New Delhi: Bharat Biotech International Limited on Monday announced that its COVID-19 intranasal vaccine iNCOVACC (BBV154) has received approval from the Central Drugs Standard Control Organisation (CDSCO) under Restricted Use in Emergency Situation for ages 18 and above in India, for heterologous booster doses.
A press release from the vaccine maker said iNCOVACC, a recombinant replication deficient adenovirus vectored vaccine with a pre-fusion stabilised SARS-CoV-2 spike protein, is the world’s first intranasal vaccine to receive both primary series and heterologous booster approval.
The vaccine candidate was evaluated in Phases I, II and III clinical trials with successful results and has been specifically formulated to allow intranasal delivery through nasal drops, it said.
The nasal delivery system has been designed and developed to be cost-effective in low- and middle-income countries, Bharat Biotech said.
Krishna Ella, Chairman & Managing Director, Bharat Biotech, said: “Despite the lack of demand for COVID vaccines, we continued product development in intranasal vaccines to ensure that we are well-prepared with platform technologies for future infectious diseases… We have also initiated development of variant-specific vaccines for COVID for future preparedness.”
iNCOVACC was developed in partnership with Washington University, St Louis, which had designed and developed the recombinant adenoviral vectored construct and evaluated in pre-clinical studies for efficacy.
Rajesh S. Gokhale, Secretary, DBT, and Chairperson, BIRAC, said, “The DCGI’s approval of Bharat Biotech’s intranasal vaccine iNCOVACC (BBV154) to be used as a heterologous booster dose against currently available COVID-19 vaccines is a moment of great pride for our country. This move will further strengthen our collective fight against the pandemic and broaden vaccine coverage.”
In a statement issued on November 28, 2022, Bharat Biotech claimed that phase-3 trials for use of the vaccine as a primary jab for knowing the “safety and immunogenicity” was conducted among 3,100 participants at 14 sites across India. Similarly, the company also said, the trials for knowing “safety and immunogenicity” of the vaccine as a ‘booster dose’ was conducted among 875 participants at nine sites across India.
However, there is no data in the public domain on these trials. “Product development data will be submitted to peer reviewed journals. It will be made available in public domain soon,” Bharat Biotech’s November 28 statement said.
Incidentally, the company had been quoted as giving the same statement – that data will be submitted to journals soon – in September as well.
While giving its nod to the vaccine, the CDSCO did not made any data public. Nor there are any details available in the Subject Expert Committee minutes of meeting section of its website.
(With PTI inputs)
