Biological E. Covid-19 vaccine candidate gets nod for Phase 3 clinical trials

The Phase III clinical study to be conducted in 15 sites across India with about 1,268 healthy subjects in the age range of 18 to 80 years

Homegrown vaccine maker Biological E. on Saturday said it had got approvals from India’s drug regulators to start Phase 3 clinical trials of its Covid-19 subunit vaccine candidate.

“We believe that our vaccine candidate will become another effective global Covid-19 vaccine as we move forward into Phase III clinical trials,” said Mahima Datla, Managing Director, Biological E. Limited.

The company had started the Phase I/II Clinical Trial of its Covid-19 Vaccine Candidate in the second week of November 2020.

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Its candidate includes an antigen developed by Texas Children’s Hospital Center for Vaccine Development and in-licensed from BCM Ventures, Baylor College of Medicine’s integrated commercialization team, along with Dynavax Technologies Corporation’s advanced adjuvant CpG 1018.

“We are delighted with the success of the Phase I/II clinical trials of our Covid-19 vaccine candidate. The results of these clinical trials are very positive and promising,” Datla said.

The Coalition for Epidemic Preparedness Innovations (CEPI) and the Biotechnology Industry Research Assistance Council (BIRAC) have provided support for the Phase I/II clinical trials and also for the upcoming Phase III trial of this vaccine candidate.

Earlier this week, NITI Ayog member (health) V K Paul had said that the Biological E. vaccine could be available for use by August this year.