Cavite COVID-19 vaccine trials to undergo FDA, ethics review first — DOH

Kristine Sabillo, ABS-CBN News

Posted at Sep 02 2020 02:01 PM

MANILA — The Department of Health on Wednesday said the planned COVID-19 vaccine trials in Cavite will have to undergo a review by the Food and Drug Administration and an ethics board before they could begin.

“Nung Sabado I read the article at may nagbigay ng report sa atin. We immediately contacted the proponent. We discussed with him ano dapat ang proseso and they should notify DOH,” Health Undersecretary Maria Rosario Vergeire said in a virtual briefing.

(On Saturday, I read the article and someone reported it to us. We immediately contacted the proponent. We discussed with him what the process is and they should notify DOH.)

Cavite Governor Jonvic Remulla last week announced that his province would undertake a COVID-19 vaccine trial through the La Salle Health Sciences Institute. He said it would happen in the next two weeks.

But the FDA earlier told ABS-CBN News that the Cavite trial does not have approval yet. All proposed COVID-19 vaccines would have to undergo FDA approval before being allowed to enter the Philippines.

Vergeire said the proponent of the Cavite study agreed and promised to update them regularly.

“They are still negotiating and finalizing their protocol,” the health official said.

She said once it is approved by the FDA and an ethics board, the proponent of the trial would inform the DOH so it could start.

Vergeire said they have yet to receive details on the planned clinical trials.

Remulla said the vaccine trial would involve those developed in the United States and the United Kingdom.

“Walang puwedeng magumpisa ng any clinical trial kung wala kayong approval ng FDA at wala kayong approval ng ethics review (You cannot start if you do not have the approval of the FDA and the approval of an ethics review). If you do that, you are violating specific laws so you will be sanctioned and you will be asked to stop,” Vergeire emphasized.

She explained that because these are new vaccines and medicines, they have to be regulated to ensure the safety of Filipinos.

Otherwise, they “may cause harm to our citizens.”

There are still no approved vaccines or drugs against COVID-19.

Vaccine frontrunners are still undergoing Phase III clinical trials, which involve large-scale testing for the safety and efficacy of the vaccine. 

The Philippine government has been in talks with vaccine developers from China and Russia but none have been finalized yet.

“Ang sabi August sila maguumpisa for the phase 3 clinical trials sa Russia,” Vergeire said of the Sputnik vaccine from Russia. “But ito ay through the emergency use approval ng gobyerno.”

(They said phase 3 clinical trials should start in Russia in August. But this is through the emergency use approval of the government.)

Russia has said it would be using its vaccine on health workers first even if it has only finished Phase II trials.

The Philippine vaccine expert panel is still studying results of Russia’s Phase I and Phase II trials to see if the vaccine is really safe and effective.

Vergeire said they will update the public once the panel shares more information with them.