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Expert panel recommends permission for phase 1 clinical trial of Bharat Biotech's nasal COVID-19 vaccine

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

January 20, 2021 / 09:20 AM IST
The nasal vaccine is different from the intramuscular vaccine which recently was approved by the Indian drug regulator for restricted emergency use approval under clinical trial mode. (Image: Reuters)

The nasal vaccine is different from the intramuscular vaccine which recently was approved by the Indian drug regulator for restricted emergency use approval under clinical trial mode. (Image: Reuters)

An expert panel of India's drug regulator CDSCO on January 19 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 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 on January 19 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) VK 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.

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A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.

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There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.

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Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.

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

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 USA and India. Phase I human clinical trials will commence during Feb-March 2021," an e-mail reply from the vaccine maker told PTI.

Follow our full coverage on COVID-19 here.
PTI
first published: Jan 19, 2021 10:00 pm

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