Philippines, all set for WHO Solidarity trials on COVID vaccines — DOST

Marje Pelayo   •   July 13, 2021   •   383

MANILA, Philippines — The Department of Science and Technology (DOST) has confirmed the signing of a letter of agreement for the conduct of the World Health Organization’s (WHO) solidarity trials for COVID-19 vaccines in the Philippines.

“Nagpirmahan na [ng letter of agreement]. Pormal na po ang ating pagsasagawa nito,” said DOST Undersecretary Rowena Guevara in an interview in Laging Handa Press Briefing Tuesday (July 13).

“Sinasabi po dito na makakadiskubre tayo ng pinaka-epektibong COVID-19 vaccines na naaayon sa pangangailangan ng Filipino population,” she added.

The official said the WHO has already given its final clinical trial protocol, standard operating procedures, and four investigational brochures of the vaccines that will be put under a study in the duration of the trial.

She added that the DOST Solidarity Vaccine Trial team has submitted its requirement for review of the vaccine expert panel, the single-joint ethics review board, and the regulatory review of the Food and Drug Administration (FDA).

For the vaccine mix-and-match, Guevarra said they will be using all COVID vaccines available in the Philippines.

The official said they already listed 3,000 participants for the entire mix-and-match project which is proposed to be conducted in eight sites including Manila, Pasig City, Antipolo, Marikina City, Makati, Pasay City, Quezon City, Muntinlupa, Cebu City, and Davao City.

“Para masiguro ang consistency at uniformity sa trial, ang ilalahok lamang ay ang mga hindi pa nabibigyan ng COVID-19 na bakuna,” Guevarra said.

“Kapag ang mga bagong bakuna ay pumasa na sa Phase 3 na may satisfactory result, maaari na po silang isama sa pagpipilian ng Pilipinas at ibang bansa sa pag-deploy para sa kani-kanilang vaccination programs,” she added.

At present, Guevarra said there are four FDA-approved clinical trials in the Philippines, while seven new vaccine clinical trial applications are now in different stages of review by the vaccine panel of experts, single-joint ethics review board, and the FDA.

Guevara stressed that clinical trials are being conducted to assess and investigate the efficacy, safety, and immunogenicity of the vaccines.

Ivermectin clinical trials to push through this September despite delays — DOST

Marje Pelayo   •   September 6, 2021

MANILA, Philippines — The Department of Science and Technology (DOST) said preparations are almost done for the start of the ivermectin clinical trial this month.

The clinical trial is necessary to find out if the controversial drug is effective against COVID-19, Dr. Jaime Montoya of the DOST-Philippine Council for Health Research and Development (PCHRD) said.

During the Laging Handa public briefing, Montoya said the agency had to adjust its protocol based on the standards of the international consortium before it launches the clinical trial for ivermectin.

“Dahil po may mga nag-review ng ating mga protocol na galing sa international reviewers po ay binago po natin ang ilang aspeto sa ating protocol para mapaganda pa po ito,” Montoya said.

Montoya added that the clinical trial for ivermectin in the country is supported by major international health bodies like the World Health Organization (WHO), the National Institute on Health, and the Centers for Disease Control (CDC).

Also, he noted the importance of the clinical trial to come up with evidence on its effectiveness against COVID-19, with Filipinos as the concentration of the trial.

“Napakahalaga na magkaroon tayo ng lokal na datos tungkol sa mga Pilipino na nabibigyan ng gamot na ito, tungkol sa safety issue, sa mga side effects, kung ito po ay totoong mabisa sa mga Pilipinong may COVID-19,” he said.

“Kailangan gumawa pa ng clinical trial para magkaroon ng sapat na ebidensya kung ito ba ay magagamit o hindi para sa COVID-19,” he added.

Currently, the DOST’s requirements are being evaluated by the consortium’s ethics committee.

Once it is finished, the DOST hopes the clinical trial for ivermectin will push through this month as initially planned.

