Reps sorry for not telling city of WestVac clinical trial

CEBU, Philippines — The head of the investigating team of the ongoing independent clinical trials in Cebu City for the WestVac COVID-19 vaccines has apologized for not informing the city about the trial.

“I would like to apologize because it is not our practice to ask permission from LGUs in clinical trials,” Dr. Jemela Anne Osorio-Sanchez, an oncologist an oncologist at Perpetual Succour Hospital, told the City Council.

She appeared before the City Council during its session on Wednesday.

She said that based on her two decades of experience conducting clinical trials, it is usually the national agencies that coordinate with the local government units.

“We did not realize that this is also a public issue… Well, maybe because it pertains to COVID… It's something we missed on our part,” she said.

Prior to appearing at the City Council, Sanchez and a representative of WestVac Biopharma Co. paid a visit to Acting Cebu City Mayor Michael Rama and also extended their apology for the oversight.

Rama said they have agreed to come up with a Memorandum of Agreement (MOA) among everyone involved in the clinical trial.

Rama said he told Sanchez and the WestVac representatives that he is not against the clinical trial, per se, but the city would need to be involved because the participants of the trial are its residents. He said earlier that the city must ensure the safety of the participants.

“I told them they just have to present it to the City Council so the Council will be able to understand… If I find it meritorious for health and science, and as long as it is on proper perspective, I will not be disagreeing with it,” Rama said.

Sanchez said the clinical trials have approvals from the Food and Drug Administration (FDA), Department of Health (DOH), and Philippine Research and Development of the Department of Science and Technology (DOST).

DOH-7’s Miguel Gerson said they were surprised upon learning of the clinical trial as they came to know about it only from Councilor David Tumulak who gave a speech at the Council about city residents participating.

But Gerson said protocols governing clinical trials are not well-defined and DOH-7 has no jurisdiction over these.

The Freeman got hold of a copy of the letter DOH Undersecretary Myrna Cabotaje has sent to Mayor Edgardo Labella concerning the research study but even City Administrator Floro Casas, Jr. said he was not aware of it.

Labella is on an indefinite medical leave.

Request

The trial is suspended as of this writing and Sanchez asked the city to allow the activity to resume as they are tight on schedule.

“This month is very crucial for us… Hoping you will be very kind to let us resume the recruitment,” she said.

At least 700 individuals have volunteered to take part in the clinical trial that, Sanchez said, were invited through word of mouth.

They reportedly received P2,500 as allowance for fare and for the pay they lost for skipping work on the day of the inoculation.

The clinical trial is a randomized, double-blind, placebo-controlled, Phase III clinical trial to evaluate the efficacy, safety, and immunogenicity of recombinant COVID-19 vaccine (Sf9 cells) by WestVac Biopharma, Co. for the prevention of COVID-19 in adults aged 18 years and older.

WestVac is one of the biggest pharmaceutical companies in China. — Decemay P. Padilla, JMO  (FREEMAN)