Fax - Response to Duramed’s IND (b)(4), Amendment #9, May 3, 2005 - Adenovirus

Memo to:         Gabriel Lebovic, Ph.D.

Director of Regulatory Affairs

Duramed Research

 

From:             Daryll Miller, M.A.

                        Regulatory Health Project Manager

                        FDA/CBER/OVRR/DVRPA

 

Date:              May 3, 2005

 

Regarding:     Response to Duramed’s IND (b)(4), Amendment #9

 

Recommendation: Reproductive toxicology studies with adenovirus vaccines types 4 and 7 are currently not feasible due to lack of an animal model (i.e., strains only replicate in human host). Thus, performing these studies would very unlikely produce any useful data. The safety of live adenovirus vaccines previously manufactured by Wyeth in pregnant individuals has not been established. Evidence in the literature that infection of human pregnant subjects with wild-type adenovirus (unknown strain) leads to placental infection and adverse fetal outcomes needs further clarification/investigation. However, precautions against becoming pregnant are in place for vaccinees, and advice against pregnancy in spouses or co-domiciles are in place in the present Phase I study. The vaccine studied under IND (b)(4) should be contraindicated for use in pregnant women. For the purpose of future licensure of the product, vaccinees and spouses or co-domiciles who inadvertently become pregnant during the time of the study should be followed in a pregnancy registry to collect relevant data.

 

This document was faxed from OVRR to Gabriel Lebovic on May 3, 2005, a pdf scanned image of the document indicating the date and time the fax was sent is attached.

 


Persons with disabilities having problems accessing the file may contact Darryl Miller 301-796-2640.

Original Faxed document
