The Drug Controller General of India’s (DCGI) Subject Experts Committee (SEC) has granted approval to Bharat Biotech for initiating Phase III and heterologous clinical trials of its booster dose of the Covid-19 intranasal vaccine.
Last December, the company had sought approval to carry out the trial of the intranasal vaccine.
Bharat Biotech plans to evaluate the vaccine in people who have already received two doses of the company’s Covaxin or Covishield of Serum Institute of India (SII).
SEC also asked the company to present the revised trial protocol, ANI reported.
The SEC minutes of the meeting reads: “After detailed deliberation, the SEC ‘in principle’ agreed for the conduct of both Phase III superiority study and Phase III booster dose study in parallel in the light of the pandemic situation.”
“Accordingly, Bharat Biotech has been asked to submit the protocol(s) as recommended for approval.”
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Nearly 5,000 healthy subjects who already received either Covaxin or Covishield will be part of the trials.
Furthermore, the company submitted a report recommending the use of a Covid-19 booster six months after the primary dosings.
In August 2021, the company received approval from the country’s drug regulator to carry out the Phase II trial of its intranasal Covid-19 vaccine, BBV154, in healthy participants.
BBV154 is a replication-deficient chimpanzee adenovirus SARS-CoV-2 vectored vaccine. Bharat Biotech in-licensed the technology from Washington University in St Louis, US.
According to the concluded Phase I trial in people aged 18 to 60 years, the vaccine was found to be well tolerated.