Pfizer's meningitis B vaccine Trumenba won the FDA's blessing nearly a year ago based on impressive midstage results and national unease about the infection spreading on college campuses. Now, just in time for the back-to-school season, the New York-based pharma announced positive late-stage results on Friday in nearly 7,000 individuals that confirmed the vaccine's effectiveness against certain meningitis B strains.
|Pfizer's Kathrin Jansen
In two Phase III studies--the first involving 3,600 patients aged 10 to 18 and the second with 3,300 patients aged 18 to 25--Trumenba met all primary immunogenicity endpoints. And, according to Pfizer's ($PFE) vaccines R&D head Kathrin Jansen, the data "extend the body of evidence that supports vaccination of adolescents and young adults with Trumenba to help prevent serogroup B meningococcal disease," she said in a statement.
The FDA approved the vaccine in October 2014 after it posted Phase II results that were convincing enough for Pfizer to pursue regulatory approval. Added to that, several meningitis B outbreaks "heightened concerns for this potentially deadly disease," an FDA official said at the time; the agency approved the jab for individuals aged 10 to 25.
But, unlike drugs which are clear to launch after an FDA approval, vaccines often need to pass another test at the hands of the CDC's Advisory Committee on Immunization Practices (ACIP) to notch big sales figures because--in many cases--physicians wait to use and payers wait to cover vaccines until they are ACIP-endorsed.
In two considerations so far, ACIP in February recommended Trumenba for high risk patients only, and then in June for all individuals aged 16 to 23. In making its June decision against a full recommendation, ACIP cited "historically low levels of the disease, limited data about the lasting effectiveness of the vaccines and potentially high costs," The Seattle Times said. It remains to be seen whether the new data will affect the body's take on Trumenba.
Pfizer, which has been working to diversify its vaccines unit beyond the world's best-selling vaccine, Prevnar 13, recently purchased two older GlaxoSmithKline ($GSK) meningitis vaccines for $130 million.
Results of the Phase III studies will be presented at an upcoming congress.
- here's the release