Clinical trial in Cebu City halted; Rama wants parties to sign MOA

CEBU, Philippines —  Acting Cebu City Mayor Michael Rama has ordered the independent clinical trial for COVID-19 vaccine in the city stopped until all parties involved can sign a formal memorandum of agreement.

Rama said the endorsement from the Department of Health (DOH) is not enough. The study evaluates the safety and immunogenicity of mixing different COVID-19 vaccines and vaccine platforms among Filipino adults.

Cebu City was identified as one of the study sites of the Department of Science and Technology (DOST).

Rama has directed Cebu City Police Office to inform the trial administrators led by China’s WestVac to stop the clinical trial.

“Let’s put a stop to it in the meantime. Even if it’s a project of the national government, atong ipahimutang, lingkuran ta na… dili basta lang… supposedly, ang trabaho ana sugod sa ubos including CHD (City Health Department), plus group from DOH, and the MOA… kinahanglan man ta ni sila’g MOA. Naa nya’y madisgrasya… it’s how intricate it is,” Rama said.

He said he wants to gather all parties involved in a meeting with the city government.

He also said vaccinations, even if initiated by the private sector, should be coordinated with the local government unit where it is being conducted.

“Mga ingon ana, dili gyud nimo i-bypass ang LGU… cardinal rule na… any vaccination, especially kani nga klaseha... even if it's initiated by the private sector, or any group, it has to be coordinated with the LGU. Clear kaayo ng pagbuhat og vaccine site... clear man gani nang vaccine supply agreement,” Rama said.

Dr. Mary Jean Loreche, chief pathologist of DOH-7, said earlier that DOH, through Undersecretary Myrna Cabotaje, actually coordinated with the city government through a letter to Mayor Edgardo Labella dated August 25, 2021.

The communication may not have been cascaded to officials now running City Hall after Labella went on leave.

Rama said he was not aware of the letter the DOH sent to Labella.

He also shared that he attended an online event where he raised the matter with DOH but no one among those present was aware of the clinical trial.

DOH spokesperson, Dr. Maria Rosario Vergeire, also said last week that she was not aware of the trial.

“I attended a platform with someone from DOH and brought the matter to them. I think the left hand does not know the right hand simply because they don’t know about the vaccination trials. They are still looking into the whole thing and it’s when they know it's with DOST,” Rama said.

LGU responsibility

Rama said it is clear in the Local Government Code that health of the people is the responsibility of the LGU.

“The least any national government agency or any entity with authority from the national government should coordinate with the LGU. They should know the importance of serious compliance of protocols,” Rama said.

According to him, it is important that LGU is ready to answer for or take responsibility   for whatever outcome the trial will have.

“Pananglitan kun naay mahitabo, diha pa ta makahibaw? Pagka-toytoy nato. At least, kon naay mahitabo, naapil ta, ready ta motubag. Pagka-toytoy kung naay mahitabo, wa gyud ta kahibaw unsa manang kalakiha... para nako, abuso man na,” Rama said.

CHD chief, Dr. Jeffrey Ibones, said he is set to meet with WestVac representatives in the coming days to listen to their side and look at the documents that they have relative to the trial.

"Gusto mi nga makahibaw kung pila kabuok ang ilang target population, asa ang target, ug unsa pay details sa ilang studies so that ato gyud masabtan ang ilang plano,” Ibones said.

He clarified that he is not against a clinical trial, per se, but emphasized the need for coordination with the LGU so that city officials can explain the trial properly to residents, especially that the respondents are chosen at random.

Vaccination concern

Rama said he had long been concern about vaccination and its safety, especially when an employee who took part of another vaccine trials succumbed to the medicine due to some allergic reaction.

“It’s not the first time I'm concerned about vaccination... long before pa, when I was the mayor and those matters with Dengvaxia... we have to be very careful, simbako, ang mga side effects ba. One of the employees, nalimtan man sigurong mga protocols, ended up dead… due to allergic reaction and some others got confined in hospitals. When I came in as vaccine czar and this vaccination (on COVID-19), I was very strict… the flow, the presence of ambulance,” Rama said.

It was Councilor David Tumulak who disclosed the clinical trial in a privilege speech at the City Council.

Based on his research, the pharmaceutical company reportedly started Phase 1 of the clinical trial in China on June 21 and is now on Phase 3 with 40,000 participants in Indonesia, Kenya, and the Philippines.

He reportedly received information that trial participants have been offered P2,500 to P5,000.

WestVac’s application is one of eight approved by the Food and Drug Administration (FDA) to conduct clinical trials in the country.

Other applicants approved for trials are IP Biotech; Janssen Vaccines & Prevention B.V; Clover Biopharmaceuticals AUS Pty Ltd; Shenzhen Kangtai Biological Products Co., Ltd; Beijing Minhai Biotechnology Co., Ltd.; Livzon Mabpharm, Inc.; and Inovio Pharmaceuticals, Inc. — Caecent No-ot Magsumbol JMO (FREEMAN)