This recommendation came in line with the proposal, which included a request for a PMS study waiver for Hepatitis B Vaccine (r-DNA) IP, presented by pharmaceutical major Biological E.
The committee noted that the firm has manufacturing and marketing permission in Form 46, vide no. MF-197/2013, for hepatitis B vaccine (r-DNA) IP with a condition to conduct the PMS study in 500 subjects.
The hepatitis B vaccine (rDNA) is used for the prevention of hepatitis B infection.
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 longer than six months.
The hepatitis B vaccine is a vaccine that prevents hepatitis B. The first dose is recommended within 24 hours of birth, with either two or three more doses given after that. This includes those with poor immune function, such as those with HIV/AIDS, and those born prematurely. It is also recommended that health-care workers be vaccinated. In healthy people, routine immunization results in more than 95% of people being protected. The vaccine works by causing your body to produce its own protection (antibodies) against the disease.
The hepatitis B vaccine (rDNA) is a vaccine that helps develop immunity by initiating a mild infection. This type of infection does not cause illness but stimulates the body's immune system to produce antibodies (proteins) to protect against any future infections.
At the recent SEC meeting for vaccines held on February 21, 2023, the expert panel reviewed the proposal for a PMS study waiver of the Hepatitis B Vaccine (r-DNA) IP, presented by pharmaceutical major Biological E.
After detailed deliberation, the committee recommended,
"The firm should conduct a PMS study in compliance with the conditions of manufacturing and marketing permission in Form 46."
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