The vaccine for young children has finally arrived in India. The Government of India has approved Covaccine for emergency use for young children. An Expert Committee (SEC) working on COVID has approved Bharat Biotech’s Covaxin for emergency use for children in the age group of 2-18 years. Hyderabad-based Bharat Biotech completed phase-2 and phase-3 trials of Covaxin on children under 18 in September and submitted trial data to the Drugs and Controller General of India (DCGI) earlier this month . Only after that the vaccine was approved.
Children will get two doses of vaccine
In addition to the covaccine, Zydus Cadila’s ZyCoV-D, the world’s first DNA vaccine used to prevent infection, has also been approved in phase 2 trials for children over the age of 12. The subject expert panel issued a statement saying that after detailed deliberations, the committee recommended approval to market authorization of the vaccine for the age group of 2 to 18 years for restricted use in case of emergency. It has been decided to give Covaccine to children in two different doses. There should be at least 20 days between the two doses.
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Company thanks DCGI
Vaccine maker Bharat Biotech said that the trial data it presented to subject experts was thoroughly scrutinized by the Central Drugs Standard Control Organization (CDSCO) and the SEC after Covaccine was approved for children. Both declared the test positive. The company said that this is the first worldwide approval for Covid-19 vaccines for the age group of 2-18. Bharat Biotech sincerely thanks DCGI, Subject Expert Committee and CDSCO for their prompt review process.
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