Bio E vax candidate gets SEC nod for phase III trials

Hyderabad: Vaccine maker Biological E Ltd has received approval from the subject expert committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) to start phase III clinical trials of its Covid-19 subunit vaccine candidate. The company is developing the vaccine with Texas-based Baylor College of Medicine (BCM).

The phase III trials of the recombinant protein vaccine will be conducted on 1,268 healthy volunteers in the 18 to 80 age bracket across 15 sites in India to evaluate the immunogenicity and safety of the vaccine. This is part of a larger global phase III study, Biological E said on Saturday.

The phase I and II trials were conducted on 360 healthy volunteers in the 18-65 years age group. The trials had commenced in the second week of November 2020.

Two shots of the intramuscular vaccine were administered 28 days apart as part of the study that evaluated the safety and immunogenicity of the vaccine candidate, consisting of the receptor binding domain (RBD) of the spike protein of SARS-CoV-2 virus, at a three-dose level, adjuvanted with CpG 1018 plus alum, it said.

BioE’s vaccine candidate includes an antigen that is developed by the Texas Children’s Hospital Centre for Vaccine Development and in-licenced from BCM Ventures, BCM'S integrated commercialisation team, along with Dynavax Technologies Corporation’s advanced adjuvant CpG 1018.

Terming the results of the phase I and II trials as “positive and promising”, Biological E Ltd managing director Mahima Datla said: “We believe that our candidate will become another effective global Covid-19 vaccine as we move forward into Phase III clinical trials.” Datla had earlier told TOI that the company was ramping up capacities to produce about 1 billion doses per annum of this vaccine.

“Having our Texas Children’s and Baylor vaccine construct advance into phase III clinical studies in India and globally, 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 Bottazi, associate dean, National School of Tropical Medicine (NSTM) at BCM, & co-director of Texas Children’s Hospital Centre for Vaccine Development (TCHCVD).

The clinical trials of the vaccine are being supported by Coalition for Epidemic Preparedness Innovations (CEPI) as well as the Biotechnology Industry Research Assistance Council (BIRAC).

In addition to this vaccine, Biological E already has a tie-up with drug giant Johnson & Johnson for manufacturing over 600 million doses of its single-shot vaccine — Ad26.COV2.S — in India. It will get funding from the US International Development Finance Corporation (DFC) to produce at least 1 billion doses of Covid-19 vaccines by the end of 2022 under the Quad initiative.