Pfizer just got a leg-up in its race with Merck & Co to bring a new-generation pneumococcal vaccine to the US market after getting a breakthrough designation (BTD) for its candidate.
The 20-valent vaccine – PF-06482077 – picked up the BTD from the US regulator for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in the vaccine in adults aged 18 years and older. The FDA also granted fast-track status for PF-06482077 last year.
Pfizer says it is expecting to start phase 3 trials of the new vaccine in the coming months, and is in pursuit of PCV-15 (also known as V114), a 15-valent candidate that Merck is bringing to market to compete with Pfizer’s established pneumococcal vaccine Prevnar-13, which brought in sales of $5.6bn in 2017. Merck started its phase 3 programme for V114 earlier this year.
With such a large franchise to defend, Pfizer is pushing hard to get PF-06482077 through development as quickly as possible and – with its broader coverage of pneumococcal strains – trump any advantage Merck may claim over Prevnar.
In phase 2 studies, PCV-15 has shown it can match Prevnar on the 13 serotypes covered by Pfizer’s vaccine in adults, with the added bonus of tackling the additional pair. However, it fell a little short in infant studies, failing to meet the non-inferiority mark for three of Prevnar’s serotypes.
Merck remains convinced it can match and exceed Prevnar-13 in phase 3, and is already starting follow-up programmes with the vaccine looking at different adult age groups, neonatal immunisation, and childhood immunisation.
Merck’s head of R&D Roger Perlmutter said a few weeks ago that there his expectation is that there will “be need in the marketplace for multiple pneumococcal vaccines… given the threat of the disease and its impact on human population.”
“We look forward to continuing our dialogue with the FDA so that we can accelerate the development program of the adult indication,” said Kathrin Jansen, head of vaccine R&D at Pfizer.
“There continues to be a global health need to protect against the potentially devastating effects of invasive pneumococcal disease and pneumonia caused by additional serotypes, and we are dedicated to continue to build on our expertise in pneumococcal conjugate vaccines with this vaccine candidate.”