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Nasal Covid-19 vaccine trials to begin in India soon: Will it be more effective than an injection?

Nasal Covid-19 vaccine trials to begin in India soon: Will it be more effective than an injection?

Experts believe that nasal Covid-19 vaccines would be more effective at blocking the viral infection and in preventing infected individuals from spreading the virus.

Written by Longjam Dineshwori |Updated : October 21, 2020 8:37 AM IST

Pune-based Serum Institute of India and Hyderabad-based Bharat Biotech will be starting clinical trials of nasal Covid-19 vaccine in India soon, the government said on Sunday, adding that the two drugmakers are waiting for regulatory approval.

Currently, three vaccine candidates against Covid-19 are being tested on humans in India, but all of them are delivered by injection. This would be the first time trials of nasal coronavirus vaccine would be conducted in the country. In fact, all of the vaccines currently in Phase 3 trials are administered by injection, according to the World Health Organization (WHO).

Bharat Biotech, which is developing India's first vaccine candidate for COVID-19 called COVAXIN in collaboration with the Indian Council of Medical Research (ICMR), has entered into an agreement with Washington University's School of Medicine for the trials of a nasal Covid-19 vaccine.

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Under this agreement, the company will conduct trials, produce and market the intranasal vaccine for the SARS-CoV-2, the virus that causes Covid-19, Health Minister Harsh Vardhan said in his Sunday Samvaad on Sunday.

The phase 1 trials will be conducted in the US in St. Louis University's vaccine and treatment evaluation unit. Then Bharat Biotech will pursue further stages of clinical trials in India, after getting regulatory approval, Vardhan said.

According to Vardhan, Serum Institute of India is also working with US-based biotech company Codagenix to develop CDX-005, an intranasal, live-attenuated vaccine candidate for SARS-CoV-2. The preclinical animal studies have been successfully completed, and Codagenix plans to initiate a Phase 1 first-in-human clinical trial in the UK by the end of 2020. Serum Institute will undertake clinical developments of this vaccine candidate in India, he said.

The late-stage trials of the nasal vaccine candidates may involve 30,000 to 40,000 participants, Vardhan added.

Why do we need a nasal vaccine?

Nasal vaccines are delivered via the nose, which is often the initial site of COVID-19 infection. Experts believe that the nasal delivery route would be more effective at blocking the viral infection as well as prevent infected individuals from spreading the virus.

Not just the use of such a vaccine will be more convenient during mass vaccination; it will also reduce the cost by doing away with the need for needles and syringes. The intranasal vaccine is sprayed into the nostrils and inhaled, which one can easily do. Thus it will help cut down on the dependence on various trained personnel to administer the vaccine. What's more, the shipping of intranasal vaccines would be much easier than intramuscular injections.

Nasal vaccine better at blocking COVID-19 infection

Scientists at Washington University School of Medicine have developed a nasal COVID-19 vaccine that can be given in one dose via the nose. It was found to be effective in preventing infection in mice susceptible to the novel coronavirus. The investigators are now testing the vaccine in nonhuman primates and humans.

In a report published in the journal Cell in August, the researchers claimed that the nasal delivery route created a strong immune response throughout the body, particularly in the nose and respiratory tract.

They administered the vaccine to the mice in two ways -- in the nose and through intramuscular injection. The injection induced an immune response that prevented pneumonia, but it did not prevent infection in the nose and lungs. This suggests that an intramuscular vaccine might reduce the severity of COVID-19, but it would not totally block infection or prevent infected individuals from spreading the virus.

When the vaccine was delivered via the nose, it prevented infection in both the upper and lower respiratory tract including the nose and lungs. This means that vaccinated individuals would not spread the virus or develop infections elsewhere in the body.

While the intranasal approach for vaccination has been tested quite extensively in animals, whether it holds true in humans still remains largely unproven.