News and Updates
Clinical TrialsVaccine clinical trials, a type of clinical research study, are medical studies that involve people. This is a process of evaluating the safety, immunogenicity, and protective efficacy in humans of a novel vaccine candidate before it can be licensed for use. Clinical trials are carefully designed, reviewed, and completed, and need to be approved by the Food and Drug Administration (FDA) before they can start. People who meet the inclusion criteria can take part in clinical trials. Vaccine development is a lengthy and a rigorous process. Before a vaccine candidate is even tested among people, it has to pass the preclinical stage of development first where it is tested on animals to see if it will cause an immune response.
PH ResponseThe clinical development is divided into three phases: For phase 1, the vaccine is tested in small groups of people to assess its safety. The coverage is expanded in Phase 2 to assess the efficacy, right dosage, and ensure that the desired effects are achieved. Phase 3 covers a larger group of people to confirm its efficacy and safety when compared to other treatments. This whole process usually takes years to complete. In the Philippines, our clinical trials are categorized into two: WHO Solidarity Vaccine Trial, as approved by the Inter-Agency Task Force for the Management of Emerging Infectious Diseases Resolutions (IATF) Resolution No. 47, as part of our country’s commitment to make the COVID-19 vaccine available in the soonest time possible for the Filipino people.
- The Solidarity Vaccine Trial is a global action led by WHO to:
- to evaluate vaccine candidates as quickly as possible (identify vaccine candidates and their progress)
- to define the desired characteristics of safe and effective vaccines to combat the pandemic, and
- to coordinate the clinical trials across the world giving the best chance of safe and effective vaccines for all
Why should the Philippines participate in the ongoing clinical trials for COVID-19 vaccines?Considering the current limitations of our country in terms of vaccine development, participation in clinical trials of the most advanced candidates developed by international partners will be the best short-term strategy for us. Participation in these clinical trials will secure a shorter and easier route in registration with the Philippine Food and Drugs Administration (FDA). By pursuing collaborations and by participating in clinical trials, we are hoping to:
- To provide efficacy and safety data for a vaccine that is directly attributed to the Filipino population
- To generate necessary long-term data on safety and efficacy of vaccines, which is also necessary for CPR application even for vaccine candidates with an EUA
- There are still a lot of unknowns about COVID-19 especially on whether this will be like flu in the long run which will need follow-up yearly vaccinations.
- With new COVID-19 variants being identified, tweaking of vaccine candidates or their dosing schedule may also be needed to improve their efficacy and clinical studies are needed to confirm this.
Get the Latest News and Updates, https://doh.gov.ph/vaccines