HHS Misses Nov. 8 Deadline for Trump's Childhood Vaccine Plan as U.S. Measles Cases Reach 5,182

Since President Trump signed an executive order on Aug. 10 giving HHS 90 days to produce childhood vaccine plans, the clock has run out. The deadline fell on Sunday, Nov. 8, and officials were expected to miss it. No report has been made public.

Asked about the missed deadline on Tuesday, an HHS spokesperson sent a statement but no date. The agency "is actively implementing President Trump's Executive Order on Gold Standard Childhood Vaccine Recommendations," the spokesperson said. The HHS Task Force on Safer Childhood Vaccines is working to "strengthen vaccine safety research, improve transparency, and expand options for American families." The statement added that the work "requires careful scientific review."

What the order required

The order told HHS to present plans to offer core childhood vaccines, starting with MMR, as single shots rather than combination products. It also required that combination vaccines stay available.

It further directed the agency to assess "the ideal timing and sequencing of all core childhood vaccines" and to adjust the federal schedule "as appropriate based on gold standard science." A third mandate covered improving vaccine safety monitoring, transparency and research. Bloomberg reported the order also asks for alternatives to aluminum in some shots.

A promise with a date on it

Health Secretary Robert F. Kennedy Jr. appeared alongside the president at the signing. Bloomberg reported that Kennedy had unequivocally promised plans by Nov. 8. He said HHS would "not wait for the 90 day period" and that "within 90 days, as you have directed, we will deliver the full response required by this executive order." He also said: "We will bring you actions and findings as soon as they are ready."

People familiar with the matter told Bloomberg that HHS has already sent a draft of the plan to the White House. They were not authorized to discuss internal deliberations, and neither HHS nor the White House has confirmed that. Bloomberg also reported that officials were expected to miss the deadline.

Measles is the backdrop

The CDC had recorded 5,182 measles cases across 45 states as of Nov. 6. Bloomberg described it as the largest outbreak the country has seen in decades. Pennsylvania has the most infections and has confirmed six measles-associated deaths.

New York reported its first measles death in three decades on Nov. 2. Three days later, Wisconsin announced its first fatality, an infant. The federal government has yet to acknowledge all of the deaths after Kennedy called into question the legitimacy of the first deaths in Pennsylvania, sparking a political fight with Governor Josh Shapiro. The CDC is working with a group of epidemiologists to determine a national definition of a measles death.

The Pan American Health Organization is set to convene to formally determine whether the U.S. has seen continued transmission for more than 12 months. A yes would trigger the loss of the country's measles elimination status.

Two doses of the MMR vaccine are considered 97% effective at preventing the disease. Merck and GSK make the MMR vaccines.

The objections

Public health specialists object both to the content of the order and to the process. Elizabeth Jacobs, PhD, a professor emerita of epidemiology and biostatistics at the University of Arizona and a founding member of Defend Public Health, said the concern with the report, "should it ever materialize," is that it will be "more textual squid ink that accomplishes nothing other than reinforcing unfounded doubts about vaccines that have been cultivated by the HHS secretary for decades."

Jacobs also said the MMR focus comes "when we are in the midst of an uncontrolled measles outbreak that is likely to result in the U.S. losing its measles elimination status this week or next." In her view, the effort should go into a public health campaign promoting the existing MMR vaccine, "the only measles vaccine we have at our disposal."

The Infectious Diseases Society of America objects to who is making the recommendations. "Any changes to vaccine recommendations should be made by a legitimate, legal ACIP whose members have the relevant expertise and who have been thoroughly vetted and appointed through the standard process," said Amanda Jezek, the society's senior vice president of public policy and government relations. She also said some of the vaccines discussed for separate offering "are not even manufactured as separate vaccines and there is no scientific justification to separate them."

HHS frames the effort differently. Its statement describes the goal as "gold standard science and informed parental choice," including more options for families.

Who sits on the task force

Top health officials sit on the task force making the plans, and by law, officials leading the top U.S. health agencies must have a seat in the group. The director of the National Institutes of Health chairs it, and it also includes the CDC director and the commissioner of the Food and Drug Administration.

What comes next

The order set a deadline and HHS did not meet it, though a draft reportedly exists. No new date for the final report has been announced.

The PAHO determination is the next fixed event on the calendar. Whether the task force report lands before or after it is an open question.