THE NATIONAL drug regulator has given the green signal to the country's first intra-nasal Covid vaccine for emergency use in adults, the Government said on Tuesday. Called iNCOVACC and manufactured by Bharat Biotech, the company behind Covaxin, the new vaccine has been approved for primary immunisation — it can be administered only to the unimmunised. Officials said those who have already received the first and second doses of other vaccines will not be eligible to get iNCOVACC as the “precaution” third dose. Yet, Tuesday's approval by the Central Drugs Standard Control Organisation (CDSCO) is significant: iNCOVACC will be delivered through the nasal route, which would potentially trigger an immune response in the mucosal membrane. It has been designed to not only protect against infection but also reduce transmission of the virus. Taking to Twitter, Union Health Minister Mansukh Mandaviya posted: “Big Boost to India's Fight Against COVID-19! Bharat Biotech's ChAd36-SARS-CoV-S COVID-19 (Chimpanzee Adenovirus Vectored) recombinant nasal vaccine approved by @CDSCO_INDIA_INF for primary immunization against COVID-19 in 18+ age group for restricted use in emergency situation.” The vaccine uses a modified chimpanzee adenovirus, which cannot replicate in the body, to carry the Covid spike protein to induce immunity. Big Boost to India's Fight Against COVID-19! Bharat Biotech's ChAd36-SARS-CoV-S COVID-19 (Chimpanzee Adenovirus Vectored) recombinant nasal vaccine approved by @CDSCO_INDIA_INF for primary immunization against COVID-19 in 18+ age group for restricted use in emergency situation. — Dr Mansukh Mandaviya (@mansukhmandviya) September 6, 2022 Bharat Biotech developed the new vaccine in partnership with Washington University-St Louis. While the US university developed the vector that carries the spike protein and evaluated it in pre-clinical studies, Bharat Biotech is handling product development and manufacturing. The development of the vaccine was partly funded by the Department of Biotechnology’s Covid Suraksha programme. “iNCOVACC has the double benefit of enabling faster development of variant specific vaccines and easy nasal delivery that enables mass immunization to protect from emerging variants of concern,” Bharat Biotech said in a statement. “Being an intranasal vaccine, BBV154 (iNCOVACC) may produce local antibodies in the upper respiratory tract, which may provide the potential to reduce infection and transmission.” Stable at 2-8°C, which makes it easy to store and distribute, the vaccine will be manufactured at multiple sites in the country, including Gujarat, Karnataka, Maharashtra and Telangana. Delivered through a nasal drop, the vaccine will do away with the need for needles and syringes that are currently required for all available Covid vaccines. It will also reduce dependence on trained personnel to administer the shots. According to Bharat Biotech, the vaccine was found to be “safe, well-tolerated, and immunogenic” when compared to its own Covaxin in a phase III trial of nearly 3,100 participants across 14 sites in India. The company also conducted a trial with 875 participants to see whether the vaccine may be used as a booster in those who received Covaxin or Covishield as their primary vaccine. India has, so far, administered a total of 213 crore vaccine doses, of which 102 crore are first doses, according to the Government’s CoWIN portal. Nearly 98 per cent of adults in India had received at least one dose by the third week of July, according to the Union Health Ministry. Currently, Covishield, Covaxin and Corbevax are part of the Government’s Covid immunisation drive while vaccines like Covovax and Sputnik are available at private centres. Dr Krishna Ella, chairman and managing director of Bharat Biotech, said, “We are proud to announce the approval of iNCOVACC, a global game changer in intra nasal vaccines technology. Despite the lack of demand for COVID-19 vaccines, we continued product development in intra nasal vaccines to ensure that we are well prepared with platform technologies for future infectious diseases.” (With ENS/Pune)
