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DOST hopeful PH COVID-19 vaccine 'mix and match' trial will get FDA's approval soon
DOST hopeful PH COVID-19 vaccine 'mix and match' trial will get FDA's approval soon
The Department of Science and Technology (DOST) expressed hope Wednesday, Nov. 10, that the Food and Drug Administration (FDA) will soon give its go signal for the conduct of the “Mix and Match” (MnM) trial which seeks to determine the safety and immunogenicity of mixing different coronavirus disease (COVID-19) vaccines and vaccine platforms in Filipino adults.
DOST Undersecretary for Research and Development (R&D) Dr. Rowena Cristina Guevara, who heads the Task Group on Vaccine Evaluation and Selection (TG-VES), said they were eyeing to start the 18 month-long study this November.
“We wish to start this November and are hopeful that FDA will soon issue clinical trial approval,” she told the Manila Bulletin in a VIber message.
She said while awaiting for the FDA clearance of the clinical trial protocol, there were ongoing site preparations for the start of the study this November.
Guevara said vaccine deliveries and allocation were made in coordination with the Department of Health-National Vaccination Operations Center (DOH-NVOC).
“So far, vaccine doses for the study have been delivered to Marikina and Muntinlupa,” she said.
The MnM study is led by Dr. Michelle De Vera of the Philippine Society for Allergy, Asthma, and Immunology. It was initially targeted to start by June this year.
The DOST-Vaccine Expert Panel (VEP), Single Joint Research Ethics Board (SJREB), and site institutional review boards have already approved the conduct of the study.
The project, “A study evaluating the safety and immunogenicity of mixing different COVID-19 vaccines and vaccine platforms in Filipino adults”, is expected to enroll 3,000 unvaccinated participants aged 18 years old and above.
Guevara said the study aims to determine the safety and immunogenicity of completing the vaccination series with available COVID-19 vaccines in the Philippines in those given Sinovac as the first dose.
The multi-site, convenience sampling, unblinded trial will also analyze whether those who already completed the dosing regimen for Sinovac will have a better immune response after the immunization of a booster dose from a different vaccine platform or brand.
The DOST official expressed hope that by “late December or early January” they will know the best vaccines or vaccine platforms that can be mixed.
She explained that the local clinical data to be generated from the Filipino people on the interchanging of available COVID-19 vaccines in the Philippines can serve as the basis for deciding which vaccines/vaccine platforms can be mixed, which may be applied by the Department of Health (DOH) for an Emergency Use Authorization (EUA).
The relevant data generated may provide basis for the guidelines/policies of the DOH on the vaccination rollout especially during situations of limited vaccine supplies or vaccine shortage, she said.
Locally available vaccines under the National Immunization Program will be used in the trial. These include Sinovac, Sputnik V, AstraZeneca, Pfizer and Moderna.