CDSCO panel noted Biological E’s Post Marketing Surveillance Report of Monovalent recombinant Hepatitis-B vaccine
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has noted the post-marketing surveillance report of the Monovalent recombinant Hepatitis-B vaccine study titled “A multicentre single arm, 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 schedules”.
This came after the vaccine major Biological E presented the post-marketing surveillance report of the Monovalent recombinant Hepatitis-B vaccine study titled “A multicentre single arm, 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 schedules”.
Hepatitis B Vaccine (Recombinant) is composed of highly purified hepatitis B surface antigen (HBsAg) adsorbed to an aluminum adjuvant. The antigen is produced from the fermentation of a recombinant strain of yeast, Saccharomyces cerevisiae.
At the recent SEC meeting for Vaccine 30th April 2024, the expert panel reviewed the post-marketing surveillance report of Monovalent recombinant Hepatitis-B vaccine study titled “A multicentre single arm, 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 schedules” presented by the drug major Biological E.
After detailed deliberation, the committee noted the results of the PMS study as presented by the firm.
