Pfizer wins EU label expansion for MenACWY vaccine Nimenrix

Pfizer has won a label expansion in Europe for its MenACWY conjugate vaccine Nimenrix.

More than a year after picking up the shot from GlaxoSmithKline, Pfizer has won a label expansion in Europe for its MenACWY conjugate vaccine Nimenrix. It’s now the only such vaccine available on the continent for those starting at 6 weeks of age.

The new label gives Nimenrix “the broadest age indication of any conjugate vaccine in Europe” against the Neisseria meningitidis serogroups A, C, W-135, and Y, Pfizer Chief Medical and Scientific Affairs Officer Luis Jodar said in a statement.

GSK originally launched Nimenrix back in 2012 for people 1 and older. Now, the first dose can be given after six weeks of age in Europe, with another two months later and a booster dose at 12 months.


Simplify and Accelerate Drug R&D With the MarkLogic Data Hub Service for Pharma R&D

Researchers are often unable to access the information they need. And, even when data does get consolidated, researchers find it difficult to sift through it all and make sense of it in order to confidently draw the right conclusions and share the right results. Discover how to quickly and easily find, synthesize, and share information—accelerating and improving R&D.

The label expansion was based off a phase 3 study testing the vaccine in more than 1,000 infants, Pfizer said.

Back in 2015, Glaxo sold the shot—along with another MenACWY vaccine—to Pfizer for $130 million as it worked to close its purchase of Novartis’ stall of vaccines. That transaction boosted GSK to the top of the vaccines world, a position it’s expected to keep through 2022, according to EvaluatePharma.

But as Pfizer experiences a slowdown for its top shot, the pneumococcal disease blocker Prevnar 13, the company has worked to diversify its vaccines offerings through external deals, R&D and M&A. Last week, it backed cancer vax startup Ignite with an option to purchase the company if the work proves promising.

Suggested Articles

Merck just last month won the world's first licensure for an Ebola vaccine. Now, an international group authorized funding to establish a stockpile.

GSK expects Shingrix supplies to rise slightly in 2020, but the real "step change" will come in 2024 with a brand-new manufacturing facility.

Ebola has claimed thousands of lives in recent outbreaks, but now the world has a licensed vaccine option in Merck's Ervebo.