Until now, AIIMS Patna has started the Paediatric clinical trial of the Covaxin
Bharat Biotech's Covaxin has been approved by the DCGI, for Phase II/III clinical trials in the age group of 2 to 18 years
Delhi's All India Institute of Medical Sciences (AIIMS) is also planning to start the clinical trials of the indigenous Bharat Biotech's Covid-19 vaccine "Covaxin" on children on Monday, news agency ANI said on Sunday, citing sources.
Until now, AIIMS Patna has started the Paediatric clinical trial of the Covaxin after Bharat Biotech received the Drugs Controller General of India (DCGI) nod to conduct clinical trials on children on May 11.
AIIMS Patna has started trials at the age of 12-18 years. After this, the trial will be conducted on the age group 6-12 years and 2-6 years, Dr Prabhat Kumar Singh, Director, AIIMS, Patna had told the news agency last week.
VK Paul, Member (Health), Niti Aayog had earlier said, "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."
The DCGI's approval follows the recommendation of a Subject Expert Committee on May 12 to grant such permission.
The trial of Bharat Biotech's Covid vaccine (Covaxin) will be conducted in 525 healthy volunteers at different sites across the country.
The trial will study aspects like--Safety of the vaccine in this age group (children), and types of adverse reactions and their causes. The trial will also examine the vaccine’s ability to prompt an immune response.
The clinical trials involve two Covid-19 vaccine shots injected on day 0 and day 28.