INDIA – Indian vaccine maker Bharat Biotech’s nasal COVID-19 vaccine candidate has received regulatory approval for mid- to late-stage trials, the government’s ministry of science and technology said in a statement.
Early stage trials of the vaccine candidate, BBV154, has been completed in subjects aged 18 to 60 years, and the doses were found to be well tolerated, the statement said.
This stage involves testing the vaccine on a large pool of participants, typically running into thousands or even tens of thousands of people.
“Bharat Biotech’s BBV154 Covid Vaccine is the first intranasal vaccine being developed in the country entering into late-stage clinical trials,” said Renu Swarup, chairperson of the Biotechnology Industry Research Assistance Council.
Earlier, in preclinical toxicity studies, the vaccine was found to be safe, immunogenic, and well tolerated, in addition to eliciting a high level of neutralizing antibodies during animal testing.
In September last year, the Indian vaccine maker had entered into a licensing agreement with Washington University School of Medicine in St Louis, United States of America (USA), to develop the novel chimp-adenovirus, single-dose intranasal vaccine for Covid-19.
They got the rights to distribute the vaccine in all markets except the USA, Japan, and Europe and envisioned scaling up the vaccine to one billion doses, which means inoculation of a billion people using this vaccine technology.
Whereas Bharat Biotech’s Covid-19 vaccine Covaxin, which was approved for emergency use and has been in circulation in India, is administered through an injection, the intranasal vaccine will be taken in through the nostril, as a drop or spray.
This kind of vaccine is administered at the site of infection, or the point of entry for the virus. In the case of Covid-19, the entry point is the nose. So, the nasal vaccine is likely to help protect against both infection and transmission of the virus.
It is also said to stimulate a broad immune response. “An effective nasal dose not only protects against COVID-19, but it also prevents the spread of the disease by offering another kind of immunity that occurs primarily in the cells that line the nose and throat,” Dr David T Curiel, Director of Biologic Therapeutics Center and Professor of Radiation Oncology at Washington University School of Medicine, had said last year after the deal between the Indian and US parties was inked.
Furthermore, an intranasal vaccine is not only simpler to administer, given that it doesn’t require trained healthcare workers, but it can lower the overall cost of inoculation, as it reduces use of medical consumables like syringes.
Russia is reportedly aiming to introduce a nasal spray for distribution by 15 September this year. The spray is said to have been already tested on children aged between eight and 12 years.
Around the world, there are seven intranasal SARS-CoV-2 vaccines in clinical trials, including Bharat Biotech’s BBV154.
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