On the 5th of January, Wednesday, the Subject Expert Committee (SEC) of the Drug Controller General of India (DGCI) approved Phase III trials of intranasal COVID-19 vaccine.
It is to be noted, the Hyderabad based Bharat Biotech International Private Limited, also the manufacturer of one of India’s COVID-19 vaccines, COVAXIN, applied for Phase III conduct of the Intranasal COVID-19 vaccine, which is likely to be used as booster shots.
After studying the report submitted to the DGCI, the SEC gave ‘in principle’ approval to Bharat Biotech.
Notably, the Hyderabad based company received the Drug Controller General of India’s (DCGI’s) nod for conducting phase 2 clinical trials of the nasal vaccine in August 2021.
The DCGI released a statement which said, “DCGI’s Subject Expert Committee has granted ‘in principle’ approval to Bharat Biotech for the conduct of ‘Phase III superiority study and Phase III booster dose study’ for its intranasal Covid vaccine and has asked it to submit protocols for approval.”
According to sources, the Hyderabad based Bharat Biotech aims to conduct clinical trials on 5,000 subjects (50% vaccinated with Covishield and 50% vaccinated with COVAXIN.) If successful and approved, the Intranasal COVID-19 vaccine would be used as a booster shot.
The DCGI approval for the booster shot trial came at a time when India is reporting a massive surge in the Wuhan virus cases. Besides, its new variant Omicron is also on the rise in India with over 2,000 cases spread in 20 Indian states and union territories.
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