The Vaccines and Medications in Pregnancy Surveillance System (VAMPSS)

American Academy of Asthma, Allergy & Immunology

A Collaboration Among:
American Academy of Asthma, Allergy & Immunology (AAAAI)
Organization of Teratology Information Specialists (OTIS)
Slone Epidemiology Center at Boston University (SEC)

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.

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