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  • DOH Rejects Sanofi's Appeal to Lift Ban on Dengvaxia Vaccine

    According to DOH, Sanofi was unable to submit the required documents by the agency and the FDA.
    by Kate Borbon .
DOH Rejects Sanofi's Appeal to Lift Ban on Dengvaxia Vaccine
PHOTO BY iStock
  • The Department of Health (DOH) announced on Thursday, August 22, 2019, that it has denied the appeal of French pharmaceutical company Sanofi Pasteur to lift the ban on the use of the Dengvaxia vaccine in the Philippines.

    The rejection of Sanofi’s Certificate of Product Registration for the anti-dengue vaccine was due to the company’s “continued failure to submit post-approval requirements.”

    According to a report by Inquirer.net, while Sanofi submitted the first and second versions of its Risk Management Plans, it failed to submit its third version and submitted the fourth version late. The DOH said this was a violation of its post-marketing commitments and the rules and regulations of the Food and Drug Administration (FDA).

    “Given that Dengvaxia is an innovative drug, the importance of complying with these post-marketing commitments is critical to public safety,” stated the DOH.

    The DOH has informed Sanofi that it could re-apply for a new certificate of registration at the FDA.

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    Dengue and Vaccine National Expert Panel also recommended that Sanofi submit the updated information on its pharmacovigilance and post-marketing surveillance. According to ABS-CBN News, this data would indicate what the company has done to monitor and prevent any adverse effects of the drug for the more than 830,000 individuals who have been vaccinated.

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    In response to the DOH’s rejection of its appeal, Sanofi stated it would “thoroughly study all possible remedies available to us under Philippine laws and regulations while keeping in mind the best interest of the Filipinos.”

    Sanofi also expressed its gratitude to the DOH for “recognizing that the safety of Dengvaxia is not on trial” and the “dire need” for the dengue vaccine.

    On July 15, 2019, the DOH declared a national dengue alert after more than 100,000 cases were recorded nationwide from January 1 to June 29, 2019, including 456 deaths. This number was 85% higher than the number of cases recorded during the same period in 2018.

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    On August 6, 2019, meanwhile, the DOH declared a national dengue epidemic after more than 146,000 cases were recorded nationwide from January to July 2019, including 622 deaths. This number was 98% higher than the number of cases recorded during the same period in 2018.

    According to a report by ReliefWeb.int on August 20, 2019, more than 170,000 cases of dengue had been recorded across the country as of August 17, 2019, including 720 deaths. Nearly 800 of these cases and around 70 of these deaths were reported across the northern region of Northern Mindanao.

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    Recommendations from pediatricians in response to dengue epidemic

    In a joint statement, the Philippine Pediatric Society (PPS) and the Pediatric Infectious Disease Society of the Philippines (PIDSP) said that while they recognize the importance of dengue vaccination in the global strategy for preventing and controlling dengue, “it is not currently recommended as part of outbreak response,” said Dr. Anna Lisa Ong-Lim, PIDSP president.

    Dr. Salvacion Gatchalian, PPS president, also told SmartParenting.com.ph that the dengue vaccine “is for future protection for those who were diagnosed or have been known to have dengue or tested positive for dengue antibody.”

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    “With the availability of the vaccine, parents and patients will be informed of the benefits and risks, and an informed decision can be made and that its administration be an informed choice,” Dr. Gatchalian continued.

    Instead, both organize recommend parents to follow the strategies of the DOH to prevent dengue, which can be summarized as the “4S Against Dengue.” These strategies are:

    • Search and destroy mosquito-breeding sites
    • Secure self-protection (such as wearing long-sleeved shirts and pants and using mosquito repellent daily)
    • Seek early medical consultation upon observation of fever and rashes which persist for 48 hours
    • Support fogging or spraying only in hotspot areas where an increase in the number of cases has been recorded for two consecutive weeks

    Read the joint statement by the PIDSP and the PPS below:

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    To learn more about the symptoms of dengue in young children, click here.

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