COVID-19 vaccine trial in Cebu City legitimate

CEBU, Philippines —  Clinical trials for “recombinant” COVID-19 vaccine in the city was legitimate and was properly coordinated with the Cebu City government, Visayas Vaccination Operations Center (VVOC) spokesperson Mary Jean Loreche clarified yesterday following concerns raised by some city officials due to alleged lack of coordination.

Acting Mayor Michael Rama and the members of city council claimed that they were all caught by surprise upon learning of the ongoing clinical trials conducted in one of the private hospitals here.

Acting City Health Office chief Dr. Jeffrey Ibones and retired General Melquiades Feliciano, the region’s vaccine czar, were also not aware of the vaccine trials.

Loreche explained that the Department of Health (DOH), through Undersecretary Myrna Cabotaje, made proper coordination with the city government. The coordination letter dated August 25, 2021 was addressed to Mayor Edgardo Labella.

The letter, however, was not properly cascaded to the concerned officials in the city government considering that Labella was on leave. In the letter, Cabotaje said that Cebu City was identified as one of the study sites of the Department of Science and Technology (DOST).

The purpose of the clinical trials is to evaluate the safety and immunogenicity of mixing different COVID-19 vaccines and vaccine platforms in Filipino adults.

The letter, however, did not specifically discuss whether the trials would also include the independent trials for WestVac. Nevertheless, Cabotaje included contact details should Labella have any inquiries regarding the trials.

“Totoo po yan and that is a valid clinical trials...Ito pong vaccine clinical trial ay approved by FDA, no.2 Single-joint research ethics board of the DOH and of course, this is spearheaded also by the PCHRD, the Philippine Council For Health, Research and Development. That is a very legal clinical trial that is being conducted in Cebu City,” Loreche said.

WestVac’s independent trial, though, has Food and Drug Administration’s approval along with the Single-joint Research Ethics Board of the Department of Health and spearheaded by the Philippine Council For Health, Research and Development.

In PCHRD’s website, WestVac’s phase 3 trials are done at Perpetual Succor Hospital. Some photos of participants of the trials in the said hospital were also posted online.

 “This is a Phase III study in a global multicentre, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy, safety and immunogenicity of the Recombinant COVID-19 Vaccine cells (Sf9 cells) produced by WestVac Biopharma Co., Ltd in the 5,000 participants/subject who will be adult participants aged 18 years and older,” read the project description.

The study enrolls participants who have no known history of SARS-CoV-2 infection but whose locations or circumstances put them at appreciable risk of acquiring COVID-19 or SARS-CoV-2 infection.

“Subject’s = 60 years old will account for about 10% of all enrolled subjects. All participants will receive three doses of either study vaccine or placebo on Day 0, Day 21, and Day 42 in a ratio of 1:1,” it added.

“This is also just performed in one private hospital because that is currently the only hospital (for Cebu City) that is currently accredited with a level 3 accreditation to conduct clinical trials,” Loreche said without mentioning the name of the hospital.

The other hospitals in the Philippines included in the project are the Makati Medical Center, the Medical City in Iloilo, Quirino Memorial Medical Center, De La Salle Medical and Health Sciences Institute, Tropical Disease Foundation, Inc., West Visayas State University Medical Center and St Luke Medical Center - Global City.

Loreche said the clinical trials here started last September yet. It is not known if there are other companies aside from WestVAc that had also conducted trials here. Other companies that had been given approval to conduct independent trials are Sinovac, Janssen Pharmaceuticals, Clover Biopharmaceuticals, Inovio Pharmaceuticals, Shenzhen Kangtai Biological PRojects, and Livzon Mabpharm.

Protocols concerning the clinical trials have not been revealed by Loreche saying it is part of the data privacy but assures the public that it is an accepted one.

“Protocols cannot be revealed...as part of their data privacy…but I am assuring the public that this is an accepted clinical (trial) that will actually study, evaluate the safety and immunogenicity of mixing different COVID-19 vaccines and vaccine platforms in Filipino adults,” she said.

Loreche explained that these clinical trials are very important and Cebuanos are also encouraged to actively participate in this for the good of everyone.

“Kasi alam po natin, alam nyo po kailangan talaga tayong maging active at sumama sa mga ganito because it is only through this clinical trials that we will truly be able see the effectiveness of weather one particular brand that we have is better or not and secondly, of course, marami pa tayong kailangang alamin sa mga bakuna na meron tayo kagaya nitong paghahalo, pagmimix ng different platforms,” said Loreche. — Decemay Padilla, FPL (FREEMAN)