Covaxin clinical trial in children to begin in 10-12 days: Centre

The Drug Controller General of India on May 13 gave permission for the vaccine, developed by Bharat Biotech and the Indian Council of Medical Research (ICMR), to be used in Phase 2 and Phase 3 trials in people below the age of 18 -- the first such trials that will begin in India.

The clinical trials for Bharat Biotech’s Covid-19 vaccine, Covaxin, in children as young as two years of age will begin in the next 10-12 days, Dr VK Paul, member (health), Niti Aayog, said on Tuesday.

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. (Sanjeev Verma/HT Photo)

The Drug Controller General of India on May 13 gave permission for the vaccine, developed by Bharat Biotech and the Indian Council of Medical Research (ICMR), to be used in Phase 2 and Phase 3 trials in people below the age of 18 -- the first such trials that will begin in India.

“Our Covid-19 vaccine, Covaxin, has been permitted to take trials forward and test in children as well. So far, the recommendation is for individuals above 18 years of age. Now we are trying to find out how the vaccine behaves in children; the trial results will tell us that. I have been informed that this work (trials) will begin in the next 10-12 days,” said Paul during the weekly media briefing on Covid-19.

“Government of India has already drafted, and made public, standard operating (SOPs) procedure for managing children who are diagnosed with Covid-19. It is a detailed, scientifically driven, guideline that is available on Union health ministry’s website for all to see, and that should be followed. It is uncommon to have severe disease in children, but should they get it then our guidelines also mention how to deal with serious illness in children,” he added.

There measures are similar to what adults need to follow to prevent disease transmission -- observing Covid-appropriate behavior including the wearing of masks, maintaining social distancing, and hand hygiene.

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.

Last week, US regulators 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.

Experts in India have also said that they believe children may be more at risk in the event of a third wave of infections, although evidence at present does not support these fears.