The Vaccine Integrity Project (VIP) at the University of Minnesota’s Center for Infectious Disease Research and Policy (CIDRAP) today said it will independently review the safety and efficacy of the tetanus, diphtheria, and pertussis (Tdap) vaccine in pregnancy.
“For Tdap, the review will assess possible safety outcomes such as miscarriage, stillbirth, preterm birth, pregnancy-related high blood pressure disorders, congenital anomalies, such as spina bifida, and newborn developmental outcomes, as well as reported data on effectiveness in preventing tetanus, diphtheria, and pertussis (whooping cough) in pregnant adults and newborns,” the VIP press release said.
Kevin Ault, MD, of the American College of Obstetricians and Gynecology’s (ACOG’s) Expert Work Group on Immunization, Infectious Disease, and Public Health Preparedness, said he thinks the review will show how successful the clinical Tdap recommendation during pregnancy has been.
“I think if you get all these studies in one place, you're going to see 80% or 90% effectiveness in the first few months of life,” he said. “Pertussis, of course, can be deadly in the first few months of life, and we've seen some unvaccinated children, unfortunately, die in the past year or two in the United States of that.”
A lot of new evidence of the vaccine’s safety and effectiveness has accumulated over the past few years, he said: “We have the new adult acellular vaccine, and the data look great. Every time I see one of those studies, I'm like, ‘wow, this is really an intervention that works against a horrible disease.’”
Filling federal public health gaps
Vaccines recommended during pregnancy have long been supported by major medical organizations such as ACOG because of their demonstrated ability to reduce severe disease in pregnant women and infants.
But this systematic review comes amid public debate, vaccine skepticism, and policy uncertainty surrounding vaccines, including the appointment by US Health and Human Services Secretary Robert F. Kennedy Jr of a slate of vaccine skeptics to the Advisory Committee on Immunization Practices (ACIP), which issues vaccine recommendations to the Centers for Disease Control and Prevention’s (CDC).
ACIP members have questioned, without evidence, the safety of vaccines given during pregnancy. For example, recent appointee Adam Urato, MD, of UMass Memorial Health erroneously stated that the safety of the four vaccines recommended for pregnant women to protect them and their babies is unproven. The four vaccines protect against Tdap, influenza, respiratory syncytial virus (RSV), and COVID-19.
