Delhi, October 19: In a major development, the center announced that the Pune-based Serum Institute of India (SII) and Hyderabad-based Bharat Biotech are expected to begin the last stage of clinical trials of intranasal COVID-19 vaccines in the coming months once they receive regulatory approval.
Vardhan said the late-stage trial generally involves thousands of participants, sometimes 30,000 to 40,000. Of the vaccines currently in Phase 3 trials, all are administered by injection, according to the World Health Organization (WHO).
Vardhan said in his weekly social media webinar called Sunday Samvaad, "Bharat Biotech has entered into an agreement with Washington University's School of Medicine under which the company will conduct trials, produce and market an intranasal vaccine for the Sars-CoV-2, the virus that causes coronavirus infection."
Under its agreement with Washington University’s School of Medicine, Bharat Biotech will conduct trials, produce and market the intranasal vaccine, Vardhan said.
Vardhan also informed about the development of another intranasal vaccine by the US-based biotech company Codagenix along with the Serum Institute of India.
"Codagenix is collaborating with the Serum Institute of India to develop CDX-005, which is the company's intranasal, live-attenuated vaccine candidate for SARS-CoV-2. The preclinical animal studies have been successfully completed, and Codagenix expects to initiate a Phase 1 first-in-human clinical trial in the UK by the end of 2020," he said.
CDX-005 is a single dose intranasal vaccine made with a live attenuated version of the virus.
The Union Minister remarked that thousands of participants are generally involved in the late-stage trial.