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Combo vaccine baseline assessment of antibody titers should be voluntary, FDA cmte. chair Roos suggests.

Executive Summary

COMBO VACCINE BASELINE ANTIBODY ASSESSMENTS SHOULD BE ENCOURAGED, not required, FDA's Vaccines & Related Biologicals Advisory Committee Chairman Raymond Roos, MD, University of Chicago, suggested at the group's Oct. 27 meeting. His comments addressed an Oct. 3 draft "Points to Consider for the Evaluation of Combination Vaccines: Production, Testing and Clinical Study" document, which recommends mandating baseline antibody assessments for companies studying simultaneous administration of licensed vaccines with combination vaccines.
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