DCGI gives approval for Bharat Biotech's nasal COVID booster dose trails

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On Friday, the Drugs Controller General of India (DCGI) gave their approval to Bharat Biotech to conduct trials of intranasal vaccine BBV154.

The letter issued by DCGI read, "Central Licensing Authority hereby permits Bharat Biotech International limited to conduct clinical trials of the new drug or investigational new drug."

As per reports, the trial will be conducted at nine different sites in India.

"The Phase-3 clinical trial should be conducted as per protocol multi-center study to compare immunogenicity and safety of BBV154 with COVAXIN" the letter further read.

  • The dosage form of the vaccine is liquid for the intranasal route of administration and every single dose will be of 0.5 ml.

This development comes a day after Bharat Biotech's Covaxin and Serum Institute of India's Covishield were given approval for sale in the market.

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