What is Full Market Authorisation of Covidshield, Covaxin Recommended by SEC
According to government sources, the Central Drugs Standard Control Organisation (CDSCO)'s expert committee (SEC) recommended regular market authorization for Covaxin and Covishield, the two most extensively used jabs in the national vaccination effort against Covid-19, on Wednesday.
The news comes only days after the SEC requested more information from the two manufacturers—Hyderabad-based Bharat Biotech (Covaxin) and Pune-based Serum Institute of India (Covishield)—for full market authorization approval. When a vaccine is deemed safe and effective for the vast majority of people who receive it, it is given full market authorization. This approval is granted following the submission and review of complete data from the jab's phase 1, 2, and 3 studies.
Covaxin and Covishield received the emergency use authorization (EUA) from the Drugs Controller General of India (DCGI) last year. On January 16 last year, the inoculation drive began in India. So far, more than 158 crore doses have been administered.
Initially, it started with adults of age 18 and above. But recently teenagers between the age group of 15-18 were included as well. Booster shots are also being given in the country.