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

Aileen Cerrudo   •   September 17, 2020   •   285

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)

WHO solidarity trial in PH to begin in December—DOH

Aileen Cerrudo   •   October 27, 2020

The solidarity trial of the World Health Organization (WHO) for potential vaccines against the coronavirus disease (COVID-19) in the Philippines and other countries will begin in December.

Department of Health (DOH) Spokesperson Usec. Maria Rosario Vergeire said 150 to 200 will participate in the trial in 12 sites in the country.

Sa November kasi parang maguumpisa sa isang site and mag-follow na po iyong iba’t ibang clinical trials in the other countries including the Philippines by December of 2020 (The trial will begin in November in one site and it will be followed by other clinical trials in other countries including the Philippines by December of 2020), she said.

The Health Department also announced Interferon will no longer be a part of WHO’s solidarity trial. Vergeire reported the said drug did not reduce the mortality rate of COVID-19 patients.

Iyong gamot hindi na-reach objective (The medicine did not reach its objective),” she said.

The WHO has previously discontinued the use of hydroxychloroquine and lopinavir/ritonavir treatment after seeing no signs of effectiveness in treating COVID-19 patients.

Meanwhile, the WHO added two drugs for the therapeutics solidarity trial, which include Acalabrutinib that is used for the chemotherapeutic regimen of patients. AAC (with reports from Aiko Miguel)

There is hope COVID-19 vaccine may be ready by end of 2020, WHO says

Robie de Guzman   •   October 7, 2020

MANILA, Philippines – The World Health Organization (WHO) has expressed hope that a vaccine against novel coronavirus disease (COVID-19) may be ready by year-end.

“We will need vaccines and there is hope that by the end of this year we may have a vaccine. There is hope,” WHO Director-General Tedros Adhanom Ghebreyesus said in his address at the end of a two-day meeting of the agency’s Executive Board on the pandemic.

Tedros did not offer any additional details.

He, however, called for solidarity and political commitment from world leaders to ensure equitable distribution of the vaccine when it becomes available.

“We need each other, we need solidarity and we need to use all the energy we have to fight the virus,” he said.

Nine experimental vaccines in various stages of trials are in the pipeline of the WHO-led COVAX global vaccine facility that aims to distribute two billion doses by the end of 2021.

A total of 172 countries have joined WHO’s COVAX initiative, excluding the United States, China, and Russia. – RRD (with details from Correspondent Mirasol Abogadil)

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)

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