India Authorizes Phase Three Study for Subunit COVID-19 Vaccine Candidate
A Hyderabad-based vaccine company today announced that it received regulatory approval to launch a Phase III clinical trial for a COVID-19 vaccine candidate.
Biological E. Limited (BE) confirmed on April 23, 2021, its subunit COVID-19 vaccine candidate includes an antigen developed by Texas Children’s Hospital Center for Vaccine Development and in-licensed from Baylor College of Medicine’s integrated commercialization team along with Dynavax Technologies Corporation’s advanced adjuvant CpG 1018TM.
“Having our Texas Children’s and Baylor vaccine construct advance into phase III clinical studies in India highlights the importance of advancing traditional protein-based vaccine platforms, which now brings added hope for a people’s vaccine to be scaled and deployed in low- and middle-income settings,” 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.
BE's previous Phase I/II clinical trial evaluated 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 level adjuvanted with CpG 1018 plus alum, in about 360 healthy subjects in the age range of 18 to 65 years.
BE’s novel Covid-19 vaccine was found to be safe and well-tolerated, and immunogenic.
“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. We believe that our vaccine candidate will become another effective global COVID-19 vaccine as we move forward into Phase III clinical trials,” said Ms. Mahima Datla, Managing Director, Biological E. Limited.
The Phase III clinical study is authorized by the Phase III clinical trial from the Central Drugs Standard Control Organization - Subject Expert Committee, to be conducted in 15 sites across India will evaluate the Immunogenicity and Safety of Biological E’s SARS-CoV-2 COVID-19 vaccine for protection against COVID-19 disease in 1,268 healthy subjects in the age range of 18 to 80 years.
Protein subunit vaccines include harmless pieces (proteins) of the virus that causes COVID-19 instead of the entire germ. Once vaccinated, our bodies recognize that the protein should not be there and build T-lymphocytes and antibodies that will remember how to fight the virus that causes COVID-19 if infected in the future, says the U.S. CDC.
Biological E. Limited is a Hyderabad-based Pharmaceuticals & Biologics Company founded in 1953. It is the first private sector biological products company in India and the first pharmaceutical company in Southern India.
Baylor College of Medicine, located 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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