposed those changes, saying they endanger public health and were made without scientific evidence or a thorough review.

Among the changes: the government was no longer recommending the flu shot, saying it should be a shared decision with parents. The health department also dropped its guidance for all kids to get respiratory syncytial virus (RSV), meningococcal disease, hepatitis A and hepatitis B vaccines. The department said it was recommending them only to certain high-risk groups. But the ruling blocks that guidance, at least for now.

The court ruling also blocks Kennedy’s shakeup of the Advisory Committee on Immunization Practices, a federal panel offering guidance on vaccine policy. Kennedy fired the panel’s 17 members last June, and critics say the new committee members were less qualified, with some being skeptics of vaccines.

In addition, the judge’s decision blocks other changes, including revised guidance on the COVID-19 vaccine. The health department last May dropped its recommendation for pregnant women and healthy children to get the COVID-19 vaccine. And the ruling also reverses the health department’s guidance that the hepatitis B vaccine is no longer recommended for all kids.

Benjamin says even though the ruling is a preliminary injunction, he hopes it’s the beginning of a return to normalcy in federal health policy.

“It stalls it for now,” Benjamin says. “We still need to have the debate on the merits of the case, but we do believe that we're in a great position to return the immunologic process, the vaccination process in our country, back to the high quality, evidence-based practice that we had two years ago.”

Murphy ruled that the health department didn’t follow proper procedures in making changes to the vaccine schedule.

“The Government bypassed ACIP to change the immunization schedules, which is both a technical, procedural failure itself and a strong indication of something more fundamentally problematic: an abandonment of the technical knowledge and expertise embodied by that committee,” Murphy wrote in the ruling.

The judge also wrote that the health groups filing the suit are likely to succeed in showing the changes to the vaccine schedule and the overhaul of the advisory panel violated the federal Administrative Procedure Act.

The health department isn’t rolling over after the court ruling.

Andrew Nixon, a health department spokesman, told the Associated Press, “HHS looks forward to this judge’s decision being overturned just like his other attempts to keep the Trump administration from governing.”

The health department said it was following an executive order from President Trump. The president issued the order in December directing the agency to examine the childhood vaccine schedule in comparison with other countries. The health department announced its slimmer vaccine schedule in January.

Benjamin says he’s as confident “as you can ever be,” even as he acknowledges that the court action continues.

“This basically takes things back to the way they were before, as we argue the merits of the case,” Benjamin says. “And so we hope … an appeals court will agree that Judge Murphy was very clear and follow the law, and that the fact is, even though they may appeal, we hope, and believe, that the appeals court will will see our way forward, realizing that Judge Murphy was very clear, that he believes that we would win on the merits, as the case continues to proceed.”

‘A science-based process’

Andrew Racine, MD, president of the American Academy of Pediatrics, said in a statement that the court ruling this week “is a historic and welcome outcome for children, communities, and pediatricians everywhere.”

“This decision effectively means that a science-based process for developing immunization recommendations is not to be trifled with and represents a critical step to restoring scientific decision-making to federal vaccine policy that has kept children healthy for years,” Racine said.

The American Academy of Pediatrics has kept its vaccine guidance intact, including recommendations of the flu shot.

In December, the health department terminated millions of dollars in grants to the academy for pediatric health initiatives, The Washington Post reported.

After the court ruling, Racine said that the academy has historically worked with the federal government.

“We would much prefer to return to that partnership and collaborate with federal healthcare agencies instead of litigating against them,” Racine said.