Clinical trials of Bharat Biotech’s intranasal COVID vaccine candidate as a primary (two) dose and a heterologous booster dose have been completed and the data has been submitted for approval to national regulatory authorities.
BBV154, the vaccine, has proven to be safe, well-tolerated and immunogenic in controlled clinical trials, the vaccine maker said, announcing submission of the data on completion of the trials in which nearly 4,000 volunteers participated.
“On this 75th Independence Day, we are proud to announce successful completion of clinical trials for BBV154 intranasal vaccine. If approved, this vaccine will make it easier to deploy in mass immunisation campaigns with an easy to administer formulation and delivery device,” Joint Managing Director Suchitra K. Ella said.
Being intranasal, it may produce local antibodies in the upper respiratory tract which may provide the potential to reduce infection and transmission. Further studies are being planned, the company said.
Two separate and simultaneous trials were conducted to evaluate as a primary, two dose schedule and as a heterologous booster dose for those who have previously received two doses of either Covishield or Covaxin vaccines. The trials were conducted in 14 sites across the country.