The results of the phase 1 trial of Bharat Biotech's nasal vaccine against the novel coronavirus caused disease were promising, and it will block virus entry into the body, said centre on 9 September. Dr VK Paul, who is a member of Niti Aayog, stated that further details about the made in India intranasal vaccine would be shared after more findings.

The Hyderabad-based pharmaceutical company Bharat Biotech has been working on the intranasal jab for a while after it successfully developed India's first Covid-19 jab Covaxin which is currently being used in the country.

As reported, the Phase 1 trial involved a healthy group of volunteers aged between 18 and 60 years old. The needle-free vaccine was found to be "well-tolerated" by the volunteers, revealed a statement from the Ministry of Science and Technology. The Department of Biotechnology (DBT) and the Biotechnology Industry Research Associate Council (BIRAC) are also assisting in developing the vaccine.

It was also reported that the nasal vaccine against the SARS-CoV-2 caused disease is expected to enter into the phase 2/3 trials within a few weeks at All India Institute of Medical Sciences (AIIMS), New Delhi and Dr Sanjay Rai is the primary investigator for Bharat Biotech's nasal vaccination clinical trial. In August, the vaccine makers gained regulatory authorisation to perform the BBV154 intranasal vaccine's trials.

These trial stages will require necessary approval from the AIIMS Ethics Committee, for which an application has already been submitted. Following the panel's approval, the experiment will be carried out by giving two dosages to volunteers, separated by four weeks. According to Dr Renu Swarup, secretary, DBT, BBV154 is the country's first intranasal vaccine to reach late-stage trials.

A Game Changer Vaccine

According to the website of Bharat Biotech, the BBV154 is a novel adenovirus vectored, the intranasal vaccine against Covid 19. It says: "An intranasal vaccine stimulates a broad immune response – neutralising IgG, mucosal IgA, and T cell responses. Immune responses at the site of infection (in the nasal mucosa) – essential for blocking both infection and transmission of Covid-19."

According to the Indian pharmaceutical company, because of the well-organised immune systems of the nasal mucosa, the nasal route has a high potential for vaccination. The vaccine also does not require trained health care workers, eliminates needle-associated risks—such as injuries and infections—and it makes the company capable of scale-up manufacturing to meet global demand.

The chief scientist of the World Health Organisation (WHO) Dr Soumya Swaminathan said on 23 May that the nasal Covid-19 vaccines, which are under development, could be a "game-changer" in India. She said: "Some of the nasal vaccines that are going to be made in India could be game-changers for children — easy to administer, will give you local immunity in the respiratory tract."

At that time, the WHO expert stated that she has been very hopeful about a nasal vaccine in India that will help children—a section of the population that is currently unvaccinated in India. But she stated that the country might not get the needle-free vaccine this year.

Earlier, Dr Randeep Guleria, who is the director of AIIMS, said earlier that nasal vaccines like Bharat Biotech's BBV154 "will be very easy to be given to children as it is a spray and not a jab and hence compliance is more".

However, just a few months ago Bharath Biotech's joint managing director Suchitra Ella earlier said: "Am hopeful that the final stage clinical trials will be completed in the next three to four months and within next six months we will be able to launch the nasal vaccine in India."

However, as reported earlier, India plans to test a combination of Bharat Biotech's Covaxin, and a prospective intranasal vaccine developed by researchers from the United States, in the hopes of boosting the two vaccines' protective efficiency against coronavirus infection.

A clinical trial involving Covaxin as the first dose on day zero and the candidate intranasal vaccine based on a chimpanzee adenovirus as the second dose on day 28 has been approved by an expert panel with India's regulatory body for medicines and vaccines.

Indian covid vaccine

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