Dengvaxia ban likely to extend for more than a year – DOH

Marje Pelayo   •   December 11, 2018   •   3645

FILE PHOTO: The controversial dengue vaccine, Dengvaxia

MANILA, Philippines – The Food and Drug Administration (FDA) is likely to extend the ban on marketing and sales of Dengvaxia, according to the Department of Health (DOH).

December 29 this year marks the first year since the license of French pharmaceutical giant Sanofi Pasteur was suspended; banning its sale of Dengvaxia in the country.

The DOH believes that since the controversy on the anti-dengue vaccine is not yet closed, the ban on sale of Dengvaxia still remains.

“Iyong one-year suspension ng Dengvaxia CPR is not yet lifted and I do not see it being lifted anytime soon. We still have a lot of pending issues with the vaccine and at this time we do not see it being registered and allowed for marketing in the Philippines…regulatory issues and cases in Court,” said DOH Spokesperson Usec. Eric Domingo.

It will be recalled that the FDA suspended Sanofi for not submitting its post-marketing authorization requirements which were supposed to prove that the products manufactured by the pharmaceutical company are safe to use.

Sanofi also couldn’t assure the safety of Dengvaxia, according to DOH.

The DOH noted that in November 29, 2017, Sanofi released a statement that Dengvaxia is not advisable to be administered to seronegative recipients —children or adults—who never had dengue infection prior to injection for the reason that their cases are likely to develop into severe dengue.

“It cannot be used without testing for children if they had dengue before. And there are no available testing kits commercially to do that. We don’t see naman any use for the vaccine at this time,” Domingo said.

The DOH also argued that the even regulatory agencies in the world that were granted with licenses to use Dengvaxia such as in Brazil, have set restrictions on the use of Dengvaxia on children who never had dengue infection prior to injection.

Hindi na rin sila magbibigay without screening,” Domingo said.

Based on the latest findings of the DOH, about 24 to 25 cases of dengue infection led to death due to severe dengue.

“We’ve seen talagang meron tayong patients who have, na ang mortality nila was due to severe dengue and I think probably from talagang seronegative patients iyon,” the health official said.

Meanwhile, the DOH is still waiting for the approval of Congress regarding the supplemental budget for vaccinees from the refund that Sanofi gave which reached P1.16-B.

Domingo said before the end of the year, the Office of the Solicitor General is likely to file a case against Sanofi Pasteur in line with the Dengvaxia controversy. – Marje Pelayo (with reports from Aiko Miguel)

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

Marje Pelayo   •   May 21, 2020

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)

Philippines eyes 30,000 daily COVID-19 tests by end of May

Robie de Guzman   •   May 12, 2020

MANILA, Philippines – The Department of Health (DOH) is eyeing to achieve 30,000 daily tests for novel coronavirus disease (COVID-19) by the end of the month as it works to ramp up the country’s testing capacity.

The DOH set the target after it finally attained its first target to conduct 8,000 COVID-19 tests in a day.

On Sunday, May 10, the agency reported it has conducted 8,637 tests in one day. This is, however, 10 days past its target date of April 30.

According to Health Undersecretary Maria Rosario Vergeire, the tests were done on 158,176 unique individuals.

She explained that one of the causes of the delay was the slow processing of samples after the Research Institute for Tropical Medicine (RITM) had to scale down its operations in April when over 40 of its medical staff contracted COVID-19.

The RITM has since returned to normal operations after most of its personnel recovered from the disease.

So far, the Philippines has 26 accredited laboratories capable of detecting the strain of coronavirus strain that causes COVID-19.

Vergeire said they are eyeing to open additional testing facilities to reach its target of 30,000 daily tests.

This way, the country will be able to improve efforts on contact tracing, isolation and treatment of COVID-19 patients to effectively curb the spread of the disease.

“Hindi pa po tapos ang laban ng World War C (COVID-19) sa bawa’t bagong impormasyon bawa’t bagong teknolohiyang nadidiskubre upang malabanan ang COVID-19 tayo’y dapat maging manatiling alerto dahil ang bawa’t bagay na nagagawa natin ay mayron buhay na mailigtas,” Vergeire said.

To date, the Philippines has recorded 11,086 confirmed coronavirus infections, with 726 deaths and 1,999 recovered patients. – RRD (with details from Correspondent Aiko Miguel)

FDA must tighten regulations on processed meat – DA

Marje Pelayo   •   September 17, 2019

MANILA, Philippines – Regulations on processed meat such as well-loved Filipino delicacies tocino and longganisa should be tightened by the Food and Drug Administration (FDA), according to the Department of Agriculture (DA).

According to Agriculture Undersecretary for Consumer Affairs Ernesto Gonzales, consumers cannot be complacent on buying these processed products especially if they are not sure of the source or origin of the raw meat.

Gonzales added that it is difficult to determine if the pork meat is contaminated with African Swine Fever (ASF) once it is processed.

He added that even ‘botcha’ or double-dead pork meat can be made into meat delicacies without the consumer noticing it because of colorings and extenders used in the process.

The official said the best way to determine if the pork meat is safe for consumption is to know the source of the raw meat, and if it is certified by the National Meat Inspection Service (NMIS).

Kapag na-issue-han na ang karne from slaughterhouse ng meat inspection certificate (once meat from the slaughterhouse is issued with meat inspection certificate), definitely that meat is safe to eat,” Gonzales said.

However, the DA admitted that the government is lacking when it comes to regulations on processed meat so the coordination of the local government units (LGUs) is of utmost importance.

Iyang problema natin yung mga maliliit na food processors na gumagawa ng mga longanisa, tocino, ang regulation hindi ganoon ka-strict ( The problem with small-time food processors or makers of longanisa and tocino is that the regulation is not that strict), ” Gonzales noted.

If ever the processed meat is infected with ASF, Gonzales said, it is still safe to eat, provided that it went through the proper cooking procedure of 30 minutes under 70’C temperature. – MNP (with details from Rey Pelayo)

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