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COVID DATA December 6, 2021 INDIA: New Cases: 8,306 Total Cases: 3,46,41,561 New Deaths: 211 Total Deaths: 4,73,537 New Tests: 8,86,263 Total Tests: 64,82,59,067 New Vax: 24,55,911 Total Vax: 127,93,09,669 Hot Spot States (daily deaths above 10) Kerala: New Deaths: 23; Old Unreported Deaths: 138 TPR: 7.7% Total Deaths: 41,600 Bengal: New Deaths: 10 Total Deaths: 19,544 Tamil Nadu: New Deaths: 10 Total Deaths: 36,529 - India Travel Times.Com   [Estd: 1998]       * * *    Travel, More Travel, Travel Means A Million Things     * * *    
DCGI authorisation for Covaxin for children of 2-18 years likely this week
The Subject Expert Committee (SEC) of the DCGI has recommended approval for Bharat Biotech's Covaxin for children and the DCGI authorisation for emergency use is expected to come in days. The Covaxin meant for children will have a different mode of inoculation than of the adult's. It will also be administered in two doses, but in a gap of only 20 days. Although Zydus Cadila had received the emergency use authorisation early, it is yet to reach the market.

NEW DELHI, Oct 12: After Zydus Cadila got the authorisation, Bharat Biotech is awaiting immediate regulatory approval for emergency use of its indigenous Covaxin for children of 2 to 18 years as it was cleared by the Subject Expert Committee (SEC) on Tuesday. Although Zydus Cadila had received the emergency use authorisation early, it is yet to reach the market.

The Covaxin for children will have a different mechanism of inoculation other than its adult vaccine. It will also be administered in two doses, but with a gap of only 20 days.

The Hyderabad-based Bharat Biotech had submitted the data of Phase 2 and 3 trials to the Drugs Controller General of India (DCGI) for authorisation early this month. After SEC recommendation the authorisation is a formality and it usually takes only a few days.

“After detailed deliberation, the committee recommended for grant of market authorization of the vaccine for the age group of 2 to 18 years for restricted use in emergency situation,” the SEC said in a statement.

"This represents one of the first approvals worldwide for Covid-19 vaccines for the 2-18 age group. Bharat Biotech sincerely thank the DCGI, Subject Expert Committee, and CDSCO for their expedited review process. We now await further regulatory approvals from the CDSCO prior to product launch and market availability of Covaxin for children," the Bharat Biotech said.

ZyCov-D of Zydus Cadila was the first vaccine approved for emergency use in children aged 12 and above in India. The DNA- based, three-dose, needle-free vaccine can also be administered to adults. However, it is yet to reach the market. The price, not yet fixed, is likely to be high.

Novavax called Covovax in India is another vaccine for children aged 2 to 18 but it is yet to get the drug regulator's permission for emergency use as the Serum Institute of India (SII) has not completed second and third phase trials

. There is also yet another called Corbevax, for children aged 5 to 18 years. The Hyderabad-based Biological E Limited is conducting the second and third phase clinical trials.

As the schools have opened in most States and more children were were found infected during the second wave of the covid pandemic, parents as well as teachers are concerned about vulnerability of children while getting exposed to the bustle of school life. The sero surveys have detected high levels of covid antibodies among children. especially in the States of Maharashtra, Kerala and Mizoram.

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