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)

Tags: dengvaxia, Department of Health (DOH), Food and Drug Administration (FDA)

FILE PHOTO: Relatives of Dengvaxia victims crying for Justice

QUEZON CITY, Philippines – Justice Secretary Menardo Guevarra on Thursday (November 8) said that the Public Attorney’s Office (PAO) is free to formulate its charges on the Dengvaxia case.

PAO Chief Atty. Persida Acosta said they are preparing the evidence that they will be presenting to the Department of Justice (DOJ) to upgrade the Dengvaxia raps from reckless imprudence resulting in multiple homicide to murder.

Respondents of the case are Sanofi Pasteur and former and incumbent officials of the Department of Health (DOH).

 “Ang elements of murder nandito na sa mga ebidensyang ito,” said Acosta.

But Secretary Guevarra said they will resolve the case on the basis of actual evidence.

“The PAO is free to formulate its charges. But the DOJ will resolve on the basis of actual evidence and nothing else,” Guevarra said.

Some parents of the children who died after being vaccinated with Dengvaxia are crying for justice.

 “Kasama ko sya papunta pgh malakas pa sya nakakalakad pa pagbaba namin sa bus wala na syang malay kala ko tulog lang yun pala nalagutan na sya ng hininga,” said Ellena Baldonado who blames her child’s death to Dengvaxia.

“Mabigat po ang nangyari sa anak ko kasi yung anak ko naturukan ng hindi sa akin humingi ng abiso nalaman ko patay na ang anak ko,” cried Annalyn Ibuña also a mother who lost her child allegedly to Dengvaxia vaccination.

Presidential Spokesperson Sec Salvador Panelo said the Palace vows to charge the people behind the Dengvaxia vaccine program.

The palace also expressed its sympathies to the grieving parents.

Panelo also ensured that the president is monitoring the development of the case. – Grace Casin

Tags: dengvaxia, Justice Secretary Menardo Guevarra, Public Attorneys Office (PAO)

MANILA, Philippines — The Public Attorney’s Office (PAO) plans to upgrade their case filed before the Department of Justice (DOJ) against former Health Secretary Janet Garin and other officials linked to the controversial Dengvaxia vaccine procurement.

PAO Chief Persida Rueda Acosta has given PAO lawyers one week to study the possibility of upgrading it from homicide to murder and the determination of who among the 39 respondents may face the said charges.

“Kung alam nila na nakamamatay ang Dengvaxia, hindi lang kapabayaan ito. Ito po ay isang murder… Guinea pigs ang ginawa nila sa mga bata. Experimental vaccine pa ito up to November 2017. Clinical phase 3 phase 4 pa nga ngayon iyan. Imagine ngayon lang sila nagpapa approve sa Europa,” Acosta argued.

After failing to attend the previous hearing, Garin submitted her counter-affidavit on the 2nd batch of Dengvaxia complaints on Monday.

Meanwhile, international representatives from Sanofi and Zuellig Pharma were directed to submit their respective counter-affidavits on November 15.

The complainants were also ordered to submit their reply on Garin’s counter-affidavit on the same date. – Mai Bermudez

Tags: dengvaxia, Janet Garin, Public Attorneys Office (PAO)