5,000 participants so far enrolled in COVID-19 vax solidarity trial

MANILA, Philippines — The government has already enrolled around 5,000 participants for the COVID-19 vaccine solidarity trial of the World Health Organization (WHO), the project leaders for the study said Friday.

Dr. Marissa Alejandria, of the University of the Philippines College of Medicine and president of the Philippine Society for Microbiology and Infectious Diseases, said in an online forum by the Department of Science and Technology (DOST) that they need 15,000 to 20,000 participants from the Philippines for the global solidarity trial.

“We’d like to thank the participants, the first 5,000 participants that we have enrolled for agreeing to be part of the trial to contribute to science, to knowledge, and we pray that we will be able to convince our community to participate also in this trial as we move out of Metro Manila and expand to other areas. We hope we will have participants who will be able to contribute to science,” she said.

According to Alejandria, the trial had a “soft start” as they recruited participants from Metro Manila in September and October.

Meanwhile, Dr. Jodor Lim, who also serves as project lead of the study in the Philippines, said that they have been preparing for the trial for more than a year.

“We started our enrollment at the end of September [and] the first week of October. We started with Philippine General Hospital, Lung Center of the Philippines, then Makati Med. And then we have community sites like Camp Crame. Later on, we moved to the Sampaloc area and St. Luke’s Medical Center and then to San Juan de Dios,” said Lim.

“So we now have eight actively enrolling sites and we hope to add more sites. I don’t know if we can do it this year, that’s for Baguio General Hospital as well as the South Luzon team, Carmona, and probably another in the South Luzon area,” he added.

“We are looking towards Laguna, Batangas, and there are teams already in Cavite. So those are areas for expansion,” he further said.

According to Lim, they are looking for areas outside Metro Manila where the vaccination rate is not that high and where the COVID-19 attack rate is more than one percent and the population per barangay is about 5,000.

The participants should be at least 16 years old, have not been inoculated with any COVID-19 vaccine, and did not have a laboratory-confirmed positive coronavirus test.

“The trial has been set for an evaluation of one year, so after a patient is evaluated, they will be monitored every week for about a year to find out if they developed any symptoms, and that will be the trigger where these participants will undergo the RT-PCR,” Lim explained.

There are currently two vaccines included in the solidarity trial in the country, according to Alejandria.

“We have one, the DNA vaccine which encodes the spike protein of SARS-CoV-2. That one is also two doses, given four weeks apart and the storage is 2 to 8 degrees centigrade. The other one, the sub-unit vaccine, is also targeting the spike protein. It’s similar to the Hepatitis B vaccine. It’s the same platform. Two doses din ito given in two weeks’ interval, and the same storage requirements of 2 to 8 centigrade,” she said.

“In the pipeline, still undergoing phase 2, hopefully as mentioned— because we are looking also at not just safety and efficacy but other modes of administration. Hopefully, we will have an intranasal vaccine in the trial, and then we are looking also at having another mRNA vaccine but the storage requirement is less stringent than the current mRNA vaccines that we have, so the storage requirement will be less and I think this might be a single dose,” she added.

According to Dr. Rowena Cristina Guevara, Undersecretary for Research and Development of the DOST, the Philippines’ participation in the solidarity trials will enable the country to “generate safety and efficacy data of vaccine candidates directly attributed to the Filipino people.”

Meanwhile, Dr. Jaime Montoya, executive director of the DOST-Philippine Council for Health Research and Development, said that the solidarity trials will also help enable the country to identify which vaccines are fit for a particular population.

“Remember that all the vaccines we have currently are under EUA (emergency use authorization) and they have not been specifically looked at to address specific populations. The research will still have to continue because some of these vaccines may be better used for a particular population than another one,” Montoya said.

“As more and more of these candidate vaccines are evaluated, we can come up with more options and choices that fit a particularly high-risk group or population that stand to benefit most in a particular type of vaccine,” he added.

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