Health Professionals, Researchers and Government Unite to Improve Safe Use of
Medicines and Vaccines by Pregnant Women
New Orleans--The American Academy of Allergy, Asthma & Immunology (AAAAI) today announced that they
are launching a new system to provide information to pregnant women and their doctors about using medications
and vaccines safely in pregnancy.
The Vaccines and Medications in Pregnancy Surveillance System (VAMPSS) unites the resources of two leading
research institutions and collaborates with five federal agencies. All share an interest in improving maternal-fetal
health. VAMPSS collects information from women who are pregnant or have recently completed their pregnancies
in order to provide information on issues that could be of concern to women and their babies.
Many women are reluctant to use any medications or receive vaccines during pregnancy out of fear about possible
harms to their unborn child. But many medical conditions such as asthma and influenza, particularly if left
untreated, can harm both the mother and her baby; so it is important to capture the experiences of women who use
medications or vaccines during their pregnancy.
In addition to coordination by the AAAAI, the VAMPSS team includes researchers from the Organization of
Teratology Information Specialists (OTIS) and the Slone Epidemiology Center (SEC) at Boston University. The
federal agencies that cooperated to make this initiative possible include: the Agency for Health Care Research and
Quality (AHRQ); the U.S. Office of Biomedical Advanced Research and Development Authority (BARDA); the
Centers for Disease Control and Prevention (CDC); the Food and Drug Administration (FDA); and the National
Institutes of Health (NIH).
VAMPSS was developed in consultation with the FDA, initially funded by AHRQ and BARDA, and uses an
independent advisory committee composed of representatives of obstetric and pediatric medical specialty groups,
the CDC, NIH and a consumer representative.
VAMPSS takes advantage of two different, well-established surveillance systems. Both have proven records in
determining the safety to the mother and her offspring of the wide range of prescription drugs, over the counter
drugs, herbal products, and vaccines.
“VAMPSS is a unique national system that will provide much-needed information regarding the wide range of
vaccines and medicines used by pregnant women,” according to project initiator Dr. Michael Schatz, past president
of the AAAAI. “A critical gap in understanding will be filled by the results of this new system.”
A major strength of the VAMPSS system is that it obtains comprehensive information on various medicine and
vaccine exposures from women who are pregnant or who have recently delivered, including those exposures that
are unlikely to be included in the woman’s medical record. Mothers are asked about all medicines taken, regardless
of whether they were prescribed, purchased over-the-counter, on the internet or borrowed from others.
Women are also asked about all vaccines they may have received, including those given in non-traditional settings
such as health fairs or at the supermarket. The research by OTIS and SEC relies on women and their doctors to
participate in this new system in order to improve their pregnancies and those of other women.
The initial focus of VAMPSS will be on the respiratory health of pregnant women, including asthma medications,
seasonal and H1N1 influenza vaccines, and antiviral medications used to prevent and treat influenza. Although
there is no evidence to suggest that influenza vaccines pose any harm to pregnant women or their offspring, the
newer and more comprehensive data provided by VAMPSS will improve understanding of the safety of these and
other medicines and vaccines that are taken in pregnancy.
Women are encouraged to enroll in the study so they and their infants can be followed through pregnancy and the
post-partum period. Pregnant women who have taken asthma medications and/or have received the seasonal
influenza vaccine, the H1N1 vaccine or any antiviral medications to prevent or treat the flu can contact OTIS at
(877) 311-8972 to learn how they can participate in this new effort.
Visit OTIS VAMPSS online
A Collaboration of
American Academy of Asthma, Allergy, 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 for 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 information 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 2009 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.
Visit OTIS VAMPSS online
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