India to conduct ‘late-stage’ clinical trials for intranasal Covid-19 vaccine
INDIA’s health minister Dr Harsh Vardhan has said that Serum Institute of India and Bharat Biotech are expected to pursue late stage clinical trials of intranasal Covid-19 vaccines in the coming months once they receive regulatory approval.
He added the late stage trial generally involves thousands of participants, sometimes 30,000 to 40,000.
While Serum Institute was manufacturing an intranasal vaccine candidate, Bharat Biotech entered in an agreement with Washington University School of Medicine to conduct trials to produce and market an intranasal vaccine.
“While there are three vaccine candidates against Covid-19 being tested on humans in India, there is no intranasal vaccine candidate under trial currently. Serum Institute has begun manufacturing Codagenix CDX 005, which is an intranasal live attenuated vaccine candidate for Sars-Cov-2,” the minister said.
“Pre-clinical animal studies have already been completed and Codagenix expects to initiate a phase 1 clinical first in humans trial in the UK by the end of 2020. Further, Serum India plans to undertake clinical developments of this vaccine candidate in India.”
The phase 1 trials for Bharat Biotech vaccine will take place in the US in St Louis University’s vaccine and treatment evaluation unit. Upon getting regulatory approval, the company will pursue further stages of clinical trials in India.
Of the vaccines currently in Phase 3 trials, all are administered by injection, according to the World Health Organization (WHO).
Recently, India’s Dr Reddy’s Laboratories and the Russian Direct Investment Fund (RDIF) have received renewed approval to conduct late-stage clinical trials in India of the Russian Covid-19 vaccine.
India’s tally of coronavirus infections stood at 7.55 million on Monday(19), having risen by 55,722 cases in the last 24 hours, health ministry said.
However, India recorded its lowest death toll in nearly four months on Monday with 579 deaths reported in the last 24 hours, taking total fatalities to 114,610.
The Indian Council of Medical Research (ICMR) said it will revisit its protocol for Covid-19 treatment after the WHO found some of the commonly used drugs, including remdesivir, had little or no impact on a patient’s chances of surviving, media reports said.
Meanwhile, Cadila Healthcare’s phase 1 clinical trial had included subjects between 18-55 years, and for phase 2, it was extended to 12 years and above. Serum Institute is conducting phase 2 and phase 3 clinical trials of their vaccine in subjects 18 years and above, till the age of 99 years.