Tuesday, July 6, 2021

Ready to square off with Pfizer in next-gen pneumococcal vaccines, a Merck exec says competition’s a good thing

As next-gen pneumococcal vaccines from Merck & Co. and Pfizer work through the FDA review process—and as an important CDC committee weighs data this week—a Merck exec says he embraces the competition that’s likely to follow.

Ahead of Thursday’s meeting of the CDC’s Advisory Committee on Immunization Practices, Merck’s Luwy Musey, executive director in biologics and vaccines clinical research, said in an interview that competition is “always good for the public.”

Both Merck’s 15-valent pneumococcal conjugate vaccine and Pfizer’s 20-valent shot have scored FDA priority reviews, setting them up for decisions in July and June, respectively. Each company has talking points designed to set its shot apart if and when the two square off in the market.

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In the meantime, experts at the CDC’s Advisory Committee on Immunization Practices are weighing data and will make recommendations about how the vaccines should be used in adults. ACIP recommendations can be critical for vaccine rollouts: Back in 2014, the committee endorsed Pfizer’s Prevnar 13 in adults over 65, leading to a blockbuster sales boost. 

This year, the Merck and Pfizer next-gen pneumococcal vaccines are looking to gain an edge in the next-gen market and supplant existing powerhouse Prevnar 13. The Pfizer shot, which protects against 13 serotypes, has been the world’s bestselling vaccine for several years, a title it’s likely to lose in 2021 as the leading COVID-19 vaccines post billions in sales. 

RELATED: Pfizer’s Prevnar gets $2B boost with CDC nod in older adults 

It’s taken Merck many years to reach this point with its own pneumococcal conjugate shot. The company had its first formulation in 2011 that “worked pretty well” but wasn’t “optimal” when used in children, Musey said. Merck stopped the program and made changes, causing a delay of two to four years, he said. In the end, Merck wanted to ensure it was coming to the market with a “high quality product.” 

As Musey sees it, Merck’s new-generation pneumococcal shot may cover 15 serotypes to Pfizer’s 20, but more serotypes isn’t necessarily better. Merck chose to focus on making sure its vaccine provides strong protection against all of the serotypes it targets, he said.

Pfizer has plenty to say about in its own program, though. When the FDA awarded the new shot priority review, Pfizer’s vaccine R&D head Kathrin Jansen said the vaccine, if approved, would “cover more serotypes responsible for the majority of pneumococcal disease than any other pneumococcal conjugate vaccine currently licensed or currently in late-stage clinical development.”

The last clause was a clear shot at Merck. And Jansen added that Pfizer’s vaccine has been “shown to induce immune memory,” she said, adding to its benefits. 

RELATED: Pfizer’s ‘Prevnar 20’ gets in FDA fast lane as next-gen pneumococcal vaccine race heats up with Merck 

Merck isn’t just confident in V114, though. Musey doesn’t see the current candidate as a one-off program in the field of pneumococcal conjugate vaccines. It’s just Merck’s “first foray” in the arena, Musey said. Looking forward, Merck is analyzing how the disease is “evolving” and working on two separate follow-up candidates targeting unmet medical need in adults and in children. 

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