E-Paper
Delhi HC refuses to stay Covaxin trial among children
The Drugs Controller General of India (DCGI), on May 13, gave permission for the vaccine -- developed by Bharat Biotech and the Indian Council of Medical Research -- to be used in Phase 2 and Phase 3 trials in children between the ages of 2 and 18.
The Delhi high court on Wednesday refused to stay the clinical trial of Covaxin for children, and sought a response from the Centre and the vaccine maker on a plea challenging the nod given by government authorities.
The Drugs Controller General of India (DCGI), on May 13, gave permission for the vaccine -- developed by Bharat Biotech and the Indian Council of Medical Research -- to be used in Phase 2 and Phase 3 trials in children between the ages of 2 and 18. The recommendation that this be allowed was made by the subject expert committee (SEC) of the Central Drugs Standard Control Organisation’s (CDSCO).
The move came as experts in India have underlined the need to vaccinate people below the age of 18 since there cannot be a proper opening up until the entire population is protected.
“No,” a bench of Chief Justice DN Patel and justice Jyoti Singh said as lawyer-petitioner Sanjeev Kumar sought a stay on the notification. His plea seeks directions to quash the May 13 order, anticipating adverse effects.
The bench issued notices to the DCGI, and the ministries of health and woman & child development, CDSCO, and Bharat Biotech, seeking their stand on the petition. The matter will be next heard on July 15
US regulators last week gave emergency use authorisation to Pfizer-BioNTech’s Covid-19 vaccine for children aged between 12 and 15. The vaccine was already being administrated to those above 16. Canada became the first country in the world to approve Pfizer’s Covid-19 vaccine for ages as young as 12 on May 5.
According to the Union health ministry, the trial will be conducted on 525 healthy volunteers, and the vaccine will be administered in two doses 28 days apart, Kumar’s plea said.
Kumar contended that there may be adverse “mental and health effects” on children due to the trials. He also argued that children could not be termed as “volunteers” because as they are not capable of understanding the consequences of the trials.
“In the present case, the subject matter of clinical trials being minors (even toddlers who - for the reason of their age only - are not capable of even speaking and understanding languages in a proper manner) cannot be supposed to volunteer for the aforesaid clinical testing,” the petition stated.
The plea sought criminal prosecution of the persons involved in such trials or authorised to conduct them, in the event of death or “loss of peaceful and pleasant enjoyment of life” of any of the minors in the trial.
