In a significant development, Bharat Biotech has sought Drug Controller General India’s (DCGI) approval to conduct nasal COVID-19 vaccine trials in India. The company has developed a new single-dose nasal COVID-19 vaccine in a partnership with Washington University in St Louis, USA. There are no intra-nasal COVID-19 vaccines under trial in India at the moment.
“Nasal vaccine may be the best choice for India because it will be a 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 and you are done” said Dr Krishna Ella, Chairman and Managing Director of Bharat Biotech.
The nasal vaccine is different from two intramuscular vaccines which recently got approval, as it is non-invasive, needle-free, doesn’t require trained healthcare workers, eliminates needle-associated risks, suits children and adults and has scalable manufacturing. Recently the two vaccines namely Covaxin and Covishield got approval for use in the country.
“We are all set to host the trials for the nasal Covaxin in the next few days. Enough scientific evidence is available that vaccines given through nasal route are more effective than injected ones” said DrChandrashekarGillurkar, Director, GillurkarMultispeciality Hospital, Nagpur.
“At the moment, four vaccines are undergoing phase 1 and 2 of nasal vaccine trials in the world. It can be a game changer but it all depends on whether it is safe and effective,” said Lalit Kant, former head of epidemiology and infectious diseases at the Indian Council of Medical Research (ICMR).
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.
Presently, Bharat Biotech is working on two intranasal vaccines. One with US-based vaccine maker FluGen and scientists from the University of Wisconsin Madison and the other with the University of Washington School of Medicine.
India Science Wire