A Collaboration Among:
American Academy of Allergy, Asthma & Immunology (AAAAI)
Organization of Teratology Information Specialists Research Center at the University of California-San Diego (OTIS)
Slone Epidemiology Center at Boston University (SEC)
Harvard Pregnancy Research Group
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.
Why was VAMPSS developed?
Major congenital malformations occur in 3-5 % of all infants, and other complications, such as preeclampsia, preterm birth and intrauterine growth retardation occur in 10-15 % of pregnancies. Although pharmacologic agents are uncommon causes of these adverse outcomes, they are among the most preventable. Because adverse effects of a drug during pregnancy are not predictable based on preclinical studies or drug class and pregnant women are not usually included in pre-marketing trials, post-marketing surveillance is required to establish the risks or safety of medications and vaccines during pregnancy. Unfortunately, no systematic surveillance system for this purpose exists in this country, and so there is a lack of adequate safety information for most pharmacologic agents taken by pregnant women. This lack of information leads to a number of potential adverse consequences.
The major goal of VAMPSS is to provide the needed national systematic post-marketing surveillance system for pharmacologic therapy during pregnancy. With this system, we hope to identify as early as possible the circumstances in which a drug or immunization causes harm. In addition, we hope to provide reassuring data in a timely manner to all concerned for those drugs and immunizations (likely the majority) that are safe during pregnancy.
FDA Pregnancy and Lactation Labeling Rule (PLLR)
In December, 2014 the US Food and Drug Administration (FDA) published a final rule that sets standards for providing a consistent way for drug manufacturers to provide information about the risks and benefits of prescription drug and biological products used during pregnancy and lactation. The new rule eliminates the old letter categories of A, B, C, D, and X, to classify various types of risks. At the same time, FDA issued draft guidance for pharmaceutical companies to assist them in including information about pregnancy and lactation in their prescribing information according to the requirements of the new rule. Any information obtained from a VAMPSS study can be used by pharmaceutical companies to meet this new post-marketing labeling requirement.
Learn more about the PLLR
Read the FDA draft guidance for industry
How is VAMPSS organized?
VAMPSS is coordinated by the 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), the Slone Epidemiology Center (SEC) at Boston University, and the Harvard Pregnancy Research Group. The Advisory Committee includes members from the Centers for Disease Control and Prevention (CDC), National Institutes of Health (NIH), American College of Obstetricians and Gynecologists (ACOG), American Academy of Pediatrics (AAP), as well as a biostatistician and a consumer representative.
Although VAMPSS activities are coordinated with relevant government agencies and professional organizations, VAMPSS represents an independent surveillance system serving the public and private sector.
The Investigative Task Force coordinates all aspects of protocol development, data collection, data analyses, data interpretation, and generation of reports, and meets weekly by teleconference to discuss methodological issues and review progress.
The independent Advisory Committee provides advice regarding overall VAMPSS goals, methods, results and reports. It provides independent, scientifically rigorous and confidential peer review of accumulating data and the related analyses.
What questions can VAMPSS help to answer?
Using complementary approaches, VAMPSS evaluates risks and safety of a wide range 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?
Data will be analyzed initially to provide odds ratios and 95% confidence intervals for the exposures of interest in relation to each primary outcome. The standing Independent Advisory Committee works with the Investigative Task Force to determine if a risk signal or safety threshold is identified and develops a plan for communicating findings to the FDA that are meaningful to clinicians and the public.
How can clinicians help support VAMPSS?
Clinicians can help support VAMPSS by referring pregnant patients exposed to influenza vaccines, influenza anti-viral medications, such as oseltamivir and zanamivir, or asthma medications to OTIS (Mother To Baby) at (877) 311-8972. A handout about the study and what it would take to enroll is available here.
How can pharmaceutical companies work with VAMPSS to assess the safety of their medications during pregnancy?
Pharmaceutical companies can act as sponsors of individual medication surveillance projects. These projects can fulfill an FDA post-marketing commitment for newly-marketed medications or provide needed information for medications which are not newly marketed. Although sponsors will have access to summaries of the accumulating data and input into their interpretation, all data are owned by VAMPSS, and all conclusions will be made independently by the Investigative Task Force and the Advisory Committee.
For patients and consumers
Learn more about how to sign up for a VAMPSS study.
For pharmaceutical sponsors
Learn more about sponsoring a VAMPSS study.
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