PARTICIPANTS to the clinical trials being conducted by the WestVac Biopharma Co. Ltd. are not entitled to privileges granted to fully vaccinated persons, Cebu City Health Department head Dr. Jeffrey Ibones said Friday, October 15, 2021.
They will not also be eligible to receive the vaccines being administered by the Cebu City Government against coronavirus disease (Covid-19), he added.
Only those who were inoculated by the Cebu City Government with vaccines approved for emergency use are included in the vaccine information management system (VIMS).
Ibones said the names of the clinical trial participants are not in the VIMS.
“If they are vaccinated as part of the trial, their names won’t be in our system (VIMS). Most likely, they will not be able to benefit (from the privileges),” Ibones said.
Fully vaccinated persons in Cebu City are allowed to dine in and avail themselves of personal care services. They may also participate in a raffle program.
A person is considered fully vaccinated only after 14 days of receiving a single-dose vaccine or the second dose of a vaccine that was issued an emergency use authorization (EUA) by the Food and Drug Administration (FDA).
The vaccines being administered by the government all have EUA.
The WestVac vaccine candidate does not have an EUA yet, but the independent phase 3 clinical trials being conducted to determine its efficacy was approved by the FDA on June 28, 2021.
Ibones clarified that they are not against the WestVac clinical trials as these are essential. The issue stemmed from WestVac’s failure to coordinate with the City Government.
“We just want to know (about the clinical trials) because the City is responsible for whatever happens to our fellow residents, even though they gave their consent. Coordination with the City is important,” Ibones said.
He said they have coordinated with the Office of Councilor Dave Tumulak, who gave a privilege speech on the matter during the last regular session on Oct. 13.
He has also called the Perpetual Succour Hospital, one of the eight identified sites for the clinical trial.
“We asked them that if the clinical trial pushes through, they should send a letter addressed to the mayor to express their intent and inform the City Government,” Ibones said.
WestVac is conducting clinical trials to evaluate the efficacy, safety and immunogenicity of its recombinant Covid-19 vaccine in 5,000 adults 18 years and older.
At the Perpetual Succour, Ibones said the target number of participants is 700 to 800.
The study is ongoing but it has yet to start in Cebu City, according to the Department of Science and Technology (DOST) website.
In a separate interview, Department of Health (DOH 7) Director Jaime Bernadas said he knew about the study, but WestVac also did not coordinate with his office.
“It came to my knowledge, but I forgot about it. I was just furnished information that they have written to Cebu City (Government) to notify the latter about the trials here,” he said.
“I was waiting for them to visit my office. But they haven’t. So I forgot about it until somebody told me about it again,” he added.
Bernadas said he does not have the details. He said it’s the DOST that can clarify the issue.
Dr. Mary Jean Loreche, spokesperson of the Visayas Vaccination Operations Center (VVOC), assured that the WestVac clinical trial is valid and legal.
She emphasized that it was approved by the FDA, Single Joint Research Ethics Board of the Department of Health (DOH), and the Philippine Council For Health Research Development.
The study, which will be conducted over three months, started on Sept. 28.
Other sites for the trial, according to the DOST, are Makati Medical Center, The Medical City in Iloilo, Quirino Memorial Medical Center, De La Salle Medical and Health Sciences Institute, Tropical Disease Foundation, West Visayas State University Medical Center and St. Luke’s Medical Center - Global City. (WBS / KFD)