The centre on Sunday announced that Serum Institute of India and Bharat Biotech will soon begin with the clinical trials of nasal coronavirus vaccine in India. It also informed that the Serum Institute of India and Bharat Biotech will begin the trials of the nasal covid-19 vaccine once they receive regulatory approval.
Currently, there is no nasal trial coronavirus vaccine being undertaken in India.
Bharat Biotech, which is manufacturing an indigenous Coronavirus vaccine in collaboration with the Indian Council of Medical Research (ICMR), has come into an agreement with Washington University and St. Louis University for the trials of the nasal coronavirus vaccine candidate in India.
In his Sunday Samvaad on Sunday, Health Minister Harsh Vardhan said, "Bharat Biotech has agreed 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."
Harsh Vardhan mentioned that Serum Institute and Bharat Biotech will soon begin the late-stage trials of a nasal coronavirus vaccine candidate in India which will, in general, involve thousands of participants and it may sometimes have 30,000 to 40,000 participants.
“Flumist nasal spray is a vaccine that is sprayed into the nose to help protest against influenza; it is not a Covid-19 vaccine. At present in India, there is no intranasal Covid vaccine which is under clinical trials. However, Serum Institute (of India) has begun manufacturing Codagenix CDX 005, which is an intranasal live attenuated vaccine candidate for Sars-Cov-2,” he said.
“Preclinical animal studies have already been completed and Codagenix expects to initiate a phase 1 clinical first in humans trial in the United Kingdom by the end of 2020. Further, Serum India plans to undertake clinical developments of this vaccine candidate in India.”
Of the vaccines currently in Phase 3 trials, all are administered by injection, according to the World Health Organization (WHO).
Vardhan added that Bharat Biotech’s vaccine candidate has been tested on subjects between 18 and 55 years in phase 1 and for second Phase trials it was extended to ages between 12 and 65 years.
On Saturday, India's Dr Reddy's Laboratories Ltd and the Russian Direct Investment Fund (RDIF) said they have received renewed approval to start with the late-stage clinical trials of the Russian coronavirus vaccine, Sputnik V. Earlier, the DGCI had stopped Dr Reddy's Laboratories from conducting the clinical trials for Sputnik V. Reasoning being the scale of Phase I and II trials of the covid-19 vaccine candidate conducted in Russia was small in size.
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Earlier, the government had said that India is expected to have a coronavirus vaccine in a few months and it plans to deliver the vaccine to people in the earliest of June 2021.
"We are very much into the vaccine development process...in the next few months at the most we should have a vaccine and in the next six months we should be in the process of delivering the vaccine to the people of India," Vardhan said.