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Deaths of 3 Children Raise Alarm on Dengue Vaccine AnewThe Food and Drug Administration has ordered the pull-out of Dengvaxia from the market.
The Volunteers Against Crime and Corruption (VACC) has requested that three children be exhumed and examined to confirm if their deaths came as a result of Dengvaxia, the anti-dengue vaccine, according to a report by The Philippine Daily Inquirer last Monday, December 4.
Dante Jimenez of the VACC said the three children received the vaccine in April 2016, which coincides with the launch of the Department of Health's (DOH) school-based dengue vaccination program.
One of the children was 11-year-old Christine de Guzman, according to a report by News 5 on December 5. Christine was in the first batch of students in Mariveles, Bataan who received the first dose of the dengue vaccine. Before her scheduled second dose, News 5 reported she contracted severe dengue and passed away in October 2016, six months after her first dose and the same month she was meant to receive her next shot.
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On her death certificate, published by Interaksyon, her official cause of death was disseminated intravascular coagulopathy, a clotting of the blood that leads to excessive bleeding caused by severe dengue. According to her father, Christine had a fever that lasted for two days and died four days after she first complained of feeling unwell.ADVERTISEMENT - CONTINUE READING BELOW
Her first symptom were a headache and a fever. The following day she was diagnosed with dengue and admitted to a hospital. She also experienced stomach ache and difficulty breathing, PhilStar reported. Christine was reported to have no history of dengue prior to her dengue vaccination.
Last year, Christine’s parents were invited to the Senate regarding an investigation on Dengvaxia. VACC said they will assist the de Guzman family in filing legal action against Sanofi.
Health officials say “they have yet to receive any reports of vaccinated children who are manifesting the signs of 'severe dengue.'” “There is no cause for alarm,” Health Undersecretary Gerardo Bayugo told CNN Philippines.
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The Philippine Star, however, said the DOH reported “997 adverse events following immunization, 30 of which were considered serious cases that needed hospitalization” between March 18 and August 20 of 2016. This was part of a draft report by the House of Representatives committee on health for their investigation on the efficacy of Dengvaxia.
“Based on information reaching the committee on health, at least four children have died,” added PhilStar, which includes Christine.
To explain the term “adverse events” pertaining to the 997 cases, Quezon Rep. Angelina Tan, who chairs the committee on health and is a medical doctor, told PhilStar, “Their sickness ranged from as simple as fever, nausea, vomiting and body pain, to serious illness that required hospital confinement.ADVERTISEMENT - CONTINUE READING BELOW
“The DOH did not have other details, highlighting its lack of proper monitoring and reporting protocols before undertaking the program.”
The Food and Drug Administration (FDA) has ordered Sanofi to pull out Dengvaxia from the market and suspend its sale, distribution and marketing “pending compliance with the directives of the FDA.”
In a press statement provided to SmartParenting.com.ph, Sanofi Pasteur, the manufacturer of Dengvaxia, says it will work with the FDA “to review the implementation of their direction” and “will continue to seek constructive and transparent dialogue with them.” It has also proposed a “label update” based on the new data.
The pharmaceutical company released a statement dated November 29 announcing that the vaccine was found to heighten the risk of severe dengue in those who have never had the mosquito-borne illness in the past.
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The DOH has put on hold the Philippines’ dengue immunization program until a proper evaluation is conducted. As as of December 2017, the DOH told CNN that more than 800,000 children received the dengue vaccine.
Department of Justice Secretary Vitaliano Aguirre II also ordered the National Bureau of Investigation to look into the P3.5 billion immunization program.
Parents of vaccinated children are advised to be vigilant of the signs of dengue, especially those pointing to severe disease. Symptoms include persistent high fever with no identifying source of infection (e.g. cough, colds, etc.), headache, vomiting and/or neausea, muscle and joint pain, diarrhea, skin rash, and bleeding nose and gums.
If your child has been given a shot of Dengvaxia but has not completed all three doses, Sanofi Pasteur advised parents to consult with their child’s doctor for the next best step to take.ADVERTISEMENT - CONTINUE READING BELOW