December 12, 2002 Blood Products Advisory Committee Draft Presentation 1 Parvovirus B19 Public Health Impact of Donor Notification and Counseling Edward Gomperts, M.D. Global Vice President, Medical Affairs Baxter BioScience For The Plasma Protein Therapeutics Association

December 12, 2002 Blood Products Advisory Committee Draft Presentation 2 Parvovirus B19 Infection Acute, self-limiting disease without chronic sequelae in normal individuals. Normally transmitted via the respiratory route. Most infections are asymptomatic. Where symptomatic, (fever, headache, malaise, myalgias, rash) the donor would be deferred. Antibodies to Parvovirus B19 confer life-long protective immunity. More significant sequelae are rare and usually occur in particularly susceptible non-donor populations with pre-existing conditions. Principles and Practice of Infectious Diseases: Mandell, Douglas, and Bennett. Fourth Edition pages

December 12, 2002 Blood Products Advisory Committee Draft Presentation 3 Parvovirus B19 Infection Parvovirus B19 infections typically resolve with the appearance of neutralizing antibodies ~10 days post infection for IgM and ~17 days post infection for IgG. Period of viremia ~14 days.* Intense viremia develops approximately one week after infection, and viremia usually lasts one week. Our screening will not detect the low NAT levels associated with chronic carriers. *In some cases it has been observed that individuals with low level viremia continue to produce Parvovirus B19 for a longer period of time.

December 12, 2002 Blood Products Advisory Committee Draft Presentation 4 Donor Notification/ Counseling Average resolution time for NAT testing ranges from days. Time would be required to identify and communicate with the donor. Infected donor would have already cleared the virus and developed sufficient antibodies to confer a life-long immunity by the time notification occurred.

December 12, 2002 Blood Products Advisory Committee Draft Presentation 5 Conclusions Donor notification/counseling lacks public health benefit. –Non-chronic virus infection. –NAT resolution times. Medical information could be provided to the donor, obviously, but would be nonactionable and irrelevant to the individual’s short or long term health status. Questionable ethics of notification of donors regarding nonactionable medical information. Medical information to the donor would not have any public health impact.