Bharat Biotech Submits Phase 3 clinical trial data of intranasal vaccine as booster shot

Amid the ongoing scare of the ‘highly transmissible’ Omicron variant, Hyderabad based Bharat Biotech has submitted the phase III clinical trial data to the Drugs Controller General of India (DCGI) to get approval for the booster dose of their intranasal COVID-19 vaccine named 'BBV154,' as per sources. 

Bharat Biotech has developed the booster Intranasal COVID-19 vaccine, which can be taken by people who have been previously vaccinated by either Covaxin or Covishield. The company is hoping for early approval of the vaccine given the fast spread of the B.1.1.529 variant.

Bharat Biotech submits Phase III clinical trial data of intranasal vaccine to DCGI

As per the company, that has previously developed inactivated whole virion COVID vaccine - ‘Covaxin,’ in association with ICMR and NIV, its intra-nasal vaccine stimulates a broad immune response – neutralizing IgG, mucosal IgA, and T cell responses. It further explained that the intranasal vaccine ‘generates immune responses at the site of infection (in the nasal mucosa) – essential for blocking both infection and transmission of COVID-19.’

The manufacturers also believe that this intranasal vaccine is highly suitable for children as well as adults. The Pharma company emphasised that the nasal route has excellent potential for vaccination due to the organized immune systems of the nasal mucosa. The vaccine can be easily administered because it is needle-free and does not require trained health care workers.
 

Moderna announces booster dose of current vaccine effective against Omicron

 In a related development, Moderna Inc on Monday announced that its current version of the vaccine would continue to be the company’s ‘first line of defence’ against the recently detected Omicron variant of COVID since its booster dose of vaccine appeared to be effective against the ‘highly mutated’ variant. The ‘highly transmissible’ variant was neutralised by the current Moderna vaccine- mRNA-1273. The pharma company had emphasised that the decision was taken, keeping in mind how quickly the B.1.1.529 variant was spreading.

 The significant development comes at a time when more than 36 countries across the globe approved the administration of booster doses for the adult population as the SARS-CoV-2 virus continues to mutate into newer variants. Amid the rising demands by the opposition members and Chief Ministers of various states and some other experts, the central government is pondering over the need for booster doses in India.

To date, India has recorded 161 Omicron cases and the country has vaccinated more than 60% of the population with more than 138 crore doses of COVID Vaccine administered.

Image: Bharat Biotech/ AP/ PTI