Govt approves Bharat Bio’s intra-nasal vax against covid

India on Tuesday gave emergency approval to the world’s second covid-19 vaccine that can be delivered as nasal drops. The vaccine was jointly developed by Covaxin-maker Bharat Biotech and Washington University St. Louis.

Drugs Controller General of India (DCGI) V.G. Somani approved restricted emergency use of the vaccine iNCOVACC (BBV154) for primary two-dose schedule for people above 18 years of age.

Dr. Krishna Ella, chairman and managing director of Bharat Biotech, termed the vaccine a “global game changer” in intra-nasal vaccine technology and delivery systems.

“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,” Ella said, expressing gratitude to the health ministry, the Central Drugs Standard Control Organisation, the government’s biotechnology department and Washington University St. Louis for support and guidance.

Hyderabad-based Bharat Biotech has established large manufacturing capabilities for the vaccine in Gujarat, Karnataka, Maharashtra and Telangana.

With the receipt of approval, the product will be launched and made available for use across the country. Trials for the vaccine were conducted at nine sites across India. The vaccine is stable at 2-8°C, enabling easy storage and distribution.

“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 an emergency situation,” Union health minister Mansukh Mandaviya tweeted.

On Monday, China became the first country to approve an inhaled version of a covid-19 vaccine made by CanSino Biologics Inc.

Delivering a vaccine in the form of nasal drops is expected to make it more cost-effective in low- and middle-income countries. Nasal vaccines stimulate antibodies in airway passages, making them effective against viruses that attack respiratory tissues. They can be self-administered, easing pressure on healthcare personnel and making them more acceptable to people who fear needles.

A recent paper published by Bharat Biotech claimed its intra-nasal covid-19 vaccine is safe, well-tolerated, and immunogenic for primary dose, as well as for heterologous booster dose, as per the results of phase 3 trials conducted in 3,100 subjects across sites in India.

Heterologous dose refers to a second or third dose vaccine which is different from the first dose. The vaccine candidate showed successful results in phase I, II and III clinical trials.

“Heterologous booster dose studies were conducted for safety and immunogenicity in approx. 875 subjects, with BBV154 intra-nasal vaccine, administered post two doses of the two commonly administered covid-19 vaccines,” the company said.

“iNCOVACC was evaluated to determine its impact on safety. An evaluation was also carried out for the ability of iNCOVACC to elicit long-term memory T and B cell responses against the ancestral and omicron variants,” the company said, adding that reactogenic events and adverse events that were documented during the trial were highly comparable to published data from other covid-19 vaccines.

The intra-nasal nature also enables faster development of variant-specific vaccines and easy delivery that enables mass immunization to protect from emerging variants of concern.

So far, India has two vaccines —Covishield, manufactured by Serum Institute, and Covaxin—approved for manufacture for sale or distribution in the country; while Sputnik-V, ZyCoV-D, Corbevax, Covovax and Sputnik Light are under restricted emergency use.