FDA warns against counterfeit anti-rabies vaccine for human use

Aileen Cerrudo   •   July 5, 2019   •   2107

File photo: Vaccine | Courtesy: Reuters / Bernardo Montoya

The Food and Drug Administration (FDA) warns the public against counterfeit versions of anti-rabies for human use.

The FDA also reminds distributors and retailers to only purchase Rabipur PCEC rabies vaccine from establishments with FDA license.

Based on the inspection of the FDA, Rabipur have two counterfeit versions. This was also verified by its Marketing Authorization Holder, GlaxoSmithKline Philippines Inc.

The box label of the fake version of the vaccine has a paler shade of gray compared to the original. Its font is not in bold format and the QR code is printed in darker ink.

There is also an email address — ‘E-Mail:CS@bd.com’ — printed in the label of the sterile syringe and needle.

For the original version, the box label should be in a darker shade of gray, with a bold format. Its QR code should be printed in lighter ink. The ‘E-Mail:CS@bd.com’ should not be in the label of the sterile syringe and needle.

The FDA also confirmed that Batch no. 3503 and Batch no. 3479 were counterfeited.

The agency also called on the Bureau of Customs (BOC) to block entry of counterfeit Rabipur vaccines at all ports of entry in the country.—AAC

EUA on Pfizer vaccine won’t be revoked yet despite Norway deaths, DOH says

Robie de Guzman   •   January 18, 2021

MANILA, Philippines — The emergency use authorization (EUA) issued last week by the Food and Drug Administration (FDA) to drug-maker Pfizer-BioNTech for its COVID-19 vaccine will not be revoked yet pending an investigation into claims that it caused the death of some elderly people in Norway, the Department of Health (DOH) said Monday.

Health Undersecretary Maria Rosario Vergeire said Norwegian authorities are still looking into reports that 23 individuals aged 75 to 80 with underlying health conditions died after getting inoculated with COVID-19 vaccine developed by Pfizer-BioNTech.

Vergeire also said that studies need to be done on the matter.

“Pfizer has to submit a report to the Philippine Food And Drug Administration regarding this matter. Once we evaluate the report, base sa kanilang conclusion, that’s the time FDA can decide on the EUA of Pfizer. For now,” Vergeire said.

“Hanggang wala pang sufficient evidence that it was caused by vaccines, status quo tayo on this EUA given to Pfizer,” she added.

The FDA granted EUA to Pfizer last January 14, the first out of four applications it received so far. Other applications are AstraZeneca, China’s Sinovac, and Russia’s Gamaleya Institute.

FDA Director-General Eric Domingo said they are still awaiting a report from Norwegian authorities and that they will “revise the conditions of the EUA as needed,” before starting vaccinations as part of the agency’s protocols on the use of vaccines.

Health authorities also reiterated that COVID-19 vaccines will go through stringent evaluation before it can be approved for use in the country.

“Aside from the safety, and the efficacy na meron ang mga bakuna na papasok, titingnan din nila iyon pong social impact nito, titingnan nila ang affordability and titingnan nila sa response ng equity,” Vergeire said.

“They will be evaluating and then they give their recommendation to the Secretary. Kapag positive ang recommendation, we can procure the specific vaccine,” she added. – RRD (with details from Correspondent Aiko Miguel)

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)

Probe on PSG COVID-19 vaccination to push through – FDA

Robie de Guzman   •   January 6, 2021

MANILA, Philippines – The Food and Drug Administration (FDA) on Wednesday said it will push through with its investigation into the unauthorized inoculation of COVID-19 vaccine to some members of the Presidential Security Group (PSG).

FDA Director-General Eric Domingo issued this statement even after President Rodrigo Duterte told his security detail to keep mum should lawmakers ask them about their vaccination.

Duterte’s order to the PSG prompted the Armed Forces of the Philippines (AFP) to call off its investigation into the controversial immunization.

Domingo said the president’s directive only applies to congressional hearings.

“Ang FDA po mayroong set po ng proseso kung paano po naming hina-handle at ini-investigate ang mga complaint at mga reports na mga ganito,” he said during a public briefing.

“Itutuloy naman po namin ‘yun according to process laid down by FDA,” he added.

The National Bureau of Investigation is also conducting a separate probe into the issue.

Malacañang earlier lauded the security group’s courage in taking an unregistered vaccine as part of their mission to protect the health and safety of the president. – RRD (with details from Correspondent Rosalie Coz)


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