World Health Organization backs Philippines suspension of Sanofi's dengue vaccine

Philippines government investigates Dengvaxia dengue vaccine

Dengue Vaccine Controversy

Children have received at least one dose through the government program.

Malacañang on Tuesday assured the public that the Duterte administration will not hesitate to use the full force of the law against those who will be found to have committed irregularities in the Dengvaxia dengue vaccine issue.

The Philippine Department of Health put on hold its 3.5 billion peso ($69.5 million) public dengue immunisation drive launched past year - the world's first such public programme - after the study was released last week.

The Reuters news agency reported that the Philippine's Department of Justice filed a probe into "the alleged danger to public health. and if evidence so warrants, to file appropriate charges thereon" on Monday.

There was no indication that Philippines health officials knew of any risks when they administered the vaccination. However, under moderate transmission, hospitalizations of vaccinated children increased three years after vaccination, compared to unvaccinated children.

According to Sanofi in Manila, 19 licences were granted for Dengvaxia, and it was launched in 11 countries, two of which - the Philippines and Brazil - had public vaccination programs.

"All drug establishments, including consumers and non-consumer user (e.g. healthcare professionals) are enjoined to take part in the post-marketing surveillance of Dengvaxia, by reporting to FDA any incident that reasonably indicates that Dengvaxia has caused or contributed to the death, serious illness, or serious injury to a consumer, a patient, or any person", the FDA said in a statement.

Anvisa did not immediately respond to a request for comment.

A spokesman for Philippines President Rodrigo Duterte said on Sunday the government would hold to account those responsible for the program. "We implemented it in accordance with World Health Organization guidance and recommendations".

Ching Santos, general manager of Sanofi Pasteur, gestures as she speaks during a press conference in Manila yesterday.

Even though analysis shows the vaccine can offer protection for those who have previously been exposed to the dengue virus, scientists have also pointed out that the vaccine has various degrees of effectiveness against four different types of the virus.

The manufacturer of a dengue fever vaccine that was suspended in the Philippines after a new study showed a greater risk of severe cases in people without previous infection said yesterday it is working with authorities to address fears and share the new information.

But for those not previously infected by the virus, more cases of severe disease could occur in the long term following vaccination, Sanofi said.

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