The Drugs Controller General of India (DCGI) has granted restricted emergency use authorization to Bharat Biotech’s Covaxin for children aged 6 to 12 years.

The panel had already approved Covaxin for emergency use in children above 12 years in December 2021.

The development comes just days after DGCI expert panel recommended granting emergency use authorization for Biological E’s Covid-19 vaccine Corbevax for children in the five to 11 years age group with certain conditions.

Now the company has been asked Bharat Biotech to submit safety data with due analysis every 15 days for the first two months and monthly thereafter for five months.

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Earlier on April 21, the DCGI’s expert panel had asked Bharat Biotech to provide additional data on the administration of Covaxin for kids in the 2-12 years age group.

India is currently administering two Covid-19 vaccines Covaxin and Corbevax to children above 12 years.

The Corbevax vaccine is currently being administered to children in the age group of 12-14 years while Bharat Biotech’s Covaxin is being administered to the age group of 15-18 years.

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After a year of launching a vaccination campaign for adults, the central government has started its immunisation drive for children between the age of 15-18 years from 3rd January across the country, terming it as the second phase of the committed and determined campaign.

The Drugs Controller General of India (DCGI) approved the administration of Bharat Biotech-manufactured Covaxin to children above the age of 12 on December 25, 2021. Shortly after, Prime Minister Narendra Modi stated that from January 3 onwards, adolescents over the age of 15 will be allowed to get jabbed.

According to the health ministry, almost 41 lakh teenagers have already taken their first dose of Covaxin, thus declaring the second phase a good start, at least in comparison to the rollout that occurred in the early months of last year.

Given the increased threat of the Omicron strain, which drove states to impose restrictions ahead of New Year’s celebrations and has now spurred states to implement further restrictions. Considering the rapid spread of Covid-19 cases, vaccinating the 8-10 crore young Indians between the ages of 15 and 17 is critical.

However, just after the vaccination registration for adolescents started, new worries about Covaxin vial expiry dates surfaced. On Monday, several people turned to social media to refute accusations that adolescents were being given Covaxin doses from vials with expired dates. These allegations were labelled false and misleading by the Union Health Ministry, which said they were based on incomplete information.

What’s the confusion about the Covaxin’s shelf life?

A vaccination is made up of a mixture of different proteins, lipids, and carbohydrates, as well as inactivated viral particles and adjuvants.  The shelf life of vaccination, like that of other medical products, is determined by how well the vaccine’s efficacy deteriorates over time.

A vaccination’s efficacy is normally determined by testing it on animals at different intervals to see when chemical processes are impaired and the vaccine loses its efficacy. According to the World Health Organization, a vaccine’s stability – which determines its shelf life – specifies the inoculant’s capacity to retain its chemical, physical, microbiological, and biological characteristics throughout time.

The Central Drugs Standard Control Organisation (CDSCO) has approved Covaxin’s shelf life from nine to twelve months on October 25 last year, in response to an application made by Bharat Biotech. It wasn’t the first time it had done so; in February last year, it approved an extension of Covishield’s shelf life from 6 to 9 months, made by Serum Institute of India.

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This is not uncommon for medication supervisors to do, but they must be persuaded by scientific evidence presented by vaccine developers. Even after vaccines have been licensed, manufacturers continue to do research in order to provide more exact studies of vaccine stability. As the COVID-19 vaccines get older, there may be some changes, the ministry said in a statement. That doesn’t necessarily imply that we’re making mistakes, but rather that we’re relying on more data to arrive at a conclusion.

Bharat Biotech has apparently begun accumulating unused stockpiles of its COVID-19 vaccinations to re-label them with the expiry date, with Covaxin being the sole vaccine available to India’s youngsters at this time.

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Bharat Biotech’s Covaxin, India’s indigenous Covid-19 vaccine has been approved by the Drugs Controller General of India (DCGI) for emergency use in children aged between 12 to 18 years.

Prime Minister Narendra Modi in his address to the nation yesterday said that from January 3, India will start rolling out vaccines for children in the age group of 15 to 18 years. He has given his consent for the use of Covaxin in children, making it the second vaccine approved for use in those under the age of 18 in India.

Earlier, Bharat Biotech has submitted data from clinical trials for Covaxin (BBV152) in the 2-18 years age group to the Central Drugs Standard Control Organization (CDSCO). After discussing Bharat Biotech’s EUA application on October 12, the CDSCO’s Subject Expert Committee on COVID-19 recommended issuing emergency use approval to Covaxin for use in the 12-18 year age range with specified standards.

Before Covaxin, Zydus Cadila’s three-dose DNA jab was allowed in August to be used on adults and children over 12. Serum Institute’s Novavax is a third possible vaccine for children, according to DCGI which cleared trials for children aged seven to eleven years old last month.

A fourth option is Biological E’s Corbevax, which has been approved for advanced testing on children over the age of five. It had granted approval to Serum Institute of India (SII) in July to begin phase 2/3 trials of Covovax on children aged 2 to 17 years with a specific condition.

After administering nearly 100 crore doses to adults, India is gradually shifting its emphasis to vaccinate children against the coronavirus.

Globally, all vaccinations have produced fewer antibodies against the Omicron variant, fueling demand for booster doses.

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