Biological E gets DGCA nod to begin the next phase of trials for its COVID-19 vaccine


HYDERABAD: Biological E said it has obtained approvals of the Drugs Controller General of India to start phase I/II clinical trials of its Covid-19 vaccine candidate in the country.

This vaccine candidate includes an antigen that was in-licensed from BCM Ventures, which is an integrated commercialisation team of Baylor College of Medicine in Houston, and an advanced adjuvant from the US-based vaccine focused pharmaceutical firm Dynavax Technologies Corporation. “Phase I/II clinical trials will evaluate the safety and immunogenicity of the vaccine candidate,” Biological E said.

The Hyderabad-based vaccine maker said trials will involve about 360 participants in the 18 to 65 age range, with two doses for each participant, administered via intramuscular injection 28 days apart.

“The results of this clinical trial are expected to be available by February 2021,” the company said in a statement on Monday.

“The transition of our vaccine candidate into human trials is an important milestone and exemplifies a successful transfer of technology with BE that could lead to a safe, effective and affordable vaccine,” said Maria Elena Bottazzi, associate dean of the National School of Tropical Medicine at Baylor College of Medicine.

Biological E managing director Mahima Datla said it would “offer one more potential option for the prophylaxis of Covid-19.”

Texas Children’s Hospital Centre for Vaccine Development co-director Peter Hotez, who is also professor and dean at the National School of Tropical Medicine at Baylor, said the vaccine “represents an urgent biotechnology innovation for ensuring health equity and combating the Covid-19 pandemic.”

Dynavax CEO Ryan Spencer hoped that their adjuvant would “boost the immune response to produce more antibodies and longer lasting immunity” that may minimise the antigen dose needed.

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