Pfizer, Novartis say meningitis vaccine scope too narrow

Saturday, Feb 28, 2015

A U.S. Centers for Disease Control and Prevention (CDC) advisory committee on Thursday recommended meningitis B vaccines for people at high risk aged 10 to 25, a population that Pfizer Inc and Novartis criticized as too narrow.

Pfizer's Trumenba, like Novartis' new vaccine Bexsero, recently won U.S. marketing approval to treat the "B" strain of the deadly bacterium in that age group.

Older vaccines have long been available in the United States and broadly recommended to protect millions of children and young adults against infection with four other serogroups, or strains: A, C, Y and W.

The CDC's Advisory Committee on Immunization Practices was more selective on Thursday in its unanimous recommendation of vaccines against serogroup "B," saying they would be appropriate for an estimated 300,000 to 350,000 people at high risk, largely those with specified pre-existing medical conditions or who have professional exposure to the bacterium.

"Today's high-risk recommendation does not cover the majority of adolescents and young adults in the United States who are at risk for contracting meningitis B," Novartis said in an emailed statement. The Swiss drugmaker said the panel's recommendation was nonetheless "a step forward."

Novartis said it hopes the panel will vote for a broader vaccination recommendation at its next meeting in June after weighing testimony from college officials and others concerned about student vulnerability to outbreaks.

Meningitis can be treated with antibiotics, but 10 percent to 15 percent of patients die and up to 19 percent of survivors have long term disabilities, including brain damage and limb amputations. Vaccination is deemed the best way to prevent the disease.

Novartis' vaccine, called Bexsero, was sold in dozens of countries before being approved by the U.S. Food and Drug Administration last month. Even before getting the nod, it was provided last winter to students at Princeton University and the University of California, Santa Barbara, in response to meningitis B outbreaks on both campuses.

Pfizer and Novartis had both won the FDA's coveted "breakthrough therapy" designation for their rival vaccines.

In October Pfizer's Trumenba became the first approved U.S. vaccine against serogroup B of the bacterium Neisseria meningitidis.

It causes disease in an estimated 20,000 to 80,000 people a year globally. The FDA estimates serogroup B causes about 160 meningitis infections annually in the United States.


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