'ACIP Members Show Inexperience, Lack of Understanding at First Meeting': Critics

 If observers were waiting for a moment when the newly anointed members of the CDC's Advisory Committee on Immunization Practices (ACIP) made a clear case against U.S. vaccine science, it didn't happen during the group's 2-day meeting

opens in a new tab or window last week.

Instead, panelists repeated old COVID grievancesopens in a new tab or window, re-litigated solved issues around thimerosalopens in a new tab or window and the measles, mumps, rubella, and varicella (MMRV) vaccine, and asked basic questions about epidemiologic methods underpinning high-quality science, some observers told MedPage Today.

"We have people who are asking questions of the CDC like it's a college epidemiology class, not understanding basic principles," said James Lawler, MD, MPH, of the University of Nebraska Medical Center's Global Center for Health Security in Omaha. "It's embarrassing for the United States and it makes me incredibly sad."

One sticking point for panelist Retsef Levi, PhD -- a professor of operations management at the Massachusetts Institute of Technology -- was that CDC's vaccine effectiveness studies used a test-negative design that he claimed oversampled for people who'd been vaccinated. An "alternative explanation," he said of the high number of vaccinated people in the study, "would be that the vaccine is actually making you more vulnerable for multiple viruses."

Ruth Link-Gelles, PhD, MPH, of the CDC's National Center for Immunization and Respiratory Diseases, who has been leading the agency's vaccine effectiveness studiesopens in a new tab or window for years now, explained that the cases are older people hospitalized with acute respiratory illness, and are at baseline more likely to be vaccinated than the general population.

"When you're up to 90% of those populations being vaccinated, of course you're going to have perceived over-representation of that population winding up in the hospital with COVID," Lawler told MedPage Today. "This is just a reflection of the fact that he doesn't understand basic principles of epidemiology."

A lack of understanding of decades of work in epidemiology and infectious disease was particularly on display when it came to panelists demanding randomized controlled trials (RCTs) for COVID vaccines, the critics said.

"In an ideal world, we would have RCTs for everything," Lawler said. "But you have to think about the practicality of doing that, the timeliness, the cost, the ethics of doing that. Is it ethical to randomize a high-risk person to placebo in 2025?"

He noted that the first test-negative studies confirmed what the initial COVID vaccine RCTs showed, and subsequent prospective cohort studies also aligned with those test-negative studies.

"You have all these data that give you a consistent arc from the beginning of the utilization of vaccines in the pandemic until now, where we've consistently reinforced the findings of these test-negative studies with other studies that are more rigorously executed," he said.

Nonetheless, FDA ex officio ACIP member Tracy Beth Høeg, MD, PhD, went so far as to say the CDC's vaccine effectiveness studies were misleading.

"I think I share with a lot of people on this panel the desire to see randomized controlled trials to minimize these types of bias," Høeg said. "So we aren't sitting here wondering if we're being misled by the data."

No epidemiologist or infectious disease expert would feel misled by CDC's vaccine effectiveness data, Lawler said.

"These are not serious, legitimate arguments by people who understand the science extensively," he added. "These are, generously, arguments that are made by people who don't really understand the epidemiology and how these vaccines are tested and evaluated."

There was no shortage of other controversial topics brought up by panelists. Robert Malone, MD, alleged that "hot lots" of COVID vaccines were to blame for causing more serious adverse events. Levi suggested that the vaccine caused evolutionary pressure that led to new mutations -- even though the COVID Delta variant evolved before vaccines were available, Lawler noted.

Paul Offit, MD, of the Children's Hospital of Philadelphia, pointed out that the measles vaccine has been around for more than 60 years and "that has in no way changed the virus."

"Even though you have a highly vaccinated population ... the vaccine still works. That's true of COVID too," he told MedPage Today.

Even the committee's lone infectious disease and pediatrics expert Cody Meissner, MD, of the Geisel School of Medicine at Dartmouth, raised the issue of dying "from" versus "with" COVID -- which certainly wasn't a concern for the 2024-2025 season as hospitals no longer test everyone for COVID, Lawler and Offit said. They also noted that studies showed that even early in the pandemic, most people who were COVID-positive and died in a hospital died from COVID.

Meissner also said COVID was a "rare illness" in kids, which Offit took issue with, noting that 2,800 children have died from COVID in the last 5 years, leaving behind thousands of bereaved families.

Meissner was, however, the voice of reason on a presentation about thimerosalopens in a new tab or window given by Lyn Redwood, RN, who was president of the World Mercury Project, which became Children's Health Defense, and has alleged that her son's autism was due to vaccination. (A presentation on thimerosal prepared by the CDC was removed from the meeting's website, which Malone said was a directive of HHS Secretary Robert F. Kennedy Jr.'s office.)

"I'm not quite sure how to respond to this presentation," Meissner said. "This is an old issue that has been addressed in the past."

Indeed, only about 5% of flu shots given annually contain thimerosal, experts said.

Similarly, Martin Kulldorff, PhD, presented on the combined MMRV vaccine, despite noting that the CDC urged a preference for separate vaccines -- the MMR vaccine and a separate varicella vaccine -- for the first dose in 2009.

Today, most pediatricians give separate vaccinations, so it's not clear why this needs to be discussed again, the outside observers said.

Are these topics new to those who don't have expertise in pediatrics, infectious disease, and epidemiology? In the past, all ACIP panelists had expertise in at least one area relevant to vaccinology. But many of the new panelistsopens in a new tab or window have no such background, including Levi and his focus on operations management. One is a psychiatrist, one is an emergency physician, and one has a doctorate in nursing.

Medical organizations have highlighted this lack of expertiseopens in a new tab or window, and several decided not to attend the meeting, including the American Academy of Pediatrics, the Pediatric Infectious Diseases Society, and the Society for Adolescent Health and Medicine.

The Infectious Diseases Society of America did not send a representative to the meeting, but told MedPage Today that it wasn't a boycott; rather, liaisons were invited to attend just a few hours before the start of the meeting.

Lawler noted that while some of the arguments made during the meeting may sound "reasonable and logical" to untrained ears, they "don't have a strong basis in data and science and are just used to impart more doubt, and that undermines confidence."

"We fired 17 peopleopens in a new tab or window who had the kind of expertise and experience that would give us the advice that would benefit this country," Offit added. "We don't have that anymore. We have anti-vaccine activists who have been shouting from the sidelines for decades, and now they're making public policy."

https://www.medpagetoday.com/infectiousdisease/vaccines/116343