Covaxin cleared for 6-12 year-olds, Bharat Biotech asked to keep submitting safety data
The Drugs Controller General of India has granted restricted emergency use authorisation to Bharat Biotech’s Covaxin for children aged 6 to 12 years. The panel had approved Covaxin for emergency use in children above 12 years in December 2021.
The company has been asked to submit safety data, including that on adverse events, with due analysis every 15 days for the first two months and monthly thereafter for five months on vaccination of 6-12 yeara-olds.
On April 21, the Subject Expert Committee (SEC) of DCGI had asked Bharat Biotech to provide additional data on administration of Covaxin for kids in the 2-12 years age group.
At the time, the panel recommended granting emergency use authorisation for Biological E’s Covid-19 vaccine Corbevax for children in the five to 11 years age group with certain conditions.
INDIA’S COVID VACCINATION DRIVE
India’s vaccination drive was rolled out on January 16 last year with healthcare workers getting inoculated in the first phase. Vaccination of frontline workers started from February 2 last year.
The next phase of Covid-19 vaccination commenced on March 1 last year for people over 60 years of age and those aged 45 and above with specified co-morbidities.
India launched vaccination for all people aged more than 45 years from April 1 last year. The government then decided to expand its vaccination drive by allowing everyone above 18 years of age to be inoculated against the viral disease from May 1 last year.
The next phase of vaccination commenced on January 3, 2022 for adolescents in the age group of 15-18 years. India began inoculating children aged 12-14 on March 16.
India began administering precaution doses of vaccines to healthcare and frontline workers and those aged 60 and above with co-morbidities from January 10. Precaution doses of COVID-19 vaccines to all aged above 18 years were allowed at private vaccination centres from April 10.
(With inputs from PTI)
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