Bharat Biotech gets approval from DCGI for intranasal booster dosage trials
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Covid vaccines

DCGI to conduct intranasal COVID-19 booster dosage experiments

Bharat Biotech gets approval for intranasal booster trials

Bharat Biotech has been granted permission by the Drugs Controller General of India (DCGI) to conduct intranasal COVID-19 booster dosage experiments, according to reports.

The trials will take place at nine separate locations, according to the newspaper.

This comes on the same day that Union Health Minister Dr. Mansukh Mandaviya stated that the government had administered over 1 crore preventive pills to the eligible people in just 19 days.

As reported on 5 January the DCGI's Subject Expert Committee (SEC) has given Bharat Biotech 'in principle' approval to perform a 'Phase III superiority trial and Phase III booster dosage research' for its intranasal COVID-19 vaccine.

Three weeks ago, Bharat Biotech received a request to submit protocols for approval. This is India's first COVID-19 intranasal booster.

Bharat Biotech is the second firm to apply for a third-dose Phase III trial. According to reports, the intranasal vaccines have the ability to stop the spread of COVID-19 variations, including Omicron.

Meanwhile, Health Minister Mansukh Mandaviya said on Thursday that the DCGI has awarded normal market approval for the COVID-19 vaccines Covishield and Covaxin for use in the adult population, subject to specific limitations.

Mandaviya says, "The regulator has upgraded the permission for COVAXIN and Covishield from restricted use in emergency situations to normal new drug permission in the adult population with certain conditions."

In just 19 days, India administered almost 1 crore preventive doses to the eligible population, according to Mandaviya.

 


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