Pharmaceutical Sponsor

Pharmaceutical sponsors can collaborate with VAMPSS in several ways:

  • Identify exposure during pregnancy of currently available medications and vaccines.
  • Evaluate the pregnancy safety of currently available medications and vaccines.
  • Provide required voluntary post-marketing surveillance for newly approved drugs and vaccines.
 

What are the advantages of pharmaceutical company involvement in VAMPSS?

When pharmaceutical companies act as sponsors for specific exposures in VAMPSS, they receive the following benefits:

  • Input into surveillance methodology
  • Regular reports on accumulating data for their products as a non-voting member of the independent Advisory Committee
  • Facilitated access to additional data analyses if needed
  • Comment on manuscripts relevant to their product prior to submission
  • The credibility that derives from data collection and analyses from highly regarded and independent researchers.

In addition, there are no start-up costs or costs of new infrastructure required when a company sponsors a new VAMPSS surveillance project. VAMPSS takes advantage of proven and credible academic research groups with decades of experience and expertise in this unique area of research. Further, VAMPSS is more comprehensive and cost-effective than alternate surveillance systems, such as a traditional pregnancy registry.

 

What are the costs of pharmaceutical company involvement in VAMPSS?

The costs of each new surveillance project will be negotiated, based on the projected number of exposed subjects, the number of years of planned surveillance, and any unique aspects of the required follow-up.  Substantial cost savings accrue from the lack of need for start-up funding, and could be enhanced due to the economies of scale of adding an exposure to the ongoing surveillance system.

 

Whom should pharmaceutical companies contact for more information on VAMPSS

Please contact Sheila Heitzig, Director of Practice and Policy at the AAAAI, to discuss the next steps in potential pharmaceutical company involvement in VAMPSS Single Company Registry.

 

Comparison of  Traditional Pregnancy Registry to VAMPSS

 

Company Registry

VAMPSS

Comparison groups

None

Unexposed normal, unexposed same condition, other defects (SEC)

Control for confounders

Variable

Extensive

Lost to follow-up

30 %

5 % (OTIS)

Specific birth defects

Numbers insufficient

Included (SEC and Harvard)

Exposure prevalence information Not available (not population based) Available (SEC and Harvard)

 

AAAAI Collaboration with UC San Diego and Boston University Publishes ‘Reassuring’ Data on H1N1 Influenza Vaccine Safety in Pregnancy »
 

 

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