While there are three vaccine candidates against Coronavirus disease (Covid-19) being tested on humans in India, there is no intranasal vaccine candidate under trial currently, said Union health minister Harsh Vardhan on Sunday. However, he also said that Serum Institute of India was manufacturing an intranasal vaccine candidate.
“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.
“Pre clinical 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.”
The minister was responding to queries on his social media accounts as part of the 6th episode of Sunday Samvaad.
He also said that India’s Bharat Biotech has also entered in an agreement with Washington University School of medicine as part of which it will conduct trials to produce and market an intranasal vaccine for Covid-19.
“The phase 1 trials will take place in the US in St. Louis University’s vaccine and treatment evaluation unit, on getting regulatory approval, Bharat Biotech will pursue further stages of clinical trials in India,” he added.
On being asked if the Covid-19 vaccine will also be for the paediatric age group, the minister said Bharat Biotech’s vaccine candidate was being tested on subjects between 18 and 55 years in phase 1, while for phase 2, it was extended to ages between 12 and 65 years.
Cadila Healthcare’s phase 1 clinical trial had also 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.
Experts, however, say that at this stage it will be difficult to predict which of the vaccines will work. “It is too early to predict as the number of participants enrolled in phase 1 and 2 trials is too small and only gives us safety profile of a vaccine candidate. Anything concrete can be said only after we get results of phase 3 trials that takes place in larger group of people and determines the efficacy of the candidate. Phase 1/2 trials show promise, while phase 3 is about knowing the performance,” said Dr K Srinath Reddy, founder, Public Health Foundation of India.
By Hindustan Times
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