New Delhi: Hyderabad-based Bharat Biotech has sought approval from the Drug Controller General of India (DCGI) to conduct a Phase-3 study of its intra-nasal Covid-19 vaccine as a booster dose on participants vaccinated with Covishield or Covaxin, PTI reported.
This comes as several rich nations are rushing to deploy Covid-19 booster shots to bolster people's protection against the Omicron coronavirus variant.
In August, Bharat Biotech had received approval to conduct phase 2 trials of its intra-nasal vaccine BBV154. BBV154 is an intranasal replication-deficient chimpanzee adenovirus SARS-CoV-2 vectored vaccine.
In the Phase 1 trial, the vaccine, administered to healthy volunteers, was well tolerated and no serious adverse events were found, the PTI report said.
Pre-clinical toxicity studies showed the vaccine to be safe, immunogenic and well-tolerated. The vaccine was able to elicit a high level of neutralising antibodies in animal studies, it said.
Opened Vials Of Covaxin Can Be Stored For Up To 28 Days
Bharat Biotech said that opened vials of Covaxin could be stored at 2-8 degrees Celsius for up to 28 days.
While highlighting its 28 days open vial policy, Bharat Biotech said, "Health care workers do not have to worry about opening a vial and its wastage. If patients are not available, they can simply store the opened vial at 2 to 8°C, and use it the next day or store it for up to 28 days."
The firm stated that the extension of Covaxin's shelf life up to 12 months from the date of manufacturing was recently approved by the Central Drugs Standard Control Organisation. It said that Covaxin had been approved for use under the 28-day multi-dose vial policy by WHO as well.
India Not Considering Booster Doses For Now
According to a Reuters report last month, India is not contemplating authorising booster doses because many people in the nation have been naturally infected and the government feels that two vaccine doses are adequate protection for the time being.
Around 87 per cent of India's adult population, estimated at 939 million people, have been administered at least one dose, with 54 per cent receiving both. Immunisations for people under the age of 18 have not yet begun.
(With inputs from Agencies)