DOST to launch study on COVID vaccine brand mixing by June

Marje Pelayo   •   May 25, 2021   •   235

MANILA, Philippines — The Department of Science and Technology (DOST) announced that it is launching a study into the mixing and matching of COVID-19 vaccine brands.

DOST Undersecretary Rowena Guevara said this mix and match project is a clinical trial agreed upon by the Department of Health (DOH) and the DOST to determine what will happen to the immunogenicity of a patient if his or her first and second doses are of two different brands, and if it’s safe specific to the Filipino ethnicity.

“Dalawang klase po ito. Iyong isa po ay ang first brand mo o dose ay iba sa second dose brand mo,” Guevarra said during the Laging Handa briefing on Tuesday (May 25).

“Iyong pangalawa ay nabigyan ka ng first at second dose ng parehong brand, titingnan kung pwede ka magkaroon ng booster na ibang brand,” she added.

The trials will be conducted using the vaccines available in the COVID-19 vaccine rollout.

It will run for 18 months, Guevarra said, but initial results will be issued after three months into the study to advise the National Task Force on vaccines.

The project is expected to start by the end of June or July.

“Sa ngayon kailangan munang pumasa ng ating protocols sa Food and Drug Administration (FDA) para magkaroon ng permit to conduct the clinical trial at kailangan din po silang makapasa sa ating tinatawag na Ethics and Review Board para makapagsimula na po sila ng kanilang study,” USec Guevarra said.

As for the safety of the participants, the official assured that they will be properly oriented to the risks and benefits of joining as volunteers in the study.

“Kasama sa protocol na isasubmit ng ating mga researchers sa FDA ay kung ano ang gagawin nila in case of emergency, kung magkaroon ng adverse event, at iba’t iba pang posibleng sitwasyon,” Guevarra noted.

“Kaya asahan nyo po na kung magpa-participate kayo dito ay sisiguraduhin po natin ang inyong safety,” she assured.

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.

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

Marje Pelayo   •   July 13, 2021

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.

DOH, may babala sa mga doktor na magbibigay ng COVID-19 booster shots

Robie de Guzman   •   July 12, 2021

MANILA, Philippines – Maaaring maharap sa parusa ang mga doktor na magbibigay ng booster shots ng COVID-19 vaccine, ayon sa Department of Health (DOH).

Ang babala ay ginawa ng DOH matapos sabihin ng isang mambabatas na nagpabakuna siya ng dalawang magkaibang brand ng bakuna.

Ayon kay DOH Undersecretary Maria Rosario Vergeire, hindi pa inirerekomenda ng mga eksperto ang paggamit ng booster shot dahil wala pa aniyang sapat na ebidensiya kung nakakadagdag ito sa immunity at ligtas sa kalusugan ng isang tao.

“Sana po huwag muna tayong mag-embark dito sa mixing and matching, iyong nagse-second dose ng ibang brand o kaya ay iyong nagpapa-booster dose dahil hindi pa po iyan recommended ng ating mga eksperto,” ani Vergeire.

Una nang inamin ni San Juan City Representative Ronaldo Zamora na nagpabakuna ito ng dalawang dose ng Sinopharm at dalawang dose ng Pfizer.

Aniya, inirekomenda ito ng kanyang mga doktor dahil sa siya umano ay immunodificient at nangangailangan ng dagdag proteksyon laban sa COVID-19.

“Sinabihan ako ng mga doktor, Congressman you are immune-deficient baka dapat mag-booster shot kayo. At kung magbu-boostershot kayo for your third, gawin n’yo nang apat para siguradong-sigurado… Sana hindi ako naririnig ni Sec. Duque ngayon,” ani Zamora.

Ayon sa DOH, hindi naabisuhan ang DOH sa hakbang na ito ni Zamora kaya paalala nito sa mga manggagamot sa bansa na sumunod sa umiiral na panuntunan sa pagbabakuna.

“This was something that they did between the individual and his physician… Nagpapaalala po tayo sa ating mga physicians, sa ating pong medical professionals, sana po ay sumunod tayo, mag-align tayo sa protocols ng gobyerno,” ani Vergeire.

Dapat din aniyang unahing mabakunahan ang mga indibiduwal na sakop ng mga sektor na prayoridad sa COVID-19 vaccination program ng pamahalaan.

“Katulad ng paulit-ulit naming sinasabi, let us give the chance for everybody to get vaccinated first before we think of booster doses. Iyan pong booster doses kapag may science na, may ebidensya na kompleto ay ipapatupad naman po natin pero katulad po ngayon na wala pa let us have that kind of protocol, let us align with the protocols iyan po muna ang ipatupad natin,” ani Vergeire.

Ayon sa DOH, posibleng sa ikatlong bahagi pa ng taon maglalabas ng mas konkretong pag-aaral ang vaccine expert panel kaugnay ng pagsusuri sa kaligtasan ng pagbibigay ng booster shot, gayundin ang mixing at matching ng magkaibang brand ng COVID-19 vaccines. – RRD (mula sa ulat ni Correspondent Aiko Miguel)

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