Bharat Biotech seeks DCGI nod to conduct trials of nasal Covid-19 vaccine
Homegrown pharma major Bharat Biotech has sought Drug Controller General India’s (DCGI) approval to conduct nasal Covid-19 vaccine trials in India. The company had received ’emergency approval’ for its Covid-19 vaccine, Covaxin, on January 3, though it is still conducting phase-3 trials in India.
There are no intra-nasal COVID-19 vaccines under trial in India at the moment. The company has developed a new single-dose nasal COVID-19 vaccine in a partnership with Washington University in St Louis, USA, which is touted to be ‘super efficient’ and a game-changer.
Krishna Ella, Chairman and Managing Director of Bharat Biotech has said this nasal vaccine will revolutionise Indian vaccine making capabilities and help the country leapfrog along with Europe, the US and China.
In an exclusive interaction with BusinessToday.In, Ella said nasal vaccine may be the best choice for India because it will be single dose, easy to administer and super efficient. “You put one drop 0.1 ml in one nostril and 0.1 ml in the other one. You are done. Just one dose.”
A study in scientific journal Cell also says that animal studies on nasal vaccine – single dose intra-nasal ChAd vaccine – protects upper and lower respiratory tracts against SARS-CoV-2.
In monkeys, this vaccine has shown 100 per cent sterilising ability. Sterilising immunity can prevent infection and transmission, says Ella, adding the company’s nasal vaccine is quite effective in preventing both.
Bharat Biotech and Serum Institute of India are the only two companies in India that have received regulatory approval to use their Covid-19 vaccines under emergency approval.
Bharat Biotech has also been allowed to carry out trials on children above the age of 12 years. The company has completed its phase-1 and phase-2 human trials, wherein its coronavirus vaccine, which was already tested on children above the age of 12 years, was found to be safe.
The Hyderabad-based company is presently conducting phase-3 clinical trials with 26,000 volunteers. Thus far, the government has said the coronavirus vaccination drive is intended only for adults, but this approval gives hope that it can be extended entirely to children in the future if there is sufficient and satisfactory data available.