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SEC recommends approval for Zydus Lifesciences' trivalent influenza vaccine in children
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Gireesh Babu, New Delhi
May 09 , 2024
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The Subject Expert Committee (SEC), which advises the Central drug regulator regarding clinical trials and approvals of drugs, has recommended approval for additional indication of Zydus Lifesciences' inactivated trivalent influenza vaccine in children above six months with clinical trial waiver subject to condition.
The decision comes at a time when the World Health Organisation (WHO) has recently recommended that all flu vaccines in countries like the US should be trivalent vaccines, as compared to the current four-component (quadrivalent) flu vaccines.
The SEC on Vaccine which met at the end of April to review the proposals related to vaccine trials and approvals in the country, and advise the Drugs Controller General (India) (DCGI) in matters for biologicals and post approval change proposals, considered the proposal submitted by the company.
The firm presented the proposal for approval of additional indication for the already approved trivalent influenza vaccine in the age group of six months to 17 years.
The Committee noted that the firm is already having manufacturing permission of inactivated quadrivalent influenza vaccine for the same age group and the applied inactivated trivalent influenza vaccine has same composition as the approved quadrivalent influenza vaccine, except that it does not contain the B/Yamagata strain.
Besides, it also noted the World Health Organisation's (WHO) recommendations for use of trivalent influenza vaccine instead of quadrivalent influenza vaccine from 2024.
The WHO, earlier this year, recommended that the flu vaccines should be of three components and include an influenza A(H1N1), an A(H3N2) and a B/Victoria-lineage vaccine virus, from this year for the northern hemisphere influenza season. The influenza B/Yamagata viruses, which are included in current four-component (quadrivalent) flu vaccines, are no longer actively circulating, their inclusion in flu vaccines is no longer warranted, it said.
Zydus has announced in 2017 that it received the regulator's approval to launch VaxiFlu-4, a first quadrivalent influenza vaccine in the country. With this, Zydus Cadila claimed that it has become the first Indian pharma company and second in the world to launch a Tetravalent Inactivated Influenza vaccine.
The vaccine provides protection from the four influenza viruses- H1N1, H3N2, Type B (Brisbane), which is B/Victoria lineage and Type B (Phuket), which is B/Yamagata lineage-like virus. There are different strains of influenza viruses that infect human beings, the predominant ones being influenza A and influenza B. The common subtypes of influenza A found in general circulation amongst people are H1N1 (which was responsible for the devastating swine flu pandemic) and H3N2. The subtypes of influenza B commonly found in circulation are influenza B (Brisbane – Victoria lineage) and influenza B (Phuket – Yamagata lineage), said the company.
The product is marketed by Zydus' preventive products division Zydus Vaxxicare, which also sells Covid-19 vaccine, rabies vaccine, among others.
The Tetravalent Inactivated Influenza vaccine has been developed at the Vaccine Technology Centre (VTC) in Ahmedabad which has proven capabilities in researching, developing, and manufacturing of safe and efficacious vaccines. The group was also the first to indigenously develop, manufacture and launch India’s first vaccine against H1N1 - Vaxiflu-S, it said during the time of announcement.
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