Pediatricians hail SEC approval for EUA to Covaxin for 2 to 18 age group for timely immunization 

Covaxin, indigenously developed by BBIL in collaboration with the Indian Council of Medical Research (ICMR), is being used on adults in India's ongoing COVID-19 vaccination drive.

By:October 12, 2021 6:02 PM
pediatricians, CDSCO, SEC, EUA, Covaxin, BBIL, childrenBharat Biotech International Limited (BBIL) had submitted Phase 2/3 clinical trials data of children's trials to the Drugs Controller General of India (DCGI) to get approval for EUA.

Pediatricians have hailed the Central Drugs Standard Control Organisation (CDSCO) Subject Expert Committee (SEC) approval for emergency use authorization (EUA) to Covaxin for the 2 to 18 age group for timely immunization. They are also optimistic about the data to come on phase four of the Covaxin trial.

Bharat Biotech International Limited (BBIL) had last week submitted Phase 2/3 clinical trials data of children’s trials to the Drugs Controller General of India (DCGI) for its verification and subsequent approval for EUA for the jab. BBIL, in a statement, said that this represents one of the first approvals worldwide for COVID-19 vaccines for the 2 to18 age group.

The SEC of the drug regulator has recommended granting an emergency use authorisation to Covaxin for 2 to 18 age groups. The data has been thoroughly reviewed by the CDSCO and Subject Experts Committee (SEC) and have provided their positive recommendations.

“Bharat Biotech sincerely thanks the DCGI, Subject Experts Committee and 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,” the company stated.

Talking about the efficacy of the Covaxin vaccine, Dr Trupti Gilada, Infectious Disease Specialist, Masina Hospital, Mumbai said, “The vaccine efficacy is found to be similar to what was observed in adults. More importantly the vaccines are extremely safe. With WHO’s approval expected in a week which will also be a welcome progress, we could see the beginning of the last leg of the fight against COVID-19. With kids getting vaccinated, we could expect schools to completely reopen in January 2022. Now all that we need is to ramp up vaccine production. The vaccine hesitancy observed during the initial phases is something that shouldn’t be observed for children because India has had a very successful children immunization tradition.”

“Covaxin is basically given to children aged 2 to 18 in two doses in an interval of 28 days apart. As a pediatrician, I would go slow into the vaccination aspect. I’ll see how the data comes in on phase four of the trial or when actually the vaccine is being given to children in various parts of the country. Following SEC approval for EUA, the DCGI is probably going to give the approval for market availability of Covaxin for children very soon. The data which BBIL has submitted to the DCGI is of about 525 children administered two doses. Even though 525 is a small number, the results have been encouraging,” said Dr (Major) Manish Mannan, HoD, Paediatrics & Neonatology, Paras Hospitals, Gurugram.

Talking about the successful trials and approval, Dr Shuchin Bajaj, Founder & Director, Ujala Cygnus Group of Hospitals said, “Trials of Covaxin in children marks another amazing victory of Indian science and scientists. This is the first time that such a vaccine has been entirely developed and produced in India and its safety and efficacy has been proven to be very high. We are very sure and confident that it will prove to be safe and efficacious in children. We have all been concerned that adults have been vaccinated whereas children were left exposed to the virus. So once they are also vaccinated, I think it will be a great achievement for mankind,”

BBIL has conducted trial on children on Covaxin from the age of 2 to 18 years. The phase two and phase three of the trial has been completed in the month of September.

The SEC has recommended EUA is subject to four conditions. Conditions listed by the expert panel are: The firm should provide updated Prescribing Information/Package Insert (PI), Summary of Product Characteristics (SmPC) and Factsheet; the firm should submit safety data, including the data on AEFI and 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 (NDCT) Rules, 2019; and the firm should submit risk management plan.

Covaxin, indigenously developed by BBIL in collaboration with the Indian Council of Medical Research (ICMR), is being used on adults in India’s ongoing COVID-19 vaccination drive.

This is the second COVID-19 vaccine to get approved for children in India. CDSCO had, in August, approved ZyCoV-D for children aged 12 and above as well as adults.


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