CDSCO panel seeks justification for Pfizer Phase III CT of 20-Valent Pneumococcal Conjugate Vaccine
New Delhi: In response to the drug major Pfizer's Phase III clinical trial proposal for Pneumococcal Polysaccharide Conjugate Vaccine (20 Valent), the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has recommended that the firm should submit the justification regarding sample size calculation for immunogenicity along with statistical power.
Furthermore, the expert panel has sought justification about the subset population for determination of OPA titres.
This came after the drug major Pfizer presented its proposal for grant of permission to conduct Phase III clinical trial of Pneumococcal Polysaccharide Conjugate Vaccine (20 Valent).
Pneumococcal infection can cause serious problems, such as pneumonia (which affects the lungs), meningitis (which affects the brain), bacteremia (which is a severe infection in the blood).This vaccine is to be given only by or under the supervision of your doctor.
Pneumococcal Polysaccharide Conjugate Vaccine (20 Valent) is a vaccine indicated for active immunization for the prevention of pneumonia and invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in adults 18 years of age and older. The indication for preventing pneumonia caused by S. pneumoniae serotypes 8, 10A, 11A, 12F, 15B, 22F, and 33F is approved based on immune responses.
Earlier the Medical Dialogues Team had reported that Pfizer had announced that the U.S. Food and Drug Administration (FDA) accepted for priority review a Biologics License Application (BLA) for its 20-valent pneumococcal conjugate vaccine (20vPnC) candidate, as submitted for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in the vaccine in adults ages 18 years and older.
Pfizer's 20vPnC vaccine candidate includes capsular polysaccharide conjugates for the 13 serotypes already included in Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine[Diphtheria CRM Protein]). The vaccine also contains capsular polysaccharide conjugates for seven additional serotypes that cause invasive pneumococcal disease (IPD), and have been associated with high case-fatality rates, antibiotic resistance, and/or meningitis.
At the recent SEC meeting for vaccine held on 29th August 2022,the expert panel reviewed the proposal presented by drug maker Pfizer to conduct Phase III clinical trail of Pneumococcal Polysaccharide Conjugate Vaccine (20 Valent).
