Duterte authorizes FDA to issue emergency use of COVID-19 vaccines

Robie de Guzman   •   December 3, 2020   •   235

MANILA, Philippines – President Rodrigo Duterte has allowed the Food and Drug Administration (FDA) to issue emergency use authorization (EUA) for COVID-19 vaccines and drugs that are expected to be made available in the Philippines next year.

Under Executive Order (EO) No. 121 signed on Dec. 1 and made public by Malacañang on Wednesday, Duterte granted authority to the FDA director general to issue EUA for COVID-19 drugs and vaccines, subject to provided conditions.

The EO stated that an EUA on a COVID-19 vaccine or drug shall be issued and remain valid only when all of the following circumstances are present:

  • Based on the totality of evidence available, including data from adequate and well-known controlled trials, it is reasonable to believe that the drug or vaccine may be effective to prevent, diagnose or treat COVID-19;
  • The known and potential benefits of the drug or vaccine when used to diagnose, prevent or treat COVID-19 outweigh the known and potential risks of the drug or vaccine, if any; and
  • There is no adequate, approved and available alternative to the drug or vaccine for diagnosing, preventing or treat9ing COVID-19

An application for the issuance of an EUA shall be submitted by the industry or government agency concerned, such as the national procurer or public health program implementer, the EO read.

The FDA shall then convene a panel of experts on drug and vaccine development to review available data on the safety and effectiveness of a COVID-19 drug or vaccine applied for an EUA. The panel will then submit its report and recommendations to the FDA director general.

“In evaluating applications for EUA, the FDA director general shall have the power to implement reliance and recognition processes for emergency use of drugs and vaccines,” the order stated.

“For this purpose, the FDA director general may accept the regulatory decision of the WHO (World Health Organization), US-CDC, or other internationally recognized and established regulatory authorities,” it added.

An EUA issued pursuant to the order shall be valid within the duration of the declared public health emergency due to COVID-19, and may be revoked or revisited by the FDA director general.

FDA director general Eric Domingo earlier assured they will not compromise public safety with the sped-up process.

The Philippine government is looking to administer the vaccines to at least 70 million Filipinos under an immunization program that may be carried out within three to five years. – RRD (with details from Correspondent Rosalie Coz)

No ‘Sara for President’ in 2022, no term extension —Pres. Duterte

Marje Pelayo   •   January 15, 2021

MANILA, Philippines — President Rodrigo Duterte said there are groups urging his daughter, Davao City Mayor Sara Duterte-Carpio, to run for president in 2022 but the Chief Executive expressed his opposition to the idea.

He stressed that the presidential seat is not for a woman to fill.

“My daughter inuudyok naman nila, sabi ko, ‘My daughter is not running,’” he said during the launch of the Metro Manila Skyway Stage 3 project in Quezon City on Thursday (January 14).

“I have told Inday not to run kasi naaawa ako sa dadaanan niya na dinaanan ko . Hindi ito pambabae. Alam mo, the emotional setup of a woman and a man is totally different. That is the sad story,” he said.

Rumors about the younger Duterte’s possible 2022 bid surfaced after a Pulse Asia survey conducted from November 23 to December 2, 2020 revealed that one in every four Filipinos expressed support for the presidential daughter’s bid for the presidency in the next election.

As for him, the Chief Executive said he will not accept any offer of term extension even if Congress moves to amend the Constitution for that matter.

On Wednesday (January 13) the House Committee on Constitutional Amendments began discussing the proposed change in the economic provisions of the 1987 Constitution.

Critics of the Duterte administration slammed such a move, claiming it is a front of Duterte allies to push for term extension and scrapping of term limits among politicians.

“Kaya nga hinihingi ko ang Congress, akala nila term extension ,” Duterte said.

