Bharat Biotech won't rush nasal vaccine trials, seeks full approval for Covaxin

India's Bharat Biotech has sought full market approval for its COVID-19 vaccine, Covaxin, from the country’s drug regulator. The indigenous Covaxin was approved on January 3, 2021, in emergency-use authorization (EUA) mode and has been administered to millions of people across India, including children, reports The Pharma Letter’s local correspondent.

Approval was granted from January 3, 2022, for Covaxin to be administered to children over 12 years of age. About 30 million children have already been vaccinated.

Bharat Biotech’s Covaxin has also been exported to several counties through India’s Vaccine Maitri (friendship) program as well as commercially. The full market authorization for the vaccine will further help the company in exports.

In a meeting today, the subject expert committee of the Drugs Controller General of India is also considering Bharat Biotech’s application for its intranasal COVID-19 vaccine as a booster or a third dose. The company has proposed to use the vaccine as a booster dose in people already inoculated with Covaxin or Covishield.

Pointing out that many trials have failed globally on a nasal vaccine, Dr Krishna Ella, Bharat Biotech managing director, said the company will not rush through with the trials and that it would finish the trial properly.

Based on the novel adenovirus vector, BBV154 is an intranasal vaccine for COVID-19 which stimulates a broad immune response neutralizing IgG, mucosal IgA, and T cell responses, he said. Most importantly, it is effective for blocking both infection and transmission of the novel coronavirus.

The company has received encouraging results from a recent study conducted at Emory University. The booster shot of Covaxin neutralizes both Omicron and Delta variants, according to the study, with the company adding that 100% of the test serum samples showed neutralization of the Delta variant, and more than 90% of the samples showed neutralization of the Omicron variant.