Palace says Sinopharm applied for EUA, FDA unaware

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MALACAÑANG claimed on Monday that the Chinese state firm Sinopharm has applied for an emergency use authorization (EUA) in the Philippines for its COVID-19 vaccine, but the Food and Drug Administration (FDA) doesn’t seem aware about it.

“They have already filed with the FDA an application for EUA for Sinopharm vaccine,” presidential spokesperson Harry Roque said in an announcement aired over the state-owned television station as the government officially starts its vaccine rollout a day after the arrival of some 600,000 doses of China-made vaccines developed by Sinovac Biotech.

President Rodrigo Duterte earlier hinted at Sinopharm as his preference for vaccination against the deadly virus from Wuhan, China.

Interestingly, FDA Director General Eric Domingo was caught flat-footed when asked to confirm Roque’s claim in another press briefing.

He said he may not be able to ascertain whether or not Sinopharm, officially known as China National Pharmaceutical Group Co., Ltd., has applied for an EUA of its vaccines.

“As of last Friday, wala pa akong nabalitaan na natanggap kami na EUA application ng Sinopharm,” he said.

He, however, said that he would check if Sinopharm applied online over the weekend.

Even on the assumption Sinopharm applied, Domingo said it will likely take time to evaluate, adding that its product is not among COVID-19 vaccines with EUAs from countries with a Stringent Regulatory Authority (SRA) or included in the World Health Organization’s emergency use listing.

Domingo cited the need for an EUA from an SRA to hasten facilitation of their bid to legalize its use in the country.

The FDA has so far granted EUA to the COVID-19 vaccines of Pfizer, AstraZeneca and Sinovac, and is currently evaluating the application of Russia’s Gamaleya Institute and India’s Bharat Biotech.

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