‘Game changer against Covid-19’: Expert panel recommends phase 1 trial of Bharat Biotech’s nasal vaccine

According to the company’s chairman, just one drop of vaccine in each of the nostrils is sufficient, and to administer the dose one doesn`t require trained healthcare workers.

By: Satata Karmakar | | Updated: January 21, 2021 11:10 am

Expert panel recommends phase 1 trial of Bharat Biotech's nasal vaccine

India’s drug regulator CDSCO’s expert panel on Tuesday recommended granting permission for conducting phase 1 clinical trial of Bharat Biotech’s intra-nasal vaccine against COVID-19. Also Read - Akshay Kumar, Piyush Mishra, Sonam Kapoor and more Bollywood celebs who opened up on facing sexual abuse in childhood

According to the officials if this vaccine works it can be a game changer in the fight against COVID-19. Also Read - Test Article 2 Covid 19 3rd wave

Earlier this month, 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. Also Read - COVID-19 Live Updates: Cases in India surge to 10,757,610 while death toll reaches 1,54,392 12d

“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.

HOW EFFECTIVE THE NASAL VACCINE WOULD BE

In response to the queries 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.

HOW NASAL VACCINES ARE DIFFERENT FROM THE REST

In comparison to the intramuscular vaccine which was approved by the Indian drug regulator for restricted emergency use under clinical trial mode, the nasal vaccine has different way of usage.

Speaking to the media, Krishna Ella, the chairman of Bharat Biotech, had earlier said that 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.

Stressing about the nature of the Covid-19 nasal vaccine, the company’s chairman said that 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. “One drop of vaccine in each of the nostrils is sufficient,” he further added.

Replying to an email, the vaccine maker said that, “BBV154 (intranasal COVID-19 vaccine) preclinical testing has been completed for toxicology, immunogenicity and challenge studies. These studies have been conducted in the USA and India. Phase I human clinical trials will commence during Feb-March 2021.

INDIA’S FIGHT AGAINST COVID-19

A total of 13,823 new Covid-19 cases were registered on Wednesday, taking the total tally of cases for the country to 1,05,95,660.

According to the reports, there are still 1,97,201 active cases in the country.

The Covid-19 vaccine drive in India which began earlier this week, has already crossed the 5-lakh mark on the fourth day with the Centre urging states to address “vaccine hesitancy” among some in the priority group, and indicating that the drive will soon be extended to the larger population.

At a press conference, NITI Aayog member (health) Dr V K Paul said, “We are not fulfilling our societal responsibility if a vaccine assigned to us is not being taken. The whole world is clamouring for a vaccine. I request you to please accept the jab”.

He further added, ”Vaccine hesitancy should extinguish because COVID-19 inoculation is taking us towards the elimination of this calamity”.

(With inputs from Agencies)

Published : January 20, 2021 12:35 pm | Updated:January 21, 2021 11:10 am

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