Three drugmakers eye vaccine emergency use in PH

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(FILE PHOTO)

Metro Manila (CNN Philippines, December 15) — Three foreign drugmakers are eyeing emergency use approval for their COVID-19 vaccines in the Philippines, the Food and Drug Administration revealed.

FDA director general Eric Domingo on Tuesday said Pfizer, AstraZeneca, and Sinovac have all inquired about the process for securing Emergency Use Authorization or EUA of their vaccines.

A new vaccine cannot be administered in the country unless it is under clinical trial or is given a special permit for "compassionate use," he said. The EUA is an exception, as it is the way to respond to a public health emergency such as the coronavirus outbreak.

"Pwede kaming mag-rely sa evaluation at decisions ng mga mature regulatory agency and the WHO (World Health Organization)," Domingo said.

"Hindi puwedeng sa Pilipinas unang kukuha ng EUA. Kailangan, meron na siyang EUA sa bansang pinagmulan niya o sa iba pang mga mature na regulatory agency," he added.

[Translation: We can rely on the evaluation and decisions of mature regulatory agencies and of the WHO. Companies cannot apply for an EUA for the first time in the Philippines. The product must be approved in their home country or by any other mature regulator.]

Pfizer's vaccine, which is said to be 95% effective in protecting a person from COVID-19 and has no safety concerns, has been approved for emergency use in the United States, the United Kingdom, and Singapore.

READ: Pfizer CEO says company on track to manufacture 1.3 billion COVID-19 vaccine doses globally next year

Philippine and Chinese regulators are not considered "mature" agencies. This means their approval can't be used as the basis of approval for EUA elsewhere.

Sinovac is the Philippines' priority for procurement. Meanwhile, the private sector has made early payments to secure doses of AstraZeneca in November, well ahead of clinical trials or EUA approval.

READ: Roque on Sinovac preference: It's the only choice for now 

Drugmakers, importers, and distributors of medicines and vaccines in the country may apply for EUA, Domingo said, but clarified the government through the Department of Health may also pursue the application.

There are several requirements to ensure the quality, such as a license to operate for the drug importer, a proof of good manufacturing practice, a complete assessment report, and clinical trial data and results especially for Filipino or Asian recipients of the doses, among others.

These are the conditions for EUA approval, Domingo said. One, it should be "reasonable to believe the vaccine may be effective," the known and potential benefits should outweigh the risks, and there is no other alternative for that drug.

The EUA will be rendered ineffective once vaccines are fully licensed by regulators, he added. The application will then be reviewed based on quality, safety, and efficacy before a decision is made.

RELATED: COVID-19 vaccine emergency approval likely in January, arrival in PH possible by March 2021 – FDA