THE NATIONAL medicines regulator has given the green light to the country’s first intranasal Covid vaccine for emergency use in adults, the government said on Tuesday. The new vaccine, called iNCOVACC and made by Bharat Biotech, the company behind Covaxin, has been approved for primary immunization – it can only be given to the unimmunized.
Officials said those who have already received the first and second doses of other vaccines will not be eligible to receive iNCOVACC as a “preventive” third dose. However, Tuesday’s Central Drugs Standard Control Organization (CDSCO) approval is significant: iNCOVACC will be administered via the nasal route, potentially triggering an immune response in the mucosal membrane. It was designed to not only protect against infection, but also limit the transmission of the virus.
Union Health Minister Mansukh Mandaviya tweeted, “Big support 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 the 18+ age group for limited use in emergency situations.
The vaccine uses a modified chimpanzee adenovirus that cannot replicate in the body to carry the Covid spike protein to induce immunity Bharat Biotech has developed a new vaccine in collaboration with Washington University-St Louis. While the American university developed the vector that carries the spike protein and evaluated it in preclinical studies, Bharat Biotech is involved in product development and manufacturing. The development of the vaccine was partially funded by the Ministry of Biotechnology’s Covid Suraksha programme.
“iNCOVACC has the dual advantage of enabling faster development of variant-specific vaccines and ease of nasal delivery that enables mass immunization to protect against emerging variants of concern,” Bharat Biotech said in a statement. “As an intranasal vaccine, BBV154 (iNCOVACC) can produce local antibodies in the upper respiratory tract that may provide potential to reduce infection and transmission.”
The vaccine is stable at 2-8°C, which facilitates storage and distribution, and will be manufactured at several locations in the country, including Gujarat, Karnataka, Maharashtra and Telangana. Administered by nasal drop, the vaccine will eliminate the need for needles and syringes currently required for all available Covid vaccines. Reliance on trained personnel to administer shots will also be reduced.
According to Bharat Biotech, the vaccine was found to be “safe, well-tolerated and immunogenic” compared to its own Covaxin in a phase III study with nearly 3,100 participants at 14 sites in India. The company also conducted a study with 875 participants to see if the vaccine could 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 million doses of the vaccine, of which 102 million are first doses, according to the government portal CoWIN. Nearly 98 percent 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 immunization efforts, while vaccines such as Covovax and Sputnik are available in private centers. Dr. Krishna Ella, Chairman and Chief Executive Officer of Bharat Biotech said, “We are proud to announce the approval of iNCOVACC, a global breakthrough in intranasal vaccine technology. Despite the lack of demand for COVID-19 vaccines, we continued to develop intranasal vaccine products to ensure we are well prepared with platform technologies for future infectious diseases.
