‘Best case scenario’: COVID-19 vaccine approval in PH may come by April 2021, says FDA

MANILA — The Philippines' Food and Drug Administration (FDA) on Friday said approval of a COVID-19 vaccine in the country may come in April next year— the best case scenario.

“The best case scenario if clinical trials are completed by December or January and a company would file with the FDA an application then it’s possible that by April 2021 we will have an approved vaccine,” FDA Director General Eric Domingo said during a Department of Health virtual briefing.

“Best case scenario 'yun. Meaning 'yung 3 to 6 months (trial) magiging 3 months and they will complete all of their analysis and submit immediately,” he added.

(That is the best case scenario. Meaning, the 3 to 6 months trial will just be 3 months and they will complete all of their analysis and submit immediately.)

This time period— 3 to 6 months— is the experts' estimate on Phase III clinical trials of COVID-19 vaccines, Science Secretary Fortunato de la Peña explained in the same briefing.

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

Currently, the Philippines is negotiating with 17 vaccine developers and 6 of them already have signed confidentiality disclosure agreements (CDA) that would allow the sharing of their earlier trial results.

However, the Philippine government said it would prioritize the World Health Organization’s Solidarity Trial. The said trial will involve simultaneous testing of several vaccines in different countries.

De la Peña said the WHO is scheduled to release its list of vaccines and protocols in October, which means they could only start recruiting patients by then.

“The fastest maybe that we can start (with the trial) is December, last quarter. And the vaccine trials according to experts will range from 3 to 6 months. I think the very early forecast that we have of 2nd quarter 2021 is still the best forecast that we can give,” he said.

This is amid the FDA's promise to expedite approval procedures.

Of the 6 vaccine developers that already have signed CDAs with the country, Russia’s Gamaleya Research Institute and China’s Sinovac are those interested in both clinical trials and local manufacturing in the Philippines.

Sinopharm, which has 2 vaccines being developed, is in talks with the Philippines for procurement. All three are already in the Phase III clinical trials and are considered among the frontrunners in the vaccine race.

Also discussing clinical trials with the Philippines are China’s ZFSW, Australia’s University of Queensland and Taiwan’s Adimmune. While ZFSW is in Phase II, the University of Queensland and Adimmune are still in Phase I.

Experts have earlier said that being a vaccine frontrunner doesn’t necessarily mean that they would have the first vaccine approved. This is why the Philippines is negotiating even with those that are still in Phase I trials.

Dela Peña said 12 hospitals have already been chosen as sites for the Solidarity Trial. Meanwhile, volunteers will be recruited from the five to 10 barangays in the country with the highest COVID-19 cases “based on the attack rates per 1,000 population per barangay,” the Secretary said.