Bharat Biotech’s intranasal vaccine gets DCGI nod for emergency use

covid-19

Bharat Biotech’s first intranasal COVID-19 vaccine received approval from the Drug Controller General of India on Tuesday for the 18+ age range for restricted usage in emergency scenarios.

Union Health Minister Mansukh Mandaviya described the accomplishments as a “big boost to India’s fight against COVID-19.”

“Big Boost to India’s Fight Against COVID-19! Bharat Biotech’s ChAd36-SARS-CoV-S COVID-19 (Chimpanzee Adenovirus Vectored) recombinant nasal vaccine approved by @CDSCO_INDIA_INF for primary immunization against COVID-19 in 18+ age group for restricted use in emergency situation,” Mandaviya tweeted.

In the subsequent tweet he said, “This step will further strengthen our collective fight against the pandemic.

“India has harnessed its science, R&D, and human resources in the fight against COVID-19 under PM @NarendraModi Ji’s leadership. With the science-driven approach & Sabka Prayas, we will defeat COVID-19”, he said.

BBV154 was developed in partnership with Washington University St Louis, which had designed and developed the recombinant adenoviral vectored constructs and evaluated them in preclinical studies for efficacy. Product development related to preclinical safety evaluation, large-scale manufacturing scale-up, formulation, and delivery device development, including human clinical trials, were conducted by Bharat Biotech. The Government of India partly funded product development and clinical trials through the Department of Biotechnology’s, COVID Suraksha program.

Two separate and simultaneous clinical trials were conducted to evaluate BBV154 as a primary dose (2-dose) schedule; and a heterologous booster dose for subjects who have previously received 2 doses of the two commonly administered covid vaccines in India.

Data from both Phase III human clinical trials have been submitted for approval to National Regulatory Authorities.

Primary dose schedule phase III trials were conducted for safety, and immunogenicity in 3100 subjects, and compared with COVAXINO. The trials were conducted in 14 trial sites across India.

Heterologous booster dose studies were conducted for safety and immunogenicity in ~875 subjects, where a booster dose (3rd dose) of BBV154 intranasal vaccine was administered to study participants who were previously vaccinated with licensed COVID vaccines. The trials were conducted in 9 trial sites across India.

Being an intranasal vaccine, BBV154 may produce local antibodies in the upper respiratory tract which may provide the potential to reduce infection and transmission. Further studies are being planned.

At the start of the COVID pandemic, Bharat Biotech commenced work on 4 platform technologies, the Vero cell inactivated platform, and the adenoviral vector platform have been developed.

“Vectored vaccines also enable faster development of targeted vaccines in response to emerging variants of concern. We hereby thank the volunteers, principal investigators, and clinical trial personnel for all their efforts,” Ella said.