Incomplete documents delay FDA review of Sinopharm COVID-19 vaccine

Jamaine Punzalan, ABS CBN News

Posted at Mar 03 2021 01:30 PM | Updated as of Mar 03 2021 02:39 PM

Incomplete documents delay FDA review of Sinopharm COVID-19 vaccine 1
A logo of Sinopharm is pictured during a government-organized visit to the production line of COVID-19 vaccine by Beijing Institute of Biological Products of Sinopharm's China National Biotec Group (CNBG), in Beijing, China Feb. 26, 2021. Tingshu Wang, Reuters/File

MANILA — The Food and Drug Administration has not yet started its review of the emergency use authorization for the COVID-19 vaccine from Chinese state firm Sinopharm due to incomplete documents.

The EUA application of Southmed Pharma, which seeks to be Sinopharm's local distributor, lacked documents like clinical trial results and certificate of good manufacturing practice for the vaccine, said FDA Director General Eric Domingo. 

"Hiningi pa po namin sa kanila iyong mga dokumento na kailangan para ma-evaluate natin iyong kanilang application," he said in a public briefing. 

(We have sought from them the required documents for us to evaluate their application.)

"‘Pag po nag-submit sila ng mga papeles, saka po natin uumpisahan ang evaluation," he added. 

(Once they have submitted the documents, we will start the evaluation.)

President Rodrigo Duterte prefers the Sinopharm vaccine over other brands, his spokesman earlier said. 

Video courtesy of PTV

Sinopharm has no published data on the results of the phase 3 clinical trials for its vaccine, said Domingo. 

"Until we see the scientific evidence at makita po natin kung kanino nila ginamit iyong kanilang clinical trial, at saka iyong kanilang experience sa paggamit po ngayon sa ibang bansa, noon pa lang po natin mabibigyan ng recommendation kung kanino po pupuwede ang bakunanang ito," he said. 

(Until we see the scientific evidence and on whom they used their clinical trial, and the experience of other countries o the vaccine's use, that's only when we could make a recommendation on whom this vaccine should be given.)

The President's security team last year took unauthorized Sinopharm jabs. Duterte's former special envoy to China Mon Tulfo recently said he, some Cabinet officials, and a senator also took smuggled Sinopharm shots last year. 

"Wala pa po kaming nakukuhang mga kasagutan, pero tuloy-tuloy naman po ang investigation d’yan," Domingo said.

(We have not yet gotten answers, but our investigation continues.)

Video courtesy of PTV

The Philippines received its first vaccine supply over the weekend, courtesy of China's donation of 600,000 COVID-19 shots from Beijing-based drug maker Sinovac Biotech. 

Domingo and other officials on Monday took Sinovac shots, along with health workers in Metro Manila. 

The FDA chief said he did not feel any adverse side effect from the vaccine. The drug regulator so far monitored 23 cases of "very mild, minor" side effects such as headaches, blood pressure spike, itch, and dizziness, said Domingo. 

"These are all expected po ito na mga adverse events. In fact, mababa nga po ang presentahe sa atin ng mga nakaramdam ng adverse events after immunization," he said. 

(These are all expected adverse events. In fact, our presentation of adverse events after immunization is low.)

Among the hardest hit in Asia by the pandemic, the Philippines has trailed its neighbors in securing vaccines, with which it hopes to inoculate 70 million people or two-thirds of the population this year. 

Officials said logistical issues delayed the supposed arrival last Monday of 525,600 COVID-19 shots from Britain's AstraZeneca, which were secured by the vaccine-sharing COVAX Facility.