KUALA LUMPUR: Ho Wah Genting Bhdâs wholly-owned subsidiary, HWGB Biotech Sdn Bhd has announced that an Interim Report of Covid-19 Vaccine Phase 4 Clinical Trial conducted by its United States-based joint-venture partner, E-MO Biology Inc (EBI) is pending approval from the US Food and Drug Administration (FDA).
In a statement today, EBI managing director Dr Xie QiYi said it had completed the first stage study of Phase 4 clinical trial and the firm is prepared for an expanded trial after gaining the FDA approval.
âThe group intends to expand the study cohort to a total of 300 subjects after the success of the pioneering 25 subjects enrolled.
âNo adverse effects were reported by the enrolled subjects which prove that we are heading in the right direction and to continue this study on a larger and more diverse group,â he said.
EBI will be able to embark on a larger group study with an additional 275 subjects, which will be stratified by age and race or ethnicity.
It added that a breakthrough was announced when the first stage of the study showed that 100% of the subjects produced an immune response that recognised protein (RdRp) of both poliovirus and SARS-Cov-2 in their blood samples after vaccination. â Bernama
