The Philippines’ study on the safety and efficacy of mixing and matching five brands of coronavirus disease (COVID-19) vaccines is expected to start in July, the Department of Science and Technology (DOST) said Thursday, June 3.
DOST Undersecretary for Research and Development Rowena Cristina L. Guevara, who chairs the Task Group on Vaccine Evaluation and Selection (TG-VES) said they are expecting the proponents from the Philippine Society for Allergy, Asthma, and Immunology (PSAAI), led by Dr. Michelle De Vera to conduct the study by next month.
"Ang aming target by July ay makapag-umpisa na sila. Ngayong buwan ng June ang gagawin nila ay yuong application po for FDA (Food and Drug Administration) clearance to conduct the clinical trial at saka yung tinatawag na Ethics Review Board clearance (Our target is they can start by July. This whole month of June, they will file an application for the FDA clearance to conduct the clinical trial and secure the Ethics Review Board clearance),” she said during the televised Laging Handa briefing on Thursday.
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DOST Secretary Fortunato T. de la Peña had maintained that before the study commences, it has to be approved by the FDA and the Philippine Health Research Ethics Board (PHREB).
Guevara said five vaccine brands will be used for the PSAAI study, which was initially targeted to start by June this year. These are Sinovac, Sputnik V, AstraZeneca, Pfizer and Moderna.
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She said the clinical trial, which will be conducted for 18 months, will involve 3,000 participants aged 18 and above.
"Ngayon po meron po tayong labindalawang eksperimento na gagawin, na tag 250 bawat isa yun pong tinatawag na same vaccine platform (We will conduct 12 experiments with 250 participants each, which we call same vaccine platform),” she noted.
Guevara said the participants will come from A1 to A4 priority groups under the country’s inoculation program amid fears that such study will affect the country’s vaccine supply.
“Yun pong gagawan ng study sila naman po ang priority dito sa ating vaccination program, A1 hanggang A4 so hindi po mababawasan ang supply kasi sila naman po talaga ay kasama sa babakunahan. (The participants in the study are those in the priority list of our vaccination program, A1 to A4 so the supply will not be reduced because they are actually included in the vaccination),” she explained.
She said the study will look into the efficacy of the booster doses, apart from determining the safety and immunogenicity of interchanging vaccine brands to complete COVID-19 vaccine series.
The DOST official said the study aims to determine if the high-risk population who already completed the dosing regimen of the Sinovac vaccine would elicit a better immune response after the immunization of a booster dose from a different vaccine platform or brand.
Related stories: https://mb.com.ph/2021/05/21/ph-allocates-p133-million-to-conduct-study-on-mix-and-matching-covid-19-vaccine-doses-dost/