China's donation of COVID-19 vaccine has no weight on EUA application of firms - FDA

Kristine Sabillo, ABS-CBN News

Posted at Jan 19 2021 02:25 PM | Updated as of Jan 19 2021 02:39 PM

Video courtesy of Laging Handa briefing

MANILA — The planned donation of 500,000 COVID-19 vaccine doses by China to the Philippines will not affect the Food and Drug Administration's assessment of vaccine candidates from Chinese developers, the regulatory agency's head said Tuesday.

The FDA is evaluating the applications of pharmaceutical firms for clinical trial and emergency use authority (EUA) of their respective COVID-19 vaccine products. Among the applicants is Sinovac from China.

During the visit in Manila over the weekend of Chinese foreign minister Wang Yi, it was announced that Beijing intends to donate half a million doses of COVID-19 vaccine.

Opposition Sen. Francis Pangilinan said the donation "should not pressure FDA" and the Health Technology Assessment Council to approve the use of the Chinese vaccines, even as he appreciated the gesture.

"Science and the data and results of clinical trials should be the sole basis and not 'political goodwill'," he said.

Asked in a press briefing on Tuesday if his agency is being pressured due to the large donation of vaccines by China, FDA Director General Eric Domingo said, “Hindi po. Hindi po kasi related yung donation at EUA.”

(No, because the donation and the EUA are not related.)

Domingo said companies can donate vaccines approved for use by another country, and this can be accepted by the Department of Health upon the FDA’s approval.

However, for vaccines procured by the government, an EUA is required, and it can only be released once the whole process is completed.

The official explained that under the Bayanihan Act, the government can accept donations of drugs.

“Of course, it should be used under the supervision of the Department of Health. Pero desisyon nila yun kung tatanggapin nila at gagamitin nila (But it’ll be their decision if they will receive and use it),” he said.

A DOH staffer told ABS-CBN News that the department "will wait for the issuance of an EUA by the Philippine FDA before we accept and administer the donated vaccines, same thing with vaccines that we will procure."

As regards Sinovac's application for EUA, Domingo said the company promised to submit all of its requirements amid a pronouncement by another official that the first batch of its vaccine doses can be expected to arrive next month.

According to Presidential spokesman Harry Roque, the Philippines already forged an agreement with Sinovac for 25 million doses of its vaccine. Terms sheets have also been signed with Moderna, AstraZeneca and Novavax drug makers.

“Ang sabi naman nila, sumulat sila sa atin, at sinabi magko-comply sila sa requirement, at sinabi magsa-submit sila ng dokumento,” Domingo said of Sinovac during a Laging Handa briefing.

(They said, when they wrote to us, that they will comply with the requirements and that they will submit documents.)

Domingo said Sinovac is still lacking the interim results of its Phase III trials, which is the most important data since it would show how safe and effective the vaccine is for those who already took it. (Incidentally, the FDA has just approved the company's application for clinical trial in the Philippines.)

The official said Sinovac has also not yet given them a copy of the EUA granted by China for the vaccine’s general use there.

In case Sinovac’s shipment pushes through, Domingo said the vaccines can’t be used without his agency's EUA issuance.

“Yung EUA nila, talagang depende kung gaano kabilis nila maipapadala yung kanilang mga datos,” he said, adding that Sinovac must also immediately respond to clarifications and requests for documents.

(Their EUA really depends on how fast they can relay their data.)

He said it would be hard to set a date for Sinovac’s EUA approval.

So far, only Pfizer has received an EUA from the Philippines. The American company submitted their documents before Christmas and got the approval 3 weeks later, within the target date of the FDA for vaccines with approval from a stringent regulatory authority (SRA).

While Pfizer has already been listed for emergency use by the World Health Organization and has received approval from the United States and the United Kingdom, which both have SRAs, Sinovac has yet to receive an EUA from a so-called mature regulatory authority.

The SRAs listed by the World Health Organization does not include China's.

The Philippines has logged 502,736 confirmed COVID-19 cases, as of Monday. The tally includes 9,909 deaths, 465,988 recoveries, and 26,839 active cases.

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