The Philippines will likely start by end of this month or early November its “Mix and Match” trial or MnM study 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 the actual trial has yet to start because it needs to secure the approval of the Food and Drug Administration (FDA)
She said the recruitment of the participants is still ongoing, and the dry run in Muntinlupa City and Davao City in preparation for the actual trial will push through this week.
“Ang paggawa ng mga mix and match and any vaccine trial, kinakailangan ng dry run so may dry run tayo ngayong lingo sa Muntinlupa at saka Davao at pag okay na ang dry run saka talaga tayo mag-uumpisa, so malamang end of the month or early November tayo magstart talaga (For the conduct of mix and match and any vaccine trial, we need a dry run so we have a dry run this week in Muntinlupa and then Davao and when the dry run is okay, we will really start, so probably end of the month or early November, we will start the actual trial),” Guevara said in an interview with TeleRadyo on Monday, Oct. 25.
To be led by Dr. Michelle De Vera of the Philippine Society for Allergy, Asthma, and Immunology, the 18 month-long study seeks to determine the safety and immunogenicity of mixing different coronavirus disease (COVID-19) vaccines and vaccine platforms in Filipino adults.
The study was initially targeted to start by June this year.
In a separate interview with the Manila Bulletin, the DOST official said while the study has already secured approvals of the DOST-Vaccine Expert Panel (VEP), Single Joint Research Ethics Board (SJREB), and site institutional review boards, it has to be approved by the FDA.
"We are waiting for clinical trial approval from FDA before the project team can start. While waiting, the project team has already delivered the vaccines in Marikina City last Oct 11,” Guevara said.
The DOST had bared around 400 doses of Sinovac vaccines have already been delivered to the Marikina City site for the dry run.
"Deliveries for Muntinlupa City is scheduled this week. For Davao, an MOU (memorandum of understanding)/MOA (memorandum of agreement) between PSAAI and the LGU will precede the dry run,” Guevara said.
READ MORE: https://mb.com.ph/2021/10/22/dost-ph-covid-19-vaccine-mix-and-match-trial-may-start-soon/
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.