Biological E Gets CDSCO panel Nod for Post-marketing Surveillance study of Hepatitis B Vaccine

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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