Bharat Biotech gets nod from Health Ministry to conduct phase-3, booster trial of intranasal vaccine

The subject expert committee (SEC) of Drugs controller General (India) has recommended that Hyderabad-based Bharat Biotech can conduct phase- three trials on its intranasal vaccine.

The company had also sought approval from the SEC to use its intranasal vaccine as a booster dose, to which the SEC asked the company to submit a revised protocol.

The company plans to administer its nasal vaccine as a booster dose for those who have received two shots of a Covid-19 vaccine. Bharat Biotech aims to conduct clinical trials on 5,000 healthy people.

The company has proposed to use its intranasal vaccine as a heterologous booster dose in individuals who are already vaccinated, those who have received two doses of either Bharat Biotech’s Covaxin or Serum Institute of India’s Covishield.