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Covovax Covid vaccine trials on children to start in August: Report

The company will conduct trials on children aged 2 to 17 years and the trial will cover about 920 children
Last Updated 04 August 2021, 09:26 IST

The Serum Institute of India is set to start trials of Covovax Covid-19 vaccine (Novavax's candidate) on children this month.

The company, one of the world's argest vaccine makers, will conduct trials on children aged 2 to 17 years and the trial will cover about 920 children in two age groups across 10 test sites, according to a report by Business Standard quoting sources.

The trials for the first group will be conducted for those between 2 and 11 years of age and the second between 12 and 17 years of age.

An expert panel of India's Central Drug Authority on July 27 recommended granting permission to Serum Institute of India (SII) for conducting phase 2/3 trials of Covovax on children aged 2 to 17 years with certain conditions late last month.

Union Health Minister Mansukh Mandaviya told BJP MPs that Covid vaccination for children is likely to start soon, sources said.

Currently, only those who are 18 or above are eligible for vaccination against the coronavirus. Very soon a vaccine is expected for children and inoculation for them will start, the sources quoted the minister as telling the MPs.

The SII is learnt to have informed that their collaborator, Novavax, Inc., US has already generated a large amount of data in adults in different countries and that the safety, efficacy and immunogenicity data on the Novavax Covid-19 vaccine are very robust which includes a safety database of more than 50,000 adults with data from Australia, South Africa, UK and USA and preliminary safety data in 2248 children.

The SEC on June 30 had recommended against granting permission to SII for conducting phase 2 and 3 trial of Covovax on children aged 2 to 17 years following which the company had submitted a revised study protocol mid-July.

(With inputs from PTI)

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(Published 04 August 2021, 08:47 IST)

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