JOIN USBiological E gets DCGI nod to conduct booster dose trials for Corbevax
Indigenous vaccine maker Biologocial E Limited’s Corbevax received the Drug Controller General of India's (DCGI) approval to conduct trials as booster shots, sources told ANI.
Bharat Biotech’s Covaxin also sought to conduct trials for booster doses after Prime Minister Narendra Modi announced the rollout of Covid-9 booster doses from January 10.
The Subject Expert Committee (SEC) granted Biological E the permission to conduct proposed phase three trials as Covid-19 'booster dose' on two conditions. The company is asked to study the administration of booster dose in two cohorts of six and nine months with age-wise stratification. Also, 50 per cent of subjects should be of high risk or comorbidity condition.
The company is required to extend safety follow-up of up to nine months after the administration of the booster dose.
Biological E plans to complete production at a rate of 75 million doses of its Covid-19 vaccine Corbevax per month, anticipating over 100 million doses per month from February 2022 which will enable it to deliver 300 million doses as promised to the Centre, the company said in a statement on Tuesday.
“Corbevax has completed two Phase III clinical trials involving more than 3,000 subjects between the ages of 18 and 80 at 33 study sites across India. The vaccine was found to be safe, well-tolerated and immunogenic," Mahima Datla, Managing Director, BE limited told PTI.
Corbevax is India's first indigenously developed protein sub-unit vaccine against the virus that received approval from the Drugs Controller General of India (DGCI).
(With PTI inputs)
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