FDA clarifies issuance of EUA of vaccine manufacturers not delayed

Aileen Cerrudo   •   January 12, 2021   •   412

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)

PH FDA OKs EUA application for Sinopharm’s COVID-19 vaccine

Robie de Guzman   •   June 7, 2021

MANILA, Philippines – The Philippines’s Food and Drug Administration (FDA) on Monday said it has approved the emergency use authorization application (EUA) for the COVID-19 vaccine made by Chinese firm Sinopharm.

FDA director general Eric Domingo made the announcement during his report to President Rodrigo Duterte in a televised briefing on the government’s COVID-19 response.

Domingo said the EUA for Sinopharm was granted on Monday.

“Ito ay tiningnan na rin ng ating mga experts at ng atin pong evaluation sa FDA and today we already granted an emergency use authorization to DOH to accept the donations of Sinopharm,” the FDA chief said.

The Department of Health (DOH) earlier filed an application for the EUA of Sinopharm’s COVID-19 vaccine after it was included in the emergency use listing (EUL) of the World Health Organization (WHO).

A WHO emergency use listing means that a product’s safety and efficacy has been rigorously evaluated. It will also allow the product to be included in the COVAX facility for faster global roll out.

The COVAX facility led by the WHO is a global program that seeks to provide vaccine supply mainly for poor countries.

The emergency use listing will also allow countries to expedite their own regulatory approval to import and administer COVID-19 vaccines.

FDA to allow use of Pfizer COVID-19 vaccines for 12 to 15 age group

Maris Federez   •   May 27, 2021

MANILA, Philippines — The Food and Drug Administration (FDA) said it is looking into the possibility of using American-made Pfizer-BioNTech COVID-19 vaccine on children aged 12 to 15, FDA director-general Eric Domingo said on Wednesday.

In the pre-recorded briefing with President Rodrigo Duterte, Domingo said that on May 20, the FDA received an application for amendment from Pfizer to include children aged 12 to 15 in the emergency use authorization for its COVID-19 vaccine.

He said that Pfizer had sought and received the approval of the US FDA of the said amendment and has started using the vaccine for the said age group.

“Ang atin pong mga experts, in-evaluate. In fact, early this evening, I already got the recommendations of our experts and it’s very favorable,” Domingo said.

“Within the week po we will be issuing an amendment to the emergency use authorization (EUA) of Pfizer and we will be able to use it in children of 12 to 15 years old,” he added.

Domingo also reported that, worldwide, there are 16 vaccines that have already secured emergency use authorization, including two new COVID-19 vaccines from China and Kazakhstan.

In the Philippines, he said, seven vaccines are currently being used under the EUA.

Domingo assured that experts are strictly monitoring the development of all the vaccines worldwide, saying that the real-world data that they receive are very encouraging.

“So ang ginagawa po natin. Binabantayan po natin yan nang masusi, ng DOH at FDA to make sure that every time we get any new information, we check all the adverse events and we make sure that the benefit definitely outweighs the known and potential risk of any vaccine,” he said. —/mbmf

Anti-Red Tape Authority to probe FDA officials over delayed permit applications

Aileen Cerrudo   •   May 14, 2021

MANILA, Philippines — The Anti-Red Tape Authority (ARTA) said it will investigate officials of the Food and Drug Administration (FDA) over delayed processing of permit applications.

During the Laging Handa press briefing, ARTA Director Atty. Jeremiah Belgica said they already filed show cause orders to the FDA on Tuesday (May 11) for alleged 600 pending drug certification applications since 2014.

He also reported that 23 pharmaceutical companies have filed affidavits against the FDA for its lack of action concerning their applications.

Belgica urged the FDA to release the pending permit applications. He said that the processing of these applications should not take long since most of the permits are under automatic renewal applications or products that have previously been approved. He stressed that these products do not need to be further reviewed.

“Simpleng affidavit lang po ang nire-require ng FDA dito. So ibig sabihin kapag naisubmit na ang mga affidavit na iyan, automatically renewed na dapat po iyan. Pero sa ganito hindi nagiging automatic ang renewal,” he said.

(The FDA is only requiring a simple affidavit, meaning, once you have submitted one it will automatically be renewed. However, with the current situation, it is not being automatically renewed).

Belgica also said ARTA is coordinating with the Presidential Anti-Corruption Commission (PACC) to conduct lifestyle checks on officials allegedly involved in red tape.

He said that red tape is connected to corruption. He also reported that the complaints exceed more than 600 since the agency is still receiving complaints against centers under the FDA.

ARTA has yet to release the number of additional complaints.

Belgica also urged the FDA and the Department of Health (DOH) to replace erring personnel to avoid any hint of corruption in the agencies.

“Tanggalin na ang mga dapat tanggalin at dapat po maglagay tayo ng mga tauhan na talagang magrereporma,” he said.

(Remove those needed to be removed and replace them with personnel who would side the reform.) AAC

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