PH seeks up to 20,000 participants for WHO Solidarity trial for vaccines

Gillan Ropero, ABS-CBN News

Posted at Dec 17 2021 05:28 PM

A healthcare worker prepares a jab of COVID-19 vaccine at the Navotas City Hospital on November 02, 2021. Jonathan Cellona, ABS-CBN News
A healthcare worker prepares a jab of COVID-19 vaccine at the Navotas City Hospital on November 02, 2021. Jonathan Cellona, ABS-CBN News


MANILA - The Philippines is seeking some 15,000 to 20,000 participants for the World Health Organization's Solidarity trial for COVID-19 vaccines, officials said Friday.

The clinical trial aims to get safety and efficacy data directly attributed to the Filipino people, said Science and Technology Secretary Fortunato de la Peña.

This can be "beneficial for eventual application for product registration" with the Food and Drug Administration and ramp up vaccine distribution, he added.

"The quicker we find the most effective and safest vaccines of distribution, the earlier the world could reach WHO's immunization targets. When we hit these targets, we could prevent people form being infected, we reduce the number people suffering and dying," he said in a recorded video message.

"We are not just looking after ourselves but after other people beyond our borders because we are contributing to the global effort find the most effective vaccines for specific populations," said Jaime Montoya, executive director of the Department of Science and Technology-Philippine Council for Health Research and Development.

The trial currently involves 2 vaccines, a subunit vaccine and a DNA vaccine, with participants to be monitored for a year, according to principal investigators Marissa Alejandria and Jodor Lim. Participants may also receive a placebo, they said.

"After a participant is evaluated, they will be monitored every week for about a year to find out if they develop any symptoms and that will be the trigger whether these participants will undergo RT-PCR," Lim said.

The subunit vaccine targets the spike protein of the virus and is similar to hepatitis B vaccines in the country, according to Alejandria. The DNA vaccine also encodes the spike protein of the virus and does not yet have an emergency use authorization in the Philippines, she said.

Both vaccines are to be given in 2 doses, four weeks apart, and have a 2 to 8 degrees centigrade storage requirement, she added.

"Indirectly, the performance of the vaccine is being tested to what the predominant variant is ongoing in the country," Alejandria said. "As the variants evolve, then we are able to test the performance of the vaccines against the circulating variants."

An intranasal vaccine is being eyed to join the clinical trial and an mRNA vaccine with a "storage requirement less stringent than the current mRNA vaccines we have," according to Alejandria.

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Lim said the trial had a "soft launch" late September at the UP Philippine General Hospital, Lung Center of the Philippines, Makati Medical Center, community sites in Sampaloc area and Camp Crame. St. Luke's Medical Center, and San Juan de Dios Hospital later on also enrolled participants, he added.

The trial is looking for participants in barangays with an average daily attack rate (ADAR) of more than 1 percent with a population of about 5,000, according to Lim.

"We are looking at expanding more to some other sites and are still actively looking for local governments who are more than willing to take us in," he said.

The clinical trial's organizers are coordinating with the National Vaccines Operation Center on possible benefits for participants, Montoya said.

"We're discussing with NVOC to recognize this particular contribution made by the trial volunteers and for them to be given, the very least of which is that for example they be given the appropriate vaccines when it becomes available just in case they are given the placebo. For the other benefits we're still working on that," he said.

The study will "fast-track the generation of necessary evidence" on vaccine efficacy and safety, said Dr. Rabindra Abeyasinghe, WHO representative to the Philippines.

"Based on emerging evidence on efficacy and safety, we will continue these trials until the required numbers and evidence is complete," he said.

"The Philippines' commitment to accept and participate in the Solidarity trial of vaccines is a major milestone in our efforts to fast-track the vaccine development."

The country has so far fully vaccinated 43 million individuals while 55.98 million have received an initial dose as of Wednesday noon, according to Department of Health data.