On Friday, Philippines health officials released the results of the investigation of the initial 14 deaths of children given Dengvaxia.
Since December 2017, under the new Department of Health (DOH) administration, we have started to address the issues surrounding Dengvaxia – a new vaccine which was given to more than 830,000 children from March 2016 to October 2017.
The DOH recognizes that these issues continue to cause fear and confusion especially to our parents whose children were given Dengvaxia. We therefore wish to clarify this matter through a transparent and objective report based on scientific evidence which is now guiding the DOH in finding solutions on the matter.
In pursuit of seeking the truth among other actions made by the Department, we immediately coordinated with an independent group of experts that would review the first cases of mortalities among Dengvaxia vaccines recipients. The Philippine General Hospital (PGH) is a government agency separate from DOH. Being part of the UP, it has a mandate to provide expert opinion on public issues. In response to our request, the PGH created the DITF to evaluate the 14 initially reported deaths.
Based on the PGH DITF report using the WHO Algorithm for Causality Assessment of Adverse Events Following Immunization (AEFI), a systematic, scientifically sound, and universally accepted proves of assessing causality of events following any vaccination, it was found that:
- Three (3) out of the 14 cases were found to be coincidental because there was inconsistent causal association to immunization
- Two (2) cases were unclassifiable due to inadequate information available
- In six (6) cases mortalities were observed in vaccine recipients with unscreened comorbidities and there is an established temporal relationship because the children died within 30 days after receiving the vaccine. Further testing of tissue samples is needed to complete the investigation. The importance of clinic-pathologic correlation is also of utmost importance in these cases
- In three (3) cases, causal association was observed. The children died due to dengue despite being vaccinated with Dengvaxia – two of which may be on account of vaccine failure. Therefore, further testing of tissue samples and antibodies is also necessary in these cases to complete the investigation.
These results strengthen our decision to suspend the Dengue Immunization Program as Dengvaxia is not fit for a mass immunization program that does not screen for prior dengue infection and comorbidities of children before the administration of the vaccine.
Related:
- Pampanga: Assistance given to more than two dozen Dengvaxia-vaccinated children
- Dengvaxia: Philippines submits refund demand to Sanofi Pasteur, Also request testing
- Brazil: Anvisa recommends if you never had dengue, don’t take Dengvaxia
- Dengue vaccine: Sanofi agrees to reimburse the Philippines for unused vials
- Philippines: Dengue vaccination program put on hold after new information
