Vaccinating Children Without Clinical Trials Would Be A Disaster: Delhi HC

"Clinical trials for the inoculation of the 12-17 age group is almost complete," the Centre said to the court.

No clinical trials required in India for global COVID-19 vaccines

(Photo: PTI)

On 16 July, the Delhi High Court while hearing a plea on the COVID-19 vaccination drive observed that administering vaccines to children without clinical trials "would be a disaster".

The observation came in a petition filed on behalf of a minor seeking a direction be issued to the central government to allow inoculation of 12-17-year-olds.

Let the trials be done. Otherwise it would be a disaster if vaccines are administered without trials, that too, in case of children...Once trials are over, you can quickly apply to children. The whole country is waiting.

Delhi High Court

The bench headed by Chief Justice DN Patel further asked the central government to take steps to vaccinate persons below 18 years of age "once the clinical trials are over".

Clinial Trials for Inoculating Children Almost Complete: Centre

During the hearing, the central government informed the Delhi High Court that clinical trials for administering vaccines to the 12-17 age group is "on the verge of completion".

"Children will be vaccinated when experts give permission," Centre informed the high court.

Additional Solicitor General Chetan Sharma, representing the Centre, said pharmaceutical company Zydus Cadila which is developing DNA vaccines has concluded its clinical trial for the age group of 12 to 18 years. He further said that subject to the statutory permission, the vaccines may be available in the near future for children of that age group.

The Centre said as of now, the companies manufacturing COVID-19 vaccines in India have given only Emergency Use Authorisation for vaccinating people of 18 years age and above.

This is also because of the fact that the clinical trial group during phase 1, phase 2 and phase 3 did not cover the persons/ children below 18 years of age.

Central Government

Senior advocate Kailash Vasudev, representing the petitioner, said vaccines are being administered to children of the age group of 8 to 18 years in various countries and the court may ask the authorities to conclude the process in a time-bound manner.

It said that on 12 May 2012, the Drug Controller General of India has permitted Bharat Biotech to conduct clinical trials on the healthy volunteers between 2 to 18 years of age for its vaccine, Covaxin.