Vaccines And Medications in Pregnancy Surveillance System (VAMPSS)
VAMPSS is a 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), the Harvard Pregnancy Research Group, and the Birth Defects Study (BDS) / Pregnancy Health Interview Study (PHIS) 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 has been supported by various government and private sources, depending on the specific medications and vaccines that are under study. The BDS component of VAMPSS was closed to data collection on 11/30/15, but the data accumulated over 39 years remains available for analyses.
Investigators and Study Staff
Allen A. Mitchell, M.D., Principal Investigator
Carla Van Bennekom, M.P.H., Epidemiologist
Stephen Kerr, M.P.H., Epidemiologist
Vaccines and Medications Under Study (2009-2015)
- H1N1 and Seasonal Influenza Vaccines and Antiviral Medications in Pregnancy
- Asthma Medications in Pregnancy — A Demonstration Project
- Menveo Meningococcal Vaccine in Pregnancy
- Afluria Influenza Vaccine in Pregnancy
H1N1 and Seasonal Influenza Vaccines and Antiviral Medications in Pregnancy
This project monitored both the H1N1 (“swine flu”) vaccine and the seasonal vaccines, as well as the antiviral medications that were used to prevent or treat influenza among pregnant women.
Within the Pregnancy Health Interview Study (Birth Defects Study), investigators collected specific data on vaccine exposure in pregnancy as part of this 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 had 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
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 utilized a comprehensive 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)
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 was conducted independently, the results were reviewed by an Independent Advisory Committee, and then the findings were 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
2010 to 2015
Afluria Influenza Vaccine in Pregnancy
This project monitored Afluria influenza vaccine among pregnant women.
Within the Pregnancy Health Interview Study (Birth Defects Study), investigators collected specific data on vaccine exposure in pregnancy as part of this surveillance program of birth defects in the United States. Because the BDS (and OTIS) studies obtained information directly from women about what they received during their pregnancies, incorporating this study into the VAMPSS system had 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 enrolled approximately 2,500 mothers of infants with and without birth defects each year.
Source of Funding:
August 1, 2013 to July 31, 2017
Carla Van Bennekom, M.P.H.