According to Bharat Biotech, two recently completed Phase 3 trials of its BBV154 intranasal COVID-19 vaccine demonstrated the safety and tolerability of the recombinant replication-deficient adenovirus vectored vaccine and as well as its ability to elicit an immune response. One of the trials enrolled approximately 3100 subjects who received either two doses of BBV154 or two doses of Covaxin as a primary vaccine; the other enrolled approximately approximately 875 subjects who received a single dose of BBV154 as a booster after having previously received two doses of licensed COVID vaccines.
In September 2020, Bharat Biotech acquired the rights to the intranasal vaccine outside of the US, Europe, and Japan from the Washington University in St. Louis. The company says that it has “large manufacturing capabilities” at facilities across India and that the vaccine can be stored and transported easily because it is stable at 2-8 °C.
Bharat Biotech Joint Managing Director Suchitra K. Ella commented, “On this 75th Independence Day, we are proud to announce successful completion of clinical trials for BBV154 intranasal vaccine. We stay committed and focused on innovation and product development; this is yet another achievement for the multidisciplinary teams at Bharat Biotech. If approved, this intranasal vaccine will make it easier to deploy in mass immunization campaigns with an easy to administer formulation and delivery device. Vectored vaccines also enable faster development of targeted vaccines in response to emerging variants of concern. We hereby thank the volunteers, principle investigators, and clinical trial personnel for all their efforts.”
Read the Bharat Biotech press release.
