Racing with Merck, Pfizer wins FDA ‘breakthrough’ tag for 20-valent pneumococcal vaccine

Pfizer and Merck are racing to the market with their next-gen pneumococcal candidates, and on Thursday, Pfizer’s program got a major boost. The FDA granted the company’s 20-valent vaccine its Breakthrough Therapy Designation in adults as the drugmaker prepares for late-stage testing.

With the breakthrough designation, Pfizer’s program gets the perks of a FDA Fast Track designation, potentially including more frequent communications with the agency. The vaccine could win accelerated approval and priority review under certain circumstances. The breakthrough designation is based on phase 2 data, and Pfizer plans to advance to phase 3 “in a few months,” the company said.

Meanwhile, Merck is already in phase 3 testing with its 15-valent program, dubbed V114.

At a healthcare conference last week, Pfizer CFO Frank D’Amelio said the company is “all in” on advancing its candidate. After Pfizer closed its internal neuroscience outfit earlier this year, the company shifted resources to accelerate the vaccine’s development, he said.

The stakes are high. Pfizer’s Prevnar 13 already pulls in billions of dollars annually, and both drugmakers want to own as much of the market as possible. Merck entered phase 3 testing in April.

Still, Pfizer executives have said they believe the drugmaker can launch its vaccine at a “competitive” time frame to Merck. If Pfizer’s launch timing is competitive, D’Amelio said extra protection offered by the shot and the strength of the Prevnar franchise should allow the company to hold market share and keep growing its business.

Merck R&D chief Roger Perlmutter, M.D., Ph.D., for his part, has said he envisions a need for multiple pneumococcal vaccines in the future. In one phase 3 study, Merck is testing its V114 in a head-to-head against Pfizer’s Prevnar 13.

Merck and Pfizer are two of the largest vaccine companies globally, generating $6.5 billion and $6 billion in the field last year, respectively.
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