In one of the first big tests for Pfizer's new vaccine R&D chief Annaliesa Anderson, Ph.D, the company appears to have passed a phase 3 study of its five-in-one meningococcal shot with flying colors.
The investigational vaccine, dubbed MenABCWY, was non-inferior against currently approved alternatives, setting up a potential submission for FDA approval in the fourth quarter. The new shot was tested against one of Pfizer's own, Trumenba, which it acquired after buying Wyeth Pharmaceuticals 2009, as well as against GSK’s Menveo.
Notably, Pfizer reported that MenABCWY wasn’t inferior in any of the five meningococcal serogroups. There’s currently no approved vaccine that protects against all five subgroups—A, B, C, W and Y. With MenABCWY, which is a combination of Trumenba and a former GSK vaccine called Nimenrix sold to Pfizer in 2015, the U.S. drugmaker is hoping to change that.
“A pentavalent vaccine has the potential to help simplify what is currently a complex meningococcal vaccination schedule in the U.S. and improve vaccine coverage,” Anderson said in a press release issued Thursday. “Our goal is to help ensure as many adolescents and young adults as possible are protected against this devastating disease.”
The phase 3 study included over 2,400 patients across the U.S., with the primary endpoints including a four-fold rise in hBSA—a correlate of protection against the virus—in all of the seropopulations, as well as non-inferiority against the two other shots. The vaccine was tested in people aged 10 to 25 years.
It’s one of the first significant wins for Anderson since taking the reins of the vaccine R&D group at the beginning of August. She was tapped for the role in June after then-chief Kathrin Jansen, Ph.D., announced her retirement from Pfizer.
It’s a fitting success story as well, after Anderson came aboard Pfizer after it bought Wyeth. Anderson initially joined the Pearl River, New York-based biotech in 2007 to help lead the bacterial vaccine research efforts.
As a result of the promising data, Pfizer says it’s planning to file an approval application with the FDA in the fourth quarter. The company also noted that regulatory actions were being planned for outside the U.S.
The news marks the latest success notched in the vaccine strategy for Pfizer, which secured its reputation as a leading player in this area as a result of its COVID-19 collaboration with BioNTech. Pfizer also recently announced a phase 3 trial of its flu vaccine, keeping in lockstep with its COVID-19 competitor Moderna.