Serum Institute of India Gets CDSCO Panel Nod to Study Yellow Fever Vaccine
New Delhi: The vaccine maker Serum Institute of India has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the Phase II/III clinical trial of Yellow Fever Vaccine (Live) (I.P).
However, this approval is subject to the condition that the firm should submit a Phase II study report along with the Data and Safety Monitoring Board (DSMB) review for approval before the initiation of the Phase III study.
In addition to the above, the expert panel suggested that the adverse events of special interest (AESI) of the Yellow Fever vaccine be included in the patient information sheet.
This came after the vaccine major Serum Institute of India presented the revised Phase II/III clinical trial protocol of the Yellow Fever Vaccine (Live) (I.P).
Yellow fever is a viral disease that is transmitted to humans by the bites of infected mosquitoes. It is prone to epidemics and is preventable with a vaccine.
The vaccine is a live, weakened form of the virus given as a single shot. The vaccine is recommended for people aged 9 months or older and who are traveling to or living in areas at risk for yellow fever virus in Africa and South America.
It is strongly recommended that all travelers be vaccinated for yellow fever if traveling to or from a yellow fever-risk country.
Vaccination is the most important means of preventing yellow fever. The yellow fever vaccine is safe, and affordable and a single dose provides life-long protection against yellow fever disease. A booster dose of yellow fever vaccine is not needed.
At the recent SEC meeting for Vaccine held on 14th and 15th December 2023, the expert panel reviewed the revised Phase II/III clinical trial protocol of Yellow Fever Vaccine (Live) presented by the vaccine maker Serum Institute of India.
After detailed deliberation, the committee recommended approval to conduct Phase II/III clinical trial as per the presented protocol with conditions that :
1) The firm should submit a Phase II study report along with DSMB review for approval before initiation of Phase III.
2) Adverse events of special interest (AESI) of Yellow Fever vaccine to be included in the Patient information sheet.
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