The slow-paced follow-up action on the part of the government is delaying the rollout of Bharat Biotech’s intranasal Covid-19 vaccine, iNcovacc. The world’s first intranasal Covid-19 vaccine had received the government nod earlier this month under restricted use in emergency situations, for ages 18 and above, for primary two-dose schedule.

The Hyderabad-based company, which also makes the intramuscular Covid-19 vaccine, Covaxin, has set up large manufacturing capabilities for the intranasal vaccine across the country, in Gujarat, Karnataka, Maharashtra and Telangana.

Not on CoWIN yet

According to sources, the company is ‘fully ready’ to roll out the vaccine but needs some facilitating actions from the government’s side to translate the approval into the actual rollout. For it to be included in the primary vaccination programme, the government needs to place the order and fix prices.

Additionally, for its sale under restricted use, the vaccine has to appear in the CoWIN app, which has not been facilitated yet.

Approval process

“Further, as most people have already received the primary dose, approval for booster doses will make the vaccine more relevant,” said a senior doctor at a city-based corporate hospital.

When contacted, a senior official of the Drugs Controller General of India (DCGI) told businessline that the process of approval for booster doses is currently on. “The approval is different from the process of procurement and making it available in the market. Different departments are involved in this,” he added.

iNCovacc is a recombinant replication deficient adenovirus vectored vaccine with a pre-fusion stabilised spike protein. This vaccine candidate was evaluated in phase I, II and III clinical trials with “successful results”, according to the company.

Heterologous booster dose studies were conducted for safety and immunogenicity in over 875 subjects, with intranasal vaccine administered post two doses of the commonly administered Covid-19 vaccines. It was developed in association with the Washington University in St. Louis.