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Clinical Evaluation of Pandemic Influenza Vaccines in Children. Vaccines and Related Biological Products Advisory Committee February 19, 2009. Agenda. Introduction and Background: Douglas Pratt European Perspective: Bettie Voordouw Subpart D: Additional Safeguards Skip Nelson
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Vaccines and Related Biological Products Advisory Committee
February 19, 2009
for Children in Clinical Studies
To be used under an emergency declared by the U.S. Secretary of HHS under Section 319 of the PHS Act
FDA reviews assessments and determines if additional
studies in children are needed. Based on specific
provisions in the law, FDA may conclude that:
Subpart D: Clinical investigations involving children can be approved by an Institutional Review Board (IRB) only if the clinical investigation:
50.51 Does not involve more than minimal risk, or
50.52 Presents the prospect of direct benefit for the individual subject, or
50.53 The risk represents a minor increase over minimal risk, and
Is likely to yield generalizable knowledge about the subject’s disorder or condition
Subpart D: Clinical investigations involving children not otherwise approvable, but
50.54 Present an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children
An IRB cannot approve research under this provision but must refer it to the FDA Commissioner for panel review.
The Pediatric Advisory Committee serves as the reviewing panel if studies are referred under 50.54.
(though in some vaccines approved in Europe)
1. Please discuss whether clinical studies in one or more pediatric age group should be conducted using inactivated pandemic influenza vaccine candidates as part of pandemic preparedness.
a. If your recommendation is that no clinical studies in any pediatric age group should be conducted prior to use of an inactivated pandemic influenza vaccine in children, please discuss whether other data, if any, would be needed to support immunizing children in the event of an influenza pandemic.
b. If your recommendation is that clinical studies should be conducted in one or more pediatric age groups prior to use of an inactivated pandemic influenza vaccine in children, please discuss your recommendations regarding: