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FDA: Philippines may accept, use donated COVID-19 vaccines allowed abroad

Gaea Katreena Cabico (Philstar.com) - January 19, 2021 - 2:54pm

MANILA, Philippines — The Department of Health may accept the coronavirus vaccines donated by other countries and use them at its own discretion even if the products are not registered in the Philippines, the country’s Food and Drug Administration said Tuesday.

FDA Director General Eric Domingo said this when asked if the agency is being pressured to approve Chinese-made vaccines after Beijing pledged to donate half a million COVID-19 shots to the Philippines.

Domingo said the DOH can receive donations of drugs that are not yet registered in the country but he stressed that these must be used “under the supervision” of the department.

“For example, a company donates vaccines that are approved in its home country. The Department of Health can accept the donation and it can use it. We’ll give the DOH a permission to accept the donation and they take responsibility for [its] use,” he said in Filipino.

In a Viber message sent to reporters, the Department of Health said it will wait for the issuance of an Emergency Use Authorization by the country’s FDA before it accepts and administers donated vaccines. The same applies to vaccines that the country will procure.

Domingo cited Republic Act 11494, or the Bayanihan to Recover As One Act, which states the that government must ensure that “donation, acceptance and distribution of health products intended to address the COVID-19 pandemic are not unnecessarily delayed and that health products for donation duly certified by the regulatory agency or their accredited third party from countries with established regulation shall automatically be cleared.”

“Provided that this shall not apply to health products which do not require a certification or clearance from the FDA,” the law stated.

'Donation not equal to approval'

But the FDA chief said the donation of vaccines will not influence the agency to approve the emergency use authorization applications of Chinese drugmakers.

“The FDA will not issue an Emergency Use Authorization until the process is completely finished,” Domingo said.

“If a donation reaches the country, the DOH can accept and use it. But those that we will order and purchase, they cannot be used until an EUA is issued. Accepting the donation is not equivalent to approving EUA application,” he added in Filipino.

China’s Foreign Minister Wang Yi pledged to donate 500,000 COVID-19 jabs. It not clear which vaccine Beijing will donate.

The Philippines has agreed to buy 25 million doses of COVID-19 vaccine developed by Chinese pharmaceutical firm Sinovac despite concerns on the product’s varying efficacy rates and prices.

Since being elected in 2016, President Rodrigo Duterte has embraced closer ties and has repeatedly defended Chinese-made vaccines in the face of uncertainties over their effectiveness.

Domingo said Sinovac’s application for EUA, which was sent last week, has still not been reviewed pending the company’s submission of the crucial late stage trial data.

Securing an EUA from the FDA will allow any vaccine to be rolled out in the country. Only the vaccine developed by US firm Pfizer and its German partner BioNTech has so far obtained an EUA.

COVID-19 VACCINE NOVEL CORONAVIRUS
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