A government official on Wednesday assured the public that the “best science and best available evidence” are the primary basis for determining which Covid-19 vaccines the government should procure.
“Accelerating the development of a vaccine does not mean that we are sacrificing quality, much less its safety and effectiveness,” said Jaime Montoya, executive director of the Department of Science and Technology Philippine Council for Health Research and Development (DOST-PCHRD), during a Laging Handa press briefing.
“Ensuring that a particular vaccine has undergone rigorous, scientific, and regulatory processes will strengthen our confidence in vaccines,” he said.
He assured that the government is adhering to scientific standards to ensure that vaccine candidates are safe and effective for humans.
Series of laboratory practice and clinical research are also done with the highest ethical standards, he added.
“It is through clinical trials or evaluation of investigational products involving humans, the scientists observe and evaluate the safety and efficacy of a vaccine under development,” Montoya said.
He said the vaccine pre-licensure requirements involve three clinical testing phases.
Phase 1 involves tests if the vaccine is safe for humans, he said.
Phase 2 includes the monitoring of the vaccine’s safety and determines the optimum dose and schedule.
Meanwhile, Phase 3 trial, which may involve tens of thousands of volunteers, evaluates the efficacy of the vaccine in disease prevention and provides further safety information in a larger population.
After a vaccine is authorized, it goes through a Phase 4 trial, where long-term effects are studied.
DOST earlier formed a Task Group on Vaccine Evaluation and Selection which oversees the evaluation of applications and Covid-19 vaccine clinical trials in the country.
“Since several Covid-19 vaccines are being developed, the creation of the task group on scientific selection and evaluation is the first stage of the government’s vaccine roadmap which ensures that we choose the best vaccine that is safe and effective for Filipinos,” he said.
Under the vaccine roadmap, a vaccine experts panel composed of Filipino scientists and vaccine experts will evaluate scientific data on the safety and efficacy of vaccine candidates obtained from clinical trials, Montoya added.
“The data from clinical research must show that the vaccine’s benefits outweigh the potential risks for people who will be recommended to receive the vaccine,” he said. “Only if a vaccine’s benefits are found to outweigh the potential risks, that the FDA grants a license for the vaccine, allowing it to be used by the public.”
To ensure the highest scientific and ethical standards are followed, Montoya said the results obtained from the clinical trials should be evaluated by the Food and Drug Administration (FDA) to assess the safety and effectiveness of each vaccine.
The FDA will give the final approval and licensing of vaccines.
“In compliance to scientific standards in evaluating and monitoring vaccines, it does not stop after approval and licensing as the FDA still regularly monitors vaccination programs, vaccine manufacturing facilities and even contract with such organizations during clinical trials to make sure that they are following strict regulations,” Montoya said.
Montoya said the approval of the FDA is a necessary requirement prior to administering Covid-19 vaccines, once supplies are available.
“It is the role of experts, advisory committees and regulatory bodies to assess the data on the efficacy of a particular vaccine as there are scientific guidelines and recommendations being followed to ensure that the vaccine candidates meet certain qualifications,” he said.
He said the applicability will depend on the pre-clinical and clinical results of each vaccine, hence the need to carefully evaluate available data.
“I would like to ensure the public that the best science and the best available evidence is the basis for determining which vaccines will be available to the Filipino people as determined by its safety and efficacy,” Montoya said.
Source: Philippines News agency