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

Marje Pelayo   •   May 21, 2020   •   456

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 prepares for clinical trials on six COVID-19 vaccine candidates

Marje Pelayo   •   July 30, 2020

MANILA, Philippines – The Food and Drug Administration (FDA) is set to launch the clinical trials on six drugs that are candidates for the treatment of coronavirus disease (COVID-19).

According to FDA Director General Eric Domingo, the selected drugs are based on the updates from the Department of Science and Technology (DOST), the agency that has been helping the FDA in searching for a potential vaccine for COVID-19.

The FDA, however, has not disclosed the details on the six candidate vaccines.

In addition to these, Domingo said the Philippines is now preparing to join the Phase 3 Clinical Trials together with other participating countries.

“Posibleng mag-apply at magsasagawa ng Phase 3 Clinical Trials on candidate COVID-19 vaccines sa bansa [We may apply and conduct a Phase 3 Clinical trials on candidate COVID-19 vaccines here in the country],” Domingo said. 

“Pinag-uusapan na rin ang pakikilahok ng Pilipinas sa gagawing Solidarity Vaccine Trials ng World Health Organization [There are also discussions on the participation of the Philippines in the upcoming Solidarity Vaccine Trials by the World Health Organization],” he added. 

Five of the 166 COVID-19 candidate vaccines that are already in the Phase 3 Clinical Trials include:

  • Sinovac
  • Sinopharm- Wuhan Institute of Biological Products
  • Sinopharm- Beijing Institute of Biological Products 
  • Astrazeneca- University of Oxford 
  • Moderna/ NIAD

The FDA clarified that though the agency is not involved in the clinical trials, it is the one that regulates the clinical products such as vaccines for public use.

Kapag napatunayan na ligtas at epektibo ang mga produktong ito, puwede na silang mag-apply for registration sa FDA upang maging available ang mga ito sa merkado,” Domingo explained.

[Once a product is proven safe and effective, the owner may apply for registration to the FDA so it may be available to the market.]

In his state of the nation address, President Rodrigo Duterte mentioned that a vaccine for COVID-19 may soon be out specifically by September this year. 

The FDA clarified, however, that developing a vaccine may take months to years, not to mention the strong scientific evidence from clinical trials and the effectiveness and safety of the product for human consumption. 

Nonetheless, the FDA is prioritizing the review of a number of applicants for potential vaccine and treatment for COVID-19.

The agency stressed, however, that there is no vaccine or drugs that have been approved yet to be taken by COVID-19 patients.

All drugs that have been selected for trial are still on trial stage and undergoing experts’ evaluation.

“Wala pa pong bakuna kontra COVID-19, kahit saang bansa [There is no vaccine yet for COVID-19 anywhere in the world],” he added.

The official advised the public to report to the agency any anti-COVID product that is being sold online through its email covidresponse@fda.gov.ph or at ereport@fda.gov.ph.

“Ipakita ninyo po sa amin. Ipadala ninyo po sa amin ang mga detalye at bahala po ang mga ahente namin na manghuhuli dahil mga manloloko po iyan [Show us the product. Send the details to us and our agents will track them and process their arrest because those are fraudulent],” Domingo stressed. –MNP (with reports from Aiko Miguel)

DOH warns against use of commercially available COVID-19 test kits

Marje Pelayo   •   April 1, 2020

MANILA, Philippines – The Department of Health (DOH) has warned the public not to purchase COVID-19 rapid test kits that are made available commercially.

“Gusto din po natin ipaalam na ang mga rapid test kits na ito ay hindi ibinebenta sa publiko. Tanging ospital at healthcare workers ang maaaring mag-administer nito. Kaya ‘wag po tayo basta magtitiwala sa mga hindi authorized mag-alok ng rapid test kits, (We would like the public to know that these rapid test kits are not sold commercially to the public. Only hospitals and authorized health care workers are allowed to administer such test. Do not easily trust unauthorized persons offering you such test kits),” said Health Undersecretary Maria Rosario Vergeire.

“Sana po ay ‘wag po kayo bibili ng ganito sa online at ipapagawa kung kani-kanino lang. Ito ay gagamitin pa din sa loob ng ospital with the guidance of a doctor, (Do not purchase such test kits online and don’t let just anybody do the test. The test kits should still be used inside the hospital with the guidance of a doctor),” she added.

At present, a total of 11 brands of rapid or anti-body test kits are registered under the Food and Drug Administration (FDA).

Meanwhile, 49 laboratories across the country are waiting DOH approval for them to operate as COVID-19 testing laboratories.

Aside from the Research Institute for Tropical Medicine (RITM), there are five sub-national laboratories authorized to conduct COVID-19 testing.

These are the Baguio General Hospital and Medical Center; San Lazaro Hospital; Vicente Sotto Memorial Medical Center; Southern Philippines Medical Center; and the UP National Institutes of Health (UP NIH). 

On Wednesday (March 31), the Lung Center of the Philippines started accepting samples after it received approval to conduct Stage 4 Proficiency Testing. MNP (with details from Aiko Miguel)

Countries sending alleged ‘faulty’ COVID-19 test kits, face masks back to China

Marje Pelayo   •   March 30, 2020

MANILA, Philippines – Several countries are sending imported medical supplies back to China after they were reportedly found defective.

The latest is the Netherlands, which ordered a recall of more than 600,000 alleged substandard face masks.

The Dutch government received on March 21 shipments of about 1.3 million face masks.

But the government’s Ministry of Health said the rest of the shipment “was immediately put on hold and has not been distributed.”

“A second test also revealed that the masks did not meet the quality norms. Now it has been decided not to use any of this shipment,” the Dutch Health Ministry said in a statement.

The imported FFP2 masks or N95 masks don’t provide full-face protection and the filters were also defective, claimed the Ministry.

Following the revealed defects, Dutch authorities said they will be stricter by doing extra standard testing to all arriving medical supplies shipment.

Prior to this, the Spanish government last week announced it would send back the rapid test kits it imported from a company in China after tests revealed only 30% detection rate.

Spain said the kits, which came from a national supplier, were ‘CE-Certified’ and passed the European standards.

However, the Chinese Embassy in Spain revealed that the supplier Shenzhen Bioeasy Biotechnology is not licensed nor registered under the National Administration of Medical Products of China to sell such medical products.

Despite the controversy, China vowed to replace the defective test kits delivered to Spain.

Countries like Turkey and the Czech Republic were also among countries that reported ‘faulty’ rapid test kits from China.

In the Philippines, meanwhile, the Department of Health (DOH) found that several COVID-19 test kits yielded only a 40% accuracy rate.

But the DOH clarified that those defective kits were not the ones from China but a brand that was said to have been donated by a private local group.

Sa ngalan po ng Kagawaran humihingi po kami ng paumanhin sa naidulot nitong pagkalito sa nasabi ko po kahapon. Sana po ay na- klaro na po namin ang isyu na ito [In behalf of the Department we apologize for the confusion caused by what I mentioned yesterday. We hope that we have clarified this issue,” said DOH Spokesperson Maria Rosario Vergeire.

The DOH stressed that the COVID-19 tests kits imported from China and were delivered to the Philippines, have passed the World Health Organization (WHO) standards. MNP (with reports from Harlene Delgado)

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