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Duque says he's hesitant to endorse waiver by PH of Phase 4 clinical trials in COVID-19 vaccine development
Duque says he's hesitant to endorse waiver by PH of Phase 4 clinical trials in COVID-19 vaccine development
Health Secretary Francisco Duque III on Tuesday admitted he is hesitant to endorse plans for the Philippines to participate in a COVID-19 vaccination plan that did not undergo Phase 4 clinical trial.
Duque said the fourth phase in vaccine development is critical as this is the completion of the post marketing surveillance and is meant to ensure that a novel vaccine is safe and efficient for use of thousands and millions of people.
“Just to ensure that this, being a new vaccine, the Universal Health Care law requires that this is undertaken to ensure the safety of the product, as we all know, that any new product has some heightened risks. And so, critical trial phase 4 is really meant to protect (people),” Duque said responding to Senate minority leader Franklin Drilon’s question during the Senate inquiry on Philippine Health Insurance Corp. or PhilHealth.
Asked by Drilon if he would endorse moves to dispense with a Phase 4 of clinical trials on COVID-19 vaccines, Duque said he would not, considering it is a novel vaccine and the situation is evolving.
“It’s very difficult to answer but…no, no sir, knowing what I know,” Duque said.
However, Sen. Pia Cayetano pointed out it is imperative that the Department of Health (DOH) soon decide on the matter since Congress is finalizing the Bayanihan to Recover As One Act or “Bayanihan 2.”
“If the phraseology in the Bayanihan (2) Law would be such that, if WHO (World Health Organization) and other countries with recognized and mature FDAs (Food and Drug Administration) would approve the waiving of a Stage 4. Would that seem acceptable to you?” Cayetano asked.
“If WHO endorses, or these countries with mature FDAs - and I understand mature FDAs include the US, UK, and Russia din pala - so if they would allow and they are okay with doing away with that, are you prepared to endorse it or do you even have to consult other experts? Hindi po kayo epidemiologist, hindi po kayo microbiologist, so do you need time to consult? Because this is very important to us,” she stressed.
To which Duque replied: “I will consult the experts, your honor. But having said that, one of the guiding principles in our pandemic response is that science should be the basis of whatever decision we make, whether to wait for Phase IV or to... We have to be open to the experts, but we have groups of experts as well, some opposing each other, some very divided, but some have very strong consensus.”
“Makikipag-usap po kami (we will consult with them). How much time can we be given, your honor?” Duque asked.
Cayetano responded that the bicameral conference committee is hoping to wrap up the final version of the Bayanihan 2 on Wednesday. “I think our deadline is tomorrow. But this is a crucial issue,” she said.
She said she fears that the Philippines could be left behind if other countries decided to waive Phase 4 of the clinical trials for COVID-19 vaccine while the government decides to wait for the final stage before approving it.
Among the vaccines being considered by the government are Moderna from the United States, Sputnik V from Russia and one from China.
“Natatakot lang po ako, kasi nami-misquote tayo sa mga napakahalagang issue na ganito (I am afraid because we are usually misquoted over important issues like this). For the record, the reason there is a provision like that in the draft is precisely because we wanted to ensure that if WHO and countries with mature FDAs like the US are already using the vaccines, and they have decided to waive stage 4, then hindi naman pwedeng tayo lang ang nakatali, yung buong mundo, nag-vaccine na (we can’t afford to be tied on this, while the rest of the world have already been vaccinated),” she pointed out.
On the other hand, Cayetano said she does not “believe in legislating science.” Congress, however, is in a rush to approve the Bayanihan 2, which aims to boost the country’s COVID-19 efforts and revive the Philippine economy battered after the series of lockdowns imposed to contain the spread of the disease.
“That’s why we are asking these questions. Because precisely, we want to craft the wording such that we are basing decisions on science. For the record because it is very important that our country’s confidence in vaccination is preserved,” she said.
“Because we already went through a trauma on vaccinations with Dengvaxia. Our country cannot afford another trauma. We cannot afford millions of infants not being vaccinated for measles, for chickenpox, for smallpox, for the polio drops, because of erroneous decisions on this, Mr. President,” Cayetano pointed out.
Sen. Francis Tolentino, meanwhile, expressed his disappointment at Duque for “dilly-dallying” on crafting a clear roadmap for a COVID-19 vaccine acquisition.
“Let me remind you Mr. Secretary that your dilly-dallying and semblance of evasion in answering the question is probably reflective of your non-bravery being the field marshall of this pandemic war,” Tolentino retorted during the hearing.