Bharat Biotech has sought permission from India's drug regulator to conduct a phase-3 study for its intra-nasal COVID-19 vaccine as a booster dose on participants vaccinated with Covishield or Covaxin, official sources said on Monday. India is yet to approve the use of the intranasal vaccine BBV154 developed by the Hyderabad-based company. The company had in August received the Drug Controller General of India's (DCGI's) nod for conducting phase 2 clinical trials of the nasal vaccine.
"Bharat Biotech has put in an application seeking permission to conduct a study titled 'A Phase 3 Study to Evaluate the Safety and Immunogenicity of BBV154 and BBV152 as third dose (booster) to participants previously vaccinated with SARS-CoV-2 vaccines'," an official said.
BBV154 is an intranasal replication-deficient chimpanzee adenovirus SARS-CoV-2 vectored vaccine. Bharat Biotech has in-licensed the technology from Washington University in St Louis, the US.
The company reports that the doses of the vaccine administered to healthy volunteers in the phase-1 clinical trial have been well tolerated. No serious adverse events were reported, the Department of Biotechnology had said.
Previously, the vaccine was found to be safe, immunogenic and well-tolerated in the pre-clinical toxicity studies. The vaccine was able to elicit a high level of neutralising antibodies in animal studies, it added.
On the government's stand over allowing the use of booster doses, NITI Aayog member (Health) Dr V K Paul had last week said these interventions and measures are driven by science, local epidemiology and resources.
"This time around, vaccine resources, broadly speaking, are in a good shape. What we are doing concurrently is engaging our scientific community to look at these issues on an ongoing basis. Have faith. When there is no resource constraint, our epidemiology and scientific discourse will decide this.
"We have competent teams which are examining this... we should be going for this option where there is appropriate evidence at an appropriate time. But all this approach comes after we have provided primary vaccination coverage to the maximum possible population and that remains the foremost goal," he had said.
The Union government recently has informed Parliament that the National Expert Group on vaccine administration for Covid (NEGVAC) and National Technical Advisory Group on Immunization (NTAGI) are deliberating and considering scientific evidence related to justification for booster dose against COVID-19.