CDSCO Panel grants Zydus Lifscience Proposal For Additional Indication of Trivalent Influenza vaccine in 6 months to 17 years age

New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved Zydus Lifscience's proposal for additional indication for an already approved Trivalent Influenza vaccine in the age group of 6 months to 17 years.

However, this approval is subject to the condition that Zydus Lifesciences conduct a Phase IV Clinical trial and submit the clinical trial protocol within 3 months.

This came after Zydus Lifesciences presented the proposal for approval of additional indication for an already approved Trivalent Influenza vaccine in the age group of 6 months to 17 years.

Trivalent flu vaccines protect against three strains of the virus: influenza A (H1N1), influenza A (H3N2), and one influenza B/Victoria lineage virus. Influenza B viruses are classified into two lineages: B/Yamagata and B/Victoria. However, as per USFDA, the evidence indicates that the B/Yamagata lineage virus no longer poses a public health threat.

In the interest of public health, the FDA strongly recommended to influenza vaccine manufacturers the removal of the B/Yamagata lineage virus from seasonal influenza vaccines in the U.S. for the 2024-2025 influenza season.

At the recent SEC meeting for Vaccine held on 30th April 2024, the expert panel reviewed the proposal for approval of additional indication for the already approved Trivalent Influenza vaccine in the age group of 6 months to 17 years.

The committee noted that the firm already has manufacturing permission for the Inactivated Quadrivalent Influenza vaccine for the same age group. The applied Inactivated Trivalent Influenza vaccine has the same composition as the approved Quadrivalent Influenza vaccine except that it does not contain the B/Yamagata strain.

Further, the committee also noted WHO recommendations for the use of the Trivalent Influenza vaccine instead of the Quadrivalent Influenza vaccine from 2024 onwards.

After detailed deliberation and based on the above, the committee recommended the approval of the additional indication in the age group of 6 months to 17 years with clinical trial waiver with the condition to conduct Phase IV Clinical trial and the clinical trial protocol should be submitted within 3 Months.

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