Insights from the Annual Conference on Vaccinology Research (ACVR) on vaccine registries and assessing the safety of maternal and fetal health.
Administering vaccines during pregnancy is recognized for its potential benefits in protecting both the pregnant individual and the developing fetus. However, understanding the spectrum of adverse events following immunization (AEFIs) in pregnancy remains a challenge.
The study emphasizes the intricate nature of AEFIs during pregnancy, encompassing outcomes conventionally evaluated in vaccine recipients, as well as pregnancy-related complications such as loss, preterm delivery, and fetal growth anomalies. Despite the importance of understanding these risks, pre-licensure data often lack enough pregnant individuals to gauge safety signals effectively.
Moreover, public health programs inadequately describe post-licensure evaluation systems for immunization during pregnancy. In response to these challenges, the study reviewed all Pregnancy Exposure Registries mandated by the US Food and Drug Administration (FDA) and documented in manufacturer package inserts for vaccine products in the US.
“Vaccination-in-pregnancy evaluation systems led by federal or academic organizations attempt to fill some, but not all, gaps in safety assessments,” according to the investigators. “For example, the US military leads evaluations of vaccines used as bioweapon countermeasures, and CDC leads the primary evaluation system for COVID-19 vaccines.”
The review outlines these registries' procedures and data elements, highlighting both open and closed registries. Additionally, it examines specialized vaccine-in-pregnancy evaluation systems led by federal and academic organizations, offering comparisons to manufacturer-led efforts.
However, despite efforts to establish registries, the study reveals inconsistencies in their establishment and operation. Among the 75 FDA-approved vaccine products, only 21 currently have manufacturer-led registries, and the alignment of these registries with potential vaccination risks during pregnancy remains unclear.
Efforts led by federal or academic organizations aim to address some of the gaps in safety assessments. Challenges persist in evaluating the safety of immunizations during pregnancy, emphasizing the critical need for strict policy and enhanced evaluation systems to benefit public health transparency and vaccine confidence.
This article was originally published by our sister publication Contagion Live.
Reference
Ryan M, Angelo S, Delapena K, et al. (2024) Immunizations in Pregnancy: Challenges and Opportunities for Vaccine Safety Evaluations. Oral Abstract #19 presented at NFID 2024 Annual Conference on Vaccine Research. May 8-10. Online.
Importance of reproductive health services for adolescents during the COVID-19 pandemic
October 30th 2024In a recent study, high rates of reproductive health service use were reported among adolescent mothers, indicating the benefits of this model for providing care when other options are unavailable.
Read More
Increasing ondansetron use reported against NVP in the United States
October 29th 2024Despite being recommended as a third-line therapy, rates of ondansetron use to treat nausea and vomiting in pregnancy have increased, making it the most common prescription antiemetic against this condition in the United States.
Read More
Study finds high rates of incidental MRI findings in endometriosis cases
October 29th 2024A recent study highlights the frequent occurrence of incidental findings on pelvic magnetic resonance imaging for endometriosis, emphasizing the need for radiologists to focus on those with higher clinical significance.
Read More