“Maski ibigay mo sa akin on a silver platter, maski ibigay mo sa akin libre another 10 years, sabihin ko sa iyo, p***** i** mo, iyo na lang iyan. Tapos na ako,” the President said. MNP (with reports from Rosalie Coz)

Duterte vouches for China’s Sinovac, says LGUs may choose any vaccine brand

Marje Pelayo   •   January 14, 2021

MANILA, Philippines — President Rodrigo Duterte on Wednesday (January 13) vouched for the efficacy of Sinovac, the COVID-19 vaccine developed in China.

He said the Chinese-made vaccine is “as good as any other” vaccines developed in the United States and Europe.

“Hindi nagkulang ang Chinese sa utak (The Chinese is not lacking in knowledge). They would not venture kung hindi sapat (if it’s not) safe, sure, and secure. Iyang tatlo. It must be safe, sure and secure. That is the guarantee,” the President said.

His remark comes after several local government units (LGUs) opted to choose and procure the brand of their choice other than the ones preferred by the national government. 

“We are not forcing anybody to join the cause of the national government,” Duterte said.

“I am addressing this to the mayors. You can choose any vaccine you like to buy. Wala kaming pakialam kung ano ang pipiliin niyo (We don’t care which one you choose). Hindi kami makialam sa lahat ng bagay in the purchase (We won’t meddle in anything that has to do with the [vaccine] purchase),” he stressed.

But he reminded the local chief executives that it is still the national government that approves whatever medicine or drugs should be made available for public consumption.

The President maintained that he prefers whatever vaccine czar Secretary Carlito Galvez will procure, for after all, he is his representative and that his decision will be the President’s responsibility.

“Ang responsibility niya ay responsibility ko rin. Kung may bulilyaso at the end of the day, akin talaga yang responsibility (His responsibility is my responsibility. If there are problems along the way, at the end of the day, it is my responsibility),” the President stressed.

During the meeting, Galvez confirmed that the national government is set to grant the Chinese drugmaker Sinovac its emergency use authorization (EUA) for its vaccine before February 20.

The official added that initial delivery will be 50,000 doses, followed by 950,000 doses in March then to one to three million in increasing volumes in the succeeding months. 

FDA clarifies issuance of EUA of vaccine manufacturers not delayed

Aileen Cerrudo   •   January 12, 2021

MANILA, Philippines — The Food and Drug Administration (FDA) has clarified there is no delay in the issuance of the Emergency Use Authorization (EUA) to vaccine manufacturers.

FDA Director General Eric Domingo said the agency managed to lessen the approval process from six months to 21 days.

Domingo added the applications should still be thoroughly reviewed especially if it will be distributed to Filipinos.

Kailangan naman natin ng magandang proseso at ng pagusuri bago natin payagan na gamitin ang bakuna sa milyon-milyong Pilipino (We need a thorough process and review before we can allow the vaccine to be used to millions of Filipinos), he said.

Three pharmaceutical companies Pfizer-BioNTech, AstraZeneca, and Gamaleya already submitted their application for the EUA.

Several local government units (LGUs) also signed a deal with AstraZeneca to purchase COVID-19 vaccines.

The FDA said that while LGUs are free to sign tripartite deals with a COVID-19 vaccine manufacturer of their choosing., they can still partner with other COVID-19 vaccine makers.

Maaari rin naman sila later on magkaroon ng agreements with other vaccines and coordinated with the DOH [Department of Health] and the NTF [National Task Force]. Hindi iyon exclusive sa isang marka lamang (They can have agreements with other vaccines later on, with the coordination of the DOH and NTF. That is not exclusive to one company), he said.

Meanwhile, Domingo said the FDA is still awaiting the guidelines of the national government on the vaccination plan, which includes the distribution of vaccines to various areas in the country.

Domingo also reiterated that individuals can opt-out of receiving the vaccine if they wish to do so.

“Even the FDA requires that if any person is going to be vaccinated especially under the EUA there should be a full, written informed consent before the vaccination,” he said. AAC (with reports from Aiko Miguel)

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