Vaccines And Medications in Pregnancy Surveillance System (VAMPSS)

VAMPSS is a new nationwide post-marketing surveillance system established to comprehensively monitor the use and safety of vaccines and medications during pregnancy. It represents a unique collaboration the American Academy of Asthma, Allergy & Immunology (AAAAI), the Organization of Teratology Information Specialists (OTIS), and the Pregnancy Health Interview Study (Birth Defects Study) at the Slone Epidemiology Center at Boston University.

The major goal of VAMPSS is to provide a badly-needed national post-marketing surveillance system that can evaluate the risks and safety of the wide range of vaccines and medicines used by pregnant women. VAMPSS is coordinated by the American Academy of Allergy, Asthma & Immunology (AAAAI) and includes investigators and data from OTIS and BDS as well as an Independent Advisory Committee composed of experts from various organizations (for example, the U.S. Centers for Disease Control and Prevention) who provide feedback and guidance to the team of scientific investigators.

Although VAMPSS activities are coordinated with relevant government agencies and professional organizations, VAMPSS is an independent surveillance system serving the public and private sector. None of the data involved in VAMPSS include personal identifiers, and the data remain under the complete control of each investigative team (e.g., BDS data are owned and controlled by investigators at the Slone Epidemiology Center of Boston University). VAMPSS is supported by various government and private sources, depending on the specific medications and vaccines that are under study.

Investigators and Study Staff

Investigators:

Allen A. Mitchell, M.D., Principal Investigator
Carol Louik, Sc.D., Co-Investigator
Martha M. Werler, Sc.D., Co-Investigator
Stephen Kerr, Data Analyst

Study Staff:

Dawn Jacobs, R.N., M.P.H., Project Coordinator
Fiona Rice, M.P.H., Program Coordinator
Nastia Dynkin, Computer Programmer
Christina Coleman, P.A., Research Coordinator

Nurse Interviewers:

Clare Coughlin, R.N.
Moira Quinn, R.N.
Kathleen Sheehan, R.N.
Laurie Cincotta, R.N.
Laine Fletcher, Interpreter
Ileana Gatica, Interpreter
Monica Martinez-Dale, Interpreter

Research Assistants:

Joan Shander
Julia Venanzi, Senior Research Assistant
Mark Abcede
Gabrielle Fortier
Michelle Eglovitch

Current Vaccines and Medications Under Study


H1N1 and Seasonal Influenza Vaccines and Antiviral Medications in Pregnancy

This project will monitor both the H1N1 (“swine flu”) vaccine and the seasonal vaccines, as well as the antiviral medications that may be used to prevent or treat influenza among pregnant women.

Within the ongoing Pregnancy Health Interview Study (Birth Defects Study), investigators will collect specific data on vaccine exposure in pregnancy as part of this ongoing surveillance program of birth defects in the United States. Because the BDS (and OTIS) studies obtain information directly from women about what they received during their pregnancies, incorporating this study into the VAMPSS system has the particular advantage of learning of flu vaccine and antiviral exposures from whatever source they were received—this includes not only doctors’ offices, but also pharmacies, public health clinics, supermarkets, and others.

Sources of Funding:

  • U.S. Biomedical Advanced Research and Development Authority (BARDA)
  • U.S. Food and Drug Administration
  • U.S. Centers for Disease Control and Prevention
  • U.S. National Vaccine Program Office

    Study Period:

    2009 to 2015


    Asthma Medications in Pregnancy — A Demonstration Project

    Asthma and allergy represent the most common conditions for which pregnant women take prescription medications, yet there is no systematic approach to evaluating the relative risks and safety of these medications with respect to pregnancy outcomes. Such information is critically needed for prescribers to make meaningful risk-benefit assessments of these widely used medications and for patients to feel comfortable that the potential adverse effects associated with the drugs prescribed for them have been adequately studied. To fill this critical gap in clinical knowledge, we propose to demonstrate the feasibility of a comprehensive and ongoing system to assess the relative safety of asthma medications in pregnancy. We will Integrate the findings from the PHIS (BDS) with data derived from the Organization of Teratogen Information Specialists (OTIS) to identify the risks and relative safety of newly-introduced asthma medications with respect to relatively common pregnancy outcomes, including preterm birth, small-for-gestational age, and risks for birth defects overall.

    Source of Funding:

    US Agency for Healthcare Research and Quality (AHRQ)

    Study Period:

    2009 to 2014


    Menveo Meningococcal Vaccine in Pregnancy

    When a new vaccine is introduced, the U.S. Food and Drug Administration, together with the manufacturer, often want to collect information on the risks or safety of the vaccine if it is given to pregnant women. This is particularly important for vaccines that are not supposed to be given in pregnancy.  A new vaccine against various strains of meningitis, called Menveo, was recently introduced in the U.S., and the product label clearly states that it should not be given to pregnant women.  Since the age group for whom this vaccine is intended includes young men and women about to enter college, it is possible that some women who receive the vaccine may be pregnant or soon become pregnant.  The manufacturer of Menveo therefore asked the VAMPSS program to study Menveo exposures in pregnancy to see if such exposures affect the risk of various pregnancy outcomes.  As with other VAMPSS projects, the Menveo study will be conducted independently, the results will be reviewed by an Independent Advisory Committee, and only then will the findings be provided to the manufacturer and relevant federal agencies (the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention).

    Source of Funding:

    Novartis Vaccines and Diagnostics

    Study Period:

    2010 to 2015


    Afluria Influenza Vaccine in Pregnancy

    This project will monitor Afluria influenza vaccine among pregnant women.

    Within the ongoing Pregnancy Health Interview Study (Birth Defects Study), investigators will collect specific data on vaccine exposure in pregnancy as part of this ongoing surveillance program of birth defects in the United States. Because the BDS (and OTIS) studies obtain information directly from women about what they received during their pregnancies, incorporating this study into the VAMPSS system has the particular advantage of learning of flu vaccine exposures from whatever source they were received—this includes not only doctors’ offices, but also pharmacies, public health clinics, supermarkets, and others.

    The investigators plan to enroll approximately 2,500 mothers of infants with and without birth defects each year.

    Source of Funding:

    CSL Limited

    Study Period:

    August 1, 2013 to July 31, 2017

    Contact Information

    Dawn Jacobs, R.N., M.P.H., Project Coordinator
    (617) 734-6006

    Participant Information:

    (866) 896-1097 (toll-free bilingual English/Spanish line)