Sanofi gets CDSCO panel okay to market Quadrivalent Inactivated Influenza vaccine

Published On 2022-03-12 08:17 GMT   |   Update On 2022-03-12 08:17 GMT
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New Delhi: Pharma major, Sanofi has got the go-head from the Subject Expert Committee (SEC) of the Central Drug Standard Control Organization (CDSCO) to market Quadrivalent Inactivated Influenza vaccine (Split Viron) in the age group of 6 to 35 months.

This approval is subjected to condition that the firm should conduct observational Post Marketing Surveillance study as per the protocol presented before the Committee.
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This came after the firm presented its proposal for grant of market authorization for Quadrivalent Inactivated Influenza Vaccine (split virion) I.P. (for 0.5ml dose) in the age group of 6 to 35 months with protocol for observational Post Marketing Surveillance study.

Quadrivalent Influenza Vaccine (split virion, inactivated) is a vaccine. This vaccine administered to child from 6 months of age helps to protect against influenza (flu).

Flu is a disease that can spread rapidly and is caused by different types of strains that can change every year. Due to this potential change in circulating strains on a yearly basis, as well as the duration of protection intended by the vaccine, vaccination is recommended every year.

Quadrivalent Influenza Vaccine (split virion, inactivated) is intended to protect one against the four strains of virus contained in the vaccine about 2 to 3 weeks after the injection. It is indicated for the prevention of influenza disease caused by the two influenza A virus subtype and two influenza B virus types contained in the vaccine.

When a person is given Quadrivalent Influenza Vaccine (split virion, inactivated), the immune system (the body's natural defence system) will produce its own protection (antibodies) against the disease. When given during pregnancy the vaccine helps to protect the pregnant women but also helps to protect her baby from birth to less than 6 months of age through the transmission of protection from mother to baby during pregnancy.

Earlier, the Medical Dialogues Team had reported that Sanofi Pasteur, the vaccine division of Sanofi, had announced the launch of its 4-strain influenza vaccine FluQuadri in India which was India's first quadrivalent vaccine to provide broader protection against influenza to population above three years of age.

FluQuadri (Quadrivalent Influenza Vaccine) for intramuscular injection is an inactivated influenza vaccine, prepared from influenza viruses propagated in embryonated chicken eggs. The virus-containing allantoic fluid is harvested and inactivated with formaldehyde.

At recent SEC meeting to review proposals and advice Drugs Controller General (India) in matters for Biologicals & PAC proposals held on 03.03.2022, the committee extensively reviewed the drug maker Sanofi's proposal for grant of market authorization for Quadrivalent Inactivated Influenza Vaccine (split virion) I.P. (for 0.5ml dose) in the age group of 6 to 35 months with protocol for observational Post Marketing Surveillance study.
After detailed deliberation, the committee recommended the grant of market authorization for Quadrivalent Inactivated Influenza vaccine (Split Viron)I.P (for a a0.5ml dose) in the age group of 6 to 35 months with condition to conduct observational Post Marketing Surveillance study as per the protocol presented before the Committee.
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