SEC approves Phase 1 trial of Bharat Biotech's COVID-19 nasal vaccine

Bharat Biotech's intranasal vaccine for COVID-19 has received preliminary approval for Phase I clinical trials. The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) on Tuesday recommended Bharat Biotech's intranasal vaccine for conducting phase 1 clinical trials for the coronavirus. The final decision will be taken by the Drugs Controller General of India.

Hyderabad-based Bharat Biotech has already received the Drugs Controller General of India's nod for restricted emergency use of India's first indigenously-made intramuscular coronavirus vaccine, Covaxin, on January 3, though it is still conducting Phase 3 trials in India. It has successfully completed enrollment of 25,800 volunteers for the Phase 3 trials of Covaxin.

The company has tied up with Washington University School of Medicine in St Louis, US, for developing the novel "chimp-adenovirus" (Chimpanzee adenovirus), a single dose intranasal vaccine for COVID-19. The intranasal vaccine is touted to be 'super-efficient' and a game-changer as it can significantly impact the overall cost of a vaccination drive.

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There are no intranasal COVID-19 vaccines under trial in India at the moment. The nasal vaccine is different from the intramuscular vaccine as it is non-invasive and needle-free which eliminates needle-associated risks and is suitable for children and adults. Besides, it does not require highly trained healthcare workers for vaccination.

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Krishna Ella, Chairman of Bharat Biotech had earlier said the company is focusing on the intranasal vaccine as the existing vaccines require two dose intramuscular injections and a country like India needs 2.6 billion syringes and needles which may add up to pollution.

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An intranasal vaccine will not only be simple to administer but reduce the use of medical consumables such as needles, syringes, etc., significantly impacting the overall cost of a vaccination drive, he had said.

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Bharat Biotech, upon obtaining required regulatory approval, will pursue further stages of clinical trials in India and undertake large scale manufacture of the vaccine at its GMP (good manufacturing practice) facility located in Genome Valley in Hyderabad, the company had earlier said.