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  • CDSCO panel seeks...

CDSCO panel seeks justification for Pfizer Phase III CT of 20-Valent Pneumococcal Conjugate Vaccine

Dr. Divya ColinWritten by Dr. Divya Colin Published On 2022-09-11T11:35:41+05:30  |  Updated On 11 Sep 2022 6:05 AM GMT
CDSCO panel seeks justification for Pfizer Phase III CT of 20-Valent Pneumococcal Conjugate Vaccine
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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...

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 20-valent conjugate vaccine is an active immunizing agent used to prevent infection caused by certain types of pneumococcal bacteria (Streptococcus pneumoniae). It works by causing body to produce its own protection (antibodies) against the disease.

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.

Also Read:Pfizer Gets USFDA Priority Review For 20-Valent Pneumococcal Conjugate Vaccine

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).

After detailed deliberation, the committee recommended that the firm should submit the justification for following:
1. Sample size calculation for immunogenicity along with statistical power.
2. Subset population for determination of OPA titres.
Accordingly, the committee asked the firm to submit their reply for further deliberation before the committee.
Also Read:CDSCO approves AstraZeneca Anticancer Drug Trastuzumab Deruxtecan Protocol Amendment
pfizerPneumococcal Polysaccharide Conjugate VaccinePneumococcal vaccinecdscophase 3 trialsec committee
Dr. Divya Colin
Dr. Divya Colin

    Doctor of Pharmacy

    Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

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