FDA awarded Pfizer pneumococcal conjugate vaccine PF-06482077 breakthrough therapy

Recently, Pfizer Inc. (PFE) announced that its 20-Valent pneumococcal conjugate vaccine (20vPnC) drug candidate PF-06482077 has been approved by the US Food and Drug Administration (FDA) for breakthrough therapy for 18 years of age and older. Invasive diseases and pneumonia caused by S. pneumoniae serotype in adults.

Streptococcus pneumoniae is a substantial inflammation of the lungs caused by Streptococcus pneumoniae. It usually begins with a sudden onset of high fever, chills, cough, blood stasis and chest pain. Gtreptococcus pneumonias, formerly known as pneumococci or pneumococci, is a Gram-positive diplococcus and is a type of streptococcus. Streptococcus pneumoniae is classified according to its capsule-specific polysaccharide antigen type. Currently, the Danish type 84 (Danish serum research institute is the only anti-serum source approved by WHO), the United States is divided into 86 serotypes. Streptococcus pneumoniae is infectious to all age groups, mainly affecting children under 2 years of age and older than 65 years old. The WHO estimates that approximately 1.6 million people worldwide die from pneumococcal disease each year.

There are two types of inactivated pneumococcal vaccines: a polysaccharide vaccine made from polysaccharide capsules surrounding pneumococci. Another conjugate vaccine is made by attaching a polysaccharide capsule surrounding pneumococci to a protein carrier. Inspired by the Haemophilus influenzae conjugate vaccine, the S. pneumoniae polysaccharide is covalently bound to the protein, and the polysaccharide antigen is converted into an antigen dependent on T cells, which can produce a good antibody response after immunization in infants and young children. Memory response.

PF-06482077 is a 20-valent S. pneumoniae (20vPnC) vaccine. The award for this breakthrough therapy was based on the results of Phase 2 clinical trials of the 20vPnC vaccine candidate. This randomized, double-blind, phase 2 trial evaluated multivalent S. pneumoniae conjugate vaccines for safety and immunogenicity in adults aged 60-64 years. Pfizer will announce the results of the clinical trial in the near future and said it is expected to begin the phase 3 clinical trial of the vaccination within a few months.

Previously, the US Food and Drug Administration approved the 20vPnC rapid approval channel in October 2017. Dr. Kathrin U. Jansen, senior vice president and head of vaccine development at Pfizer Research and Development, said that we look forward to continuing our dialogue with the FDA so that we can accelerate the development of Pfizer's new generation of pneumococcal candidate vaccine adult indications.

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