China's Sinopharm seeks EUA for its COVID-19 vaccine in PH, says Palace; FDA yet to confirm

Jamaine Punzalan and Kristine Sabillo, ABS CBN News

Posted at Mar 01 2021 12:51 PM | Updated as of Mar 01 2021 02:30 PM

China's Sinopharm seeks EUA for its COVID-19 vaccine in PH, says Palace; FDA yet to confirm 1
Staff members stand next to a production line of COVID-19 vaccines at a packaging workshop inside the Beijing Institute of Biological Products of Sinopharm's China National Biotec Group (CNBG), during a government-organized visit to the company in Beijing, China Feb. 26, 2021. Tingshu Wang, Reuters/File 

MANILA (UPDATE) — Chinese state firm Sinopharm has applied for an emergency use authorization in the Philippines for its COVID-19 vaccine, Malacañang said on Monday, although the country's drug regulator could not immediately confirm it.

Presidential spokesman Harry Roque issued the announcement as the country rolled out its official vaccination program against the disease, courtesy of donated CoronaVac vaccine doses from another Chinese drugmaker, Sinovac Biotech.

"They have already filed with the FDA (Food and Drug Administration) an application for EUA for Sinopharm vaccine," Roque, in a televised briefing, said of the product that President Rodrigo Duterte supposedly prefers to take and which some members of his security detail received last year despite lack of FDA approval.

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FDA Director General Eric Domingo, in a separate briefing, said he cannot yet confirm if Sinopharm, officially known as China National Pharmaceutical Group Co., Ltd., has indeed applied for EUA of its vaccine candidate in the Philippines.

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

(As of last Friday, I did not hear any report that we already received an EUA application from Sinopharm.)

The health official said he is not sure if Sinopharm applied online over the weekend. He said he could not immediately check it as of press time as the FDA, which is located in Muntinlupa City, is closed Monday due to a local holiday.

Nonetheless, he said he is having the information checked.

If Sinopharm has indeed applied, Domingo said it will likely take a longer time to evaluate it because 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.

Having an EUA from an SRA, which is recognized by the WHO, can expedite a company’s application within 21 days, as what happened to Pfizer and AstraZeneca.

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.

In February, the agency issued a "compassionate use license" for the Presidential Security Group to take 10,000 Sinopharm jabs. 

Duterte last year admitted that some PSG members took the vaccine candidate of Sinopharm. Last week, columnist Mon Tulfo said he, the PSG, a senator, and some members of Duterte's Cabinet took smuggled Sinopharm shots. 

Duterte, who is turning 76 later this month, is excluded from the priority recipients of Sinovac's COVID-19 shots, which the FDA said were not recommended for the elderly and health workers who have direct contact with COVID-19 patients.

The Philippines on Sunday received China's donation of 600,000 Sinovac doses, the country's first coronavirus vaccine supply.

The country, which has recorded more than 576,000 COVID-19 cases over a year since the pandemic struck, is the last in Southeast Asia to get COVID-19 shots.