Biological E Gets CDSCO panel Nod for Post-marketing Surveillance study of Hepatitis B Vaccine
New Delhi: The Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) has given its nod to the vaccine maker Biological E to conduct the Phase IV or Post-marketing Surveillance (PMS) study of the Hepatitis B Vaccine (rDNA) to evaluate the safety of Biological E’s monovalent recombinant Hepatitis B vaccine when administered to 6-8 weeks old infants in 6-10-14 weeks dosing schedule.
This came after the firm presented its proposal for a grant of permission to conduct a Phase IV/PMS study of the Hepatitis B Vaccine (rDNA) titled “A multicentre single-arm, Phase IV, post-marketing surveillance study to evaluate the safety of Biological E’s monovalent recombinant Hepatitis B vaccine when administered to 6-8 weeks old infants in 6-10-14 weeks dosing schedule”.
The Hepatitis B vaccine is indicated for active immunization against hepatitis B infection in subjects considered at risk of exposure to HBV-positive material.
Hepatitis B is a vaccine-preventable liver infection caused by the hepatitis B virus (HBV). Hepatitis B is spread when blood, semen, or other body fluids from a person infected with the virus enters the body of someone who is not infected.
Hepatitis B is a serious liver infection caused by the hepatitis B virus (HBV). For most people, hepatitis B is short-term, also called acute, and lasts less than six months. But for others, the infection becomes chronic, meaning it lasts more than six months. Having chronic hepatitis B increases your risk of developing liver failure, liver cancer, or cirrhosis — a condition that permanently scars the liver.
Most adults with hepatitis B recover fully, even if their symptoms are severe. Infants and children are more likely to develop a long-lasting hepatitis B infection. This is known as a chronic infection.
At the recent SEC meeting for Vaccine held on 27th June 2023, the expert panel reviewed the proposal for the grant of permission to conduct Phase IV/PMS study of Hepatitis B Vaccine (rDNA) titled “A multicentre single-arm, Phase IV, post-marketing surveillance study to evaluate the safety of Biological E’s monovalent recombinant Hepatitis B vaccine when administered to 6-8 weeks old infants in 6-10-14 weeks dosing schedule”.
After detailed deliberation, the committee recommended the conduct of a PMS study of the Hepatitis B Vaccine (rDNA) as per the presented protocol.
Accordingly, the expert panel suggested that the firm is required to revise the title and submit a revised protocol to CDSCO.
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