Despite approval, Bharat Bio’s intranasal Covid-19 vaccine has yet to hit the market

The slow follow-up action by 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’s nod earlier this month under limited emergency use, for ages 18 and above, for primary two-dose schedule.

The Hyderabad-based company, which also manufactures the intramuscular Covid-19 vaccine, Covaxin, has set up large manufacturing capacities 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 facilitative action from the government to translate the approval into actual rollout. In order for it to be included in the primary vaccination programme, the government must order and set prices.

In addition, the vaccine for sale under restricted use must be displayed in the CoWIN app, which has not yet been facilitated.

Approval process

“Furthermore, since most people have already received the primary dose, approval of booster doses will make the vaccine more relevant,” said a senior physician at a city-based corporate hospital.

When contacted, a senior official of the Drug Controller General of India (DCGI) said. business line that the approval process for booster doses is underway. “The approval is different from the process of procurement and making it available on the market. Various departments are involved in this,” he added.

iNCovacc is a recombinant replication-deficient adenovirus vectored vaccine with a prefusion stabilized 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 after two doses of the commonly administered Covid-19 vaccines. It was developed in collaboration with Washington University in St. Louis.

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