Bayanihan 2 allows gov't to buy ₱10B COVID-19 vaccines ahead of phase 4 trials

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Russia's Sputnik V vaccine (FILE PHOTO)

Metro Manila (CNN Philippines, August 21) — Lawmakers are fast-tracking the purchase of COVID-19 vaccines through the Bayanihan to Recover as One Act, Senator Sonny Angara said Friday.

The ₱165.5-billion stimulus plan includes a provision that lets the Department of Health proceed with pre-procurement for a coronavirus vaccine prior to its approval under phase 4 or final clinical trials for the rollout of the doses. The waiver will overrule the Universal Healthcare Law which prohibits the government from buying and distributing a medicine or vaccine without clearing phase 4 trials.

"Ang stage 4 trials, medyo tumatagal 'yan and it involves a big portion of the population... Ang reality on the ground sa pag-procure ng potential vaccine, unahan ito with the limited supply. It will take a few more months from the development of the vaccine, there's just an initial batch or supply of vaccines produced," Angara told CNN Philippines' The Source.

[Translation: Stage 4 trials take time and it involves a big portion of the population... The reality on the ground in procuring a potential vaccine is it's a race to be first to secure the supply. It will take a few more months from the development of the vaccine, there's just an initial batch or supply of vaccines produced.]

"Ang gusto natin, nasa unahan tayo. If we strictly follow the protocols — stage 4 — kapag natapos na 'yun, wala ka na, ubos na 'yung vaccine [We want to be first. If we strictly follow the stage 4 protocol, there will be no more supply to buy]," he added.

The Bayanihan 2 bill ratified by the Senate on Thursday night and scheduled for ratification in the House of Representatives next week allotted a ₱10-billion standby fund to purchase vaccines once available.

RELATED: IATF approves guidelines for COVID-19 vaccine clinical trials in PH

"For procurement, we distinguished... You can already start that kahit wala ka pang phase 4. Pero kapag dini-distribute mo na 'yung vaccine at ina-administer mo na, those are when they have to kick in. Kailangan at least simultaneous," he added, referring to approval by the Food and Drug Administration and the DOH through the Health Technology Assessment Group.

[Translation: "For procurement, we distinguished... You can already start that even without phase 4 trials. But when you're already distributing and administering the vaccine, the protocols have to kick in. (Phase 4 approval) should be at least simultaneous.]

Phase 4 trials seek to confirm if a vaccine is safe and effective for the long term after doses are administered to thousands of volunteers.

Meanwhile, House Deputy Speaker LRay Villafuerte reminded the DOH and FDA to choose COVID-19 vaccine brands that are accredited by the World Health Organization since such requirement is stipulated under the Bayanihan 2 Bill.

The Camarines Sur lawmaker made the call amid the poor track record of vaccine production in China and Russia, which both assured the Philippines it will be a priority in the procurement of COVID-19 vaccines in the country.

“The Philippines should not be left behind in terms of vaccine procurement. However in the law, we leave it up to the FDA and DOH to determine which brand. We just specified that whatever company whatever brand you’re gonna procure, it should be within WHO standards,” Villafuerte told CNN Philippines’ Rico Hizon on Friday night.

Russian President Vladimir Putin announced earlier this month that their scientists have made a COVID-19 vaccine called Sputnik V, but these have not yet gone through phase 3 or efficacy trials.

President Rodrigo Duterte earlier ordered the national COVID-19 task force to buy at least 60 million doses of the vaccine once available. Prior to Russia, China committed to prioritize the Philippines in the supply of vaccines once their drug makers are able to secure regulatory approvals.

The FDA said it has not officially received a proposal for phase 3 trials of the Russian vaccine in the country. Presidential Spokesperson Harry Roque has confirmed that the Philippines will join Phase 3 of the medical research, which will be fully funded by Russia.

RELATED: Philippines reviews 'accelerated' approval of Russia's coronavirus vaccine

The Department of Science and Technology Philippine Council for Health Research and Development earlier said that 1,000 healthy Filipino volunteers will receive the first doses of Russian vaccine by October. Duterte earlier said he will be the first to get the vaccine to boost confidence, but estimates for the clinical trials showed he could be getting the shot by May 2021 the earliest. 

Drug makers in China, the United States, and the United Kingdom are also on phase 3 trials for potential vaccines.

The City of Manila has allotted ₱200 million as a standby fund to buy vaccines once available.