New Delhi, Aug 15 : Hyderabad-based manufacturer of vaccines Bharat Biotech on Monday announced it had completed the clinical development phase 3 trials as well as booster doses of India’s first intranasal Covid vaccine -BBV154.BBV154. The manufacturer of the vaccine said that BBV154 (intra nasal vaccine) has been proven safe, well-tolerated and also immunogenic in the subjects in controlled clinical studies.
The BBV154 is a recombinant replication-deficient adenovirus vectored vaccine with a pre-fusion stabilized spike protein.
“This vaccine candidate has been tested earlier in the phase II and I clinical trials with excellent results.BBV154 is specifically designed to permit intranasal delivery.Additionally the nasal delivery method was designed and designed to be economical in low – and middle-income countries” said Bharat Biotech in an announcement.
Two distinct and simultaneous clinical trials were conducted to test BBV154 as a first dose (2-dose) schedule and also as a heterologous booster dose for those who had previously received two doses of the two most commonly given Covid vaccines in India it stated further.
The initial Phase III trials of the dose schedule were conducted to determine safety and the immunogenicity in about 3,100 participants and the results were compared with COVAXIN.These trials took place in 14 trial locations across India.
However the heterologous booster dose trials were conducted to determine safety and the ability to fight infection in around 875 subjects in which an additional dose (3d dose) of BBV154 intranasal vaccine was administered to participants who had been previously vaccine-free with licensed Covid vaccines, Bharat Biotech claimed in the statement.The studies took place in 9 trial locations across India.
“On this day, which is the 75th Independence Day, we are happy to announce the successful conclusion of clinical tests for the BBV154 intranasal vaccination.We remain focused and committed on product development and innovation This is yet another accomplishment by the multidisciplinary team at Bharat Biotech,” said Suchitra K.Ella Joint Managing Director of Bharat Biotech.
She added that if it’s accepted, the intranasal vaccination will allow for easier deployment in mass vaccination campaigns with easily administered formulation as well as a delivery device.
Vectored vaccines also facilitate the creation of specific vaccines in response to new variants of particular concern.
The results from both Phase III human clinical trials have been submitted for approval by the National Regulatory authorities.
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