CDSCO SEC okays Covovax for 12-17 year-olds
New Delhi: The Subject Expert Committee (SEC) has recommended granting emergency use authorisation (EUA) to Serum India of India's COVID-19 vaccine Covovax for the age group 12-17, said the official sources.
SII also submitted the data for phase 3 trials of the Covovax booster dose.
Earlier, the Drugs Controller General of India (DCGI) had approved Covovax for restricted use in an emergency situation for adults last year on December 28.
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The Subject expert committee of the Central Drugs Standard Control Organisation (CDSCO) meeting today recommended EUA to Covovax. The meeting for COVID-19 related proposals today was held between 12 noon and 6 pm.
However, the final approval for emergency use authorisation from DCGI is still awaited.
After receiving the emergency use authorisation from DCGI, Covovax will become the fourth vaccine that can be administered for the age group of 12-17 years old.
Notably, this vaccine has not been still included in the Country's vaccination programme so far.
Covovax was also granted emergency use listing by the World Health Organization. It is manufactured by technology transfer from Novavax and is approved by the European Medicines Agency for conditional marketing.
