While there are three coronavirus disease (Covid-19) vaccine candidates being tested in humans in India, there are currently no intranasal vaccine candidates on trial, Union Health Minister Harsh said on Sunday. Vardhan. However, he also said that the Serum Institute of India was manufacturing an intranasal vaccine candidate.
“The Flumist nasal spray is a vaccine that is sprayed into the nose to help protest against the flu; it is not a Covid-19 vaccine. At present, in India, there is no intranasal Covid vaccine that is in clinical trials. However, the Serum Institute (of India) has started to manufacture Codagenix CDX 005, which is a candidate for a live attenuated intranasal vaccine for Sars-Cov-2, ”he said.
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“Pre-clinical studies in animals have now been completed and Codagenix expects to start a phase 1 clinical trial first in humans in the UK by the end of 2020. In addition, Serum India plans to undertake clinical development of this candidate vaccine in India.”
The minister was answering inquiries on his social media accounts as part of the sixth episode of Sunday Samvaad.
He also said that India’s Bharat Biotech also signed an agreement with the University of Washington School of Medicine as part of which it will conduct trials to produce and market an intranasal vaccine for Covid-19.
“Phase 1 trials will be conducted in the US at St. Louis University’s Vaccine and Treatment Evaluation Unit. Once they gain regulatory approval, Bharat Biotech will continue with the clinical trial stages. in India, “he added.
When asked if the Covid-19 vaccine will also be for the pediatric age group, the minister said that Bharat Biotech’s candidate vaccine was being tested in subjects between 18 and 55 years old in phase 1, while for phase 2 , spread to ages between 12 and 65 years.
Cadila Healthcare’s phase 1 clinical trial also included subjects between the ages of 18 and 55, and for phase 2, it was extended to 12 years or more. Serum Institute is conducting phase 2 and phase 3 clinical trials of its vaccine in subjects 18 years of age or older, up to the age of 99 years.
However, experts 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 Phase 2 trials is too small and only gives us the safety profile of a vaccine candidate. Anything concrete can be said only after we get the results from phase 3 trials that are carried out on a larger group of people and determine the efficacy of the candidate. Phase 1/2 trials are promising, while Phase 3 is all about knowing performance, ”said Dr K Srinath Reddy, founder of the Public Health Foundation of India.
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