Another firm likely to apply for COVID-19 emergency use

Published January 5, 2021, 5:08 PM

by Genalyn Kabiling

Another foreign firm is expected to apply for the emergency use of its coronavirus vaccine in the country in the coming days, Malacañang said Tuesday.

(Joe Raedle / Getty Images / AFP / FILE PHOTO / MANILA BULLETIN)

The planned emergency use authorization application (EUA) of the foreign vaccine maker was disclosed by vaccine czar Carlito Galvez and Food and Drug Administration (FDA) director general Rolando Enrique Domingo during the meeting with President Duterte Monday night, according to Presidential spokesman Harry Roque.

“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 Usec. Domingo himself and Secretary Galvez,” Roque said during a televised press briefing.

Asked to identify the company, Roque said it was prudent to just wait for the application “in two to three days.”

So far, American drug manufacturer Pfizer filed for an EUA application for the use of its coronavirus vaccine in the Philippines.

Two Chinese vaccine makers are also expected to apply for FDA approval this week, according to Philippine Ambassador to China Jose Santiago Sta. Romana.

Apart from the vaccine maker, Roque said the entity buying the vaccines could also take steps to apply for the EUA.

“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,” he said.

“That is why there is that provision in the FDA law which allows the procuring entity itself to apply for the EUA,” he added.

President Duterte earlier issued Executive Order No. 121 granting authority to the FDA director general to issue EUA for coronavirus drugs and vaccines. The order noted that no unregistered COVID-19 drug and vaccine may be manufactured, sold, imported, exported, distributed or transferred without an EUA “outside clinical trials and except in cases where a compassionate special permit is issued.”

The EUA shall be issued on three factors, including proven efficacy to prevent, diagnose or treat COVID-19 based on evidence and trials; the benefits outweigh the risks of the drug; and there is no adequate, approved and available alternative to the vaccine.

An application for EUA issuance shall be submitted by the industry or government agency concerned. 

 
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