BackCovid-19: Bharat Biotech expects DCGI’s nod for nasal vaccine this month
Krishna Ella said that Bharat Biotech will be applying for licenses of nasal vaccine against Covid-19 disease and expecting a positive response in August this year.
PremiumBharat Biotech, Hyderabad-based vaccine manufacturer, is expecting the regulator's nod for its intranasal Covid-19 vaccine in August this year, informed Chairman and Managing Director of BBIL, Krishna Ella as quoted by news agency PTI.
He said that the vaccine manufacturing plant of BBIL (Bharat Biotech International Limited) in Gujarat's Ankleshwar is one of the two plants in the world that can manufacture monkeypox vaccine. BBIL's another plant is in Bavarian Nordic, Germany.
In a recently held event, Ella said that the drug development organization will be applying for licenses and expecting a positive response. "We know that by August this year, people would get the coronavirus vaccine, if everything goes well," he stated.
He informed that if any new variant comes, it will be easy to plug in quickly and move fast, hence the BBIL is optimistic that both injectable and nasal strategy will work protecting people's lives in the future.
The firm has completed all the clinical trials of this nasal vaccine with about 4,000 volunteers and no single case of side effect or adverse reaction reported so far, he added. The Drug Controller General of India (DCGI) gave its nod earlier for the clinical trial of intranasal vaccine as booster dose.
Separately, the regulator had also granted permission to Bharat Biotech to conduct phase-3 clinical trial at nine sites to compare the immunogenicity and safety of BBV-154 (intranasal) with Covaxin.
Ella clarified that any injectable vaccine only gives protection to the lower level of a body, while this nasal vaccine protects the whole body.
Earlier in January this year, Dr Sanjay Rai, AIIMS, Delhi told ANI, if the nasal vaccine is going to provide mucosal immunity, it would be a great achievement for human race. “No vaccine is completely effective in preventing infection. We are hoping this vaccine to provide mucosal immunity to prevent further infection," he said.
Dr Rai also said that the nasal vaccine could be a game-changer in the fight against the pandemic if it provides mucosal immunity.
DCGI's Subject Expert Committee (SEC) had granted 'in-principle approval to Bharat Biotech for the conduct of 'Phase III superiority study and Phase III booster dose study' for its intranasal Covid vaccine BBV154 earlier this year.
(With inputs from agencies)
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