COVAXIN approved for Phase 2/3 trials on 2-18-year-olds
India's apex drug regulator has granted permission for conducting the Phase II/III clinical trial of Bharat Biotech's COVAXIN in the age group of 2 to 18 years, the Union Health Ministry said on Thursday. The trial will be conducted on 525 healthy volunteers. During the trial, the vaccine will be given by intramuscular route in two doses on day 0 and day 28.
DCGI granted permission based on SEC's recommendation
The National Regulator of the country, the Drugs Controller General of India (DCGI), after careful examination, accepted the recommendation of the Subject Expert Committee (SEC). It accorded permission to conduct the Phase II/III clinical trial of COVAXIN (COVID-19 vaccine) in the age group 2 to 18 years, to its manufacturer Bharat Biotech Ltd. on May 12, the ministry said.
Bharat Biotech was asked to submit revised clinical trial protocol
As a rapid regulatory response, the proposal was deliberated in the Subject Expert Committee (SEC) at the COVID-19 meeting held on May 11. Earlier, the proposal was deliberated in the SEC meeting on February 24 and the firm was asked to submit a revised clinical trial protocol. COVAXIN is currently being used on adults in India's ongoing COVID-19 vaccination drive.
Children will likely be at higher risk in third wave
Notably, this development comes amid reports that the possible third COVID-19 wave in India is likely to be dangerous for children. Experts say that the first wave affected older people, and in the ongoing second wave, youngsters are getting more infected, while the third wave could see more infections in children. Hence, ensuring vaccination of children is crucial to prepare for the third wave.
Over 93.5 lakh people have taken first dose of COVAXIN
According to data released by the government, COVAXIN has been administered to 1.1 crore people across India. 93.5 lakh people (93,56,436) received the first dose of the vaccine and 4,208 people among them (0.04%) tested positive for COVID-19. 17.3 lakh people (17,37,178) received the second dose of the vaccine and 695 people among them (0.04%) tested positive.
