Vaccine 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.
The 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
Independent Trials, where other vaccine developers can conduct independent clinical trials in the Philippines provided that they will be able to fund their own trials and have their application registered and approved by the FDA.
The Task Group on Vaccine Evaluation and Selection (TG VES), composed of the Department of Science and Technology, Department of Health, Food and Drug Administration, Research Institute for Tropical Medicine , Department of Foreign Affairs, Department of Trade and Industry - Board of Investments and the National Development COmpany, oversees the applications for the conduct of clinical trials in the country, and evaluate the results of these trials. The TG VES provides recommendations on which vaccines will be considered for negotiation and procurement by evaluating: safety, efficacy and other relevant data from clinical trials, existing evidence and updates on vaccine development, and international recommendations on vaccine use.
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.