“Ito po sa kasalukuyan ay tinatapos na ang ethics at technical review bago po ito magsimula dahil ang target natin ay this month po ‘yan dapat magsimula,” he said.

Clinical trials on COVID vax for minors ongoing; no vaccine rollout yet for children in PH — PPS

Marje Pelayo   •   June 11, 2021

MANILA, Philippines — The Philippine Pediatric Society (PPS) confirmed that there are cases of COVID-19 among the country’s younger population.

However, no severe cases of COVID-19 among children have been recorded yet as the disease mostly affects the older age groups.

Though minors are considered low-risk, they still have to get vaccinated, according to a pediatric group.

“Kahit paano tinatamaan pa rin sila. Hindi naman natin masasabi kung sinong bata ang tatamaan at sino ang hindi. At least, protektado sila,” said Dr. Maria Karmela Kasala, spokesperson of the Philippine Pediatric Society.

Kasala said there are vaccines for minors that are under clinical trials in other countries.

“Other vaccine companies are also doing their own trials for these younger children. We have to wait for the results of those trials, at kapag nareview at na-evaluate na ng ating mga vaccine experts itong mga bagong studies sa mga kabataan. Kung nararapat sa ating (nakababatang) populasyon ay gagawan ng paraan para maipasok na sa priority vaccine rollout,” Kasala said.

The Food and Drug Administration (FDA) has recently allowed the emergency use of Pfizer’s Covid-19 vaccines for minors aged 12 to 15.

Meanwhile, China has also allowed the use Sinovac’s CoronaVac on children as young as three years old.

As for the Philippines, there is no approval yet from the government to inoculate the younger population with  available COVID-19 vaccines.

“Pero wala pang polisiya kung paano natin i-ro-rollout ang mga bakuna para dito sa mga edad na ito,” Kasala said.

She added that clinical trials on COVID-19 vaccines are ongoing around the world, but no results have been published yet.

“Ang ating mga bakuna, ang lahat ay naka-EUA pa sa buong mundo. In normal times, hindi pa iyan papayagang maibenta kasi kailangan ng certificate of product registration, at nakaraan sa clinical trial phase 4,” Kasala explained.

“Hindi na tayo umabot sa Phase 4 dahil nasa emergency pandemic tayo globally,” she said.

VCO as treatment for COVID-19 needs further study — DOST

Marje Pelayo   •   June 10, 2021

MANILA, Philippines — The Department of Science and Technology (DOST) cannot confirm yet whether virgin coconut oil (VCO) can treat COVID-19 based on current studies being conducted.

DOST Philippine Council for Health Research and Development Executive Director Jaime Montoya said that the Food and Drug Administration (FDA) has already approved VCO as a food supplement.

“Pero po para gamitin siya sa COVID-19 — although meron na po tayong pag-aaral na ito po ay nakatutulong para mas mabilis gumaling ang ating mga pasyente na may COVID-19— kailangan pa po natin gumawa ng karagdagang pag-aaral para maunawaan kung paano ito ginagawa ng VCO,” Montoya said.

“Huwag po tayong dedepende muna sa VCO para gumamot ng COVID-19, karagdagan lang po ito,” he said, adding that the application with the FDA also needs updating.

As for the initial results, the official said they have received positive feedback from the ongoing clinical trial which has been acknowledged already by the International Journal of Functional Foods.

“Nakatulong po ito upang mas mabilis na mawala ang mga sintomas,” he said of the clinical trial conducted in Sta. Rosa, Laguna for mild cases of COVID-19.

Montoya clarified that the VCO cannot be compared with COVID-19 vaccines in terms of benefits.

“Magkaiba po ‘yan. Ang bakuna po ay ibinibigay sa mga wala pang sakit and ibinibigay ‘yan para hindi sila magkasakit,” he said.

“Ang VCO po ay kasalukuyan pinag-aaralan natin kung may natutulong sa paggaling ng mga mayroong COVID-19,” Montoya explained.

He reiterated that the public still needs to get vaccinated to protect themselves from COVID-19.

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