Bharat Biotech gets nod for India's first nasal COVID vaccine: Why this is a potential game-changer

India may have a game-changer on its hands with the Drugs Controller General of India (DCGI) approving Bharat Biotech’s intranasal COVID vaccine for restricted emergency use for those above 18.

“Big Boost to India’s Fight Against COVID-19! Bharat Biotech’s ChAd36-SARS-CoV-S COVID-19 (Chimpanzee Adenovirus Vectored) recombinant nasal vaccine approved by @CDSCO_INDIA_INF for primary immunization against COVID-19 in 18+ age group for restricted use in emergency situation,” Union health minister Mansukh Mandaviya tweeted.

Mandaviya added that this step will further strengthen “our collective fight” against the pandemic. India has harnessed its science, research and development (R&D), and human resources in the fight against COVID-19 under Prime Minister Narendra Modi’s leadership, he said.

“With the science-driven approach & Sabka Prayas, we will defeat COVID-19,” Mandaviya also said.

Let’s take a closer look at the vaccine:

How does it work?

As per News18, Bharat Biotech’s nasal vaccine uses a chimpanzee cold virus to deliver a harmless copy of the coronavirus spike protein to the lining of the nose.

As per Hindustan Times, the theory behind delivering the vaccine through intranasal route is that both influenza and COVID-19 follow the same pattern of infection – nose and mouth route into the lungs.

That is why having mucosal immunity is important and the vaccine will also use the same nasal (drop) route, as per the report.

It has been specifically formulated to allow intranasal delivery and has been developed in partnership with Washington University St Louis, which had designed and developed the recombinant adenoviral vectored constructs and evaluated them in preclinical studies for efficacy, as per the report.

The trial sites included All India Institute of Medical Sciences, Delhi and Patna (Bihar), Aatman Hopsital, Ahmedabad (Gujarat), PGIMS, Rohtak (Haryana), and Prakhar Hospital, Kanpur, and Rana Hospital, Gorakhpur (Uttar Pradesh), as per Hindustan Times.

What are its advantages?

Hindustan Times quoted Bharat Biotech as saying that as the vaccine is easy to administer as it is non-invasive and does not require trained health care workers.

It further eliminates needle-associated risks such as injuries and infections, has higher compliance and is scalable as far as manufacturing is concerned.

News18 quoted an article published by Gavi the Vaccine Alliance as noting other advantages including the fact that the sprays don’t need to be refrigerated and don’t need to be administered by health professionals.

“People would be able to self-administer them at home," the article says, adding “they are likely to be more popular for the millions of people who don’t like needles".

What has company said?

The Hyderabad-based firm completed clinical trials of the nasal vaccine with about 4,000 volunteers and there is no side effect or adverse reaction reported so far, company sources said.

As per Mint, Bharat Biotech in August after completing the phase-III and booster dose trials for its intranasal Covid-19 vaccine, said it had conducted two separate trials for its intranasal Covid vaccine – one as a primary dose schedule and another as a booster dose, for subjects who have been double vaccinated with the two commonly administered Covid vaccines in India.

It has proven to be safe, well-tolerated and immunogenic in subjects in controlled trials, BBIL said in a statement.

The data from both Phase III human clinical trials have been submitted for approval to national regulatory authorities, the company had said.

“If approved, this intranasal vaccine will make it easier to deploy in mass immunisation campaigns with an easy to administer formulation and delivery device. Vectored vaccines also enable faster development of targeted vaccines in response to emerging variants of concern,” Bharat Biotech joint managing director Suchhitra K Ella had said, as per the report.

Ella was earlier quoted by news agency PTI as saying that any injectable vaccine only protects the lower level (of the body). That’s why people vaccinated with injectable vaccines may still get RT-PCR positive, whereas the nasal jab protects the whole body.

Bharat Biotech also claimed that the “intranasal vaccine stimulates a broad immune response.”

India’s COVID-19 situation

India on Tuesday saw a single-day rise of 4,417 coronavirus infections, which is the lowest in three months, as per government data updated at 8 am.

According to the ministry, 213.72 crore doses of Covid vaccines have been administered in the country so far under the nationwide COVID-19 vaccination drive.

India’s COVID-19 tally had crossed the 20-lakh mark on 7 August, 2020, 30 lakh on 23 August, 40 lakh on 5 September and 50 lakh on 16 September.

It went past 60 lakh on 28 September, 70 lakh on 11 October, crossed 80 lakh on 29 October, 90 lakh on 20 November and surpassed the one-crore mark on 19 December.

India crossed the grim milestone of two crore on 4 May, three crore on 23 June last year and four crore on 25 January.

With inputs from agencies

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