MANILA, Philippines — The Department of Health said safeguards such as safety surveillance and pilot implementations will still be in place after it recommended doing away with the final stage in the clinical trials for potential coronavirus vaccines.
Lawmakers inserted a waiver in the proposed Bayanihan to Recover as One Act that allows the government to purchase coronavirus vaccines even if they are yet to undergo Phase 4 clinical trials or the final stage in the vaccine development process in a bid to fasttrack procurement.
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The waiver will overrule the Universal Health Care Act, which bars the government from buying drugs and vaccines that did not pass Phase 4 trials.
The DOH, along with the Health Technology Assessment Council and the Food and Drug Administration, said it recommended waiving the requirement of a Phase 4 in the clinical trials. In Phase 4 or the post marketing surveillance trials, the long-term safety and the effectiveness of a drug or vaccine are evaluated.
“We were part of that group which has recommended for the exemption for the Phase 4 clinical trial. This is for us to expedite the process so we can use the vaccines as soon as possible once it reaches the country,” Health Undersecretary Maria Rosario Vergeire said in a media briefing Monday.
Vergeire added the accelerated process of clinical trials has been done before in responding to threats of Ebola and meningitis.
The health official assured the public that even without the final stage, safeguards will be in place. These include safety and surveillance monitoring following the recommendations of the World Health Organization, the setting up of a database of recipients of the vaccine, risk communication on the benefits and risks of vaccine and the conduct of a pilot implementation before mass roll out.
“These are the safeguards that we have included. It will be just like having Phase 4 clinical trials. The process has been slightly relaxed but the safeguards are still there,” Vergeire said.
The country is in talks with 16 pharmaceutical companies that are developing coronavirus vaccines worldwide.
Last week, the WHO Western Pacific office urged countries to focus on improving their response to slow the spread of COVID-19 instead waiting for a vaccine to be developed and distributed.
The country’s coronavirus caseload reached 189,601, with 131,459 recoveries and 2,998 deaths.