Philippines pulls plug on vaccine

Philippines invokes maximum penalty on drug firm after alleged deaths

The world's first dengue vaccine has been permanently banned in the Philippines where it set off a health scare. The country's Food and Drug Administration said the French drugmaker failed to submit post-approval documents required by regulators, according to a statement. The vaccine wasn't on sale in the Philippines, having already been suspended ther for a year.

Manila: The Philippines has revoked the registration of the worlds first dengue vaccine amid reports of deaths allegedly related to the drug, a government agency said.

The Food and Drug Administration (FDA) said it permanently revoked the registration of Dengvaxia after its manufacturer, French pharmaceutical company Sanofi Pasteur, failed to supply post-approval documents.

Sanofi disputed that, saying it had provided the FDA with post-approval documentation and regular updates from post-marketing studies. It said it had formally requested a reconsideration of the decision.

The FDA first suspended the drugs registration for one year in December 2017, due to a controversy over children allegedly dying after being given the vaccine.

Sanofi Pasteur’s “brazen defiance of FDAs directives and its continued failure to comply leave us no other recourse but to impose the maximum penalty of revocation of the (product registration) covering Dengvaxia”, said FDA director gen- eral Nela Charade Puno.

“It is important to note that the Philippines FDA is not questioning the safety and efficacy of Dengvaxia,” Sanofi Pasteur said in a statement, citing approval for the vaccine from the World Health Organization (WHO) and the European Medicines Agency.

Dengvaxia was given to about 830,000 children in the Philippines in the worlds first mass vaccination using the new drug from April 2016 to December 2017, when the programme was stopped due to safety concerns.

Sanofi Pasteur disclosed on Nov 29, 2017, that a long-term follow-up study showed children who had not previously been infected by dengue might be at risk of contracting a more dangerous infection if given Dengvaxia.

Since then, the public attorneys office has documented more than a dozen cases of children who died after receiving the vaccine. Most of them had no history of dengue infection before the vaccination.

According to the WHO, the sec- ond dengue fever infection in any given individual presents the highest risk of severe complications.

The UN body says one possible explanation for the results is that the vaccine, if given to persons who had not previously suffered dengue fever, may lead to an immune status similar to that of persons who have been infected once before.

The WHO currently says its preferred option is that the vaccine should be given only to persons who test positive for previous exposure to dengue fever.