New Delhi: An expert panel of the drug regulator CDSCO recommended granting permission for conducting phase 1 clinical trials of an intranasal COVID-19 vaccine, officials said on Tuesday.
The COVID-19 vaccine developed by Bharat Biotech is being touted as a game changer in the fight against novel coronavirus infection.
Just one drop of vaccine in each of the nostrils is sufficient and to administer the dose one doesn`t require trained healthcare workers. It eliminates needle-associated risks, is suitable for children and adults.
The Hyderabad-based pharma sought permission from the Drugs Controller General of India (DCGI) to conduct phase 1 and phase 2 clinical trials of the intranasal vaccine. The matter was referred to the subject expert committee of the CDSCO, who on Tuesday deliberated on the matter and recommended granting permission for phase 1 clinical trial.
“Based on the safety and immunogenicity data of the phase 1 clinical trial, the company would be given permission for conducting phase 2 clinical trial,” an official was quoted as saying by PTI.
Earlier, NITI Aayog member (health) V K Paul confirmed that a nasal vaccine candidate had been identified.
“It looks like an exciting development because potentially, yes, this route can be used to deliver the safe antigen against which an immunological response would happen. If it does work it can be a game-changer because it is so easy to use and we look forward to this development. Such a possibility is very plausible scientifically,” Paul said told reporters in a press conference.
Krishna Ella, the chairman of Bharat Biotech, had earlier said the company is focusing on the intranasal vaccine as existing vaccines require two-dose intramuscular injections and a country like India needs 2.6 billion syringes and needles which may add to pollution.