Hyderabad-based pharmaceutical company Biological E Limited’s (BE) application for trials of vaccine in children did not get recommendation as the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) asked for additional safety and immunogenicity data from the ongoing clinical trial in adult. The company had, earlier, said its major subject recruitment, interim safety and immunogenicity data will be available in August.
Biological E had said the Phase III trials of its vaccine CORBEVAX is currently underway and the firm expects to apply for emergency use authorisation by August 21. The company said it will supply a minimum of 300 million doses of vaccine to the Central government on obtaining that Emergency Use Licence (EUL), which it hopes to secure by September 21.
The Phase III clinical study is being conducted in 15 sites across India and it will evaluate the immunogenicity and safety of Biological E’s Covid-19 vaccine for protection against the disease in about 1,268 healthy subjects in the age range of 18 to 80 years.
The firm has started at-risk drug substance manufacturing of CORBEVAX and expects to fill at a rate of 75 million doses per month at the time of launch. It further said the country can anticipate 100 plus million doses per month starting February 2022.
As per reports, Corbevax vaccine has shown promising results in Phase 1 and 2 clinical trials. The vaccine is a RBD protein sub-unit vaccine and is likely to be available in the next few months.
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