Vaccine maker Bharat Biotech has sought regulatory nod to conduct Phase-3 trials of its nasal Covid-19 vaccine that can be used as a booster shot for those vaccinated with Covaxin and Covishield.
Bharat Biotech’s nasal vaccine, BBV154, has already completed Phase-2 trials with Covaxin. The proposed Ph-3 trials will cover those who have been administered with any two doses of the Covid-19 vaccine.
Company sources said the intranasal vaccine would be easier to administer as a booster dose in mass vaccination campaigns as the nasal route is non-invasive and needle-free and hence eliminates needle-associated risks. It is also considered ideal for children. Company sources said its manufacturing is scalable and could meet global demand.
Meanwhile, the Central Drugs Standard Control Organisation (CDSCO) has approved the extension of Covaxin’s shelf life up to 12 months from the date of manufacture, the vaccine maker said in a press release. “This approval of shelf life extension is based on the availability of additional stability data, which was submitted to CDSCO. With the shelf life extension, hospitals can now utilise the stock which was nearing expiry and avoid vaccine wastage,” the company said.
Covaxin is approved for use under the 28-day multi-dose vial policy from the Drugs Controller General of India (DCGI) and the WHO Emergency Use Listing (WHO EUL).