Covaxin gets SEC emergency use nod for children between 2-18 years of age

  • Bharat Biotech, the Hyderabad based biotechnology company, submitted data from Covaxin's trial in children aged 2 to 18 years to the DCGI on October 6
Bharat Biotech was granted approval for conducting Covaxin trials in children back in May.(AP)
Bharat Biotech was granted approval for conducting Covaxin trials in children back in May.(AP)
Published on Oct 12, 2021 01:58 PM IST
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Byhindustantimes.com, Hindustan Times, New Delhi

Bharat Biotech’s Covaxin, the vaccine against coronavirus disease (Covid-19), has received the recommendation of a subject expert committee (SEC) for use in children between the ages 2 to 18. The Drug Controller General of India (DGCI) will give the final approval for the use of Covaxin on children and when that comes through it will become the second vaccine, after Zydus Cadila's DNA-based vaccine ZyCoV-D, to be approved for inoculating kids in the country.

Bharat Biotech, the Hyderabad based biotechnology company, submitted data from its Covid-19 vaccine trial in children aged 2 to 18 years to the DCGI on October 6, after being granted approval for conducting trials in children back in May.

Sanjay K Rai, a professor at Centre for Community Medicine, All India Institute of Medical Sciences (AIIMS), and the principal investigator of Covaxin’s trial on children told news agency ANI that the trial was carried out in three age groups. "Covaxin's trial was done on three age groups. The first group examined was between 12 -18 years, the second group was between 6- 12 years and the third age group was between 2-6 years," he said, claiming that the trial found safety and immunogenicity levels were the same in children as it was in adults.

Besides Covaxin and Zydus Cadila’s ZyCoV-D, Serum Institute of India (SII) has also been given permission to conduct phase II and III clinical trials of Novavax in children between 7 and 11 years of age.

India is gearing up to vaccinate children as schools and educational institutions start reopening up across the country and experts continue to caution against a potential third wave being deadly for children. Many states have also ramped up paediatric facilities to help combat any rise in Covid-19 infection in children. The Union government has, however, repeatedly insisted that there is no need to panic about successive waves infecting children.m

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Thursday, December 02, 2021