Sunday, October 17, 2021

Govt seeks more opinion on Covaxin for kids

Thursday, October 14, 2021, 18:31
This news item was posted in Business category and has 0 Comments so far.

The Centre is treading cautiously on giving its approval to Bharat Biotech’s Covaxin for paediatric use, especially for children as young as 2 years.The subject expert committee (SEC) under Drugs Controller General of India (DCGI) had considered the company’s data from clinical trials on three age groups, 2-6 years, 6-12 years and 12-18 years, in its meeting on Tuesday. It recommended that DCGI give emergency use authorisation for paediatric use of Covaxin in India.However, health minister Mansukh Mandaviya said: “We have to move ahead carefully keeping all safety aspects in mind. The DCGI will seek more expert opinion and consider all aspects before giving a go-ahead.”The government is wary of the fact that no country is administering a Covid-19 vaccine to children as young as 2 years. A senior health ministry official said: “So far, no country has approved Covid-19 use for children between 2 and 6 years. At present, no country has included children younger than 12 years in its public immunisation drive. All aspects – especially adverse events following immunisation (AEFI) – will be considered before giving any nod in India.”US and UK have introduced Covid-19 vaccines for adolescents between 16 and 18 years. Several countries have given emergency use authorisation for administering vaccines to children above 12 years and US has also initiated this exercise. However, it has not initiated vaccination of children in the age group of 2-12 years.”This is a very tough call – to say this vaccine is safe for children. The data clearly shows the same safety and immunogenicity results in children as in adults but to tell a parent to get the child vaccinated at a time when the incidence is very low is very difficult,” said the official quoted above.According to sources, DCGI will take expert opinion fand could give emergency use authorisation in a phased manner, first to immune-compromised children, followed by children between 16 and 18 years and then to those between 12 and 16 years.

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