Pfizer applies for emergency use authority in Philippines

MANILA, Philippines — US pharmaceutical company Pfizer Inc. has officially applied for the required authority to supply and market COVID-19 vaccine in the Philippines.

During an emergency meeting between President Duterte and several Cabinet members last Saturday night, the Department of Health (DOH) confirmed that Pfizer filed for emergency use authority (EUA) at the Food and Drug Administration (FDA) on Dec. 23.

“It will take 21 days to evaluate and approve the EUA, but vaccination would start as soon as stocks become available,” the DOH said.

FDA director general Eric Domingo said it would not be difficult for Pfizer to obtain the EUA for its COVID vaccine.

“’Pag nanggaling na sa (If it has already come from) stringent regulatory authority like the US FDA and UK, there would be minimal requirement,” Domingo added.

Among the additional requirement to be given by Pfizer are information showing efficacy and safety of the vaccine to the Asian population and assurance that the product registered with the country of origin would be the same vaccine to be supplied to the receiving country.

“They also need to show the stability of the vaccine in the Philippine climate at hindi masira sa pagbiyahe papunta rito (and that it won’t be destroyed during its transportation here),” Domingo said.

During the meeting, Duterte asked Domingo about the possible use of the vaccine from China.

Domingo said the Chinese vaccine Sinopharm is expected to also apply for EUA in January, and the application would be immediately evaluated upon application.

“Mas strict lang kasi wala pang (It’s just stricter because there is still no) EUA from FDA counterpart, but our panel of vaccine experts will help us in the evaluation,” he added.

The President told Domingo that there are Filipinos who have already been vaccinated with the COVID vaccine from China.

The FDA conducted several raids, but all the operations yielded negative results, according to Domingo.

In a press briefing yesterday, Health Secretary Francisco Duque III said he had no information concerning the President’s statement.

DOH Technical Advisory Group member Edsel Salvana, however, cautioned the public against having themselves inoculated with unregistered vaccine.

“You are not just losing money, you are putting life at risk in getting unregulated vaccine,” Salvana said.

Moderna ‘on board, accelerating’

Meanwhile, American biotechnology company Moderna is “on board” and “accelerating” huge shipment of COVID-19 vaccine to the Philippines, Foreign Affairs Secretary Teodoro Locsin Jr. said yesterday.

Locsin said he received the information from Philippine Ambassador Jose Manuel “Babe” Romualdez.

On Monday last week, Locsin said the country would start negotiations with Moderna on or before Dec. 30 for the supply of COVID-19 vaccine.

“More good news from Babe: Moderna on board and accelerating huge shipment. Everything’s falling back into place,” Locsin tweeted.

“We will have complete range of vaccines from least effective to most available for everyone to choose from. No vaccine will be mass deployed unless the official recommending it for mass deployment is seen taking it himself,” he added. “The only proof of the pudding is in the eating it oneself and no one else in his place until we see the side effects of the pudding if any.”

The foreign affairs chief confirmed in an interview on CNN Philippines last week that Duque was the one who had “dropped the ball” in the negotiations with Pfizer for the COVID-19 vaccine supply to the country.

The Philippines was assured of getting 10 million doses of COVID-19 vaccines from Pfizer by January until “somebody dropped the ball.”

Romualdez on Tuesday said the country is not yet ready to handle millions of COVID-19 vaccine doses by January 2021 as it takes a lot of logistical work.

Pfizer vaccines are to be stored in an ultra-cold freezer, thermal shipping container or refrigerator. Cold storage is crucial to COVID-19 vaccine distribution.

“It is just as well that we were not able to get this because we were not ready to receive them, anyway. It takes a lot of logistical work to do all of this,” Romualdez said.

“And even if we were able to close that deal, it will probably be very difficult for us to bring all of them. I guess it’s better that the deal didn’t push through,” he added.

The vaccine developed by Moderna, according to the ambassador, does not require that kind of refrigeration.