U-led vaccine project seeks to counter federal inaction, misinformation

The Minnesota-based Vaccine Integrity Project followed through Tuesday on a promise to provide scientific data on vaccine safety and effectiveness ― with the results contradicting President Donald Trump’s federal health advisers.

The project collected results from 590 studies and pooled them to see what they collectively show about the latest vaccines against COVID-19, influenza and the respiratory virus RSV. Twenty-four doctors reviewed the results and generally found the vaccines continued to protect three key populations: Children, pregnant women and people with diminished immune systems.

“The new data does not indicate the emergence of a signal [indicating safety concerns] or sudden drop of effectiveness” in the vaccines, said Michael Osterholm, director of the University of Minnesota’s Center for Infectious Disease Research and Policy. The center houses the new Vaccine Integrity Project, privately funded by the iAlumbra foundation.

The analysis released Tuesday mimicked the research reviews routinely provided in the past by the Centers for Disease Control and Prevention, Osterholm said. He said the information coming now from federal health sources ahead of the respiratory virus season is “flawed, analytically fraught or flat-out wrong.”

For example, he said there is no credible scientific evidence to support this summer’s federal Health and Human Services (HHS) decision to soften COVID-19 vaccine guidance for pregnant women and children at risk of severe illness themselves or for transmitting the infection to others at high risk of complications.

“The government agencies that we have previously counted on to provide us with the factual-based information to support recommendations are going to be at odds with us,” Osterholm said. “We have to do whatever we can to eliminate the politics of this. It shouldn’t be partisan. Stick with the facts.”

The project’s goal wasn’t to offer vaccine recommendations, but rather to make a massive amount of vaccine data understandable to others.

The American Academy of Pediatrics (AAP) coincidentally issued its own vaccine recommendations Tuesday. The organization recommended children aged 6 months to 23 months should receive COVID-19 vaccines unless they have allergies to the ingredients. Older children should also receive the vaccines if they’re at elevated risk of transmitting the virus to others at high risk of COVID-related complications.

That breaks with the CDC’s softer recommendation for parents and clinicians to use “shared decision-making” to decide whether children 6 months and older should be vaccinated.

HHS communications director Andrew Nixon accused the AAP of “undermining national immunization policymaking” by making recommendations that differed with federal guidance. He added in his written statement that HHS Secretary Robert F. Kennedy Jr. “has stood firm in his commitment to science, transparency, and restoring public trust.”

The Integrity Project also plans to synthesize data on vaccine safety and effectiveness for older adults at elevated risk for infection-related hospitalizations and deaths, and for the general population. The project is creating a searchable website so people can look up vaccine safety and effectiveness for different demographic groups.

The focused analysis of studies published over the last year limited the conclusions. The researchers found plenty of evidence supporting the strong effectiveness of the nirsevimabc immunization in preventing RSV-related hospitalizations and medical complications in children. But none of the most recent studies offered safety or effectiveness results for clesrovimab, an antibody therapy also federally recommended to reduce the risk of RSV.

“Most appear to be mild cases,” she added.

Four health care experts, including the editor-in-chief of the New England Journal of Medicine, reviewed Tuesday’s data for the first time and questioned the presenters on the results. Dr. Oliver Brooks of the Charles R. Drew School of Medicine and Science in Los Angeles said the observations on the myocarditis risk were limited because they did not compare the equivalent risk of developing that complication from COVID itself.

Katelyn Jetelina, CEO and founder of Your Local Epidemiologist, said she was “blown away” by the latest data showing how strongly vaccines protect children from RSV.

The researchers found at least one study showing a concern about preterm birth in pregnant women who received the RSV vaccine. Osterholm said further research on that potential complication is ongoing. Another study included in their analysis suggested influenza vaccines offered a potential protective effect against preterm birth.

Osterholm said the project went to great lengths to scrutinize bias in the studies it included, and among the experts selected for the analysis.