NEW DELHI: India's first intranasal Covid vaccine was approved by the Union Health Ministry and will be available on CoWIN from Friday onwards, officials said, as India steps up surveillance in the wake of Covid surge globally.
The move came following a high-level review meeting by Prime Minister Narendra Modi on Thursday with ministers and senior officials, in which he urged people to wear masks in crowded places while also directing officials to strengthen surveillance measures, especially at international airports.
Bharat Biotech's needle-free vaccine - BBV154 - received approval from the Drugs Controller General of India in November for restricted use in emergencies for those above 18 as a heterologous booster dose. The vaccine will be available in private centres.
The vaccine, iNCOVACC, is the world’s first intranasal vaccine for Covid to receive approval for the primary 2-dose schedule and heterologous booster dose, the Hyderabad-based company said earlier.
“BBV154 has proven to be safe, well-tolerated and immunogenic in subjects in controlled clinical trials," the statement said.
Two separate and simultaneous clinical trials were conducted to evaluate BBV154 as a primary dose (2-dose) schedule; and a heterologous booster dose for subjects who have previously received two doses of the two commonly administered covid vaccines in India.
The trials for the primary dose were conducted among 3100 subjects in 14 trial sites across India, while the heterologous booster dose was done at nine trial sites among 875 subjects.
iNCOVACC is stable at 2-8°C for easy storage and distribution. Bharat Biotech has established extensive manufacturing capabilities at multiple sites across India, including in Gujarat, Karnataka, Maharashtra and Telangana.
India has administered as many as 22.35 crore booster doses, 27 per cent of the total eligible population. The first and second doses' coverage currently stands at 97 per cent and 90 per cent, respectively, according to Health Ministry data.