Roque says Sinopharm has applied for emergency use; FDA yet to confirm

Sinopharm has applied for an emergency use authorization (EUA) of its COVID-19 vaccine before the Food and Drug Administration (FDA), presidential spokesperon Harry Roque said Monday.

”It has been filed. They have already filed with the FDA an application for EUA,” Roque said during the briefing on Day 1 of the country’s COVID-19 vaccination program.

But FDA chief Eric Domingo said he has yet to receive such information.

“As of last Friday, wala pa naman akong nabalitaan na natanggap kami na EUA application from Sinopharm,” Domingo told state-run PTV. “Hindi ko alam kung nag-apply sila over the weekend pero wala pa pong sinasabi sa’kin.”

Domingo said the FDA office is closed on Monday due to the Araw ng Muntinlupa holiday.

“As far as I know, wala pa pong ine-evaluate kami na EUA application ng Sinopharm,” he stressed.

Domingo said the FDA will take four to six weeks to evaluate the Sinopharm vaccine once it applies for EUA due to its lack of approval from any stringent regulatory authority such as the US FDA or the World Health Organization (WHO).

“Similar siguro sa Sinovac. Hindi namin kaya yan ng 21 days... Depende na lang kung in the meantime, kung in between ng application nila ay magkaroon sila ng gano’n, ng US FDA [approval] o kaya as UK o kaya itong mga Asian countries na alam nating stringent sila o sa WHO,” he explained.

GMA News Online has been trying to get Roque for a clarification but has yet to reply as of posting tim.

Roque earlier said President Rodrigo Duterte prefers the Sinopharm vaccine. 

Last year, Duterte himself revealed that military men received the Sinopharm jab even though it has not yet been authorized for use in the country. 

Journalist Mon Tulfo, formerly Duterte’s special envoy to China, also claimed that government officials were preventing the President from accessing Sinopharm vaccines. 

During the arrival of 600,000 Sinovac doses on Sunday, Duterte said he requested for a personal supply of a COVID-19 vaccine that he did not name. 

The 75-year-old Chief Executive said his doctor had a Chinese vaccine brand in mind for him since he is not qualified to receive the Sinovac shot, which is only recommended for healthy individuals aged 18 to 59.

“Ako naghingi ako, personal. Wala silang stock. Nanghingi ako para sa pamilya ko pati sa akin. I do not know if we would have enough vaccines for everybody, but I think I can accommodate itong Cabinet members,” Duterte said.

The rollout of the Sinovac doses began with the vaccination of PGH Director Dr. Gerardo Legaspi. — RSJ, GMA News