The Vaccine Integrity Project, based in Minnesota, has fulfilled its commitment to provide comprehensive scientific data on the safety and effectiveness of vaccines. The project’s findings, released on Tuesday, stand in stark contrast to the assertions made by federal health advisers under President Donald Trump. By analyzing results from 590 studies, the project aimed to evaluate the latest vaccines against COVID-19, influenza, and the respiratory virus RSV.
A team of 24 medical professionals reviewed the data and concluded that the vaccines continue to offer protection to three critical populations: children, pregnant women, and individuals with weakened immune systems. Michael Osterholm, the director of the University of Minnesota’s Center for Infectious Disease Research and Policy, stated, “The new data does not indicate the emergence of a signal indicating safety concerns or a sudden drop in effectiveness” regarding the vaccines.
Osterholm, whose center houses the Vaccine Integrity Project, criticized the information being disseminated by federal health sources, particularly as the respiratory virus season approaches. He described the current federal guidance as “flawed, analytically fraught, or flat-out wrong.” For instance, he pointed out that there is no credible scientific evidence backing the recent decision by the federal Health and Human Services (HHS) to relax COVID-19 vaccine guidelines for pregnant women and children who are at high risk for severe illness.
“The government agencies that we have previously relied on to provide factual information are now at odds with our findings,” Osterholm remarked. He emphasized the importance of eliminating political biases from the discussion surrounding vaccines, stating, “It shouldn’t be partisan. Stick with the facts.”
The Vaccine Integrity Project’s primary objective was not to issue vaccine recommendations but rather to make a wealth of vaccine data accessible and understandable. Dr. Michael Abers, an infectious disease physician at Albert Einstein College of Medicine, highlighted that the project’s goal was to assemble and synthesize information to assist professional societies in making informed recommendations.
Coincidentally, the American Academy of Pediatrics (AAP) also released its vaccine recommendations on the same day. The AAP advised that children aged 6 months to 23 months should receive COVID-19 vaccines unless they have allergies to any vaccine ingredients. Additionally, older children at elevated risk of transmitting the virus should also be vaccinated. This stance diverges from the Centers for Disease Control and Prevention’s (CDC) more lenient recommendation, which calls for “shared decision-making” regarding vaccination for children aged 6 months and older.
Andrew Nixon, communications director for HHS, accused the AAP of “undermining national immunization policymaking” by issuing recommendations that contradict federal guidance. He affirmed that HHS Secretary Robert F. Kennedy Jr. remains committed to science, transparency, and restoring public trust in vaccine information.
The Vaccine Integrity Project is also focused on synthesizing data concerning vaccine safety and effectiveness for older adults at heightened risk for infection-related hospitalizations and deaths, as well as for the general population. The project is developing a searchable website where individuals can access vaccine safety and effectiveness data tailored to different demographic groups.
The analysis of recent studies yielded strong evidence supporting the effectiveness of the nirsevimab vaccine in preventing RSV-related hospitalizations and medical complications in children. However, the researchers noted that none of the latest studies provided safety or effectiveness data for clesrovimab, another federally recommended antibody therapy for RSV.
The analysis echoed prior research indicating a risk of myocarditis, an inflammation of the heart muscle, in children receiving COVID-19 vaccines. Dr. Harleen Marwah, a pediatrician at Massachusetts General Brigham for Children, highlighted that the myocarditis risk appeared most significant after the second dose but diminished with subsequent vaccinations. One study included in the analysis reported up to three cases of myocarditis per 100,000 recipients, predominantly affecting males who received the Pfizer COVID vaccine.
Four health experts, including the editor-in-chief of the New England Journal of Medicine, reviewed the data presented on Tuesday and raised questions regarding the findings. Dr. Oliver Brooks from the Charles R. Drew School of Medicine and Science pointed out that the observations on myocarditis risk were limited, as they did not compare it to the equivalent risk posed by COVID-19 itself.
Katelyn Jetelina, CEO and founder of Your Local Epidemiologist, expressed her astonishment at the new data indicating how effectively vaccines protect children from RSV. Interestingly, the researchers also identified at least one study raising concerns about potential preterm birth in pregnant women who were vaccinated against RSV, with further research ongoing to investigate this complication. Additionally, one study suggested that influenza vaccines might offer a protective effect against preterm birth.
Osterholm stated that the Vaccine Integrity Project took significant steps to scrutinize biases in the included studies and among the experts involved in the analysis. He concluded, “Americans will also have the peace of mind that experts assembled by the Vaccine Integrity Project have independently analyzed the information they need to use to decide how best to protect themselves and their families.”
