Drug Approval | April 26, 2022
DCGI grants Covaxin Emergency Use Approval for children 6-12 years
Covaxin was earlier approved for children 12-18 years of age
Covaxin was earlier approved for children 12-18 years of age
The approval by the DCGI comes following recommendations by the Subject Expert Committee (SEC) on Covid-19 of the Central Drugs Standard Control Organisation(CDSCO)
WHO’s post EUA inspection found deficiencies in Good Manufacturing Practice at the facility
Covaxin is not approved in the USA for any age group
Covaxin is a whole-virion inactivated Covid-19 investigational vaccine candidate that uses the same vero cell manufacturing platform that has been used in the production of polio vaccines for decades
The vaccines are currently only authorised for emergency use in the country
However, these won’t be available at the nearest chemist store soon
The study will be published on the pre-print server, medRXiv, shortly
Six months after receipt of the second Covaxin dose, participants received booster dose of the same. The trial demonstrated long-term safety with no serious events
The first pilot study from India analyzing Covaxin-Covishield mixed doses
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