Bharat Biotech seeks nod for trials of intranasal vax

Hyderabad: Buoyed by the Emergency Use Authorisation approval from the Drug Controller General of India (DCGI) for its COVID-19 vaccine Covaxin, Bharat Biotech has said Phase-1 clinical trials of its new intranasal antidote for the killer virus will begin during February-March this year.

Besides Covaxin, Bharat Biotech has been actively working on developing another vaccine, for which it tied up with Washington UniversitySchool of Medicine in St Louis for the novel "chimp-adenovirus" (Chimpanzee adenovirus), a single dose intranasal vaccine for COVID-19.

BBV154 (intranasal COVID-19 vaccine), preclinical testing has been completed for toxicology, immunogenicity and challenge studies. The Phase-1 trials will be conducted in Saint Louis University's Vaccine and Treatment Evaluation Unit, the company sources said, adding Bharat Biotech owns the rights to distribute the vaccine in all markets except USA, Japan and Europe.

Krishna Ella, Chairman of Bharat Biotech, had earlier said the company is focusing on the intranasal vaccine as the existing vaccines require two dose intramuscular injections and a country like India needs 2.6 billion syringes and needles which may add up to pollution. 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, he had said. "One drop of vaccine in each of the nostrils is sufficient," he had said.

According to the firm, an intranasal vaccine stimulates a broad immune response at the site of infection, in the nasal mucosa, which is essential for blocking both infection and transmission of Covid-19.

The vaccine has demonstrated protective efficacy in mice and hamsters. Mice and hamsters immunised with its single dose conferred superior protection against SARS-CoV-2 challenge, "more so than one or two intramuscular immunisations of the same vaccine and dose".

"Thus, intranasal immunisation of ChAd-SARS-CoV-2-S can create an immune response in the nose, which is the point of entry for the virus, thereby protecting against disease, infection and transmission," Bharat Biotech said in a statement.

On January 3, two intramuscular vaccines - Bharat Biotech's Covaxin and Oxford-AstraZeneca's Covishield manufactured by Serum Institute of India - were approved for restricted emergency use. Both are two-dose vaccines.

While the full efficacy of Covaxin is yet to be determined, it was given go-ahead by the DCGI citing 'public interest'. Covaxin is an indigenously developed vaccine by Bharat Biotech, in collaboration with the Indian Council of Medical Research (ICMR).

SIMPLE & EFFECTIVE

♦ The vaccine will be a single-dose one

♦ Non-invasive, needle-free, eliminating needle-associated risks

♦ It also eliminates the need for trained healthcare workers

♦ It is suitable for children and adults, facilitates scalable manufacturing

♦ It stimulates a broad immune response at site of infection in nasal mucosa

♦ It essential for blocking both infection and transmission of Covid-19