Duterte set to issue EO allowing emergency use for COVID vaccines with proven safety, efficacy

Also approves proposal on advance payments for vaccines to secure supplies for PHL

President Rodrigo Roa Duterte joins his fellow leaders from the Asia-Pacific Economic Cooperation (APEC) member countries in the virtual 27th APEC Economic Leaders’ Meeting at the Malacañang Palace on November 20, 2020. TOTO LOZANO/ PRESIDENTIAL PHOTO

(Eagle News) — President Rodrigo Duterte is set to issue an executive order that would allow the “emergency use authorization” of COVID-19 vaccines in the country if these have been proven to be safe and effective in clinical trials, even in other countries.

With an emergency use authorization, vaccines could be used within 21 days, after securing the approval of the Food and Drug Administration (FDA).

President Duterte has also agreed to make advance payments for COVID-19 vaccines to be chosen by the FDA and by vaccine czar Secretary Carlito Galvez Jr., to ensure that the country will get its advance supplies of much-needed vaccines to fight COVID-19.

This was revealed by Palace spokesperson Harry Roque in a press briefing in Malacanang.

Roque said that Duterte had been increasingly convinced that the Philippines should start getting vaccines already as there was a race to buy vaccines worldwide as various countries scrambled to put a stop to a COVID-19 spike that they could not control.

He noted how other countries had already allowed the use for emergency of various COVID-19 vaccines such as China and Russia, adding that the United States is also expected to grant an emergency use authorization for the vaccine developed by Pfizer which claimed to have proven 95 percent efficacy based on clinical trials.

So makikita ninyo po, sa China, iyong China National Medical Products Administration ay nag-isyu na ng dalawang emergency use authorizations sa Sinopharm at sa Sinovac. At ang Estados Unidos naman po sa US FDA inaasahan na mag-iisyu rin po sila ng emergency use authorization para sa Pfizer mahigit kumulang itong buwan po ng Disyembre. Now, ibig sabihin po nito ay ginagamit na po iyong bakuna sa Tsina; ito po ay for limited time among high risk population,” Roque said.

He also explained why the President was finally convinced to make “advance market commitments” and advance payments to “private vaccine developers. This is because in the race to get the COVID-19 vaccines, the Philippines should not be left behind.

-Palace: PHL should not be left behind in race to get vaccines-

Roque said that the recommendation to make advance payments was made by Galvez himself.

Ito naman po ang mga inaprubahang rekumendasyon ng Pangulo matapos magprisenta ang ating Vaccine Czar. Unang-una, papasok po tayo ng advance market commitments kasama ng private vaccine developers, at pagbigay ng advance payment sa kanila. So medyo pumayag na po tayo na magkakaroon po tayo ng advance. Kasi kapag hindi po tayo pumayag ay baka mangulelat tayo doon sa mga bansa na makakakuha ng vaccine,” he noted.

Roque said that at first, the President hesitated on this, but changed his mind when he saw the list of countries which were already making advance payments to get the vaccines.

So alam ko po noong una, ayaw ni Presidente iyan. Pero noong nakita po niya iyong listahan ng mga bansang nag-a-advance payment eh hindi naman tayo magpapahuli ‘no basta mayroon naman tayong pondo; kung kinakailangang ibenta ang mga ari-arian ng gobyerno, gagawin niya iyan. Pero dahil nga importanteng masiguro na mayroon po tayong bakuna, pumayag na po siya nung mga tinatawag na advance payments,” he said.

The various modes of financing to get these vaccines would include “private-public tripartite agreements” at no cost to the government. This has a commitment of not less than 1 million doses.

The FDA will also issue the emergency use authorization through an executive order.

Now, hindi pa po nailalabas ni Presidente ang executive order. Pero kapag nilabas na po iyan ni Presidente at sinabi naman ni Presidente ilalabas niya iyan, mapapabilis po iyong proseso ng paggamit ng mga bakuna na mayroon na ring authorization sa mga FDAs ng mga bansa kung saan na-develop ang vaccines,” Roque said.

The Department of Science and Technology’s vaccine expert panel will also play a big role in choosing the right vaccine for the country’s use.

-From six months down to 21 days-

With the emergency use authorization, the country can get these vaccines and use these within 21 days, foregoing with the previous six months of study before a vaccine can be used.

“So ibig sabihin, dati-rati po, bago magamit ang isang bakuna rito na approved na ng US FDA o ng Chinese FDA, kinakailangan muna ng anim na buwan na pagsusuri. Pero kung mapipirmahan po itong executive order na ito, aba’y bente uno araw na lang po ay magagamit na rin natin sa Pilipinas,” Roque explained.

-Gov’t procurement for vaccines set in motion-

The government can also procure vaccines through the Government Procurement Reform Act or Republic Act 9184, which is also in accordance with the Bayanihan to Recover as One Act. This will be done by the Procurement Serviceof the Department of Budget and Management (DBM).

The government can also avail of multilateral loans from the Asian Development Bank (ADB) and the World Bank, through what they called “project loans” for vaccines. This is what the Department of Finance will focus on, Roque said.

A third option is through bilateral loans with countries which produce these vaccines.

“Pangatlo po, bilateral loans. Iyong utang sa mga bansa na nagpu-produce ng bakuna gaya ng mga pinu-produce sa Inglatera at saka sa Tsina at posible rin po sa Amerika,” Roque said.

Roque said that Galvez had already presented these various options President Duterte last Nov. 17, all of which had been approved by the President.

The advance market commitments would also entail signing of confidentiality data agreement. Advance payments will be made based on “negotiated terms.” Also discussed was the mobilization of the vaccines and their delivery that would still ensure their safety and efficacy.

(Eagle News Service)