Bharat Biotech’s Covaxin will become the world’s first Covid-19 vaccine approved for use in children as young as 2 years. The expert panel advising India’s drug regulator on Tuesday recommended granting emergency use authorisation to the vaccine for children in the 2-18 years age group.
The Hyderabad-based company has been asked to submit data on any adverse event following vaccination every 15 days for the next two months. It has also been told to update the package inserts, fact sheet, and summary of product characteristics for its vaccine pack.
Bharat Biotech said it was awaiting further regulatory approval from the Central Drugs Standard Control Organisation (CDSCO) before the company could launch the product for children. The Subject Expert Committee (SEC) has submitted its recommendation to the drug regulator, and a formal approval from the Drugs Controller General of India (DCGI) is expected after he examines the data and the recommendation.
“Bharat Biotech has submitted data from clinical trials in the 2-18 years’ age group for Covaxin (BBV152) to the CDSCO. The data has been thoroughly reviewed by the CDSCO and SEC, and they have provided their positive recommendations,” the company said. The firm had submitted data from its paediatric trials to the regulator last week.
The gap between the two doses of Covaxin will be 28 days, as in the case of adults, the company said. Sources in the company confirmed that the vaccine for children was the same drug substance as Covaxin.
“This represents one of the first approvals worldwide for Covid-19 vaccines for the 2-18 age groups,” the company said.
The SEC has asked Bharat Biotech to continue the study according to the whole-virion inactivated coronavirus vaccine-approved clinical trial protocol. The company has also been asked to submit safety data, including data on adverse events following immunisation (AEFI) and adverse event of special interest (AESI) every 15 days for the first two months, and thereafter on a monthly basis. The firm should submit a risk management plan according to the New Drugs & Clinical Trials Rules, 2019.
A Mumbai-based analyst said, “It is estimated that 350-400 million people in India are below the age of 18 years. A two-dose Covid vaccine regimen would translate into 700-800 million doses of potential demand.”
Bharat Biotech has struggled to keep pace with demand for its Covid-19 shots. The company has indicated it would make 55 million doses in October and is aiming to touch 80 million doses a month by December.
As of now, the other vaccines approved for children so far are for use in three years and above.
Serum Institute of India is conducting trials on children aged 7 years and above for US major Novavax’s Covid-19 vaccine (Covovax) here. The next leg of Covovax trials will include children aged 2 years and above. The permission from the regulator is coming in phases. Zydus Cadila’s DNA vaccine has been approved for adolescents 12 years and above. The three-dose product is yet to be made available in the market. This would make Covaxin the first paediatric product available in India.
Clinicians felt that vaccine hesitancy would not be a problem for the paediatric vaccine.
“The vaccine efficacy has been found to be similar to what was observed in adults. More importantly, the vaccine is extremely safe. With the 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,” said Dr Trupti Gilada, infectious disease specialist at Masina Hospital, Mumbai. She added that vaccine hesitancy observed during the initial phases was something that shouldn’t be observed for children because India has had a very successful children immunisation tradition.
Globally, Sinovac had said its vaccine was safe for use in children aged 3 years and above. In September, Chile approved it for children aged 6 years and older. The Pfizer and Moderna mRNA vaccines have been used for adolescents.
Around June 2021, some cases of myocarditis (inflammation of heart walls) were reported in the US after taking the Pfizer-BioNTech vaccine, primarily among young males after they got the second shot. The US Centers for Disease Control and Prevention’s advisory committee on immunisation practices reviewed available data and concluded that the benefits of Covid-19 vaccination to individual persons and the population outweigh the risks for myocarditis and recommended continued use of the vaccine in persons aged 12 years and above.