Covaxin approval for kids under experts' evaluation: Report1 min read . Updated: 14 Oct 2021, 04:59 PM IST
- Recently, an expert panel has recommended granting emergency use authorization (EUA) to Bharat Biotech’s Covaxin for vaccinating kids
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The final approval for Covaxin for children aged 2 years and above is under expert opinion and evaluation, news agency ANI reported on Thursday quoting government sources.
Recently, an expert panel of the Central Drugs Standard Control Organization (CDSCO) has recommended granting emergency use authorization (EUA) to Bharat Biotech’s Covaxin for vaccination of 2 to 18-year-olds against covid-19.
Bharat Biotech has submitted data from clinical trials in the 2-18 years age group for Covaxin to CDSCO. "The data has been thoroughly reviewed by the CDSCO and SEC and have provided their positive recommendations," the vaccine maker said in the statement.
Meanwhile, Hyderabad-based Biological E is likely to submit final data for its coronavirus vaccine Corbevax by November-end, according to the agency sources.
Currently, phase 2/3 clinical trials of Corbevax, an RBD protein sub-unit vaccine to be administered in adults aged 18 years to 80 years, is underway and the results are likely to be declared this month.
Meanwhile, Biological E has recently sought permission from India's drug regulator to conduct the phase-3 clinical trial for Corbevax as a single booster dose for those who have been fully vaccinated with Covishield or Covaxin.
The Hyderabad-based pharma firm has inked an agreement with the Central government to supply 30 crore doses of Corbevax by December. The vaccine has been developed with support from the Department of Biotechnology and its PSU Biotechnology Industry Research Assistance Council (BIRAC) from the preclinical stage to phase-3 studies.
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