JNS: The subject expert committee (SEC) of Drugs controller General of India (DCGI) 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.
According to the reports, 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.
According to the sources, Bharat Biotech has to conduct clinical trials on 5,000 healthy people, which includes 2,500 people who have received Covishield and another 2,500 who inoculated with Covaxin. The intranasal booster dose will be administered after a time period of six months from the second COVID-19 vaccine, sources said.
Notably, in December 2021, the company had sought permission to conduct a phase 3 clinical trial of its intranasal COVID-19 vaccine as a booster dose from the DCGI. The intranasal vaccine, which is expected to be suitable for both children and adults, is a needle-free, non-invasive, and easy to administer vaccine.
