FDA recalls locally-made COVID-19 test kits for ‘minor defects’

Marje Pelayo   •   May 21, 2020   •   649

MANILA, Philippines — Some ‘minor defects’ have been seen in the test kits made by the University of the Philippines – National Institute of Health (UP-NIH), according to the Food and Drug Administration (FDA). 

This prompted the agency to order the recall of all locally-made coronavirus disease (COVID-19) test kits and stop its use in medical facilities until the problem is resolved.

Specifically, FDA Director Eric Domingo said evidence of contamination had been traced in the reagents that were used in the test kits of UP-NIH; hence, they should not be sold or used for now. 

The said locally-made test kits were approved for use by the FDA in April.

Nonetheless, Health Spokesperson Undersecretary Maria Rosario Vergeire ascertained that the UP-NIH is soon to complete correcting the deficiencies in their test kits. 

“They are in the final stages of correcting the identified deficiencies of the kits by RITM and hopefully by next week they can be re-validated by RITM and we can already use the UP testing kits,” Vergeire said. 

As regards the rapid antibody test kits, Malacañang maintained that local government units (LGU) may still use the said kits despite claims by medical societies that the use of such would be a waste of resources when they only give false results. 

According to Presidential Spokesperson Secretary Harry to  Roque, the LGUs just need to confirm the results of the rapid antibody test kits through real-time reverse transcription polymerase chain reaction (rRT-PCR) test within the succeeding 14 days. 

Sa ngayon po, dahil po wala pa tayong sapat na kakayahan at dahil tayo po ay nagbi-build up pa lang ng capacity ng PCR testing, siguro naman walang mawawala kung ira-rapid testing natin ang gusting magpa-rapid testing at yung mga positive, ipa-verify natin sa PCR [For now, since we do not have enough capacity yet and we are still building up our PCR testing capacity, there’s no harm if we still proceed with rapid testing to those who request it, and if it yields a positive result, then have it confirmed through PCR],” Roque explained.

 FDA-approved rapid test kits costs around P3,500 and up depending on the source company and the country of origin. MNP (with reports Aiko Miguel)

FDA warns against purchase, use of AiDeLai face masks

Marje Pelayo   •   January 15, 2021

MANILA, Philippines — The Food and Drug Administration (FDA) on Friday (January 15) warned against the purchase and use of AiDeLai face masks.

In an advisory dated January 8, the FDA said it cannot guarantee the safety and quality of the popular face mask brand because it has not gone through the agency’s evaluation process.

The regulator also warned establishments not to distribute, advertise, or sell the medical product until Product Notification Certificate is issued.

“Otherwise, regulatory actions and sanctions shall be strictly pursued,” the FDA mentioned.

The agency urges the public to always check certain products on their website www.fda.gov.ph before purchasing. MNP / Raymund David

No photo description available.

Philippines approves emergency use of Pfizer-BioNTech’s COVID-19 vaccine

Marje Pelayo   •   January 14, 2021

MANILA, Philippines — The Food and Drug Administration (FDA) on Thursday (January 14) granted emergency use authorization (EUA) for the coronavirus disease (COVID-19) vaccine developed by US pharmaceutical giant Pfizer Inc. and its German partner BioNTech SE.

The approval followed issuance of Executive Order No. 121 s. 2020, which grants vaccines under development an EUA “where there is no adequate, approved and available alternative to a vaccine for preventing COVID-19 during this present public health emergency.” 

The FDA clarified, however, that the EUA does not mean that the vaccine would be available for use as the country has yet to settle an agreement for its supply.

“The granting of the EUA is not a marketing authorization or a Certificate of Product Registration, hence this cannot be used to market the vaccine commercially,” the FDA explained.

Pfizer-BioNTech’s COVID-19 vaccine, which boasts a 95% efficacy rate, is expected to arrive in the country by February according to vaccine czar Carlito Galvez Jr., in a meeting with President Rodrigo Duterte on Wednesday evening (January 13).

“After a thorough review of the currently available data by medical and regulatory experts, the FDA is granting Emergency Use Authorization to Pfizer-BioNTech COVID-19 vaccine,” Director General Eric Domingo said.

“The interim data from the ongoing phase 3 trial shows that the vaccine has an efficacy of 95% in the study population and at least 92% among all racial groups,” he added.

Domingo noted the adverse events that happened in other countries following the inoculation of the vaccine. 

Thus, he said, close monitoring of the COVID-19 immunization programs is necessary to ensure adverse reactions will be properly addressed.

“The roll out of the vaccine and use in more than five million people worldwide has identified severe allergic reaction in a few individuals,” Domingo said.

“Therefore, the vaccinations must be done by health professionals trained to recognize and manage adverse reactions and they should have resources at hand to adequately respond,” he added.

The FDA noted also that reporting of the patient’s response to the vaccine shall be through the pharmacovigilance system that will be activated once the vaccination program is implemented.

DOH, FDA to tap PRC in determining liability of doctors involved in unregistered vaccination

Robie de Guzman   •   January 4, 2021

MANILA, Philippines – The Department of Health (DOH) on Monday said it will coordinate with the Professional Regulatory Commission (PRC) in relation to the investigation on doctors involved in the administration of unregistered vaccines against novel coronavirus disease (COVID-19).

DOH spokesperson Undersecretary Maria Rosario Vergeire said they will be working with the PRC in determining the possible liability of medical professionals who participated in unauthorized COVID-19 vaccination.

Vergeire also stressed that the unauthorized inoculation of the COVID-19 vaccine to some members of the Presidential Security Group (PSG) is now being investigated by the Food and Drug Administration (FDA) and that the response of concerned agencies will depend on the agency’s findings.

“The FDA and DOH is also would be coordinating with the Philippine Regulatory Commission para nga doon sa mga involved professionals na sinasabing pagbibigay nitong unregistered vaccine na ito,” she said.

The vaccination of some PSG members came to light after President Rodrigo Duterte revealed last week that some military men had already received a COVID-19 vaccine.

PSG commander Brigadier General Jesus Durante had confirmed that his unit obtained the vaccine but refused to disclose its source. He also clarified that the president was only informed of their move after the fact.

Durante also stressed that their decision to inoculate some members sans the FDA approval is based on their mission to protect the president’s health and safety.

The PSG drew both criticisms and support from various quarters over the issue, while the Palace lauded the group’s bravery in taking unregistered and possibly smuggled vaccines.

But for Health Secretary Francisco Duque III, the incident is now being investigated by the FDA, as well as by the National Bureau of Investigation, and the Bureau of Customs.

“Nire-respeto po natin ang mga opinyon ng sinoman at ang mahalaga po rito ay kung ano po ang kakalabasan ng imbestigasyon na ginagawa ng FDA,” he said.

“Huwag po natin pangunahan ang anomang resulta na ilalabas ng FDA, NBI at Bureau of Customs sa naturang imbestigasyon… Sila po ang lead agency patungkol sa imbestigasyon na binanggit ko,” he added.

The DOH, meanwhile, urged local government units to coordinate with the agency and strictly observe protocols in rolling out their respective COVID-19 vaccination programs.

“So that we can have a unified effort at hindi tayo magkaroon ng technicalities and also we can be able to monitor as well.  We have to remember the National Immunization Program rests on the mandate of the Department of Health,” Vergeire said. – RRD (with details from Correspondent Aiko Miguel)

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