ACIP gives Glaxo, Pfizer a lukewarm decision for new meningitis B vaccines

The CDC's Advisory Committee on Immunization Practices (ACIP) voted on Wednesday to expand its recommendation for meningitis B vaccines, but it wasn't the broad recommendation that many--including GlaxoSmithKline and Pfizer--were hoping to see. The committee voted for a Category B recommendation for young adults aged 16 to 23, with a preferred age of 16 to 18, meaning that doctors will make decisions on an individual basis whether to vaccinate their patients against meningococcal group B.

ACIP cited "historically low levels of the disease, limited data about the lasting effectiveness of the vaccines and potentially high costs" as arguments against a wider recommendation, The Seattle Times reported.

While vaccines for meningitis A, C, W and Y are in broad use for adolescents aged 11 to 18, there are only two FDA-approved meningitis B jabs: Pfizer's ($PFE) Trumenba and GlaxoSmithKline's ($GSK)--formerly Novartis' ($NVS)--Bexsero. These 5 serogroups cause most of the meningitis cases in the U.S., but group B is one of the most prevalent: it caused 32% of all meningitis cases in 2013.

ACIP's vote comes four months after its last decision on Trumenba and Bexsero--in February, the committee voted unanimously to recommend them for use in "high-risk groups," a recommendation that was too narrow, Novartis previously told FierceVaccines. Princeton University, UC Santa Barbara and the University of Oregon have had meningitis B outbreaks recently.

While some--including meningitis survivors and parents who have lost children to meningitis--are disappointed by the new decision, all is not lost. Even if the meningitis B jab didn't make it onto the list of routine vaccinations, ACIP's decision could increase availability of the vaccine in doctors' offices and could lead to wider coverage by insurance providers.

"GSK welcomes this vote as an important step forward to help protect against meningococcal disease in the U.S.," said Patrick Desbiens, senior vice president, U.S. Vaccines. "Meningococcal disease is fast-moving, unpredictable and can cause irreversible damage, so vaccination is the best tool to help prevent it. Today's vote is the latest milestone on a 20-year journey to develop a vaccine in order to help protect individuals from this devastating condition."

Glaxo has just agreed to sell two of its older quadrivalent meningitis jabs to Pfizer for $130 million.

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