SERUM INSTITUTE ALLOWED VACCINE TRIALS ON CHILDREN

The Central Drugs Standard Control Organisation (CDSCO) has allowed Serum Institute of India (SII), the country’s largest vaccine manufacturer to enroll kids from age 7-11 for its trial of Novavax’s COVID-19 vaccine. Novavax, a US-based vaccine developer had partnered with SII for the launch of its vaccine in India earlier this year.

Reportedly, a subject expert panel of the Central Drugs Standard Control Organisation said that after detailed deliberation, the committee has recommended, allowing enrolment of subjects of 7 to 11 years of age group as per the protocol.

The Novavax vaccine has not gained the approval of the Drug Controller General of India yet. However, SII has been manufacturing the vaccine for Novavax in abundance. Currently, Serum Institute has been conducting trials of ‘Covovax’ that is its own locally produced version of Novavax’s vaccine.

The trials have been conducted on the population of 12-17 years old and have presented safety data for the initial 100 volunteers. Adar Poonawalla, CEO, Serum Institute had said earlier this month that the Covovax approval for the age group below 18 years should be granted till early 2022.

As of now, only Gujarat-based vaccine developer Zydus Cadila has gained approval for the use of its vaccine ‘ZyCOV-D’, on adults as well as children above the age of 12.

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