Today, the Vaccine Integrity Project of the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota presented reassuring data from its comprehensive evidence review on the safety and efficacy of the US influenza, respiratory syncytial virus (RSV), and COVID-19 vaccines ahead of the upcoming respiratory virus season. CIDRAP is the publisher of CIDRAP News.
In April, CIDRAP launched the VIP to gather the latest evidence on vaccine effectiveness and safety for medical societies such as the American Academy of Pediatrics (AAP) to draft and communicate their own guidelines independently.
No notable safety issues
The VIP’s first live-streamed presentation, which focused on the COVID-19 and RSV vaccines in pregnant women, children, and those with weakened immune systems, included opening and closing remarks by CIDRAP Director Michael Osterholm, PhD, MPH, and a panel that included New England Journal of Medicine Editor-in-Chief Eric Rubin, MD, PhD, and Fox News Senior Medical Analyst Marc Siegel, MD.
“What you heard clearly today is that new data do not indicate the emergence of a safety signal or a sudden drop in effectiveness of these immunizations,” Osterholm said. “There is no scientific evidence to support the changes HHS [the Department of Health and Human Services] made to COVID recommendations for pregnant women or for children.”
Nor did the review uncover any new evidence of safety signals related to myocarditis after COVID-19 vaccination, but it did identify a potential risk of preterm birth linked to the RSV vaccine for pregnant women.
“One new study supported the effectiveness of influenza vaccination in pregnancy to reduce medically attended infection and in pregnant women,” Osterholm said. “For all other studies reviewed, COVID, RSV, and influenza vaccination resulted in similar or better outcomes compared to no vaccination. Of the close to 17,000 abstracts reviewed and nearly 600 papers extracted, autism was not raised as a significant adverse event.”
Almost 550 papers reviewed, including 50 RCTs
For the review, 24 experts in infectious diseases and epidemiologic methods from academic institutions screened about 16,000 abstracts and reviewed 755 full-text articles published in the last couple of respiratory virus seasons and chose 547 papers for detailed data extraction, including 50 randomized controlled trials.
VIP spokesman Kevin Griffis told CIDRAP News, “We wanted to take a look and see in that intervening time since the last review was done, has there been some type of new safety signal? Has there been some type of significant change to the effectiveness of the COVID, RSV, or flu vaccines? What are we seeing since that last literature review was done?”
“The CDC has access to data that we don’t have access to, but we do have all of the literature that was funded all the way up to July,” he added.
Since 1964, the US Centers for Disease Control and Prevention (CDC) had regularly reviewed the evidence on the safety and efficacy of fall vaccines and gave the results to its Advisory Committee on Immunization Practices (ACIP) to make recommendations for the upcoming respiratory virus season.
But in June 2025, HHS replaced all 17 experienced ACIP members with eight new members, including vaccine skeptics.Â
VIP findings, AAP guidelines consistent on vaccines for kids
Since the ACIP was upended and despite a lack of evidence or federal vaccine advisory group input, HHS removed the CDC’s recommendation to vaccinate healthy children and pregnant women against COVID-19, and the Food and Drug Administration (FDA) announced that the COVID-19 vaccine would be recommended only for adults 65 and older and those at high risk for poor outcomes.Â
Today, consistent with the findings of the VIP review, the AAP published its independent evidence-based immunization schedule for children and adolescents, including a recommendation that all children aged 6 to 23 months be vaccinated against COVID-19, as well as those aged 2 to 18 years in certain risk categories. The academy also urged insurance companies to pay for the vaccines. (See today’s related CIDRAP News story.)
Other societies, such as the American College of Obstetricians and Gynecologists, the Infectious Diseases Society of America, and the American Academy of Family Physicians, are expected to follow suit in the coming month or two.
Among other decisions experts say are not supported by evidence, the FDA has signaled that it might not renew the emergency use authorization for Pfizer’s COVID-19 vaccine for children aged 6 months to 4 years, which could limit the supply of vaccines for the youngest kids.
HHS also terminated 22 mRNA vaccine-development contracts totaling just under $500 million and accepted an ACIP recommendation to remove the mercury-based preservative thimerosal from flu vaccines, despite its safe use since the 1930s.
What’s next for the VIP?
The webinar and the data shared in today’s session is posted on the CIDRAP website, and the VIP will continue sharing more information with the medical and public health community and the public.
