Dr VK Paul, member (health) of Niti Aayog, said on Tuesday that Bharat Biotech is set to begin the phase II and III clinical trials for Covaxin in children in the age group of 2 to 18 years in the next 10-12 days.
“Covaxin has been approved by the Drugs Controller General of India (DCGI), for Phase II/III clinical trials in the age group of 2 to 18 years. I have been told that trials will begin in the next 10-12 days,” Paul said during a press conference.
This is the first time in India that a Covid-19 vaccine will be tested on children.
The clinical trials involve two Covid-19 vaccine shots injected on day 0 and day 28.
The trials will take place at several sites, including AIIMS, Delhi, AIIMS, Patna and Meditrina Institute of Medical Sciences, Nagpur.
India’s drug regulator has accepted the recommendation of the Subject Expert Committee (SEC) and given a nod to the Hyderabad-based Bharat Biotech to conduct Phase II/III clinical trial of Covid-19 vaccine Covaxin in the age group 2 to 18 years.
Covaxin maker Bharat Biotech had proposed to carry out a Phase-II/III clinical trial of Covaxin in the age group of 2 to 18 years. The trial will be conducted in 525 healthy volunteers.
Apart from Covaxin, vaccine maker Serum Institute’s Covishield is being used to vaccinate people in the country. Meanwhile, Russia’s Covid-19 vaccine Sputnik V is also available at Apollo Hospital at Hyderabad’s Jubilee Hills and is being administered only to the beneficiaries who are 45 years or older.
Reports also suggest that RDIF will soon launch its single-dose vaccine Sputnik V Light in India. “We hope for the introduction of Sputnik V Light in India soon,” RDIF CEO Kirill Dmitriev had said.
Miniscule bleeding, clotting events post-vaccination
Earlier on Monday, the Union Health Ministry said that over 23,000 adverse events have been reported since the vaccination drive involving Covishield and Covaxin vaccines started in the country and of these 700 cases were reported to be serious.
The National Adverse Event Following Immunisation committee (AEFI) has completed an in-depth case review of 498 serious and severe events, of which 26 cases have been reported to be potential thromboembolic (formation of a clot in a blood vessel that might also break loose and carried by the blood stream to plug another vessel) events – following administration of Covishield vaccine – “with a reporting rate of 0.61 cases/ million doses”.
“There were no potential thromboembolic events reported following administration of Covaxin vaccine,” the ministry added.