DOST exec allays fears of having COVID-19 vaccine sans clinical trials in Philippines

An official of one of the agencies under the Department of Science and Technology on Saturday allayed fears that a COVID-19 vaccine will be approved for use via an emergency use authorization in the country even without prior local clinical trials.

"Ang emergency use authorization ay isang form of approval din na binibigay sa mga bakuna kahit hindi pa sila tapos sa kanilang clinical trial basta makapagbigay sila ng evidence na maganda naman ang resulta ng mga clinical trial o interim analysis," Dr. Jaime Montoya, executive director of the Philippine Council for Health Research and Development under DOST, said in an interview on Dobol B sa News TV.

"Kahit ito ay emergency use authorization, wala pong mga shortcuts. Ito ay masusing pag-aaralan ng ating mga expert, unang-una ng ating vaccine panel. Dadaan din 'yan sa ethics review. At ikatlo ang regulatory approval na ibibigay ng FDA [Food and Drug Administration]," he said.

"Ginagawa ito [EUA] 'pag may public health emergency katulad ng COVID-19 pandemic," he added.

Montoya said those who will receive the vaccine in the country will be monitored closely for one to two years at the minimum to ensure efficacy.

He also said that even before a vaccine is approved by the FDA, the vaccine expert panel already reviews initial data.

"Kahit hindi pa ho sila nagsa-submit ng aplikasyon para sa registration [sa FDA], may mga pangunang datos na tinitingnan ang ating  vaccine expert panel," Montoya said.

He added that the FDA will also check if the vaccine developer has been given EUA in the country of origin.

"Hindi sila puwedeng mag-apply ng EUA sa ibang bansa kung hindi sila naaprubahan muna sa kanilang home country," Montoya said.

On Wednesday, Malacañang announced that President Rodrigo Duterte, through Executive Order 121, has allowed the FDA to issue an EUA for COVID-19 drugs and vaccines.

With this, FDA approval of a drug or vaccine can be expected in 40 days or less instead of the usual six months, Montoya said Thursday.

The Philippines is eyeing to acquire vaccines developed by the United States, China, Russia, and the United Kingdom with the government assuring that the vaccination program is still on track to be implemented by next year.

“Our best case scenario that we have presented is more or less May but for now, if we will succeed in negotiating [for] two to three vaccines from different countries, we might be able to get it during the first quarter,” National Task Force Against COVID-19 Chief Implementer Carlito Galvez Jr. said at a recent Laging Handa briefing.

Last Friday, the Philippine government, the private sector and AstraZeneca signed a tripartite agreement for the country to secure a supply of 2.6 million doses of the pharmaceutical firm’s potential COVID-19 vaccine.

This supply, to be paid for by the private sector, will inoculate over one million Filipinos as the British drugmaker's vaccine requires two doses.

The Department of Health clarified however that the COVID-19 vaccine developed by AstraZeneca and Oxford University should first get the nod of the vaccine experts panel before the FDA can approve it. The deal will be called off if the vaccine does not get FDA's approval.

AstraZeneca and the University of Oxford has said their jointly-developed vaccine against COVID-19 has shown "an average efficacy of 70%" in trials.

Regular approval, clinical trials

As for vaccine developers seeking regular approval — not EUA — of their vaccines, Montoya said AstraZeneca is just one of five companies that have already submitted an application to do clinical trials in the country.

"Ang AstraZeneca ay isa sa limang kompanya o vaccine developer na nag-submit ng aplikasyon para magsagawa ng clinical trial sa ating bansa," Montoya said.

"'Yung mga bakuna na magiging available sa bansa ay marami po 'yan. Ang kinakausap ng pamahalaan ay umaabot na sa 19 na vaccine developer pero ito ay may iba't ibang stages of development. Meron pong nasa phase 1, phase 2 at phase 3," he said.

"Doon sa mga advanced na phase 3 trial, 'yan ang requirement ng FDA bago nito pag-aralan ang kanilang aplikasyon. Ito po ay mga nine na kompanya. Lahat po ay kausap natin sa posibilidad na mabigyan tayo ng supply kung magiging successful ang kanilang mga trial at maaprubuhan ng FDA," Montoya said.

"Ang unang requirement ay maaprubahan muna ng FDA. 'Pag walang approval ng FDA, hindi puwedeng maging available dito at hindi rin puwedeng ipagbili sa merkado. 'Pag sinabing approval, ito 'yung regular approval," he said.

Asked if it would it be more prudent to wait for the approval of a COVID-19 vaccine with more than 90% efficacy, Montoya said the World Health Organization has set a minimum requirement of 50% efficacy.

"Ang WHO ay nag-set ng minimum requirement na 50%. Ibig sabihin 'pag 50% efficacy or more, puwede nang gamitin ng ating mga, of course, after ma-approve na ng FDA. 'Pag 70%, okay na 'yan, lalo na kung 95%," he added.

Montoya also said more than one vaccine may be approved for use in the country.

"Hindi lang isang bakuna ang puwedeng gamitin. Maaaring higit tatlo po ang rerekomenda namin," he said, adding that some vaccines may be more suited for adults, for children, or for those with comorbidities.

As for local clinical trials, Montoya said those who will be accepted as volunteers should first undergo a workup and examination to ensure they have no existing infection.

"Generally speaking sa pangkalahatan para kayo ay makasama, dahil ito ay boluntaryo, bago kayo maisama sa clinical trial ay kailangang sumailalim sa eksaminasyon at workup para mapatunayan na wala kayong impeksyon bago kayo sumama sa trial," he said.

"Ang pakay o layunin ng bakuna ay hindi kayo ma-impeksyon," he added.

Montoya said data from local clinical trials will be submitted to the FDA along with data from clinical trials conducted abroad. —KG, GMA News