PH won’t pay ‘reservation fee’ for COVID-19 vaccines — Duterte

Marje Pelayo   •   September 15, 2020   •   92

MANILA, Philippines — The Philippine government will not shell out a single peso for a reservation fee to any pharmaceutical company that will develop a vaccine for coronavirus disease (COVID-19). 

According to President Rodrigo Duterte, paying such a reservation fee is against the country’s procurement laws.

Wala pa iyong vaccine (The vaccine is not yet available). There is nothing with finality and you want us to make a reservation by depositing money? You must be crazy. Bakit ako magbili ng ganoong style (Why would I buy in such a manner)?” President Duterte said. 

“The Procurement Law of the Philippines does not allow you to buy something which is non-existent or to-be-produced as yet,” he explained.

This was the President’s stand amid reports that some pharmaceutical firms are asking buyers to fund their research and development efforts for a vaccine against the deadly disease.

“Like in other countries, they want cash advance bago tayo deliver-an ng vaccine (before they deliver vaccines to us). Kung ganun, patay tayong lahat (If that is the case, then we will all die). Every Filipino will die I can assure you,” he said. 

“Kung wala tayong ibigay sa kanilang cash advance, walang vaccine (If we don’t give them a cash advance, then we won’t get a vaccine). That’s one thing wrong about the western countries. It’s all profit, profit, profit,” he added.

The President said this is why he prefers to buy vaccines from Russia and China if theirs are proven effective. 

Russia first offered a joint vaccine production effort with the Philippines, while China gave its commitment to provide the Philippines priority access should a vaccine be made available.

Four of the nine Chinese vaccine candidates are in the late-stage trials, while Russia’s Sputnik V is also in its Phase 3 trials. MNP (with Rosalie Coz)

COVID-19 vaccine approval in PH possible in April 2021 – FDA

Robie de Guzman   •   September 25, 2020

MANILA, Philippines – The country’s Food and Drug Administration (FDA) on Friday said the approval of a vaccine against novel coronavirus disease may be possible in April 2021.

During a virtual press briefing, FDA Director General Eric Domingo said this is “the best case scenario” if clinical trials are completed on schedule.

“If clinical trials are completed by December or January, and a company would file an application with FDA, it’s possible that by April 2021 we will have an approved vaccine,” he said.

“Talagang best case scenario yun, meaning yung three to six months, magiging three months; assuming that they will complete all their analysis and submitted immediately to FDA,” he added.

In the same briefing, Department of Science and Technology (DOST) Secretary Fortunato dela Peña said the time period of three to six months is the experts’ estimate on the completion of Phase III clinical trials for vaccine candidates.

“When they say 3-6 months, we prefer to use the longer forecast in our estimates. That would indicate in that period they would have finished clinical trials and probably already submitted to FDA their application and results of their trials,” he said.

Dela Peña said the World Health Organization (WHO) is set to release its list of selected vaccines and protocols in October and that the fastest that they can start the clinical trials will be in the last quarter of 2020.

“The vaccine trials according to experts will range from 3 to 6 months. I think the very early forecast that we have of second quarter 2021 is still the best forecast we can give,” he said.

The DOST said the Philippines is currently negotiating with 17 vaccine developers from other countries and six of them have already signed confidentiality disclosure agreements that would allow the sharing of their earlier trial results.

Among the six vaccine developers are Russia’s Gamaleya Research Institute and China’s Sinovac.

The FDA earlier promised it would expedite the approval procedures but assured that no steps will be skipped to ensure public’s health and safety. – RRD (with details from Correspondent Aiko Miguel)

DOST names 13 hospitals involved in WHO COVID-19 vaccine solidarity trials

Robie de Guzman   •   September 22, 2020

MANILA, Philippines – The Department of Science and Technology (DOST) on Tuesday announced that 13 hospitals will be involved in the solidarity trials of the World Health Organization (WHO) for potential novel coronavirus disease (COVID-19) vaccines in the country.

In a statement, DOST Secretary Fortunato dela Peña said the Inter-Agency Task Force for the Management of Emerging Infectious Disease (IATF-MEID) has adopted the agency’s recommendation for zoning on the solidarity trials for the vaccine candidates against COVID-19 which will be conducted this year.

Dela Peña said the vaccine candidates will be tested in eight trial zones, involving a total of 13 hospitals.

He identified these facilities as the Philippine General Hospital, Manila Doctors Hospital, San Lazaro Hospital, Lung Center of the Philippines, St. Luke’s Medical Center-Quezon City, the Research Institute for Tropical Medicine, Makati Medical Center, The Medical City, and St. Luke’s Medical Center-BGC, Vicente Sotto Memorial Medical Center, Chong Hua Hospital in Cebu City, De La Salle Health Sciences Institute in Cavite, and Southern Philippines Medical Center in Davao City.

The WHO solidarity trials will start this October and expected to be completed by the second quarter of the following year.

The DOST chief also confirmed that the Philippines is in agreement with five COVID- 19 vaccine developers that will enable clinical trial data sharing.

Solidarity trial for potential COVID-19 vaccines to last 18 months

Aileen Cerrudo   •   September 17, 2020

The solidarity trial for potential vaccine for the coronavirus disease (COVID-19) will begin in October and will last for 18 months, according to the Department of Health (DOH).

“The expected start, though we say that this is tentative because things might change, would be the 3rd week of October. The duration of this solidarity trial for vaccines would be 18 months,” according to DOH Spokesperson Usec. Maria Rosario Vergeire.

The Health official also reported that the total approved budget is P89.1 million and will be funded by the Department of Science and Technology.

She also clarified that the budget is only allotted for the operational expenses as the vaccine manufacturer will be the one to supply the vaccines to be used in the clinical trial.

The World Health Organization (WHO) is currently looking into 34 potential vaccines: nine are under Phase III, while the remaining are under clinical trial Phase II.

The Health Department reported that 12 out of the 34 manufacturers are under negotiations with the Philippines through bilateral agreements.

“By doing this, we also increase our chances of having this allocation coming from these manufacturers because we have agreed to have the Phase III Clinical Trial here,” Vergeire said.

Vergeire also said the DOH is awaiting the response of the manufacturers to sign the Confidential Disclosure Agreement to begin trials in the country.

“All efforts are being strengthened. We can also access vaccines in spite of the different provisions of our law,” she said. -AAC (with reports from Aiko Miguel)

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