Here's why Bharat Biotech's nasal Covid-19 vaccine could be a game-changer

An intranasal vaccine against Covid-19 by Bharat Biotech may soon receive permission for conducting Phase I clinical trials.

In January, an expert panel of India's drug regulator Central Drugs Standard Control Organisation (CDSCO) had recommended the trials be allowed and a top government official said that if the vaccine works it can be a game-changer in the fight against Covid-19.

Also read: Expert panel recommends permission for phase 1 clinical trial of Bharat Biotech's Covid-19 nasal vaccine

DCGI considering the nasal vaccine

Bharat Biotech has applied to the Drugs Controller General of India (DCGI) in January seeking permission for conducting Phase I and Phase II 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.

"A nasal vaccine candidate has been identified. It has come for consideration to the drug regulator for Phase I and Phase II clinical trials." NITI Aayog member V K Paul had said at a press conference.

"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 is the nasal vaccine different?

The nasal vaccine candidate by Bharat BioTech is different from the intramuscular vaccine which was approved for restricted emergency use approval under clinical trial mode. Unlike the vaccine currently in use, a nasal vaccine is administered in the nostrils.

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 Krishna Ella, the chairman of Bharat Biotech had said ahead of applying for permissions.

Bharat Biotech 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.

Also read: How does Covaxin stack up against other Covid-19 vaccines?

"One drop of vaccine in each of the nostrils is sufficient," Ella had said.

The vaccine maker had told news agency PTI 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.

The pharma company was quoted as saying that Phase I human clinical trials should commence during February-March 2021.

Nasal vaccine will be easy to administer to children

AIIMS Director Randeep Guleria believes that a nasal Covid-19 vaccine will be easy to give to school-going children who bear a "very mild" load of the disease but are infectious.

"The vaccines that have come are not approved for children because there have been no studies conducted on children but this (vaccination) is a very important step and trials are being done," the noted pulmonologist said.

Guleria pointed out that although vaccines for children may come later, Bharat Biotech's nasal vaccine will be very easy to be given to children as it is a spray and not a jab and hence "compliance" is more.

"In half-an-hour, you can vaccinate an entire class. So, if that (nasal vaccine) is approved it will be even easier to give the vaccine (for Covid-19)," Guleria said.

(With PTI inputs)