Pfizer, Novartis get MenB ACIP nod--but not the one they're really after
Pfizer ($PFE) and Novartis ($NVS) officially have a nod from the CDC's Advisory Committee on Immunization Practices (ACIP) for their recently approved meningitis B vaccines. Problem is, it doesn't cover nearly as large a population as the pharma giants would like.
On Thursday, ACIP voted unanimously to recommend Pfizer's Trumenba and Novartis' Bexsero for use in so-called high-risk groups--namely individuals with immune deficiencies and those in close proximity to ongoing outbreaks. And while both vaccinemakers agree the verdict is a step in the right direction, it's not nearly as broad as their FDA approvals, which cover adults ages 10 to 25.
"While this is a step forward … it still leaves many college students and adolescents at risk for contracting the disease for the foreseeable future," Novartis spokeswoman Liz Power told FierceVaccines in an emailed statement. "With two outbreaks last year (Princeton and UCSB), and cases this year at Yale, Providence College and the University of Oregon, it is becoming clear that a high-risk recommendation is not enough to provide adequate protection against this aggressive disease."
Unlike drugs, which normally are good to go after snagging an FDA green light, vaccines oftentimes need ACIP's blessing before physicians will use them and payers will cover them. Pfizer, for one, knows just how valuable ACIP's favor can be: Last summer, it scored what analysts dubbed a $2 billion boost when the committee recommended its Prevnar 13 for universal use in adults over the age of 65.
|Pfizer Vaccines President Susan Silbermann|
So it's no surprise that both Pfizer and Novartis say they'll be following up to encourage ACIP to widen the scope of its recommendation--and to do it soon. Specifically, ACIP meets again at the end of June, a meeting Power said Novartis hopes will feature a vote for "more permissive vaccination."
"We believe a recommendation for adolescents and young adults to be vaccinated against serogroup B meningococcal disease can't come early enough," Susan Silbermann, president of Pfizer Vaccines, agreed in a statement. "Everyone's goal should be to allow enough time for students to start their vaccination before they return to school next fall."
Pfizer trumpets positive Trumenba data ahead of ACIP vote
Novartis' Bexsero picks up FDA nod--but with competition looming, approval isn't everything
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Pfizer beats out Novartis with FDA MenB nod
Pfizer's Prevnar gets $2B boost with CDC nod in older adults