Biological E gets DCGI nod to conduct trials of Corbevax as booster dose

New Delhi, Dec 29: The Hyderbad-based pharmaceutical company Biological E has got approval from the Drug Controller General of India (DCGI) to conduct phase 3 clinical trials of its COVID-19 vaccine Corbevax as a booster dose, sources informed news agency ANI.

The Subject Expert Committee (SEC) recommended granted permission to conduct proposed Phase 3 clinical trials after a detailed deliberation, sources told ANI.

After Bharat Biotech, Biological E has become the second company to conduct clinical trials for a booster dose. Sources further said that it is generating the data in a systematic manner to study booster dose on the basis of approvals.

According to the ANI report, the SEC recommended granting of permission to conduct proposed phase 3 clinical trials for boosters of biological vaccine subject to the two conditions: The first is that the administration of booster dose after primary immunization should be studied in two cohorts of six and nine months with age-wise stratification and including 50 per cent subjects with high risk or comorbidity condition.

The second being that the safety follow-up should be extended to nine months. On December 10, SEC in its meeting reviewed the data provided by Biological E. The firm had presented its revised clinical trial protocol for the conduct of phase 3 clinical trial for the administration of booster dose of COVID-19 vaccine containing receptor-binding domain (RBD) antigen of SARS-CoV-2.

The firm had submitted six months' safety follow up post second dose from phase 1 clinical trials, 90 days safety data from phase 2 part and 60 days safety data from phase 2/3 and phase 3 active comparator study. Corbevax is India's first indigenously developed protein subunit vaccine against COVID-19 that got DCGI's approval for emergency-use authorization on Tuesday. The vaccine maker company plans to deliver more than 1 billion additional doses globally, ANI report said.

As per the Union Health Minister, Corbevax vaccine is India's first indigenously developed RBD protein sub-unit vaccine against Covid-19.