WHO Solidarity trial para sa potensiyal na bakuna vs COVID-19, posibleng simulan sa Oktubre – DOH
Robie de Guzman • September 11, 2020 • 133
MANILA, Philippines – Inilatag na ng Department of Health (DOH) ang timeline sa isasagawang solidarity trial ng World Health Organization (WHO) sa bansa para sa potensiyal na bakuna laban sa novel coronavirus disease (COVID-19).
Ayon kay DOH Undersecretary Maria Rosario Vergeire, bago matapos ang buwan ng Setyembre ay tutukuyin na ang COVID-19 vaccine candidates na isasama sa trial at kung saan ito isasagawa. Nasa 34 vaccine candidates ang pinagpipilian para sa nasabing pagsusuri.
Sa Oktubre naman target simulan ang solidarity trial ngunit paglilinaw ni Vergeire, maaari pang magbago ang schedule depende sa magiging pasya ng WHO.
“Nagkaroon na ng meeting with the subtechnical working group for vaccine development kung saan, nagbigay naman ng mga updates ang WHO regarding this kasama ng team natin. Mag-uumpisa kasi una sa isang pilot site tapos, all the sites that were identified already, isasama na,” ayon sa opisyal ng DOH.
Maliban sa WHO, patuloy rin aniya ang negosasyon ng pamahalaan sa iba’t ibang kumpanyang developer at nagsasagawa ng pag-aaral para sa potensiyal na COVID-19 vaccine.
“Iyong Sinovac, yung Sinopharm, iyong kanilang confidentiality disclosure agreement we have already transmitted it to them, so while we have not received their response yet, we cannot say anything about the negotiations first because of the CDA,” ani Vergeire.
“So, hintayin natin bumalik sa atin yun with their comments and then we can finalize it and then we can give information to the public,” dagdag pa niya.
Una nang sinabi ng Department of Science and Technology na sa walong zone mula sa Metro Manila, Cebu at Calabarzon na may matataas na kaso ng COVID-19 isasagawa ang solidarity trials. – RRD (mula sa ulat ni Correspondent Aiko Miguel)
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)
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.
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)
UNTV is a major TV broadcast network with 24-hour programming. An Ultra High Frequency station with strong brand content that appeal to everyone, UNTV is one of the most trusted and successful Philippine networks that guarantees wholesome and quality viewing experience.