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.
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