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

Marje Pelayo   •   December 11, 2018   •   3735

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 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 orders public hospital to increase bed capacity for COVID-19 patients

Marje Pelayo   •   July 22, 2020

MANILA, Philippines — One after the other, major hospitals in Metro Manila last week declared full capacity of its designated beds for COVID-19 patients.

According to their respective statements, the hospitals fear that operations would collapse with the daily surge of COVID-19 patients.

Thus, the Department of Health (DOH) has required all public hospitals to increase their bed capacity to accommodate more COVID-19 patients.

“ [For] public hospitals, we require them to allocate 30 percent of their bed capacity for COVID-19 patients,” said Heath Undersecretary Maria Rosario Vergeire.

Kapag nag-surge ang cases, 50 percent [dapat], at ‘pag kailangan pa, dapat 70 percent of their bed capacity should be allocated for COVID-19 patients, [When cases surge, hospitals’ bed capacity for COVID-19 patients should be 50 percent and if necessary, 70 percent),” she added.

Private hospitals, meanwhile, are required to initially allot 20 percent of their bed capacity for COVID-19 patients and if necessary, expand further to 30 percent bed capacity as dictated by the “One Hospital Command” launched by the DOH.

Under the program, an incident command system network between hospitals will be established to coordinate transfers in case one hospital can no longer accommodate incoming COVID-19 patients.

“That is our answer to this problem, the One Hospital Command. Kasi kung di magtutulong tulong bawat mga ospital both public and private in a specific locality, we will not be able to have this proper referral system,” Vergeire expalined.

Gaya ng puno na ICU ng hospital, kapag di nya maaccept ang isang pasyente, meron silang incident command system, kung saan ibabato lang nila ang pasyente, enroll the details and ang system ang maghahanap kung saan pwedeng dalin among all of the hospitals in NCR,” she added.

The official noted that due to the rising number of COVID-19 cases, government hospitals like Lung Center of the Philippines, Philippine Children’s Medical Center, Dr. Jose Fabella Memorial Hospital, Heart Center and other hospitals for specific specialization also have been accepting COVID-19 patients in response to the demand after major hospitals declared full bed capacity. MNP (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)

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