Patna’s All India Institute of Medical Sciences (AIIMS) will be holding press conference on Thursday with regard to clinical trial on children aged between 2-18 years. Last week, AIIMS Patna had started the pediatric trials for the COVID-19 vaccine manufactured by the Bharat Biotech, Covaxin.
Meanwhile, Bihar health department has revised drastically upwards, the total number of fatalities caused by the pandemic at 9,429. According to the department, which had till the previous day stated the number of deaths to be under 5,500, as many as 3,951 deaths have been added to the number of deaths after verification.
However, it was not specified as to when these additional deaths took place, though a breakup was provided for all 38 districts.
Covaxin received the Drugs Controller General of India (DCGI) nod to conduct clinical trials in children on May 11. 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.”
India started the world’s largest vaccination drive on January 16 this year in a phased manner with healthcare workers (HCWs) getting inoculated first. The vaccination of frontline workers (FLWs) started on February 2.
The next phase of Covid-19 vaccination commenced from March 1 for those over 60 years of age and for people aged 45 and above with specified co-morbid conditions. India launched vaccination for all people aged more than 45 from April 1.
The third phase of the vaccination started on May 1 for the beneficiary aged between 18-44.
India has three COVID-19 vaccine – Bharat Biotech’s Covaxin, Serum Institute’s Covishield and Russia’s Sputnik V. Covaxin and Covishield are being manufactured in India.
AIIMS Delhi also plans to begin clinical trials of Bharat Biotech’s Covid-19 vaccine “Covaxin” on children, news agency ANI cited sources as saying.
The trial will be conducted on 525 healthy volunteers across different sites across the country and the vaccine will be given by intramuscular route in two doses at day 0 (the first day) and day 28, according to the Health Ministry.
The trial will look into the vaccine’s safety in this age range as well as the adverse reactions and their causes. The vaccine’s ability to elicit an immunological response will also be tested in the trial.