The Philippines will be conducting a study that will look into the effectiveness of coronavirus vaccines in a real-world setting, Department of Science and Technology (DOST) Undersecretary Rowena Guevara said on Tuesday, May 25.
Guevara told reporters in a media briefing that the study will include all vaccines readily available in the country by the start of the study, targeted to begin in June.
“Real world data will answer questions on the effect of ethnicity because it will be given to Filipinos who will be vaccinated. Second, the most important question we want to answer is what is the efficacy of these [vaccines] over time? We don’t have clear answers for this yet because Phase 3 trials for all vaccines are not done,” Guevara said in a mix of English and Filipino.
The study on the performance of vaccines in a real-world setting will be one of two vaccine clinical trials the DOST will mount in 2021. A separate study will also be done to review the possibility of mixing vaccines brands in a two-dose regimen, as well as the use of a COVID-19 vaccine booster.
Guevara said the study on vaccines in a real-world setting will be led by the University of Philippines-Philippine General Hospital’s Dr. Nina Berba, an infectious disease specialist.
About P100 million is needed for the study, which will follow participants for about a year to review the effect of COVID-19 vaccines. Guevara said the number of participants who will take part in the study is pegged at about 1,000, though this was not yet final and was still subject to approval by the Food and Drug Administration (FDA).
Guevara said the DOST was eyeing to start the study as soon as the trial protocol was finalized and approved by the FDA.
What to expect
Participants of the study will include those who have not received a COVID-19 vaccine by the time the trial starts, Guevara said. This was needed as the study will include a “baseline workup” of volunteers’ health profiles before getting vaccinated.
“As they get vaccinated and as time passes, they will monitor the serological and clinical analysis from their blood to find out how effective or what is the efficacy of particular vaccines,” she added.
The study will match outcomes with age groups and comorbidities and seek to answer questions on how long immunity from particular vaccines may last.
Once approved and underway, the Philippines’ study on the impact of vaccines in a real-world setting will be the latest done in addition to similar studies conducted in Israel, the United States, United Kingdom, Chile, and Indonesia, among others. – Rappler.com