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.

On-Demand Webinar

Leveraging A Medical Record-Enriched Patient Dataset for COVID-19 Research

You are invited to join a webinar that will explore the ways researchers can leverage this enriched dataset for important COVID-19 research. Sign up today for this informative webinar to learn how you can leverage one of the only medical record reviews solely using real-world data from hospitalized COVID-19 patients.

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

Iowa State University is working on a room-temp-stable nasal spray vaccine for COVID-19, and it recently tapped device maker Zeteo for support.

Pfizer's shot will go before an FDA expert panel on Dec. 10, with Moderna's review pegged for the 17th, Warp Speed chief Moncef Slaoui, Ph.D., said.

As soon as Pfizer gets go-aheads from regulators for its COVID-19 vaccine, it'll be ready to distribute, CEO Albert Bourla says.