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

Marje Pelayo   •   December 11, 2018   •   3334

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)

Sanofi Pasteur optimistic Dengvaxia will be restored in PH market

Aileen Cerrudo   •   August 15, 2019

French Pharmaceutical firm, Sanofi Pasteur expressed optimism that the Dengvaxia vaccine will be restored in the Philippine market.

In a statement, Sanofi Pasteur Philippines General Manager Jean Antoine Zinsou said they are open for a discussion with the Food and Drug Administration (FDA) and the Department of Health (DOH).

He also clarified that Dengvaxia is safe and effective to use.

According to Zinsou, the said vaccine was only banned in the Philippines because of incomplete documents or due to “administrative consideration.”

“We definitely need to settle this issue. One way to do it is to discuss with FDA and see what is needed to have this revocation lifted,” he said.

Zinsou also said Dengvaxia is registered in 20 countries across the globe and is acknowledged by the United States Food Drug Administration and the World Health Organization (WHO).

Meanwhile, Sanofi agrees with the DOH that Dengvaxia is not a solution to the Dengue epidemic in the country.

READ: Dengvaxia won’t bring dengue cases down – DOH

“The vaccines that we are mentioning is not a solution or a silver bullet for the ongoing outbreak. We are open to any discussion with the health authorities to see what is needed, what do they need for the future,” Zinsou said.

In February this year, the FDA revoked the certificate of product registration of Dengvaxia.

Sanofi already filed an appeal two weeks ago and the DOH will release their decision on the issue on August 19.—AAC (with reports from Aiko Miguel)

DOH belies bribery allegations by families of Dengvaxia vaccinees

Aileen Cerrudo   •   August 12, 2019

Families of children who had Dengvaxia vaccine rally in front of the Department of Health in Manila, 01 October 2018. (Photoville International)

The Department of Health (DOH) has belied the accusation made by families of Dengvaxia vaccinees that they received a P50,000 bribe from the department.

Health Secretary Francisco Duque III clarified that the P50,000 financial assistance did not come from the DOH.

“Iyang ayuda na iyan galing iyan sa Office of the President so hindi iyan galing sa DOH. Ito lamang ay dahil sa malasakit ng Pangulong Duterte para sa mga magulang na namatayan at gumastos para sa kanilang wake at paglibing at mga iba pang mga gastusin (That assistance came from the Office of the President, not the DOH. It was borne out of President Duterte’s concern for the parents of alleged Dengvaxia victims who had to pay for the wake, burial and other expenses),” he said.

This was after reports that several families of the Dengvaxia vaccinees are accusing the DOH of bribery after the department has offered them P50,000 financial assistance.

Several of them said they were asked to submit original documents and other information. They think these would be used as evidence in order to bring back the use of Dengvaxia amid the rise of dengue cases.—AAC (with reports from Aiko Miguel)

DOH: Dengue death cases reach 661

Aileen Cerrudo   •   August 12, 2019

Patients with dengue receive medical treatment at a hospital in Island Garden City of Samal, Davao del Norte, Philippines, 16 July 2019. (Photoville International)

Dengue death cases in the country have already reach 661, according to the latest record of the Department of Health (DOH) from January to July 27, 2019.

The overall dengue cases peaked at 167,000 which is double compared with the recorded cases in the previous year.

There are already 10 regions in the country that are on the Dengue epidemic threshold, including CALABARZON, MIMAROPA, Central Visayas and BARMM.

Meanwhile, Ilocos and the National Capital Region (NCR) are on the alert threshold.

According to DOH Spokesman Usec. Eric Domingo, it won’t be until December before a decline in dengue cases could be seen.

“We are expecting the cases na talagang peak natin August, September, October hanggang November. Minsan ang mag- start pa lang decrease ng December (We are expecting the cases to peak in August, September, October until November. The decrease might begin in December),” he said.—AAC (with reports from Aiko Miguel)

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