Both Serum Institute of India’s and Bharat Biotech’s COVID-19 vaccine approvals for emergency use have been rejected, due to inadequate data, said reports on December 9.
Both proposals are not approved due to inadequate safety and efficiency data available currently. Both have been asked for more data,” reported a television channel.
The Subject Expert Committee of the Central Drugs Standard Control Organisation (CDSCO) committee reviewed the applications of Pfizer, Serum Institute of India and Bharat Biotech.
The Serum Insitute of India had filed for emergency use authorisation on Monday, while Bharat Biotech filed for the same on Tuesday.
“It is standard practice for the government to hold several meetings. The process is expected to go on for one or two weeks,” sources in Serum Institute said, reacting to the development.
The Oxford-AstraZeneca COVID-19 vaccine is being produced and tested in India by the Serum Institute of India, while Bharat Biotech, in partnership with ICMR has developed and is testing India’s first home-grown COVID-19 vaccine.
More than 200 COVID-19 vaccines are currently under development around the world. However, some of these have emerged as frontrunners and even received authorization for use by some regulatory bodies in different countries.
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