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.

FDA appears to have added a post-marketing commitment for its approval of Prevnar 13 for adults age 50 and older as a result of advisory committee concerns about the immunogenicity data.

Pfizer Inc.’sconjugate vaccine was approved Dec. 30 to prevent pneumonia and invasive disease caused by streptococcus pneumoniae bacteria serotypes...

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