Covaxin for children is set to begin phase 2/3 trials after expert panel approval

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Published by Tapasya Iyer on 12 May 2021

The long wait if finally over. The Indian pharmaceutical company Bharat Biotech (BBL)’s Covaxin on late Tuesday has been given the approval by an expert panel of the Central Drugs Standard Control Organization (CDSCO) to carry out phase 2/3 clinical trials on 2 to 18 year-olds. The vaccine is currently in use for 18+ throughout the country.

According to reports, the trial will be conducted in 525 subjects at various reputed institutions which includes AIIMS (Delhi), AIIMS (Patna) and Meditrina Institute of Medical Science (Nagpur). Th results of efficacy in the phase 3 will be inspected for the final nod for nation-wide use in the inoculation drives. However, this process might take 3-4 months.

Talking to a Republic TV, BBL founder Dr. Krishna Ella said, “Many children carry virus but they don’t show the symptoms. They act as the carrier of the disease. It affects their lungs too leading to future complications. So, there is a need to vaccine them at the earliest.”

Apart from Covaxin, Pfizer’s vaccine has already been approved for children between 12 to 15 years of age. In the deadly second wave of the virus, it has been observed that the highest risk is among the children resulting in mortality of many. The new development in vaccine production stage is a much-needed move in the present situation.

Meanwhile, the marathon to book slots for vaccination continues amid shortage of vaccines available in various urban areas of the country.

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