The Department of Science and Technology (DOST) said Friday, Nov. 12, that the recruitment of 3,000 participants for the country’s “Mix and Match” (MnM) study has yet to start.
DOST Undersecretary for Research and Development Dr. Rowena Cristina L. Guevara said they have to wait for the approval of the Food and Drug Administration (FDA) before they start the recruitment of the unvaccinated participants aged 18 years old and above.
The 18 month-long project, “A study evaluating the safety and immunogenicity of mixing different COVID-19 vaccines and vaccine platforms in Filipino adults”, is expected to enroll 3,00 participants in five cities —Manila, Marikina, Muntinlupa, Davao City and Dasmariñas City.
“Sa kasalukuyan, hindi pa tayo nagrerecruit kasi Inaantay pa natin ang final approval ng FDA bago tayo magsimula ng pagbabakuna ngunit ang project team ay handa naman po na (Currently, we are not yet recruiting because we are still waiting for the final approval of the FDA before we start vaccination but the project team is ready,” Guevara said during the Laging Handa briefing on Friday.
She said the project team, led by Dr. Michelle De Vera of the Philippine Society for Allergy, Asthma, and Immunology (PISAAI) is closely coordinating with the involved local government units (LGUs) to ensure the deployment of personnel to the vaccination sites.
The MnM trial seeks to determine the safety and immunogenicity of mixing different coronavirus disease (COVID-19) vaccines and vaccine platforms in Filipino adults.
Guevara expressed hope that the FDA will soon approve the study.
“Binibilisan talaga ng FDA ang pag-aapprove nitong mga clinical trials natin kung dati anim na buwan, ngayon less than 21 days nilalabas nila (The FDA is actually speeding up the approval of our clinical trials, before it was six months, now they release it less than 21 days),” she said.
Guevara said De Vera’s team has been coordinating with the DOST and Department of Health (DOH) for the conduct of training on “Good Clinical Practice”, deployment of personnel, and the preparation of the vaccination sites as well as the delivery of the coronavirus disease (COVID-19) vaccines that will be used in the trial.
“Sa kasalukuyan, ongoing ang pagsasagawa ng virtual site initiation visit (SIV) ng project team kasama ang kanilang clinical research organization (CRO) (Currently, the project team is conducting a virtual site initiation visit (SIV) with their clinical research organization (CRO),” she said.
The DOST official said the interim analysis or preliminary results may be out after the enrolment of 1,000 participants which is expected to be completed within two to three months.
“Ang pagbabakuna ay tatagal lamang ng hanggang limang buwan, ngunit ang mga participants ay i-fa-follow up at pangangalagaan na project team na binubuo ng medical experts ng hanggang isang taon (The vaccination will only last up to five months, but participants will be followed up and cared for by a project team consisting of medical experts for up to a year),” she said.
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, she said.
The DOST official 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 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.