Sanofi takes appeal for Dengvaxia permit to President's office –Duque

Pharmaceutical giant Sanofi Pasteur has taken its appeal to the Office of the President on the revocation of the certificate of product registration (CPR) of the controversial anti-dengue vaccine Dengvaxia, Health Secretary Francisco Duque III said Saturday.

In August, the Department of Health (DOH) denied Sanofi's appeal as the agency upholds the revocation of Dengvaxia's CPR by the Food and Drug Administration for failure to submit post-marketing requirements.

Health Secretary Francisco Duque III at a Quezon City forum on Saturday, November 9, 2019. By Ted Cordero.

The DOH sustained the decision revoking the registration of the vaccine for "failure to submit documents pertaining to risk management or risk assessment which is a requirement for continuing certification of product registration," Duque said during the "In Focus" news forum at Annabel's Restaurant in Quezon City.

With DOH's denial of the pharmaceutical firm's appeal, Sanofi raised its appeal  with the Office of the President, said Duque.

"The ball is in the court [of the Office of the President]... We leave it to the [OP] to decide on the matter as the appeal is now pending."

Based on DOH data, 320,000 dengue cases have been recorded from January 1 to September 21 this year.

Duque insisted that the DOH has "to be on the side of safety and caution" despite other countries' —including the US –approval on the use of Dengvaxia.

"Kung ma-aprubahan man ito... Number 1, the WHO (World Health Organization) says Dengvaxia is not recommended for mass immunization," he noted.

"It has to be under very strict conditions. Kailangan i-test muna ang bata... establish whether the child has had dengue infection," he added.

Meanwhile, the Health chief, citing the finding of the London School of Hygiene and Tropical Medicine, said that the Dengvaxia scare had caused damage to the integrity of the DOH's immunization program.

"In 2018, vaccine confidence and trust in the Philippines plummeted to about 30% to 32% from a high of 85% to 90%," Duque said, noting that measles and polio outbreak might have been caused by the decline in vaccination confidence. —LBG, GMA News