Encouraged by the recent approval by Drug Control General of India (DCGI) for its Covid-19 vaccine, Bharat Biotech is now gearing up for conducting the phase-1 clinical trial for its new intranasal antidote to beat the deadly spreading coronavirus.
While informing about the company’s plans for getting approval from DCGI for conducting the phase-1 clinical trials of the new intranasal vaccine, Dr. Krishna Ella, chairman and managing director of Bharat Biotech said, “With the DCGI’s recent approval of Covaxin for emergency restricted use in India, were are further encouraged to expedite our new intranasal vaccine to beat the killer virus. As part of our plans we are planning to seek DCGI’s approval for conducting phase-1 clinical trials in India for the intranasal vaccine to contain the spread of Covid-19 disease,” informed Dr. Ella.
It is learnt that the Bharat Biotech is planning to carry out the phase-1 clincial trails for the new intranasal antidote in the month of February-March this year. For which the company authorities are ensuring all the research data and other necessary documents about the new nasal vaccine are being prepared to be submitted to the DCGI for getting the approval for the clinical trials on humans.
Earlier, the Bharat Biotech had announced that apart from working on the development of Covaxin, it was also developing another vaccine for which it had tied up with Washington University School of Medicine in St Louis of the novel “Chimp-anenovirus’ (Chimpanzee adenovirus), a single dose intranasal vaccine for Covid-19 disease.
As part of its development, now the authorities of Bharat Biotech have reached to a stage where they have successfully completed the preclinical tests of BBV154 (intranasal Covid-19 vaccine) for toxicology, immunogenicity and challenge studies.
Apart from planning to conduct phase-1 clinical trials in India, the company is also planning to carryout the phase-1 trials in Saint Louis University’s vaccine and Treatment Evaluation unit.
It is also learnt that the Bharat Biotech owns the rights to distribute the vaccine in all markets except in USA, Japan and Europe. “Unlike the conventional vaccines that we have developed, the intranasal vaccine is simple to administer as one drop of vaccine in each nostrils is sufficient to attain immunity. The present vaccines that are coming in the market for Covid-19 disease are two dose vaccines and for a country like India, we need 2.6 billion syringes and needles, which will lead to heavy biomedical pollution. In view of this we are fast bring out the intranasal vaccine for Covid-19, as it is not only simple to administer but also reduce medical consumables significantly,” observed Dr. Ella.
The new vaccine has already completed animal studies and it has demonstrated protective efficacy in mice and hamsters. The animal studies has exhibited a very good immune response and with a single dose it has conferred superior protection against SARS-Cov-2 disease.
