The Vaccines and Medications in Pregnancy Surveillance System
(“VAMPSS”)
A Collaboration of
American Academy of Allergy Asthma and Immunology
Organization of Teratology Information Specialists
Slone Epidemiology Center at Boston University
What is VAMPSS?
The Vaccines and Medications in Pregnancy Surveillance System (VAMPSS) is a new nationwide post-marketing surveillance system established to comprehensively monitor the use and safety of vaccines and medications during pregnancy through the initial support of the U.S. Office of Biomedical Advanced Research and Development Authority (BARDA) and the Agency for Healthcare Research and Quality (AHRQ).
How is VAMPSS Organized?
VAMPSS is coordinated by the American Academy of Allergy Asthma and Immunology (AAAAI) and includes an Investigative Task Force and a standing Independent Advisory Committee. The Investigative Task Force includes representatives from the AAAAI, the Organization of Teratology Information Specialists (OTIS), and the Slone Epidemiology Center (SEC) at Boston University. The Independent Advisory Committee includes membership from the Centers for Disease Control and Prevention, National Institutes of Health, American College of Obstetrics and Gynecology, American Academy of Pediatrics, as well as a consumer representative.
How Does VAMPSS Work?
The VAMPSS system provides a coordinated effort involving both prospective registry surveillance and case-control surveillance to study the safety of exposures in pregnancy. VAMPSS for the first time establishes the infrastructure under the leadership of a national professional practice group, AAAAI, to bring together two complementary methods of surveillance, taking advantage of the benefits of both.
The prospective surveillance arm of VAMPSS is coordinated by OTIS and involves prospective enrollment and follow-up of pregnant women exposed to vaccines or medications during pregnancy. Outcomes among participants exposed to a vaccine or medication under evaluation are compared to outcomes among participants not exposed.
The case-control surveillance arm of VAMPSS is coordinated by SEC and involves enrollment of mothers of infants with congenital malformations and infants without malformations. Among mothers of infants with each specific malformation, the prevalence of vaccines and medications of interest is compared to the corresponding prevalence in comparison groups: mothers of non-malformed infants and mothers of infants with other malformations.
Both arms of VAMPSS collect information directly from participating mothers, thus obtaining comprehensive data on exposures and important confounders such as alcohol and tobacco use. This coordinated effort will provide the ability to address questions regarding the safety of over-the-counter medications, dietary supplements, and products not acquired by the pregnant woman in traditional medical settings.
What Questions Can VAMPSS Help To Answer?
Using complementary approaches, VAMPSS evaluates risk or safety of pregnancy exposures with respect to spontaneous abortions, preeclampsia, fetal deaths, preterm births, intrauterine growth restriction, total major congenital malformations, and specific major malformations. In addition, the case-control component of VAMPSS provides exposure prevalence data drawn from a population-based sample.
How Will VAMPSS Information Be Used?
The standing Independent Advisory Committee works with the Investigative Task Force to determine if a risk signal or safety threshold is identified and, working in close coordination with the FDA, develops a plan for communicating findings that are meaningful to clinicians and the public.
How Can Clinicians Help Support VAMPSS?
The inaugural focus of VAMPSS is respiratory health of pregnant women. The target vaccines and medications for this initial effort include seasonal and H1N1 influenza vaccines, antiviral medications used to treat or prevent the flu in pregnancy, and asthma medications used in pregnancy. Clinicians can help support VAMPSS by referring pregnant patients to OTIS at (877) 311-8972 to learn more about how they can participate in this important new effort.
How Can Women and Health Care Providers Learn More About Medications and Vaccines Used in Pregnancy?
OTIS, which coordinates the prospective arm of VAMPSS, is a nation-wide service and research organization. Trained Specialists offer information and support to pregnant women who have concerns or questionsabout medications, vaccines or other agents that they have been or might be exposed to during pregnancy. Consultation is also provided for health care providers.
The Asthma and Asthma Medications in Pregnancy Study - A VAMPSS project