After the Pediatric Infectious Disease Society of the Philippines (PIDSP) and the World Health Organization (WHO) updated their recommendations on Dengvaxia, the Food and Drug Administration (FDA) confirmed the suspension of the sale of Dengvaxia for a year, several news outlets have reported.
Sanofi Pasteur will also be fined with P100,000 for “failing to comply with post-marketing authorization requirements,” said the FDA.
Last December 4, five days after Sanofi’s statement that announced Dengvaxia’s risks, the agency already ordered the market pullout of the controversial vaccine.
Responding to the suspension, Sanofi Pasteur provided a statement to SmartParenting.com.ph, where it “confirms that in accordance with international and local laws, regulations and company standards, post-approval commitments for Dengvaxia...have been – and will continue to be – fulfilled.”
The company adds that it will “continue to cooperate in full transparency with the Philippines FDA and is committed to comply with the Philippines laws and regulations.”
In recently released statements, the PIDSP and WHO recommended the anti-dengue vaccine should only be given to those 9 years old and above and have had dengue in the past.
“WHO recommends vaccination only in individuals with a documented past dengue infection, either by a diagnostic test or by a documented medical history of past dengue illness,” read a document published by the organization on December 22.
The PIDSP stressed the dengue infection must be documented (your child was diagnosed by a doctor) as dengue tests are only limited to patients showing signs of the illness. There is no test available locally that will be able to tell if a person has had dengue in the past.
“It is recommended that only children with documented prior dengue infection can be vaccinated after an informed discussion,” said the PIDSP in a statement published on December 12.
Also included in PIDSP’s statement response are clarifications on what “severe” dengue is as defined by Sanofi. The case is considered a “severe” disease if the dengue-confirmed patient has had a fever lasting for at least two days and at least one of the following:
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low platelet count
bleeding requiring transfusion
unconsciousness or poor conscious state
impaired kidney function
If your child was given Dengvaxia, familiarize yourself with these symptoms and other signs of dengue. The PIDSP also advised prompt consult with a doctor if you suspect your child is infected with the mosquito-borne disease.
If your child has only been partially vaccinated (received only one or two doses), vaccination can be continued if she has a documented history of dengue, said PIDSP. However, it is best to consult with your doctor on the next steps to take in lieu of the suspension of the sale of Dengvaxia.