Beating Merck, Pfizer gets priority review as the first Prevnar follow-up heads to the FDA
It won’t get quite the work-on-Thanksgiving welcome that the Covid-19 jab received, but another Pfizer vaccine is headed to the FDA, where it will receive a speedy review.
Pfizer announced Wednesday that an application for its new pneumococcal vaccine, 20vPnC, has been accepted and granted priority review at the agency, setting up a decision by June of next year.
With the acceptance, Pfizer remains a step ahead of Merck in the race to develop a follow-on to one of the Big Pharma’s most important profit generators. While most vaccines are slim margin product, Prevnar collected $6 billion in revenue last year, more than any other fully owned Pfizer product.
With Prevnar nearing patent expiration and rival vaccines advancing in late-stage trials, though, Pfizer has pushed to get a next generation pneumococcal shot approved.
Unlike Prevnar, which protects against 13 different strains of pathogenic pneumococcal bacteria, the new shot is designed to protect against 20. Pfizer is touting it as superior to any pneumococcal shot on the market and any of the other ones nearing the market.
“If approved, 20vPnC will 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,” Kathrin Jansen, Pfizer’s vaccine chief, said in a statement. “Importantly, 20vPnC has shown to induce immune memory, which provides protection and efficacy against non-bacteremic pneumonia, particularly in older adults.”
In a Phase III trial unveiled in March, Pfizer announced that the vaccine successfully stimulated antibodies against 19 of the 20 strains in volunteers over the age of 50, including all 13 of the strains in Prevnar 13. The 20th strain narrowly missed, the company said.
Merck, meanwhile, announced in September positive Phase III data for its vaccine designed to defend against 15 different strains. That included one strain where, the company claimed, they outperformed Prevnar.
Both Merck and Pfizer’s candidates have received breakthrough designations from the FDA.
The two behemoths may soon also have to contend with an additional player. The California biotech Vaxcyte raised nearly $300 million on private markets and, this year, launched a $287.5 million IPO to develop its own pneumococcal vaccine. The company expects to file an IND until the second half of next year, with the first clinical data coming in 2022.