The Department of Health (DOH) reiterated its assurance that all potential COVID-19 vaccines —- that will enter the Philippines — will undergo a strict regulatory process to ensure its efficacy and safety.

vaccine 1 - COVID-19 vaccines will undergo thorough evaluation — DOH
(PIXABAY / FILE PHOTO / MANILA BULLETIN)

“As I’ve said, all of the vaccines that will come into the country should be able to undertake itong regulatory process na meron tayo dito [this regulatory process that we have here],” said DOH Undersecretary Maria Rosario Vergeire in an online forum Wednesday. 

Vergeire asked the public to trust the government’s process when it comes to COVID-19 vaccines. 

“The population or our Filipino public should just trust na ang proseso ng gobyerno ay sisiguraduhin na ligtas  at saka magiging epektibo ang mga bakunang papapasukin natin dito sa ating bansa [The population or our Filipino public should just trust that the government’s process will ensure that the vaccines we will bring into our country are safe and effective],” she added. 

Update on potential independent clinical trials

The Health official said that the American Biotech company Moderna is not keen in conducting a clinical trial in the Philippines for its COVID-19 candidate vaccine. 

“Ang Moderna, nakausap na sila ng Department of Science and Technology about a month ago and ang kanilang intent is not to have a clinical trial in the Philippines but they would want na doon na sila papasok sa vaccine procurement [Moderna already talked to the Department of Science and Technology about a month ago and their intent is not to have a clinical trial in the Philippines but they would want to enter (a negotiations) for vaccine procurement],” said Vergeire. 

Vergeire said that they would have wanted for the American firm to conduct clinical trials in the Philippines to test the efficacy of their candidate vaccine.

“Ang objective ng Pilipinas ay magkaroon ng clinical trials dito ang mga manufacturers so that we can see the effect of these vaccines among our population kasi sabi nga natin iba-iba ang epekto ng bakuna sa bawa’t race, so mas maganda makikita natin [The objective of the Philippines is for manufacturers to have clinical trials here so that we can see the effects of these vaccines among our population because it can have different effects to every race. It would be ideal if we can see its effects in our population],” she said. 

Not having conducted  clinical trials here, Vergeire said, would not prevent the Philippines from procuring proven and approved vaccines from their manufacturers. 

“If the manufacturer will not conduct a clinical trial here in the country, hindi po iyan makakaapekto sa pagpili natin. Although of course, that is the ideal…but if they do not intend, hindi po naman iyan makakapag stop sa gobyerno para mag procure tayo as long as they would go through the regulatory process [If the manufacturer will not conduct a clinical trial here in the country, that will not affect our selection process. Although of course, that is the ideal… but if they do not intend, that will not stop the government in procuring as long as they would go through the regulatory process],” she said. 

Moderna recently announced that its candidate vaccine posted 94.5 percent efficacy based on the preliminary results of their clinical trials. 

Meanwhile, the application of  China’s Sinovac Biotech for holding clinical trials in the Philippines is still being reviewed by the health authorities, said Vergeire. 

“They are just completing some documentary requirements for our Ethics Review Board while the Food and Drug Administration is already conducting an initial evaluation,” said Vergeire. 

Sinovac already passed the evaluation of the vaccine experts panel of the Department of Science and Technology. 

Indian vaccine maker

Serum Institute of India (SII) has committed to make its COVID-19 candidate vaccine available to the Philippines once it is already developed. 

Faberco Life Sciences Inc,  a local pharmaceutical distributor, said it was authorized by SII to “represent it in the Philippines for the supply of the COVID-19 vaccine it is developing with Novovax.”

“The President himself has expressed doubts if the Philippines will get vaccines being developed in the West. If and when the vaccine becomes available, SII and Faberco hope to bring a pleasant surprise,” Faberco Life Sciences medical director Dr. Luningning Villa said in a statement. 

The vaccine being developed by SII and Novovax is set to start the phase three trials in the United States this month. 

“SII has become a supplier of choice for those looking for high quality vaccines and India has a good track record and enjoys a high level of trust,” said Villa. 

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