CEBU CITY, Philippines — The Chinese pharmaceutical company, WestVac BioPharma has assured the safety of their clinical trial in Cebu as they face inquiry from the local government unit (LGU).
In a letter to CDN Digital, Yu‘quan Wei, MD, PhD, the chairman, and General Manager of WestVac Biopharma Co., Ltd, said they have partnered with Trigermed and Pi Health Inc. in the Philippines to conduct the Phase III global multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy, safety, and immunogenicity of the recombinant COVID-19 vaccine (Sf9 cells) in 40,000 participants aged 18 years and older.
Wei explained that the Phase III trials in the Philippines have been approved by the Philippine Food and Drug Administration (PFDA) for the trial to be conducted starting June 28, 2021.
Department of Health-Single Joint Research Ethics Board (DOH-SJREB) likewise issued on June 21, 2021, its Notice of Approval granting WestVac the authority to conduct the clinical trial of Recombinant Covid-19 Vaccine.
Department of Science and Technology – Philippine Council for Health Research and Development (DOST-PCHRD) also issued on May 17, 2021, a certification attesting that the protocol of this clinical trial has been found to be technically sound and that it has approved the trials‘ objectives, endpoints, clinical safety, and overall clinical trial design.
As for the clinical trial process, WestVac explained that the steps undertaken are made to ensure the maximum safety of the participants.
“Before enrolling the research participants in the clinical trial, the study team checks the participant‘s health and carefully screens the participant based on the eligibility criteria outlined in the research protocol.”
“During the informed consent process, the investigator provides all information about the research study to every potential individual research participant and ensures that all the research participants understand the responsibilities, risks, benefits of the clinical trial,” they said.
As proof of their participation in the research, each of the participants is issued a “Trial Participation Card.” This was the card Cebu City Councilor David Tumulak presented to the City Council.
WestVac said that because participation in a clinical trial is voluntary, there is no cost for participating in this study, including receiving the investigation vaccine, medical examination, blood sampling & testing, etc.
During the consent process, the research participants are informed of any fees (e.g., meal and transportation fees) given to them that are attached to their inclusion in the study.
“The fee to the participants is reflected in the informed consent form which has been approved by PSH TERB. All research participants have the right to withdraw from continued participation in the clinical trial, at any time, without penalty or loss of benefits to which they are otherwise entitled,” they added.
The study team also made the research participants aware that they do not have to participate in the study and that it is fully voluntary. If they decide not to participate, they are well informed that it will not affect any relationships they have with the researcher and/or facility in which it is administered.
“The study team conducts clinical research in a manner that recognizes the importance of protecting the safety of and respecting research participants. All the study teams involved in clinical research recognize this fundamental principle and reinforce the precautions established to protect research participants,” said Wei.
WestVac assured the Filipinos that their health and safety are of paramount importance in participating in their clinical. The company hopes this will assure the LGUs of the safety and efficacy of their trials.
Cebu City Health Officer-in-charge, Doctor Jeffrey Ibones, said they never doubted the safety of clinical trials and understand the importance of such in science.
However, the city hopes for better coordination so that the CHD can monitor these patients and ensure that the trials will not affect the city’s vaccination program.
“Coordination lang gyod ang among hangyo para mabantayan nato ang mga participants, mamonitor nato ilang health,” said Ibones. /rcg
RELATED STORY:
Cebu City Council questions clinical trial of COVID-19 vax