DCGI approves Covaxin for emergency use in age group between 12 and 18 years

Updated on Dec 26, 2021 01:12 AM IST

The approval from DCGI came nearly 10 weeks after the subject expert committee of central drugs standard control organisation (CDSCO) recommended Covaxin’s use in children on October 12, this year, based on the clinical trials data submitted by the Hyderabad-based company.

The Drugs Controller General of India (DCGI) on Saturday granted approval for restricted use in emergency situation to Bharat Biotech’s Covaxin in the paediatric age group between 12 and 18 years. (HT PHOTO.)
The Drugs Controller General of India (DCGI) on Saturday granted approval for restricted use in emergency situation to Bharat Biotech’s Covaxin in the paediatric age group between 12 and 18 years. (HT PHOTO.)
By, Hindustan Times, New Delhi

The Drugs Controller General of India (DCGI) on Saturday granted approval for restricted use in emergency situation to Bharat Biotech’s Covaxin in the paediatric age group between 12 and 18 years, people familiar with the matter said, making it the second vaccine after Zydus Healthcare’s ZyCoV-D that was approved for use in children aged 12 years and above.

“Yes, DCGI has granted approval for use of Covaxin in children,” confirmed a senior government official aware of the matter, on condition of anonymity.

However, it is still time before the Union health ministry starts jabbing children under the national Covid-19 immunisation programme as it is waiting for the expert scientific opinion on the matter.

“Even though the approval has been granted by the DCGI for paediatric emergency use of Covaxin, we will await the inputs of the standing group on Covid of NTAGI (National Technical Advisory Group on Immunisation) on lowering the age of beneficiaries,” said a senior health ministry official, requesting anonymity.

The approval from DCGI came nearly 10 weeks after the subject expert committee of central drugs standard control organisation (CDSCO) recommended Covaxin’s use in children on October 12, this year, based on the clinical trials data submitted by the Hyderabad-based company.

Covaxin is one of the two anti-Covid vaccines being currently used in India’s Covid-19 immunisation programme; the other vaccine being Oxford-AstraZeneca vaccine that is being locally manufactured by Serum Institute of India under the brand name Covishield.

For a vaccine to be included formally in the government’s coronavirus immunisation campaign for children or adults, DCGI’s approval is mandatory.

It is for the first time that DCGI has taken this long to approve recommendations of the subject expert committee of CDSCO with regard to a Covid-19 vaccine; so far the DCGI approval has been granted in a day or two max. Six anti Covid-19 vaccines have been granted emergency use authorization by the national drugs regulator so far based on the recommendations of the subject expert committee.

“The drugs controller general of India took his time to approve the vaccine for paediatric use after carefully scrutinizing the data and looking at some additional data from around the world where vaccination in children has begun. It is a sensitive matter, which is why it made sense to be thorough before granting the approval,” said a senior official in the Union ministry of health and family welfare, on condition of anonymity.

“We will have to be extremely careful when talking about Covid-19 vaccination in children as even the developed countries that have begun vaccinating their children have been treading cautiously,” added the official cited above.

According to the conditions laid down by the subject expert committee, the company should submit safety data, including the data on adverse event following immunisation (AEFI) and adverse event of special interest (AESI), with due analysis, every 15 days for the first two months and monthly thereafter and also as per requirement of New Drugs and Clinical Trials Rules, 2019.

The company should also continue the study as per the approved clinical trial protocol and provide updated prescribing information/package Insert (Pl), Summary of Product Characteristics (SmPC) and Factsheet.

Experts welcome the approval and say it is high time children are also vaccinated against Covid-19.

“Children may not get severe disease but there will always be the risk of others getting infected through children, especially elders and those at high risk in the family. Government should take a stand on it soon as the numbers currently are low,” said Dr Vikas Maurya, director and head of respiratory medicine department, Fortis Healthcare.

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  • ABOUT THE AUTHOR

    Rhythma Kaul works as an assistant editor at Hindustan Times. She covers health and related topics, including ministry of health and family welfare, government of India.

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