A panel of the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) has assembled to debate the permission sought out by vaccine developer Bharat Biotech to begin clinical trials for its intranasal vaccine for COVID-19.
The Union Health Ministry on 19th January 2021 has identified Bharat Biotech as a nasal vaccine candidate and termed it as a “game-changer”. The ministry requested citizens to terminate hesitancy related to the vaccine and assured both the vaccines for Coronavirus are safe.
On 16th January 2021, after the Drugs Controller General of India’s nod for confined emergency use of India’s engineered COVID-19 vaccine, Bharat Biotech had applied to the drug regulator for permission to begin Phase 1 and 2 trials for the nasal vaccine.
Dr V. K. Paul, NITI Aayog member said at a press briefing, “A nasal vaccine has been identified. It has come for consideration for Phase 1 and 2 trials. If it works then it could be a game-changer.”
The nasal vaccine is quite distinct from the intramuscular vaccine which began supply on 16th January 2021 as it is non-invasive, needle-free which eliminates risks with the needle, doesn’t need trained healthcare workers, comfortable for children and adults and has increased manufacturing.
Bharat Biotech’s ‘BBV154’ – a novel adenovirus vectored intranasal vaccine for COVID-19 – will be managed at several locations, a source close to the development told IANS. This vaccine will be single-dosed in comparison to the double-dosed vaccine with a gap of 28 days.
According to the firm, an intranasal vaccine leads to a broad immune response at the place of infection, in the nasal mucosa, which is required for blocking both infection and transmission of the Coronavirus.
Public health experts trust that the intranasal vaccines for COVID-19, given through the nose rather than muscles, can be a possible game-changer in fighting the pandemic.
Pune-based Serum Institute of India and Codagenix Inc had reported that they have received regulatory approval in the U.K. to begin an early-stage trial of their single-dose, intranasal Coronavirus vaccine.
A health ministry official made a statement that the side-effects of taking the intramuscular vaccines that are being distributed are insignificant. “Data shows that we are in a comfortable situation and we would like to reassure you that the two COVID-19 vaccines are safe. We would like to reassure with the data we have seen that the two vaccines are safe. The vaccine hesitancy should end. How will we defeat the pandemic then,” he said.