Here’s what you need to know about the process of approving clinical trials, when a COVID-19 vaccine might be rolled out, and who might receive it first
Over 8 months into the pandemic, scientists around the world continue their search for a viable COVID-19 vaccine as countries continue to fight the spread of the new virus that has infected millions.
Here in the Philippines, a panel of vaccine experts under the Department of Science and Technology (DOST) has been reviewing a roster of potential vaccines with the interest of conducting Phase 3 clinical trials in the country.
Filipino diplomats abroad have also been in talks with vaccine developers and manufacturers to make sure the Philippines has access to an effective vaccine once it becomes available. Among these are vaccines being developed in the US and China.
But these efforts are only half the challenge in ensuring Filipinos are able to receive a COVID-19 vaccine once it is ready for mass use.
While clinical trials and discussions take place with vaccine developers, any potential vaccine will still need to go through regulatory processes in the Philippines before studies here can begin, or the use of vaccines can be allowed.
That includes vaccines President Rodrigo Duterte has shown a preference for – like Russia’s Sputnik V COVID-19 vaccine and those being developed by research and pharmaceutical firms in China or the United States’ Moderna.
Here’s what you need to know about how the Philippines will approve trials, how they will be regulated, and when a COVID-19 vaccine might be rolled out to the public.
What’s a clinical trial?
Clinical trials are a type of research that evaluates potential medical interventions that affect humans’ health. During trials, medicines, treatments, procedures, and devices may be tested to study or verify their clinical or pharmacological effects before they are approved for public use.
Trials need to be carefully designed, reviewed, and approved before they can start. Like most clinical trials, tests for a COVID-19 vaccine consist of 3 phases to determine its safety and efficacy.
In the Philippines, the Food and Drug Administration (FDA) is the body tasked with regulating clinical trials.
Why regulate trials?
Clinical trials deal with humans as subjects. FDA Director General Eric Domingo said this means that in any study, “the primary concern is always their human rights and safety.”
By regulating trials, there is oversight in the way these are crafted, ensuring that trials meet good clinical practice standards and are able to ethically conduct tests involving humans.
What might this look like? Domingo said participants should be able to understand fully what trial they are volunteering to join, as well as its benefits and risks. Volunteers should also know what safeguards will be afforded them, like close monitoring, checkups, and health insurance. Participants should also be free to leave the study.
In regulating trials, the FDA will also form its own panel of experts to review adverse events that could occur during trials. This will be apart from the clinical trial expert team and safety monitoring committee part of the DOST.
Aside from this, clinical trials are regulated to ensue the integrity of data collected, which will be used to determine whether or not a treatment is ultimately safe and effective. This is especially true in the case of vaccines, which require extreme safety since they are designed to be given to millions of healthy people.
Who can conduct trials?
Only establishments with an FDA-issued license to operate as a clinical trial sponsor or contract research organization can conduct trials in the Philippines. This ensures that the group carrying out the research is legitimate and has the capacity to conduct such studies.
In the case of Phase 3 clinical trials for COVID-19 vaccines, interested groups will also need to secure the endorsement of the Philippines’ vaccine expert panel (VEP) and ethics review board.
The added step in securing approval from the country’s VEP and ethics board is unique to COVID-19 vaccine trials, Domingo said, because the global search for a vaccine has become much more accelerated due to the pandemic.
In this case, the VEP reviews data from Phase 1 and 2 trials of vaccine development companies that intend to conduct Phase 3 trials in the country. Meanwhile, the ethics board ensures that prospective trials will be carried out in such a way that the rights and health of volunteers are protected.
What vaccine companies are interested in trials?
So far, health officials cited China’s Sinovac and Russia’s Sputnik V among candidate vaccines that could possibly see independent trials in the country.
For Russia’s COVID-19 vaccine, the VEP is still evaluating data from phases 1 and 2 of its clinical trials. According to the New York Times’ vaccine tracker, this vaccine is a “combination of two adenoviruses, Ad5 and Ad26, both engineered with a coronavirus gene.”
As for Sinovac, the VEP has endorsed this to the FDA. Domingo said the agency is anticipating the submission of its application for Phase 3 trials after it gets the endorsement of the ethics board.
Vaccine experts under the DOST also earlier identified vaccines that were being developed by Sinopharm in China, as well as Addimune Corporation and Academia Sinica in Taiwan, as possibly conducting Phase 3 trials in the Philippines.
Sinopharm, however, told Philippine health officials it was no longer interested in pushing through with Phase 3 trials in the country and was instead looking to head straight to providing possible supplies. (Over 1,000 Filipinos are participating in Phase 3 trials being done in the United Arab Emirates.)
These independent trials are separate from the World Health Organization’s solidarity trials for vaccines, which the Philippines will also participate in.
Domingo said it may take at least 21 days for FDA regulatory reviewers to evaluate and process applications of companies seeking to do trials. This includes 14 days for initial evaluation and a period of 7 days for applicants to respond to any clarifications.
After this, the FDA is expected to issue a decision on applications in not more than 8 days after it receives the recommendation of regulatory reviewers.
Vaccine experts earlier eyed to have Phase 3 trials start by October, though this has been moved to November 2020.
After trials, what happens next?
Once clinical trials are successfully completed and a vaccine is demonstrated to be safe and effective for humans, companies can apply for a certificate of product registration. The FDA is again in charge of evaluating and approving these.
Conducting Phase 3 clinical trials in the Philippines is not a prerequisite for a vaccine to be registered for use in the country.
In evaluating a vaccine or any type of medicine, the FDA reviews its scientific data and can also consult with other similar regulatory bodies in other countries to compare findings.
Apart from this, the Philippines is also a participant in the Global Alliance for Vaccines and Immunization COVAX facility designed to guarantee rapid, fair, and equitable access to COVID-19 vaccines worldwide.
When will a vaccine be available – and who will receive it first?
Experts are hopeful that a vaccine may be available for wide use sometime during the first half of 2021.
While many candidate vaccines are still in their development phase, manufacturers have also begun the work of preparing for production and distribution.
In the Philippines, the Department of Health (DOH) is in the planning phase of how to handle the complex procurement, storage, and distribution of vaccines once they are available.
In administering the vaccines to Filipinos, the DOH has experience in carrying out mass vaccination programs through similar campaigns done in the past for vaccine-preventable diseases like measles and polio.
Duterte earlier said he wanted the entire Filipino population inoculated with a COVID-19 vaccine “without exception,” adding that his goal was for the government to shoulder the costs for the country’s 113 million population.
This remains unlikely for now. In reality, the DOH said it lacked P10 billion of the P12.1 billion needed to vaccinate an initial priority population of 20 million Filipinos.
Initial priority groups include health workers and indigent citizens. – Rappler.com