People may be wondering what is the difference between the vaccine clinical trials, which involved the Task Group on Vaccine Evaluation and Selection (TG-VES) of the Department of Science and Technology (DOST) and the actual vaccination program that is set to be implemented by the Duterte government within this month.
Department of Science and Technology Secretary Fortunato T. de la Peña is gracious enough to walk us through how clinical trials are being conducted.
"'Yung clinical trials na involved ang DOST through the Task Group on Vaccine Evaluation and Selection ay part pa ng process bago makabuild ng sufficient basis to determine its safety and efficacy (The clinical trials involving the DOST through the Task Group on Vaccine Evaluation and Selection are still part of the process before building a sufficient basis to determine its safety and efficacy),” he told the Manila Bulletin.
He said in general, there were three phases after animal trials.
Phase 1 to Phase 3 for humans, if it is for drug or vaccine, he explained.
"Sa Phase 1 ang ino-observe ay toxicity or harmful effects with just a few samples like 30 or something less than a hundred. Then kung walang observed toxicity or harmful effects, you proceed to Phase 2 where you get a bigger sample which is already in the hundreds. Safety pa rin ang main concern in the trials (In Phase 1, we observe the toxicity or harmful effects with just a few samples like 30 or something less than a hundred. Then if there is no observed toxicity or harmful effects, you proceed to Phase 2 where you get a bigger sample which is already in the hundreds. Safety remains the main concern in the trials),” de la Peña said.
"Then if it is shown that it is safe this is when you go to Phase 3 where your concern is efficacy or effectiveness to make one immune from the viral disease. Here you talk of thousands already,” he further explained.
The DOST Chief noted that it is only when the vaccine is found safe and efficacious that the developer applies for Food and Drug Administration (FDA) approval to market.
"It may also be advantageous to do the Phase 3 with different ethnic groups because different ethnic groups may exhibit different efficacies. So if they do a Phase 3 in a country like the Philippines, the vaccine developer gets more data that could help them in applying for approval in this country,” he said.
"The country also benefits because they see how it performs on their people,” he added.
In all of these the procedure or protocol should get the approval of the Health Research Ethics Board in that place because in all experiments involving humans and animals an ethics clearance is required, de la Peña said.
“In certain cases even if the vaccine has no FDA approval yet for commercial distribution a vaccine can be allowed to be used under an Emergency Use Authorization (EUA) approval but in these cases, only the Department or Ministry of Health or its equivalent can procure the vaccines,” he said.
He said a vaccine is not required actually to do clinical trials in a country before applying for an EUA or for an approval for commercial distribution.
"The EUA takes a shorter time for approval compared to the approval for commercial distribution because in the EUA case it is still considered to be in Phase 3 trials.”
"During trials the volunteers are usually divided into two. One group is a control group, the other group receives the vaccine under trial. The control may be receiving placebo or it may be receiving a vaccine with which the vaccine under trial is being compared.”
On the other hand, vaccine rollout is the actual vaccination program.
DOST Undersecretary Rowena Cristina Guevara, who heads the TG-VES, said the Philippines’ quest to look for "vaccines that will be affordable, accessible and available, and even better than those that have received EUA, so far” continued.
So far, three vaccine developers were approved to conduct their Phase 3 clinical trial in the Philippines. These were Janssen Pharmaceuticals, Sinovac Biotech, and Clover Pharmaceuticals.
The Philippines has signed a Confidentiality Disclosure Agreement (CDA) with at least 12 vaccine developers in relation to the vaccine trial.
The Task Group on Vaccine Evaluation and Selection, chaired by DOST inked CDAs with the following vaccine developers: Janssen, Sinovac Biotech, AstraZeneca, Gamaleya Research Institute, Sinopharm Group, Anhui Zhifei, University of Queensland, Adimmune Corporation, Academia Sinica, Tianyuan Biopharma, Bharat Biotech and CureVac.
De la Peña said 19 of the 25 vaccine developers that were working with the Task Group have signified their interest to conduct clinical trials in the country.
He noted that the 25 vaccine developers hail from 10 countries: six each from China and the United States, three from Chinese Taipei, two each from Russia, Australia, and Germany; and one each from India, Japan, United Kingdom, and Canada.