Pharmaceutical Sponsor

The inaugural focus of VAMPSS is respiratory health of pregnant women. However, since VAMPSS intends to expand its focus to the wide range of available medications and vaccines, pharmaceutical companies can get involved by:

  • Using VAMPSS to evaluate the pregnancy safety of other currently available medications and vaccines, whether for asthma, allergy, or other indications
  • Using VAMPSS for 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 drugs
  • Facilitated access to additional data analyses if needed
  • Review of manuscripts relevant to their product prior to publication
  • 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 single company registry or computerized database surveillance.

 

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.  Cost savings should accrue due to the economies of scale of adding an exposure to the ongoing surveillance system and the lack of need for start-up costs.

 

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 Single Company Pregnancy Registry to VAMPSS

 

Company Registry

VAMPSS

Comparison groups

None

Normal, other meds, other defects

Control for Confounders

Variable

Extensive

Lost to follow-up

30 % (Singulair)

5 % (OTIS)

Specific birth defects

Numbers insufficient

Included (SEC)

 

Comparison of Computerized Databases to VAMPSS

 

Databases

VAMPSS

Diagnostic accuracy

Variable

Medical record review (SEC, OTIS)
Physical exams (OTIS)

Control for confounders

Limited (e.g., no folic acid, smoking, OTC  medications)

Extensive

Exposures accuracy

Prescriptions issues/filled

Actual use



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

 

AAAAI - American Academy of Allergy Asthma & Immunology