|William Gruber, Pfizer's SVP of vaccine clinical R&D|
Pfizer ($PFE) may have FDA approval for meningitis B vaccine Trumenba, but it can only take the jab so far without a nod from the CDC's Advisory Committee on Immunization Practices (ACIP). Now, though, it's got some positive new data on the shot just in time to help it make its case for one.
The vaccine met its co-primary immunogenicity objectives in a Phase II trial that studied it alongside other recommended adolescent vaccines--routine meningococcal shots and Tdap shots--in a study of 2,600 healthy adolescents ages 10 through 12, Pfizer said Tuesday. And Pfizer has passed those results along to ACIP, which will vote this Thursday on whether to recommend vaccinating high-risk groups of U.S. adolescents against meningitis B.
"The results observed in our Phase II study of Trumenba co-administered with other routine and recommended adolescent vaccines provide important evidence that we've shared with the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices to review as they consider recommendation of meningococcal B vaccination for adolescents and young adults," William Gruber, Pfizer's SVP of vaccine clinical R&D, said in a statement.
The company also announced rosy safety and tolerability data from a Phase III trial in 5,600 individuals between the ages of 10 and 25, which proved consistent with the Phase II study data on which the FDA based its quick approval last October.
While drugmakers only need to snag the FDA's green light before diving deep into launch-mode, vaccinemakers need ACIP's blessing to really get things going: Not only will physicians oftentimes not use vaccines until they get ACIP's blessing, but many payers won't cover them, either. And Pfizer in particular knows just now important ACIP's favor can be. Last August, its top-selling Prevnar 13 grabbed a $2 billion boost when the panel recommended its universal use in adults over 65.
But it's not just Pfizer that could benefit from ACIP's endorsement. Last month, the FDA gave a thumbs up to Novartis' ($NVS) Bexsero in the same 10 to 25 age group as Trumenba, setting up a market showdown between the two vaccines. And with Bexsero about to change hands as part of the mega asset swap between the Swiss pharma giant and GlaxoSmithKline ($GSK), CEO Andrew Witty's crew is hoping for some love from ACIP, too.
- read Pfizer's release
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