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

Robie de Guzman   •   September 25, 2020   •   349

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)

Phase 3 clinical trials for CoronaVac to possibly begin in November—FDA

Aileen Cerrudo   •   October 23, 2020

The Food and Drug Administration (FDA) said the phase 3 clinical trials for Sinovac’s CoronaVac would possibly begin in November, once the Chinese biopharmaceutical company submitted all the necessary documents.

The FDA said they are awaiting three documents from Sinovac to begin phase 3 of the clinical trial.

FDA Director-General Eric Domingo expressed confidence there will be a potential vaccine in the country by next month.

Ang aming timeline is mga two to three weeks. So once ma-complete naman nila ang submission at ma- kompleto nila lahat ng requirements ng FDA at ng Research Ethics Board, then maaari na silang magka-approval in the middle of November (Our timeline is around two to three weeks. So once they completed the submission and the requirements of the FDA and the Research Ethics Board, then there will be an approval by the middle of November), he said.

However, the agency clarified that CoronaVac could still not be administered to Filipinos.

The FDA assures that they will monitor the effect of the CoronaVac if it will be safe to use.

Hindi siya pwedeng dalhin dito at ibenta dito kasi hindi pa natin nakikita at hindi pa subok kung siya ay effective. Kaya hindi po tayo dapat mag- panic at biglang gumamit ng mga ito (It cannot be brought and sold here because we still cannot prove if it is effective. So we should not panic and use it), Domingo said. -AAC (with reports from Aiko Miguel)

FDA confirms Sinovac submitted application for independent clinical trial

Aileen Cerrudo   •   October 22, 2020

The Food and Drug Administration (FDA) has confirmed Sinovac, a China-based biopharmaceutical company, had submitted its application to conduct independent clinical trials in the country.

FDA Director-General Usec. Eric Domingo, however, said Sinovac has yet to submit other documents for the agency to process its application.

“That is undergoing regulatory evaluation, ganoon din iyong Ethics Board Evaluation niya—tuloy-tuloy po iyon (this also includes its Ethics Board Evaluation, it is ongoing), he said.

Department of Health (DOH) Spokesperson Maria Rosario Vergeire said vaccine experts panel also approved Sinovac in their preliminary review.

Kapag na complete na iyong requirements at nabigyan na sila ng approval then maari na pong mag umpisa (Once the requirements are complete and they received an approval, clinical trials can begin), she said.

Sinovac is among the three vaccine manufacturers that submitted their application to vaccine experts. -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)

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