Hyderabad 15 August : The manufacturer of vaccines Bharat Biotech announced on Monday that its intranasal vaccine against Covid-19 has been found to be safe, well tolerated and immune-genic in the subjects in controlled clinical studies. The Hyderabad-based company has completed the clinical trials for phase III as well as booster doses of BBV154 (intranasal vaccine).
“On this Independence Day, we are pleased to announce the successful completion of clinical tests for the BBV154 intranasal vaccination.We remain committed and focused on product development and innovation and this is another accomplishment for our multidisciplinary teams at Bharat Biotech,” said Suchitra K.Ella Joint Managing Director, Bharat Biotech.
“If approved this intranasal vaccine is approved, it will allow for easier deployment in large-scale vaccination campaigns with easy-to-use formulation as well as delivery system.
Vectored vaccines can also speed up the creation of specific vaccines in response to new varieties of concerns,” she said.
Two separate and concurrent clinical trials were conducted to test BBV154 as a first dose (two-dose) schedule as well as the booster dose that is heterologous for patients who had previously received two doses of the two commonly administered Covid vaccines in India.
The results of both Phase III human clinical trials have been submitted for approval by the national regulators, the company announced.
BBV154 (intranasal vaccine) is a recombinant replication-deficient adenovirus vectored vaccine with a pre-fusion stabilized spike protein.The vaccine candidate was tested earlier in the phase I and II clinical trials with excellent results.
Primary Phase III trials of the dose schedule were conducted to determine safety and the ability to induce immunogenicity in approximately 3,100 subjects and then compared with Covaxin.
These trials took place in 14 trial locations across India.
Studies on booster doses that were heterologous were conducted to test safety and the ability to fight infection in approximately 875 subjects which included an additional dose (3rd dose) of BBV154 intranasal vaccine was administered to participants who had been previously vaccine-free with approved Covid vaccines.
The studies took place in nine trial locations across India.
As an intranasal vaccine BBV154 could create local antibodies in the upper respiratory tract that could help to reduce transmission and infection.More studies are in the pipeline according to the vaccine maker.
BBV154 was specifically developed to enable the intranasal delivery.Additionally the nasal delivery method has been developed and designed to be efficient in low – and middle-income countries.
The intranasal was created in collaboration with Washington University St Louis which has developed and designed the vectored adenoviral recombinant constructs and examined the constructs in preclinical studies to determine their efficacy.
Development of products in the area of preclinical safety assessment and large-scale scale manufacturing scale-up formulation and delivery device development including human clinical studies, was conducted by Bharat Biotech.The Government of India partly funded clinical trials and product development via the Department of Biotechnology’s Covid Suraksha program.
BBV154 remains stable at 2-8 AoC to make it easy to store and distribute.Bharat Biotech has established manufacturing facilities of a large size at multiple locations across India which include Gujarat, Karnataka, Maharashtra and Telangana, with operations pan India.
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