CDSCO’s expert panel recommends approval for phase 1 trial of Bharat Biotech’s nasal vaccine for COVID-19

CDSCO’s expert panel recommended granting permission for conducting phase 1 clinical trial of an intranasal vaccine against COVID-19 developed by Bharat Biotech, official sources said.

A top government official said that if this vaccine works it can be a game changer in the fight against COVID-19.

Bharat Biotech had applied to the Drugs Controller General of India (DCGI) seeking permission for conducting phase 1 and phase 2 clinical trials of the intranasal vaccine following which the subject expert committee of the CDSCO deliberated on the application and recommended granting permission for phase 1 trial.

“Based on the safety and immunogenicity data of the phase 1 clinical trial, the company would be given permission for conducting phase 2 clinical trial,” an official said on the condition of anonymity.

Earlier in the day, in response to a query on whether a nasal vaccine would be effective against the disease, NITI Aayog member (health) V K Paul at a press conference said, “A nasal vaccine candidate has been identified. It has come for consideration to the drug regulator for phase 1 and phase 2 clinical trials.”

“It looks like an exciting development because potentially, yes, this route can be used to deliver the safe antigen against which an immunological response would happen. If it does work it can be a game-changer because it is so easy to use and we look forward to this development. Such a possibility is very plausible scientifically,” Paul said.

The nasal vaccine is different from the intramuscular vaccine which recently was approved by DCGI for restricted emergency use approval under clinical trial mode.

Dr Krishna Ella, the chairman of Bharat Biotech, had earlier said the company is focusing on the intranasal vaccine as existing vaccines require two-dose intramuscular injections and a country like India needs 2.6 billion syringes and needles which may add to pollution.

An intranasal vaccine will not only be simple to administer but reduce the use of medical consumables such as needles, syringes, etc., significantly impacting the overall cost of a vaccination drive, he had said.

“One drop of vaccine in each of the nostrils is sufficient,” he had said.

“BBV154 (intranasal COVID-19 vaccine) preclinical testing has been completed for toxicology, immunogenicity and challenge studies. These studies have been conducted in the US and India. Phase I human clinical trials will commence during Feb-March 2021,” an e-mail reply from Bharat Biotech informed.