After seven months of quarantine, the novel coronavirus is still infecting hundreds daily. President Rodrigo Duterte has repeatedly told Filipinos to keep wearing masks and wait for a vaccine, which could take a while, according to experts.
Authorities have moved on to the next phase in the country’s fight against the novel coronavirus by coming up with a vaccine plan. The country’s vaccine czar, Carlito Galvez Jr., said immunization could start as early as May 2021 if everything goes smoothly.
The Philippines is part of the World Health Organization’s solidarity trials, with officials eyeing 10 vaccine candidates. Before any of those can run through the system of the Filipino population, it must first be scrutinized in a local vaccine clinical trial, which aims to test efficacy and safety.
What exactly is a vaccine clinical trial and why do we have to undergo one before getting a vaccine? We break down the Department of Health’s guide on vaccine clinical trials.
Here's what you need to know about vaccine clinical trials in the Philippines:
What makes a successful vaccine?
Vaccines should both be safe and effective. Affordability and accessibility are just as important. Ensuring that a vaccine can be distributed widely can help create herd immunity.
A successful vaccine should also put the general population at ease with its efficacy and safety.
Not all vaccines are the same.
Vaccine developers are coming up with different types of vaccines to yield an immune response against the novel coronavirus.
Some are protein-based, while some are genetic-based.
Each type has its advantages and drawbacks, which affect the vaccine’s route of administration.
What’s a vaccine clinical trial?
Clinical trials are medical studies that involve volunteers. The goal is to assess a vaccine candidate’s safety and efficacy before it’s mass-produced and rolled out to the public for use.
Vaccine clinical trials compare the results of those vaccinated versus those who aren’t to check if immunity is triggered or if protection is observed.
Why conduct clinical trials?
Before vaccines—or even forms of therapy or other medical procedures—are administered, they must first undergo clinical trials with volunteers in order to provide a scientific basis for use.
Any potential side effects, limitations, and important observations will surface once the vaccine is tested under controlled conditions.
How do clinical trials work?
First, a plan, called a protocol, must outline all the components of the trial. Said plan must be submitted for approval from several professionals and experts before clinical trials can begin.
How are participants chosen?
Those eligible to participate will be specified by the study criteria in identified study sites. All potential participants will be screened for inclusion and exclusion criteria.
Certain groups, such as healthcare workers, frontliners, and contacts of COVID-19 patients, may be prioritized.
What are my rights as a clinical trial participant?
- Right to know compensations, if any
- Right to privacy and confidentiality
- Right to beliefs
- Right to documents
- Right to post-trial care
- Right to complain
- Right to ask
- Right to full disclosure
- Right to be informed of the risks
- Right to clear information
- Right to decide
- Right to refuse
For more information, a detailed primer of participant rights has been uploaded by DOH.
How are volunteers grouped?
Volunteers will be randomly assigned to a specific study group. Some will receive a placebo, while another group will be administered the comparator vaccine. Their results will be compared afterwards.
What about side effects?
Finding a vaccine comes in three phases, with the first two to be completed before proceeding to clinical trials. By the time clinical trials with Filipino volunteers push through, vaccine candidates must have already passed safety standards from previous studies.
However, side effects may still occur.
These can be mild or localized, but there’s a slim chance a participant may react to a vaccine negatively.
For observed side effects, investigators and researchers must ascertain if they are causally-related to the administered vaccine.
Is a government agency regulating the study to protect participants?
The Food and Drug Administration is tasked with regulating the conduct of vaccine clinical trials in the Philippines.
What will be done to ensure safety of participants?
The FDA along with its partner evaluators will follow a strict review process for each trial to ensure the participants’ safety. The Department of Science and Technology’s Vaccine Expert Panel, which consists of experts and scientists in the field, and the Philippine Health Research and Ethics Board will work hand in hand with the FDA.
Who will monitor vaccine candidates?
An independent Data and Safety Monitoring Committee will be created to monitor the vaccine candidates under the World Health Organization Solidarity Trials.
What will be done prior to the vaccine’s potential approval?
Expert panels must assess the risks and benefits of the vaccine candidate. The safety and well-being of the participants are the number one priority, and the potential benefits of the vaccine must outweigh the potential risks.