Serum Institute gets CDSCO Panel nod to conduct phase III clinical trial of Yellow Fever Vaccine

New Delhi: Noting the interim results of the Phase II clinical trial of Yellow Fever Vaccine, the Subject Expert Committee (SEC), functional under the Central Drug Standard Control Organization (CDSCO), has recommended the vaccine major Serum Institute for conducting a Phase III clinical trial as per the presented revised protocol.

This came after the firm submitted the interim analysis of the safety and immunogenicity study report (Blinded) (Phase II) along with Data Safety Monitoring Board (DSMB) recommendations and revised Phase III study protocol.

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 yellow fever vaccine is a live, weakened version of the yellow fever virus that protects against the viral infection. It's recommended for people who are traveling to or living in areas of Africa and South America where the virus is a risk.

At the recent SEC meeting for vaccine, the expert panel observed that permission was granted to conduct Phase II/III clinical trial of Yellow Fever Vaccine as per 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 the Yellow Fever vaccine to be included in the patient information sheet.

Now, in continuation, the firm has submitted the Interim Analysis of Safety and Immunogenicity Study Report (Blinded) (Phase II) along with DSMB recommendations and a revised Phase III study protocol.

After detailed deliberation, the committee noted the interim results of the Phase II clinical trial and recommended the conduct of the Phase III clinical trial as per the presented revised protocol.

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