MANILA — The Food and Drug Administration on Tuesday announced it has approved the COVID-19 vaccine clinical trial application of Janssen, which is owned by Johnson & Johnson.
“Yesterday we already approved one. Ito po yung clinical trial ng Janssen. This has been given the go signal by FDA. And siguro mag-start na sila ng kanilang clinical trial mga after ng New Year,” FDA Director General Eric Domingo said during a virtual forum with the Department of Health.
(Yesterday we already approved one. This is the clinical trial of Janssen. This has been given the go signal by FDA. Ang maybe they’;; start their clinical trial after New Year.)
“I think the next step now is for the DOST expert panel to assign the area where the trial will take place,” Domingo said, explaining that preliminary preparations and recruiting of trial participants will also have to be done.
“I suppose in the next few weeks they will be ready to begin the clinical trial,” he said.
Phase 3 clinical trials involve thousands of people being tested for the safety and efficacy of the vaccine being tested. Some developers seek participants from various countries to check the vaccine’s efficacy for different ethnic groups.
Domingo said while hosting clinical trials in the Philippines won’t assure a supply of COVID-19 vaccines for the country, “the added bonus for us is that if this turns out to be a good vaccine then at least we know with a few thousand filipinos it has been tested and we’ve seen the effects and the possible adverse effects, and the possible side effects.”
“That will probably make it easier for us to make decisions when it comes to authorization and maybe even actual use of that vaccine,” he said.
Domingo said the participation of countries in clinical trials is really to contribute to world knowledge and the development of a vaccine that will benefit everyone.
Domingo said there are two other vaccine developers being evaluated by the FDA — Clover Biopharmaceuticals and Sinovac, which are both from China.
He said officials are still waiting for additional documents from Clover while Sinovac requested for a change in the clinical trial’s protocol.
“Once matapos yun and ma-complete din nila ang requirement they will also be given approval,” Domingo said.
(Once they finish and complete the requirements, they will also be given approval.)
Russia’s Gamaleya Institute has also applied for clinical trials but its application has not yet reached the FDA. It is still undergoing review by the vaccine expert panel and the ethics review board.
As for applications for emergency use, Domingo said only Pfizer has applied.
He said Pfizer’s application was submitted online in the afternoon of December 23.
“Na-download na namin ang submissions nila yesterday and this has been distributed already to our reviewers and our regulators,” he said.
(Their submission was downloaded yesterday and this has been distributed already to our reviewers and our regulators.)
Domingo said their preliminary evaluation for Pfizer will be concluded in about 2 weeks.
“Halos naman lahat ng requirement nila nandun na sa kanilang submission. We just have to go through it,” he said.
(Almost all requirements are in their submission. We just have to go through it.)
Domingo said is expecting more vaccine developers to apply in January.