Covid-19 Vaccine: Biological E Initiates Clinical Trials Following Approval Of DGCI

Hyderabad: Hyderabad-based vaccines and pharmaceutical company Biological E. Ltd (BE) announced that it has initiated clinical trial of its Covid-19 subunit vaccine candidate in the country on Monday following approval from the Drugs Controller General of India (DGCI).

BE collaborated with Dynavax Technologies Corporation (Dynavax), a US-based vaccine focused biopharmaceutical company, and Baylor College of Medicine, a health sciences university in Houston for making the vaccine.

The vaccine candidate includes an antigen in-licensed from BCM Ventures, Baylor College of Medicine's integrated commercialisation team, along with Dynavax's advanced adjuvant CpG 1018, BE said in a statement.

BE's Phase 1/2 clinical trials will evaluate the safety and immunogenicity of the vaccine candidate consisting of the receptor binding domain of the spike protein of SARS-CoV-2 at three dose levels adjuvanted with CpG 1018 plus alum, in about 360 healthy subjects in the age range of 18 to 65 years, it said.

The vaccination schedule consists of two doses for each study participant, administered via intramuscular injection 28 days apart.

The results of this clinical trial are expected to be available by February 2021.

"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 Dr Maria Elena Bottazzi, associate dean of the National School of Tropical Medicine at Baylor College of Medicine and co-director of Texas Children's Hospital Center for Vaccine Development.

"This vaccine represents an urgent biotechnology innovation for ensuring health equity and combating the Covid-19 pandemic," said Dr. Peter Hotez, professor and dean of the National School of Tropical Medicine at Baylor and co-director of Texas Children's Hospital Center for Vaccine Development.

"We are very happy indeed to transition our potential vaccine candidate to clinical trials and offer one more potential option for the prophylaxis of Covid-19," said Mahima Datla, Managing Director, Biological E. Ltd.

"We are proud to contribute CpG 1018 to support development of an adjuvanted vaccine to prevent Covid-19. CpG 1018's potential to boost the immune response to produce more antibodies and longer lasting immunity may also minimise the dose of antigen needed, enabling vaccination of a greater number of people," said Ryan Spencer, Chief Executive Officer of Dynavax.

While India's first indigenous coronavirus vaccine Covaxin is entering its third phase of human trials, earlier on Monday, Bharat Biotech raised the logistical query on “how to vaccinate 1.3 billion (130 crore) people with two injectable doses of India’s first indigenous coronavirus vaccine Covaxin”. Terming the exercise a “challenge” it also said that work was on single-dose nasal drop vaccine.

Bharat Biotech International Limited (BBIL) Chairman and Managing Director Krishna Ella further informed that the company is working on another vaccine which is a single dose nasal drop. Ella stated, "We have experience of making Rotavirus and Polio nasal drop vaccines. We can scale up to 1 billion doses and my feeling is that by next year we will reach there."

(Nitesh Kumar Sahoo With IANS Inputs)