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The screening of children for the clinical trial of COVAXIN, India’s indigenously developed COVID-19 vaccine, among those aged between 2 and 18 has started at AIIMS, Delhi on Monday.

Why is it relevant?

India currently has three vaccines approved for adults – COVAXIN, Serum Institute of India’s Covishield and Russia’s Sputnik V, but there are none for children.

If the phase 2/3 trials on children are successful, COVAXIN will be used to inoculate India’s children. The trials also assume significance as they are being held at a time when the Centre cautioned that though the virus has not affected children seriously till now, its impact can increase among them if there is a change in virus behaviour or epidemiology dynamics.

Moreover, Karnataka and Maharashtra have recently seen a spike in paediatric COVID cases, making the trials the need of the hour.

What’s the current status of COVXAIN trials on children?

India’s drug regulator had granted permission for conducting the Phase 2/3 clinical trial of COVAXIN in the age group 2 to 18 years on 12 May.

The trial on children had already started at AIIMS Patna to see if the Bharat Biotech jab is suitable for children. AIIMS Delhi and Meditrina Institute of Medical Sciences Nagpur are two other institutes that were roped in to conduct the trials.

These trials will be conducted on 175 children across the country with every centre carrying out 20 (trials) each, AIIMS Patna Superintendent Dr CM Singh told NDTV.

In total, the trials will be conducted on 525 healthy volunteers — 175 of 12-18 years, 175 of 6-12 years and 175 of 2-6 years — to judge the safety, reactogenicity and immunogenicity of the vaccine in children.

Participants would be given the vaccine after their screening report comes.

In the trial, the vaccine will be given by intramuscular route in two doses at day 0 and day 28. “The screening of children for conducting the trial of COVAXIN has started. Participants would be given the vaccine after their screening reports come,” Dr Sanjay Rai, Professor at the Centre for Community Medicine at AIIMS, told PTI.

Dr Prabhat Kumar Singh, Director, AIIMS, Patna said 54 children registered for the trials of which 16 were in the age group of 12-18. Twenty children of 12-18 years have been vaccinated till now as part of the clinical trial at AIIMS Patna, for which 100 minors have lined up so far, officials told NDTV.

Apart from physical examination, RT-PCR tests were also conducted on these children to check for COVID-19 antibodies or any other pre-existing diseases, he added. “After these trials, the age group will be 6-12 years and then 2-6 years but now we have started trials in the age group of 12-18 years,” Singh said.

How are these clinical trials in India different?

The trials in India are restricted to a number much smaller than those cited by other countries. Pfizer’s trial enrolled 2,260 children aged 12-15 years in the United States, while Moderna will enrol approximately 6,750 children in the US and Canada between the age of six months and 11 years, according to a Deccan Herald report.

The US rolled out a vaccination drive for children aged 12-15 on 14 May, and Canada had approved the Pfizer shots for the same age group on 5 May.

The United Kingdom has also approved the Pfizer/BioNTech vaccine for this age group. China too authorised the emergency use of CoronaVac, a COVID-19 vaccine manufactured by Chinese firm Sinovac, for children aged between 3 and 17 years.

What other vaccines for children are undergoing trials in India?

According to News18, Ahmedabad-based Zydus Cadila is testing its COVID-19 vaccine candidate on children of 12-18 years, apart from adults, and the company is likely to apply for licensure of the vaccine in the next two weeks, a government official said.

Russian news agency TASS in May quoted the director of Gamaleya National Research Center for Epidemiol as saying that trials of the Sputnik V vaccine against the coronavirus infection in children may begin in the next few weeks provided a corresponding permit from the Russian Health Ministry is obtained.

Asked if the Pfizer vaccine, if it comes to India, will be considered for children between the age of 12 and 15 years as being approved by the UK, NITI Aayog Member (Health) VK Paul had said that the country has its own vaccines which are being readied for children.

“Child cohort is not a small cohort. My rough guess is that if it is between 12 to 18 years, this itself is about 13 to 14 crore population and for which we will need about 25-26 crore doses,” he said.

He further shared that Zydus Cadila’s vaccine is already being tested in children. “So when Zydus comes for licensure, hopefully in the next two weeks, maybe we have enough data to take a view on whether the vaccine can be given to children,” he said.

With inputs from agencies