Duterte approves advance payments to foreign COVID-19 vaccine developers, emergency use on PH patients

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Metro Manila (CNN Philippines, November 19) — President Rodrigo Duterte has agreed to advance supply agreements and make early payments to COVID-19 vaccine manufacturers, Malacañang said Thursday.

Presidential spokesman Harry Roque said Duterte accepted the proposal of vaccine czar Carlito Galvez, Jr. to enter advance market commitments with private foreign developers and provide advance payments to ensure the Philippines will secure vaccine doses once these are cleared for widespread use.

"Kapag hindi po tayo pumayag, baka mangulelat tayo doon sa mga bansa na makakakuha ng vaccine [If we don't agree to advance payments, we will be left out as other countries secure vaccines]," Roque said in a press briefing.

Duterte previously rejected the idea, but Roque said the President changed his mind upon seeing how other countries were handling the early procurement.

The Universal Healthcare Law prohibits the government from buying and distributing a medicine or vaccine without clearing phase 4 trials, but this has been waived under the Bayanihan to Recover as One Act. The stimulus plan allows the Department of Health proceed with pre-procurement for a coronavirus vaccine prior to its approval under final clinical trials.

The procurement law also prohibits the government from paying for pre-ordered goods, unless with prior approval from the President.

Galvez said Duterte cleared the plan to ink tripartite agreements, wherein private businesses will support the financing and provide some of the vaccine doses for free. Bilateral loans are also an option, he added, against the existing plan to have the vaccines financed through the state-owned Philippine International Trading Corp.

Philippine authorities are in talks with China, the United Kingdom, and Singapore so far, with hopes they will be able to close a supply deal within the next two weeks and get pharmaceutical firms to conduct a clinical trial in the Philippines between December and January. He said these vaccine producers have a "quota" set for the Philippines from between 15-50 million vials.

Galvez added there was an earlier commitment involving the five drug makers in the United States as well as with Russia's Sputnik V. Discussions will also be started with Australia.

"They are more than willing na talagang magbigay ng napakalaking amount sa atin [They are more than willing to supply a huge volume of vaccines to us]," the vaccine czar and national COVID-19 task force chief implementer said.

At this rate, Galvez expressed confidence the Philippines can secure vaccines for 25 million people, which may rise to as much as 50 million if advance agreements and payments are made with three companies this month.

However, he refused to disclose the price of each dose, saying it was covered by a confidentiality clause. He only said prices will be "super low" given the bulk buying.

China's Sinovac has cleared pre-screening and has submitted an application to hold phase 3 clinical trials in the country. Other vaccines like Pfizer, Moderna, and Sputnik V have reported above-90% efficacy, better than the 70% threshold.

READ: Moderna's vaccine has a significant advantage over Pfizer's

Emergency use approved

The President also approved the suggestion to allow the Food and Drug Administration to authorize the emergency use of vaccines. However, Roque said Duterte has yet to issue the formal executive order about it.

​Once this order is issued, the regulator can cut its six-month review process to 21 days, but with an assurance that vaccines invented abroad will still undergo evaluation from the vaccine expert panel, ethics review board, and the FDA. Galvez added that this will trim government red tape.

"Meron silang tinatawag na collaborative regulatory evaluation with other countries. Ang assumption ay kapag na-approve sa US FDA at saka sa mga stringent FDA commissions 'yung isang vaccine, most likely it will be safe," Galvez said.

[Translation: They have what is called a collaborative regulatory evaluation with other countries. The assumption is if a vaccine is approved by the US FDA and other stringent FDA commissions, most likely, it will be safe.]

READ: How a COVID-19 vaccine could change travel for good

However, he maintained that May 2021 remains to be the best-case scenario for most vaccines, but confirmed the Russian vaccine may be available by January. Philippine Ambassador to Russia Carlos Sorreta said earlier this week production will be quick, but it will depend on local FDA approvals. 

Local laws require a separate set of regulatory approvals for a vaccine before it can be given to Filipinos. The FDA previously said this may take 45-60 days following approval from a foreign regulator.

RELATED: BioNTech and Pfizer will seek emergency US authorization for vaccine on Friday, CEO says