Clinical Trial Update

Bharat Biotech Asked To Conduct Phase III Trials For Its Intranasal Vaccine

January 05,2022 11:28 AM
- By Admin

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

The subject expert committee (SEC) under India’s drug regulator has recommended that Hyderabad-based Bharat Biotech can conduct phase-3 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

However, the SEC asked the company to conduct standalone phase-3 trials on the nasal vaccine and asked them to submit a revised trial design. “The SEC made some suggestions on the basis of which the company will come with a revised proposal,” a senior government official told ET. 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. The interval between the second dose and the intranasal booster dose will be six months. The SEC deliberated on Bharat Biotech'sapplication for clinical trials of its intranasal Covidvaccine as a booster or a third dose on Tuesday. The company has developed a new, single-dose nasal Covid-19 vaccine in partnership with Washington University, based in St Louis, USA. The vaccine is being touted by some as a possible game-changer. A nasal vaccine may be the good choice for India because it will be single-dose and easy to administer, according to health experts. Bharat Biotech chairman Krishna Ella had earlier said that nasal vaccine would represent a breakthrough. “This vaccine can be given to two-month-old babies as well and a nasal vaccine can be administered to the entire population except for cancer patients and pregnant women.