Expert panel endorses Covaxin for kids, vaccine may come in pre-filled syringes

The Subject Expert Committee (SEC) on COVID-19 examined the data and deliberated on the EUA application on Monday.
For representational purpose. (Photo | AP)
For representational purpose. (Photo | AP)

NEW DELHI: An expert panel on Covid under the country’s apex drug regulator has approved administering Covaxin for kids and adolescents, paving the way for the availability of the country's first indigenous vaccine for children as young as 2 years.

Though a last regulatory hurdle, in terms of final approval by the Drug Controller General of India still remains before the vaccine -- developed jointly by Bharat Biotech and the ICMR -- can be launched officially for kids aged 2-17 years, it is expected shortly.

In a statement on Tuesday, Bharat Biotech said it had submitted data from clinical trials in the 2-18 years age group for Covaxin to the regulator which was thoroughly reviewed by the Central Drugs Standard Control Organisation and the subject expert committee.

“This represents one of the first approvals worldwide for Covid-19 vaccines for the 2-18 age group,” said the company. “We now await further regulatory approvals from the CDSCO prior to product launch and market availability of Covaxin for Children.

Raches Ella, clinic lead of Covid vaccines at the company, said in a tweet that Covaxin has been “reported to be safe and immunogenic” in a pediatric cohort and “the approval in children will help expedite the reopening of schools”.

When finally approved, Covaxin would be the second vaccine, after Zydus Cadila’s ZyCoVD to be permitted for under 18 population group in India.

Though approved for adolescents aged 12-17 years in August by the DCGI, along with adults, ZyCoV D is still to be rolled out for any population group in the country.

Sources in the drug regulatory body said that though the amount of Covaxin recommended for kids remains the same -- 0.5 ml -- as it is for adults and will also be administered in two doses -- 28 days apart -- there will be slight difference in the approach.

“It has been suggested that for less than 18 population group, vaccines be supplied in pre-filled syringes, instead of vaccines being taken out of vials at the time of administration,” said an official.

This, he explained, was recommended in order to ensure that exactly the specified quantity of vaccines are administered in kids as the higher quantity may have adverse effects on children, especially younger ones.

It is said that in the last 24 hours, 65,86,092 Covid-19 vaccine doses have been administered. India's COVID-19 vaccination coverage exceeded 95.89 crores, informed the Ministry of Health and Family Welfare on Tuesday.

As per provisional reports, till 7 am today, 95,89,78,049 vaccine doses have been administered so far through 93,66,392 sessions.

Of the total, 1,03,75,424 health care workers received the first dose and 90,36,583 second vaccine doses; 1,83,59,259 front line workers were administered the first dose and 1,53,98,857 vaccine doses given as the second dose to front line workers.

According to the health ministry, 38,68,20,261 vaccine doses were administered as the first dose and 10,40,73,546 vaccine doses were given as the second dose in the age group 18-44 years.

Also, in the age group of 45-59 years, 16,61,56,424 people have received the first dose and 8,38,76,362 have received the second dose whereas 10,48,69,202 vaccine doses were administered as first dose and 6,00,12,131 vaccine doses given as the second dose to the people over 60 years.

Meanwhile, 14,313 new cases were reported in the last 24 hours, which is the lowest recorded daily new cases in 224 days.

The recovery of 26,579 patients in the last 24 hours has increased the cumulative tally of recovered patients to 3,33,20,057.

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The New Indian Express