Bharat Biotech’s needle-free intranasal vaccine against Covid-19 has been granted approval for emergency use in India, Union health minister Mansukh Mandaviya said on Tuesday. The new vaccine can be delivered through the nasal route, making it a safer and more effective option.
“Big Boost to India’s Fight Against COVID-19! Bharat Biotech’s ChAd36-SARS-CoV-S COVID-19 (Chimpanzee Adenovirus Vectored) recombinant nasal vaccine approved by @CDSCO_INDIA_INF for primary immunization against COVID-19 in 18+ age group for restricted use in emergency situation,” the minister tweeted.
“This step will further strengthen our collective fight against the pandemic. India has harnessed its science, R&D, and human resources in the fight against COVID-19 under PM @NarendraModi Ji’s leadership. With the science-driven approach & Sabka Prayas, we will defeat COVID-19,” he said in another tweet.
The logic behind intranasal route platform is that both influenza and Covid-19 follow the same pattern of infection- nose and mouth route into the lungs, which is why having mucosal immunity is important and the vaccine will also use the same nasal (drop) route.
Highlighting the benefits of the intranasal vaccine, the company said that by virtue of being non-invasive (needle-free), it is easy to administer and does not require trained health care workers; eliminates needle-associated risks (injuries and infections); has higher compliance (ideally suits for children’s and adults); and is scalable as far as manufacturing is concerned.
{{/usCountry}}Highlighting the benefits of the intranasal vaccine, the company said that by virtue of being non-invasive (needle-free), it is easy to administer and does not require trained health care workers; eliminates needle-associated risks (injuries and infections); has higher compliance (ideally suits for children’s and adults); and is scalable as far as manufacturing is concerned.
{{/usCountry}}In September, 2020, Bharat Biotech inked a licensing agreement with Washington University School of Medicine in St. Louis for a novel chimp- adenovirus, single dose intranasal vaccine for Covid-19.
In January last year, the company applied to the central drugs regulator to allow it to start clinical trials in humans.
The phase 3 trial was conducted at nine sites across the country with almost 900 participants in all, according to people familiar with the matter.
The trial sites included All India Institute of Medical Sciences, Delhi and Patna (Bihar), Aatman Hopsital, Ahmedabad (Gujarat), PGIMS, Rohtak (Haryana), and Prakhar Hospital, Kanpur, and Rana Hospital, Gorakhpur (Uttar Pradesh).