Bharat Biotech's nasal vaccine to be rolled out as booster dose, likely to be available on Cowin by next week

New Delhi, Dec 22: Amid a Covid-19 boom in China and several other countries, Bharat Biotech's needle-free intranasal Covid vaccine will now be available as a booster dose for all those above the age of 18 years.

Going by the reports, intranasal COVID-19 vaccine iNCOVACC will be introduced on Co-WIN by next week to enable the recipients of the jab to get vaccination certificate. The expert committee which approves vaccines has given a nod to the nassal vaccine today.

The nasal vaccine, BBV154 or Incovacc, had last month received approval from the Central Drugs Standard Control Organisation (CDSCO) under Restricted Use in Emergency Situation for ages 18 and above in India, for heterologous booster doses. The vaccine was developed in partnership with Washington University, St Louis, which had designed and developed the recombinant adenoviral vectored construct and evaluated in pre-clinical studies for efficacy.

Currently Bharat Biotech's Covaxin, Serum Institute's Covishield and Covovax, Russian Sputink V and Biological E Ltd's Corbevax are listed in the CoWin portal. The vaccine maker on September 6 announced that its iNCOVACC (BBV154), world's first intranasal COVID-19 vaccine has received approval from Drugs Controller General of India under Restricted Use in Emergency Situation for ages 18 and above.

A press release from the vaccine maker said iNCOVACC, a recombinant replication deficient adenovirus vectored vaccine with a pre-fusion stabilised SARS-CoV-2 spike protein, is the world's first intranasal vaccine to receive both primary series and heterologous booster approval.

The vaccine candidate underwent Phases I, II and III clinical trials with successful results and has been specifically formulated to allow intranasal delivery through nasal drops. Phase-III trials were conducted for safety, immunogenicity in approximately 3,100 subjects, at 14 trial sites across India, it said.

The nasal delivery system has been designed and developed to be cost-effective in low- and middle-income countries, Bharat Biotech said.

The vaccine had earlier received approval under Restricted Use in Emergency Situation for ages 18 and above for primary two-dose schedule. Phase-III trials were conducted for safety, immunogenicity in approximately 3,100 subjects, at 14 trial sites across India.

Krishna Ella, Chairman & Managing Director, Bharat Biotech, said: "Despite the lack of demand for COVID vaccines, we continued product development in intranasal vaccines to ensure that we are well-prepared with platform technologies for future infectious diseases... We have also initiated development of variant-specific vaccines for COVID for future preparedness."

Rajesh S Gokhale, Secretary, DBT, and Chairperson, BIRAC, said, "The DCGI's approval of Bharat Biotech's intranasal vaccine iNCOVACC (BBV154) to be used as a heterologous booster dose against currently available COVID-19 vaccines is a moment of great pride for our country. This move will further strengthen our collective fight against the pandemic and broaden vaccine coverage."