DGCA approves Bharat Biotech’s intranasal COVID-19 vaccine, India second in world
In a significant development, Bharat Biotech’s intranasal COVID-19 vaccine iNCOVACC has been granted the Indian drug regulator’s approval to be used as a heterologous booster (a mix-and-match dose after the primary dose.), on November 28 (Monday).
iNCOVACC has received the nob for restricted use in emergencies on those aged 18 years and above, for heterologous booster after two doses of either Covidshield or Covaxin. With that development, iNCOVACC became India’s second approved COVID-19 vaccine to be used as a mix-and-match booster.
The Drugs Controller General of India (GCI) approved the intranasal COVID-19 vaccine in September, becoming the second intranasal COVID-19 vaccine globally, the first being China’s CanSino Bilogics vaccine.
Earlier, Krishna Ella, chairman and managing director of Bharat Biotech, admitted that there is hardly any demand for the iNCOVACC as almost everyone in the country has taken a single shot of the COVID-19 vaccine.
“Despite lack of demand for COVID-19 vaccines in the market, we developed the vaccine to ensure that we are well prepared with platform technologies for future need,” she said in September.
According to Bharat Biotech, the study for booster dose was conducted for safety and immunogenicity on around 875 subjects.
The company claims that iNCOVACC is the only intranasal vaccine for COVID, which received approval for the primary two-dose schedule and a heterologous booster.
Notably, the intranasal COVID-19 vaccine was developed in partnership with Washington University-St Louis, which also pioneered the development of the recombinant adenoviral-vectored constructs and studied it in preclinical studies for efficacy.
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Additionally, the GoI partly funded product development and clinical trials of the intranasal COVID-19 vaccine, through the Department of Biotechnology’s Covid Suraksha programme.
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