The DCGI (Drug Controller General of India) on Friday has given its nod to Bharat Biotech to conduct the Phase-3 trials for its Coronavirus Intra-nasal vaccine (BBV154) as per the sources. The Phase-3 trials would be evaluating the nasal vaccine for both the 2-dose primary schedule and also to use it as a booster dose.
Most viruses enter the human body through the mucosa which is a wet squishy tissue-lined in the nose, mouth, lungs, and digestive tracts. This triggers a unique immune response from the cells and molecules located in the above-mentioned areas. According to the experts, an intranasal vaccine will act against the virus as soon as the virus tries to break the barrier of the body, making it much more effective than the intramuscular ones.
Most vaccines are jabbed into the upper arm of the person as far as the protection of people against pathogens that invade the airway is concerned. For viruses like the novel Coronavirus, an intramuscular shot is not the only available strategy.
The BBV154 or nasal covid vaccine has received approval for the conduction of Phase-3 of the clinical trials. This phase of the trials will be evaluating the nasal vaccine for the two-dose schedule and the booster dose schedule, the sources have revealed. The chairman of Bharat Biotech Krishna Ella said that the Intra-Nasal vaccine is easier to administer in mass vaccination drives and does not require the use of syringes and needles as well. It would impact the overall cost of the vaccination drive. He further stated that the nasal vaccine would not require trained healthcare personnel for its administration. It will aid in covering a larger area in a relatively short period for vaccination.
The trials by the vaccine manufacturer Bharat Biotech will be conducted across nine locations in the nation. The Hyderabad-based manufacturer had sought approval from the drug regulator last month for the Phase-3 trials. According to Bharat Biotech, the nasal vaccine or the BBV154 stimulates the immune responses at the site of infection which is the nose and will be very effective in blocking the transmission and infection of Coronavirus.
The approval has come after Covaxin, the vaccine developed by Bharat Biotech, and Covishield developed by the Serum Institute of India were cleared for sale in the market meaning that the two vaccines can now be bought from hospitals and clinics. Further details on this are awaited by the government.
Both the vaccine manufacturers, Bharat Biotech and Serum Institute of India had submitted the data of their respective ongoing clinical trials to the Drug Controller General of India, which was then approved for market sales after an SEC (Subject Matter Committee) on Coronavirus recommended the approval on January 19, 2022.
