Bharat’s Intranasal Vaccine Speeding into Phase II

BioSpace

 

Bharat Biotech’s intranasal COVID-19 vaccine candidate is expected to enter the Phase II portion of a Phase II/III study within the next few weeks. This marks the second vaccine against the novel coronavirus developed by the India-based company.

It’s a significant milestone for intranasal formulations. The nod from India’s Health Authority makes Bharat’s BBV154 candidate the first intranasal vaccine in development for COVID-19 in the country. 

Phase I data from the intranasal formulation, is promising. Not only was the vaccine candidate well-tolerated, but the medication also blocks viral entry into the body. Full details of the study will be presented at a later date.  

The company has suggested that an intranasal formulation of the vaccine provides a broad immune response at the site of infection, the mucus membranes of the nasal passages. There is a school of thought that this type of administration will provide a stronger immune response than intramuscular injections currently used in multiple vaccines, including Bharat’s Covaxin, a whole virion inactivated COVID-19 vaccine, which has already been authorized in India. This is essential for blocking infection within an individual and the ability to transmit the virus. 

The company and its U.S.-based partner Ocugen, are seeking authorization for Covaxin in the United States as well. However, earlier this summer, the Pennsylvania-based Ocugen ran into some trouble with its plans to bring Bharat’s vaccine to the U.S.  

As BioSpace previously reported, Ocugen was forced to change its application from potential emergency use to a full Biologics License Application. And that requires additional data. Bharat aims to use real world data from the millions of doses of Covaxin administered in India as part of a planned Phase IV study. 

The intranasal approach Bharat is taking with its second COVID-19 vaccine candidate is also one unsuccessfully attempted by Maryland-based Altimmune. In June, the company announced its intranasal vaccine candidate, dubbed AdCOVID, fell short in a Phase I study. 

The company acknowledged that the immunogenicity data generated in the study “exhibited very low immune responses in every parameter where it was tested.” As a result, Altimmune halted the development of that particular vaccine candidate. 

According to the U.S. Centers for Disease Control and Prevention, approximately 54% of the eligible population in the United States is fully vaccinated against COVID-19. About 75.3% of eligible adults have received at least one jab of the available vaccines.