Covaxin Phase 2, 3 Clinical Trials Approved by DCGI for Children Aged 2-18 Years
- Covaxin trial approved by DCGI for children
- The decision came under rapid regulatory response
- Bharat biotech informs they have been endlessly supplying vaccines to 18 different states
New Delhi: In an initiative to boost the vaccination procedure for children below 18 years of age, the Drugs Controller General of India (DCGI) gave its nod for the phase 2 and phase 3 trials of Bharat biotech’s covaxin to start soon. If the trial becomes successful then the next phase of vaccination may be started for children aged 2-18 as the third wave of the pandemic is expected to hit children of this age category.
The ministry of health and family welfare said, “The National Regulator of the country, the Drugs Controller General of India (DCGI), after careful examination, has accepted the recommendation of Subject Expert Committee (SEC) and accorded permission to conduct the Phase II/III clinical trial of Covaxin (COVID vaccine) in the age group 2 to 18 years, to its manufacturer Bharat Biotech Ltd on May 12, 2021”.
This decision came in as part of a rapid regulatory response that was subjected to the SEC on May 11 for approval. Now that the trial phase is given a nod, Bharat biotech will conduct the trial of the vaccine on 525 healthy volunteers from across the nation. “In the trial, the vaccine will be given by intramuscular route in two doses at day 0 and day 28”, said the health and welfare ministry. Hopefully, the trial gets succeeded and the children get vaccinated after that!