Another Western drugmaker to seek emergency use of COVID-19 vaccine in Philippines

MANILA, Philippines — Another Western manufacturer of COVID-19 vaccine is expected to apply for emergency use authorization (EUA) in the Philippines this week, Malacañang said Tuesday.

"Right now, we are expecting in a day or two, I believe another western company to apply for an EUA. Let’s hope that they will because that’s the declaration of (Food and Drug Administration director-general) Usec. (Eric) Domingo himself and (vaccine czar) Sec. (Carlito) Galvez (Jr.)," presidential spokesman Harry Roque said at a press briefing yesterday. 

Pressed for more details, Roque replied: "Yesterday, they said (the application would be submitted) in two to three days. Let's just wait for it," he added. 

So far, only American drug maker Pfizer has submitted an application for EUA to the Philippine Food and Drug Administration (FDA). 

Roque said under FDA's rules, the procuring entity may also seek an EUA for COVID-19 vaccines. 

"If the DOH (applies), then we would need the assistance of our diplomatic missions in the place where they are manufactured to present or to procure the necessary documents and data that will be required by the FDA," the Palace spokesman said. 

"We have to understand that there is probably hundred plus countries right now and all these jurisdictions, you are probably required to apply an EUA and I see no reason why they should in fact prioritize the Philippines. That is why there is that provision in the FDA law which allows the procuring entity itself to apply for the EUA," he added.

Last month, President Rodrigo Duterte signed Executive Order No. 121 authorizing the FDA director general to issue EUA for COVID-19 drugs and vaccines. An EUA permits the use of COVID-19 medicines and vaccines pending approval by health authorities as long as there is credible information suggesting that the drug or immunization can stop, diagnose, or treat the virus. 

Last Monday, Philippine Ambassador to China Chito Sta. Romana said Chinese drug makers Sinopharm and Sinovac may apply for EUA this week. He said Sinopharm has secured approval for general use in China while Sinovac is expected to hear from Chinese authorities this month.