Awaiting regulatory approval for rolling out Covaxin for children aged 2-18 yrs, says Bharat Biotech

By Shalini Bhardwaj
New Delhi [India], October 12 : The Subject Expert Committee (SEC) has given a recommendation to the Drugs Controller General of India (DCGI) for the use of Bharat Biotech's COVID-19 vaccine, Covaxin, for the beneficiaries aged between 2-18 years, the official sources said on Tuesday.
Sources told ANI today that after evaluation of the data, the final approval will be given by the Drug Controller General of India (DCGI).
Bharat Biotech in an official statement has said they are waiting for further approvals from drug regulators.
"This represents one of the first approvals worldwide for COVID-19 vaccines for the 2-18 age group. Bharat Biotech sincerely thanks the DCGI, Subject Experts Committee, and Central Drugs Standard Control Organization (CDSCO) for their expedited review process. We now await further regulatory approvals from the CDSCO prior to product launch and market availability of Covaxin for children," stated the statement issue by Bharat Biotech.
This is one of the first worldwide approval for COVID-19 vaccines for the age group of beneficiaries belonging to 2-18 years.
Bharat Biotech has submitted data from clinical trials in the 2-18 years age group for Covaxin (BBV152) to CDSCO. The data has been thoroughly reviewed by the CDSCO and Subject Experts Committee (SEC) and have provided their positive recommendations, the vaccine maker said.
The Subject expert committee on COVID-19 examined the data on Monday.
"After detailed deliberation, the committee recommended for grant of a market authorization of the vaccine for the age group of 2 to 18 years for restricted use in the emergency situation subject to the setting conditions."
According to Dr Shuchin Bajaj, Founder and Director, Ujala Cygnus Group of Hospitals," The trials of Covaxin in children mark another amazing victory of Indian science and scientists. India has always been known as a vaccine and a medicine drug 'producer' but never a medicine or a drug 'developer'.
Dr Bajaj further said, "Never have we heard of new drugs being developed in India nor new vaccines being developed in India. This is for the first time that such a large scale vaccine development has been taken and produced in India. Its efficacy has been proven to be of very high safety. So, I think it is a wonderful victory of Indian scientists and we must applaud them."
"Supply of vaccine and role out is going to play an important role, the priority should be given first to those children who come under comorbidities, then to other three groups 12 to 18 years, 6-12 years old and 2-6-year-old children," said Dr Sameer Bhati, a public health expert.
Earlier, Dr Sanjay K Rai, a professor at Centre for Community Medicine, All India Institute of Medical Sciences (AIIMS) had claimed that the latest trials show almost similar safety and immunogenicity of India's indigenous COVID-19 vaccine -- Covaxin -- are almost the same in children, as adults above 18-years of age.
Meanwhile, India's COVID-19 vaccination coverage has crossed 96 crores today.