Gov’t eyes 15K volunteers for WHO’s COVID-19 vax solidarity trial — DOST exec

The Philippines is aiming to recruit at least 15,000 individuals to participate in the solidarity trial led by the World Health Organization (WHO) to test two types of COVID-19 vaccine in the country.

At the Laging Handa briefing, Department of Science and Technology’s Philippine Council for Health Research and Development (DOST-PCHRD) Executive Director Dr. Jaime Montoya said these clinical trials are made because the “ideal vaccine” has not been developed yet.

He explained that the current vaccines, while effective, have certain conditions. Thus, health experts are looking for other vaccines that are equally effective but have less requirements.

One condition is that of mRNA vaccines like Pfizer, that need to be stored at minus 70°.

“Mahirap i-maintain ‘yan. So, naghahanap pa tayo ng mga equally effective vaccines na siguro ang transport requirement at storage requirement ay hindi katulad nung sa mRNA,” he said.

(This is difficult to maintain. That’s why we are looking for other equally effective vaccines that have transport and storage requirements that are not the same with the mRNA.)

Montoya added they are also searching for vaccines that may be more apt for particular groups such as senior citizens, minors, and people with comorbidities.

“Kung mapapansin ninyo po ngayon, ‘yung bakuna na ginagamit natin ay tine-test for all ages. Pero baka meron diyang mga bakuna na mas aangkop pa sa naturang age groups o mga grupo ng ating mga mamamayan,” he said.

(If you would notice, the current vaccines are being tested for all ages. Maybe there are vaccines that would be better for certain age groups and other more groups.)

Efficacy and safety of vaccines

According to WHO, the Solidarity Trial Vaccines (STV) aims to evaluate the efficacy and safety of new COVID-19 vaccines. The primary objective of this is “to evaluate the effect of each vaccine on reducing the rate of virologically confirmed COVID-19 disease, regardless of severity.”

Two candidate vaccines have been so far approved for the STV. These are a spike adjuvanted vaccine developed by Medigen, and a DNA vaccine encoding the spike protein developed by Inovio.

“New platforms po itong dalawang ito. ‘Yung subunit vaccine katulad lang ito ng Novavax, pero bukod doon, wala pang ibang subunit vaccines. ‘Yung DNA vaccine, kauna-unahan ‘yan,” Montoya stressed.

(These two are new platforms. The subunit vaccine is like Novavax, but aside from that, there are no more subunit vaccines. The DNA vaccine, that is the first one of its kind.)

WHO is also looking at adding two more vaccines, a SARS-CoV-2 self-amplifying RNA vaccine from Arcturus and a SARS-CoV-2 live attenuated vaccine from Codagenix and the Serum Institute of India.

Montoya noted that interested participants must be at least 16 years old, living in the area that will be participating in the trials, have not received any COVID-19 vaccine dose yet, and have not had COVID-19 before.

“Ang pinaka-importante po ay magbigay sila ng informed consent na sila ay sumasama at naipaliwanag sa kanila kung ano ‘yung trial at willing silang sumali sa pananaliksik na ito,” Montoya said.

(The most important is that they give their informed consent that they are willing to join the trials and they have understood what the trial is all about.) 

A study team will then check their eligibility and obtain their informed consent at registration. They will be followed up weekly by the trial team for at least one year.

Aside from the Philippines, WHO has started recruitment in selected sites in Mali and Colombia for the STV.

“Ito po ay mabilisang pag-aaralan para ang target natin ay in 2-3 months, kung ma-assess na natin na ito’y mukhang epektibo, ay pwedeng lumipat na sa ibang bakuna na pwedeng pag-aralan pa,” he said.

(This will be a fast-paced study and our target is 2-3 months. If we have assessed by then that the new vaccines are effective, then we can study them more.)

The SVT will be expanded to include new countries upon WHO’s review of requests from those that expressed interest in delivering the trial.

Montoya said that until no vaccine brand was given a full Certificate of Product Registration by any Food and Drug Authority (FDA) all over the world, the vaccine trials would continue.

“Alam natin na may kakulangan din ng suplay ng bakuna. Kailangan pa tayong gumawa ng madaming bakuna at tumingin pa ng ibang bakuna na maaaring maging safer or mas epektibo for particular groups,” he added.

(We know that there is limited vaccine supplies. Thus, we should make more vaccines and look for other vaccines that may be safer and more effective for particular groups.) — RSJ, GMA News