Prevnar 13 Post-Market Trials Must Confirm Surrogate Endpoint, Deal With Immunogenicity
New post-marketing commitment will look at conjugate pneumonia vaccine when given in patients 50 and older who have already received Merck’s polysaccharide vaccine.
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If a sponsor wants to use a biomarker to show vaccine effectiveness, it should first explain why a clinical endpoint study is not feasible, US FDA official advises.
ACIP still supports use of Pfizer’s pneumococcal vaccine in immunocompetent individuals ages 65 years and older based on shared clinical decision-making, but concludes that routine immunization is no longer warranted due to herd effect from pediatric vaccination.
CDC advisory committee support for Pfizer pneumococcal vaccine in adults 65 and older comes with caveat that recommendation will be re-examined, and possibly revised, in 2018 due to effects of herd immunity.