SEC Recommends Bharat Biotech to Conduct Late-stage Trials, Submit Booster Protocol
SEC Recommends Bharat Biotech to Conduct Late-stage Trials, Submit Booster Protocol
This is a needle-free, non-invasive and easy to administer vaccine, which is expected to be suitable for both children and adults.

The Subject Expert Committee (SEC) of India’s drug authority has recommended Bharat Biotech to conduct late-stage trials for its intranasal vaccine BBV154.

After discussions and deliberations for almost five hours on Tuesday, the expert panel has asked Bharat Biotech to add a Covishield arm in the booster trails and submit a protocol for the same. Bharat Biotech will submit a revised application tomorrow as per government sources.

Bharat Biotech aims to conduct clinical trials on 5,000 healthy subjects: half or 2,500 individuals who have received Covishield and another 2,500 who have been administered Covaxin. The interval between the second and the intranasal booster dose is expected to be six months.

This is a needle-free, non-invasive and easy to administer vaccine, which is expected to be suitable for both children and adults.

Prime Minister Narendra Modi in his December 25 address to the nation had assured that soon the country will develop a nasal vaccine.

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