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If approved, Zydus Cadila’s vaccine will become the second indigenous vaccine to receive emergency authorization in India after Bharat Biotech’s Covaxin.

CNBC-TV18 quoted sources as reporting that the subject-matter expert committee of the Indian drug regulatory agency has recommended the emergency use of Zydus Cadila’s three doses of COVID-19 vaccine.

CNBC-TV18 said in a tweet on Friday that the committee added that Zydus needs to submit additional data for its two-dose vaccine.

The generic drug manufacturer named Cadila Healthcare Ltd applied for the authorization of the vaccine ZyCoV-D on July 1, based on the effective rate of 66.6% in the late-stage trials of more than 28,000 volunteers across the country.

If approved, Zydus Cadila’s vaccine will become the second indigenous vaccine to receive emergency authorization in India after Bharat Biotech’s Covaxin.

Zydus Cadila and the Indian drug regulatory agency did not immediately respond to Reuters’ request for comment.

Johnson & Johnson seeks trial on Indian teenagers

At the same time, Johnson & Johnson said on Friday that it has sought approval from the Indian drug regulatory agency to conduct research on its COVID-19 vaccine in people aged 12 to 17.

Johnson & Johnson said in an email statement that clinical trials of vaccines among young people are critical to achieving herd immunity against the coronavirus.

The US pharmaceutical giant received emergency use approval for its single-dose vaccine in India earlier this month, making it the fifth authorized vaccine in the country.

Although Johnson & Johnson has signed a supply agreement with Indian vaccine manufacturer Biological E Ltd to bring its vaccines to the country, the company said it is too early to give a delivery timetable.



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