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FDA grants breakthrough therapy designation to 20-valent pneumococcal conjugate vaccine

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The FDA has granted breakthrough therapy designation to Pfizer for its 20-valent pneumococcal conjugate vaccine candidate for preventing invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in the vaccine in adults aged at least 18 years, according to a press release.

The decision was based on results of a phase 2, randomized, double-blind study of the candidate, PF-06482077, to determine safety and immunogenicity of a multivariate conjugate vaccine in adults aged 60 to 64 years, according to the release. Pfizer announced it will present published outcomes of the clinical trial at a future time.

Pfizer also announced that it expects to start phase 3 trials of PF-06482077 within the next few months.

“We look forward to continuing our dialogue with the FDA so that we can accelerate the development program of the adult indication of Pfizer’s 20-valent next-generation pneumococcal vaccine candidate,” Kathrin U. Jansen, PhD, senior vice president and head of vaccine research and development for Pfizer, said in the release. “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.”

Pfizer reported that breakthrough therapy designation is created to expedite the development and review of drugs and vaccines intended to treat or prevent serious conditions, and when preliminary clinical evidence indicates the drug or vaccine could demonstrate substantial improvement of treatment compared with available therapy. The FDA had granted 20-valent pneumococcal conjugate vaccine its fast track designation in October 2017 in the use of adults aged at least 18 years, according to the release.