An expert panel on Tuesday recommended Covaxin, Bharat Biotech’s COVID-19 vaccine, for use in children between the ages of two and 18.
“Bharat Biotech has submitted clinical trial data in the two – 18 year age group for Covaxin to CDSCO (Central Organization for Standard Control of Medicines). The data has been thoroughly reviewed by the Subject Matter Expert Committee (SEC) … provided positive recommendations. ” the Hyderabad-based company said.
“This represents one of the first approvals worldwide for COVID-19 vaccines for the age group 2-18 years … We now await further regulatory approvals prior to product launch and market availability of Covaxin for Children, “the company said.
“We (always) said we would get a vaccine for children between the ages of two and 18 … it will be approved soon. The SEC recommended … it will be approved soon … the trials were conducted with the safety of children in mind. We are committed to your safety, “Young Health Minister Dr. Bharti Pravin Pawar told NDTV.
That final approval, considered a formality, will be granted by the Comptroller General of Drugs of India.
When it arrives, Covaxin will be only the second vaccine approved for use in children in India; In August, the use of the three-dose DNA injection of Zydus Cadila was allowed in adults and children over 12 years of age.
A third potential vaccine for children is Novavax from the Serum Institute, for which DCGI last month approved trials for children ages seven to 11. A fourth is Corbevax from Biological E, which has been licensed to perform advanced trials in children over the age of five.
Last week, the manufacturers Bharat Biotech said they had submitted data on vaccine trials in children.
The Covaxin vaccine tested in children is the same formulation used in adults, but separate trials were needed to ensure safety and efficacy in younger recipients.
The data on these trials have not yet been released, but more than 1000 children were tested across the country. However, the panel noted that the trial in children showed efficacy rates similar to those in adults.
Data on vaccine efficacy (for adults) were submitted to DCGI in June; the data indicated that Covaxin is 77.8 percent effective in protecting against the virus.
India is slowly turning its focus towards vaccinating children against coronavirus, having administered nearly 96 crore doses to adults.
Dr Randeep Guleria, head of AIIMS Delhi, has emphasized that children in the age group of two to 18 should be vaccinated “because that is the only way to get rid of the pandemic.”
Earlier this month, Dr NK Arora, head of India’s Vaccine Task Force, told the ANI news agency that children with severe comorbidities would be prioritized and other (healthier) children would subsequently be immunized. .
“We are trying to identify (the children) most at risk … within the next two weeks, the list will be in the public domain. We are also making arrangements so that these children do not have to travel (too far) to get the vaccine. … “, said.
As schools reopen and students (and teaching and non-teaching staff) return to classrooms, concerns have been raised about an increase in cases and the possibility of children becoming infected, as well as the need for also vaccinate adults who work in schools.
So far, India has fully vaccinated less than 30 million million of its 130 million people.
Meanwhile, the World Health Organization has yet to grant Covaxin an EUA or emergency use authorization. Following delays in the process, WHO had asked Bharat Biotech for additional data from the trial, a decision is expected next week.
Without a USA, Covaxin will not be accepted as a valid COVID-19 vaccine by most countries in the world. This means that Indians who received the jab will be forced to self-quarantine when traveling abroad, unlike those who received Covishield from SII.
With contributions from ANI