India and Texas Partner to Develop COVID-19 Vaccine

A Hyderabad-based vaccine and pharmaceutical company announced the initiation of a Phase I/II clinical trial of its COVID-19 subunit vaccine candidate in India following approval from the Drugs Controller General of India.

This early-stage study’s results are expected to be available by February 2021.

Biological E. Limited (BE), Dynavax Technologies Corporation, and Baylor College of Medicine, a health sciences university in Houston, Texas, stated in a press release issued on November 16, 2020, this Phase I/II clinical trial 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, adult subjects.

The vaccination schedule consists of 2-doses for each study participant, administered via intramuscular injection 28 days apart.

“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,” commented 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.

“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,” added Ms. Mahima Datla, Managing Director, Biological E. Limited.

“We are proud to contribute CpG 1018 to support the 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 minimize the dose of antigen needed, enabling vaccination of a greater number of people,” commented Ryan Spencer, CEO of Dynavax.

Biological E. Limited is a Hyderabad-based Pharmaceuticals & Biologics Company founded in 1953, is the first private sector biological products company in India and the first pharmaceutical company in Southern India. BE has seven WHO pre-qualified vaccines and is working to expand its pipeline of generic vaccines. Additionally, it is leveraging its past experience in the vaccines space to transition to developing novel vaccines. BE is the largest producer of Tetanus Vaccine in the world and the leading supplier of Pentavalent Vaccine. It is also one of the leading suppliers of Polyvalent Snake Antivenom in India.

Baylor College of Medicine in Houston, Texas is recognized as a health sciences university and is known for excellence in education, research, and patient care.

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