2021-06-24 11:45:47

HWGB’S EBI SUBMITTED POLIO VACCINE TO FDA UNDER AN EMERGENCY USE AUTHORIZATION FOR COVID-19 VACCINE PURPOSE

KUALA LUMPUR, 24 JUNE 2021 – Ho Wah Genting Berhad (“HWGB” or the “Company”) (Bursa Stock Code: 9601), through its wholly-owned subsidiary HWGB Biotech Sdn Bhd (“HWGB Biotech”), today announced E-MO Biology Inc.(“EBI”) has submitted to US Food and Drug Administration (“FDA”) under Emergency Use Authorization on 22 June 2021. The EUA will authorize EBI on the usage of the polio vaccine for COVID-19 and continue the next step for the clinical trial.
 
The Emergency Use Authorization (EUA) authority allows FDA to strengthen the nation’s public health protections against threats such as the COVID-19 pandemic by facilitating the availability and use of medical countermeasures (MCMs) needed during public health emergencies. When the Secretary of US Department of Health and Human Services declares that an emergency use authorization is appropriate, the FDA may authorize unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases when certain criteria are met, including if there are no adequate, approved, and available alternatives.
 
FDA may issue a EUA only if FDA concludes that the statutory criteria for issuance have been met, and the product is intended for use during an actual or potential emergency. If the product does not meet the statutory criteria for issuance or is not otherwise an appropriate candidate, an alternative regulatory mechanism will be provided to patients to access to unapproved use of a product in an emergency. The FDA had issued the EUA to Pfizer-BioNTech COVID-19 Vaccine, Moderna COVID-19 Vaccine, Janssen COVID-19 Vaccine, and AstraZeneca COVID-19 Vaccine.
 
HWGB Biotech’s General Manager (Medical & Pharmaceutical Research), Dr. Yaman Walid Kassab said: “Our JV partner EBI has submitted to the FDA under EUA and we believe that this is the right step to have the necessary approval for the continuation for the usage of polio vaccine in the clinical trial and eventually releasing it to the public. With the promising result shown on the clinical trial, we are confident we will be able to get the EUA from the FDA”.
 
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