New Delhi: An expert panel on Tuesday recommended Kovacin-Bharat Biotech’s Kovid-19 vaccine for use by children between the ages of two and 18.
“Bharat Biotech has submitted the data from the clinical trials of two-eighteen-year-olds to the Covaxin CDSCO (Central Drugs Standard Control Organization), which has been thoroughly reviewed by the Data Expert Committee (SEC),” said the Hyderabad-based company.
“This represents one of the first worldwide approvals for Kovid-19 vaccines for two- to 18-year-olds … We look forward to further regulatory approvals before the product launch and the covaxin market availability for children,” the company said.
“We (always) say that children between the ages of two and 18 will get a vaccine … it will be approved soon. The SEC has recommended … it will be approved soon … we have conducted tests for the safety of children. We are committed to their safety,” said Junior Health Minister Dr. Bharti Praveen Pawar told NDTV.
That final approval – which is seen as a malpractice – will be given by the Drug Controller General of India.
When it comes down to it, covaccine is only the second vaccine to be used for children in India; In August, Sydus Cadilla released three doses of DNA Jab for use by adults and children over 12 years of age.
The third vaccine for children is the Serum Institute’s Novavax, which was tested last month by DCGI for children aged seven to 11 years. The fourth is Korbevax, a biological drug that has been approved for extensive testing in children over the age of five.
Last week, manufacturers Bharat Biotech said it had submitted information about vaccine trials in children.
The covaxin vaccine tested in children is the same formulation used in adults, but requires special experiments to ensure the safety and efficacy of younger recipients.
Information about these experiments has not yet been made public, but tests have been performed on 1,000+ children across the country. However, the panel commented that the experiment in children showed a similar efficacy rate than in adults.
Vaccine efficacy data (for adults) submitted to DCGI in June; Covaxin has been shown to be 77.8 percent effective in protecting against the virus.
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India is slowly focusing on immunization against the corona virus, giving about 96 million doses to adults.
Delhi AIIMS chief Dr Randeep Guleria has said that children between the ages of two and 18 should be vaccinated.
Earlier this month, the head of India’s vaccine task force, Dr. NK Aurora told the news agency ANI that children with severe comorbidity would be given priority and other (healthy) children would be vaccinated later.
“We are trying to identify the most vulnerable children (children) … In the next two weeks, the list will be in the public domain. We are making arrangements so that these children do not have to go (too far). The vaccine …” he said.
As schools reopened and students (teachers and non-teaching staff) returned to classrooms, there was a growing concern about the increasing number of cases and the need for children to be vaccinated against adults working in schools.
Out of a population of 130 crore, less than 30 crore have so far been fully vaccinated by India.
At the same time, the World Health Organization has not yet approved Kovacin for EUA or emergency use. Following the delay in the process – the WHO had asked Bharat Biotech for more trial data – a decision is expected next week.
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Without an EU, covaxin would not be recognized by most countries around the world as a valid COVID-19 vaccine. This means that Indians who get a job while traveling abroad will have to stay in quarantine, unlike those who received SII’s Covshield.
