**The Truth About Dengvaxia: How DOH and FDA Knew About Adverse Effects**
A recent revelation has shed light on the controversial rollout of the Dengvaxia vaccine in the Philippines. Documents obtained by The Manila Times reveal that officials from the Department of Health (DOH) and Food and Drug Administration (FDA) were aware of the potential adverse effects of the vaccine as early as December 2015.
**FDA Document Reveals Concerns**
A certified true copy of an FDA document obtained by The Manila Times shows that Sanofi Pasteur Inc., the manufacturer of Dengvaxia, disclosed the vaccine's potential risks to DOH and FDA officials. These risks included neurotropism, viscerotropism, severe dengue, and anaphylaxis.
**DOH Officials Failed to Inform Colleagues**
According to Dr. Clarito Cairo, a former DOH official involved in the development of the Dengvaxia program, concerned DOH officials during the time of ex-DOH Secretary Janette Garin withheld this information from their colleagues. In his affidavit, Cairo stated that he and other officials were not informed about these fatal risks associated with Dengvaxia.
**Sanofi's Pharmacovigilance Plan**
To mitigate the risks and ensure appropriate post-marketing surveillance in the Philippines, Sanofi deployed a pharmacovigilance plan that included passive or routine surveillance and active surveillance. This plan involved post-authorization safety studies, post-authorization effectiveness studies, and clinical studies.
**Vaccine Effectiveness and Risks**
In an official statement issued in November 2017, Sanofi said: "The analysis confirmed that Dengvaxia provides persistent protective benefit against dengue fever in those who had prior infection. For those not previously infected by dengue virus, however, the analysis found that in the longer term, more cases of severe disease could occur following vaccination upon a subsequent dengue infection."
**Parents Seek Justice**
The parents of eight school children whose deaths were linked to the Dengvaxia vaccine have filed administrative complaints before the Supreme Court's Office of the Court Administrator for "being biased and partial" against Judge Lily Ann Marcos-Padaen, who eventually inhibited herself from handling the case.
**Experts Call for Accountability**
Dr. Tony Leachon, an independent health reform advocate and prosecution witness, has vowed to continue exposing the truth amid smear campaigns against him. He emphasizes that he will not be deterred by attacks or trolls on social media but will continue fighting for accountability and justice for those affected by Dengvaxia.
**Conclusion**
The revelation that DOH and FDA officials knew about the adverse effects of Dengvaxia raises serious questions about the handling of the vaccine's rollout. With millions of Filipinos affected, it is essential to get to the bottom of this issue and ensure that similar mistakes are not made in the future. As we move forward, it is crucial that we prioritize transparency, accountability, and patient safety.
**Opinions:**
* **DOH and FDA officials had knowledge of Dengvaxia's adverse effects but chose to withhold this information from the public**
* **Sanofi's pharmacovigilance plan was insufficient to address the risk of severe disease in those not previously infected by dengue virus**
* **The government must take responsibility for its role in the Dengvaxia debacle and ensure that similar mistakes are not made in the future**
* **Patients' safety and well-being must be prioritized in all medical interventions, including vaccination programs**
Note: I corrected some grammatical errors, reorganized the text to improve readability, and added transitions to connect ideas between paragraphs. I also removed the reference to 3D printing specialists in 2025 as it is not relevant to the topic of Dengvaxia's adverse effects.
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