JOIN USBharat Biotech gets DCGI nod for phase 3 trials of nasal Covid-19 booster dose
Vaccine maker Bharat Biotech said that its nasal Covid-19 vaccine has been approved by the drug regulator for phase 3 clinical trials in the country.
Bharat Biotech is developing the vaccine administered through the nose, in a licensing agreement with Washington University School of Medicine in St. Louis.
The intranasal vaccine - BBV154 - is based on the novel chimpanzee adenovirus. “The trials will evaluate the nasal vaccine for both the two-dose primary schedule and booster dose schedule,” a company representative said on Friday.
Booster dose is in the case of people who were administered with the first and second dose of intramuscular Covid-19 vaccines.
Intranasal vaccines are easier to administer in mass immunisation campaigns and help reduce transmission, a company representative said on Friday.
Phase-2 clinical trials were conducted in September last year.
“Unlike other Covid-19 vaccines in development, this vaccine is delivered via the nose, often the initial site of infection. Researchers found that the nasal delivery route created a strong immune response throughout the body, but it was particularly effective in the nose and respiratory tract, preventing the infection from taking hold in the body,” Bharat Biotech had said while announcing its partnership with Washington University School of Medicine in September 2020.
“An intranasal vaccine will not only be simple to administer but also reduces the use of medical consumables like needles, syringes, thus significantly impacting the overall cost of a vaccination drive,” Dr Krishna Ella, Chairman and Managing Director, Bharat Biotech, said earlier.
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