When to vaccinate children? India asks for biotech trial approval, then government bids – show data first

There is a vaccination campaign in India with two vaccines, Covshield and Kovacsin, but so far no vaccine has been given to children. India’s National Ugs Controller has not yet allowed anyone to conduct clinical trials of coronavirus vaccine on children. Meanwhile, Bharat Biotech is seeking the permission of the government to test its vaccine for children, i.e. under 18 years of age. Explain that the Bharat Biotech and Serum Vaccine is approved by the Government of India, they are for adults only.

A panel of experts from the Drugs Standard Control Organization of the Hyderabad-based India Biotech International National Drugs Control Center on Wednesday received an application to approve a phase III clinical trial of the ‘coaxin’ vaccine for children aged 5 to 18. .

During this demanding hearing of the company, the committee told the company that it would like to see the data and its impact on adults being given the opportunity to test children for coaxin. That is, the company wants to see the effectiveness of what impact it has on adults before approving a vaccine trial on children.

An official said the vaccine effectiveness data committee is the first priority and the company should also present the requested data before seeking approval from a panel of experts. Tell us that Kovaccine has already been approved for adult use in India and is also based on safety and immunogenicity data presented by the company.

However, the company has not yet presented data on the phase III trial of the corona vaccine. Meanwhile, the three-member Ukraine delegation is headed by the country’s health minister Dr. A visit to the India Biotech Manufacturing Center in Hyderabad, led by Maxim Stepanov. Explain that Bharat Biotech has developed Kovasin in collaboration with Indian Medical Research Council.

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