Loading ...

This fall, guidance for protection against the flu, COVID, and other respiratory infections remains consistent with previous years, with no new safety signals, based on evidence reviewed by the Vaccine Integrity Project and presented in an online webinar. 

The Vaccine Integrity Project (VIP) was created by the University of Minnesota’s Center for Infectious Disease Research and Policy (CIDRAP) to provide evidence on vaccine safety and effectiveness as a resource for clinicians and for medical societies.

Overall, the experts found that vaccination against COVID, respiratory syncytial virus (RSV), and influenza yielded similar or better outcomes compared to no vaccination. Additionally, the VIP experts found no sufficient evidence of new safety signals to justify the CDC’s rescinding of the previous recommendation to vaccinate pregnant women and healthy children against COVID this season, said CIDRAP director Michael Osterholm, PhD, MPH, in a press release. 

The VIP is a response to the gaps left by federal changes that have altered the dissemination of evidence-based scientific information, according to CIDRAP. In advance of the upcoming respiratory virus season, the VIP presented its first live-streamed webinar on August 19 with data on influenza, COVID, and RSV vaccines, focusing on indications for pregnant women, children, and immunocompromised individuals. 

For the presentation, a team of 24 infectious disease experts and epidemiologists reviewed data from 1406 full-text articles published within the last few years and identified 590 for detailed examination. Jake Scott, MD, of Stanford University, established the VIP’s credentials by reviewing their strict research criteria and outlined the specific safety events analyzed for three vaccines of interest: COVID vaccines, RSV vaccines and antibodies, and influenza vaccines. 

Pregnancy Protection

Some infections, such as influenza, are more severe during pregnancy and in fact may increase the risk of adverse outcomes, including preterm birth and stillbirth, said Caitlin Dugdale, MD, an infectious diseases physician at Massachusetts General Hospital and assistant professor of medicine at Harvard Medical School, Boston. Dugdale presented the VIP’s evidence base for vaccines in pregnancy. 

The researchers focused on safety and effectiveness of COVID, RSV, and influenza, and found no studies with new epidemiologic trends related to RSV or influenza; the one study involving epidemiology of COVID showed a 7% incidence of long COVID among vaccinated pregnant patients compared to a 12% incidence among unvaccinated pregnant patients. As for COVID vaccine safety, no concerns were identified for outcomes of miscarriage, stillbirth, or congenital anomalies with either the Pfizer or Moderna vaccines, she said.

Considerations for Children

Harleen Marwah, MD, a pediatrician at Mass General Brigham for Children, presented the evidence review for the flu, COVID, and RSV vaccines in children. 

Children are especially vulnerable to respiratory infections because they are in critical stages of development, Marwah said. The VIP experts reviewed data on myocarditis and Guillain-Barré syndrome associated with COVID vaccination. The studies of myocarditis were consistent with previous research, and new data showed that risk decreased with subsequent booster doses, she said. Similarly, pediatric studies of co-administered COVID mRNA vaccines and flu vaccines showed no increased risk of serious adverse events. 

Immunocompromised Individuals

Michael Abers, MD, a physician scientist at Albert Einstein College of Medicine, New York City, presented the evidence base for vaccination of immunocompromised individuals against COVID, RSV, and influenza.

Vaccines work by training the immune system to more rapidly recognize pathogens, but someone with a compromised immune system may be less responsive to vaccination, Abers said in his presentation. 

However, the most recent data showed that vaccines for COVID were similarly safe and effective among immunocompromised individuals and the general population. The RSV vaccine was especially effective among patients with solid organ transplants, he noted. The flu vaccine, while slightly less effective among immunocompromised individuals compared to immunocompetent individuals, was still effective, he said. 

Support for Society Guidelines

The goal of the VIP webinar was to assemble information that could be shared with professional societies to make recommendations, Abers said in a discussion period.

Based on the data reviewed by the VIP, the American Academy of Pediatrics (AAP) released its own recommended childhood vaccination schedule, independent of the CDC. Other societies, including the Infectious Diseases Society of America, the American College of Obstetricians and Gynecologists, and the American Academy of Family Physicians, are expected to release independent vaccine guidelines based on the VIP evidence review.

Evidence Clinicians Need

“The work of the Vaccine Integrity Project is urgently needed because of the myriad questions [about vaccines] that have now been raised,” David J. Cennimo, MD, associate professor of medicine & pediatrics at Rutgers New Jersey Medical School in Newark, told Medscape Medical News.

“Unfortunately, the past work of ACIP and CDC which has been grounded in vaccine science and public health has been destabilized, often with unfounded speculations and misinterpretation of data,” said Cennimo, who is not involved in the VIP. 

“I commend CIDRAP and Dr Osterholm for their steadfast leadership and commitment to protecting the nation’s health,” Cennimo added. “They have worked to recreate the unbiased, evidence-based research presentations that characterized the ACIP’s gold standard of open debate.” The medical community will need these data not only to make informed decisions, but also to support educated and informed discussions for shared decision-making with parents and families, he said. 

“For instance, the safety and efficacy of COVID vaccines in children are actually supported by a plethora of data, contrary to recent reports,” he said. 

“As clinicians, we must become familiar with these debates as well as the incorrect messages permeating our media,” Cennimo told Medscape Medical News. He expressed confidence that the AAP and other medical organizations will strengthen the vaccine message, but also expressed concerns about vaccine funding, which is tied to CDC recommendations.

The VIP is funded by an unrestricted gift from a foundation known as Alumbra, established by philanthropist Christy Walton. The Vaccine Integrity Project presenters reported no relevant financial relationships. Cennimo reported no relevant financial relationships.