Posted by Michael Wonder on 20 Sep 2018
Pfizer granted FDA breakthrough therapy designation for 20 valent pneumococcal conjugate vaccine for the prevention of invasive disease and pneumonia in adults aged 18 years ands older
20 September 2018 - Breakthrough therapy designation designed by FDA to expedite the development and review of drugs and vaccines which may demonstrate substantial improvement over available therapy.
Pfizer announced today that its 20 valent pneumococcal conjugate vaccine (20vPnC) candidate, PF-06482077, received breakthrough therapy designation from the US FDA for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in the vaccine in adults aged 18 years and older. Pfizer expects to start Phase 3 trials in a few months.
The FDA decision is informed by the results of the 20vPnC Phase 2 randomized, double-blind trial to evaluate the safety and immunogenicity of a multivalent pneumococcal conjugate vaccine in adults 60 through 64 years of age. Pfizer will seek to present and publish outcomes from this clinical trial at a future date.
