• Congress scrutinizes dengue vaccine program

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    The House of Representatives’ Committee on Health heard the views of government officials and health advocates on the government’s dengue vaccination program during the panel’s second day of hearings into the efficacy and safety of the Department of Health’s (DOH) school-based immunization, after two pupils who received the first dose of the Tetravalent dengue vaccine died last April.

    Committee chair Rep. Angelina Tan, MD (4th District, Quezon) requested her colleagues and invited resource persons to let the proceedings take their due course.

    The inquiry opened with a sponsorship speech by Rep. Estrellita Suansing (1st District, Nueva Ecija) of House Resolution 480, calling for an inquiry, in aid of legislation, into the Department of Health’s (DOH) school-based immunization of Tetravalent to ferret out the truth on the department’s claim of cost-effectiveness; review its processing and registration, including the contract to purchase from pharmaceutical maker Sanofi Pasteur; examine research studies on the dengue vaccine’s efficacy and safety; determine if government standards of accountability and transparency have been followed; and determine possible negligence on the part of the implementers.

    Suansing’s resolution further noted that the approval of the vaccines and the budget allocation of P3 billion to purchase them seemed hasty and impulsive, and might have been grossly disadvantageous to the government. The fund source also might not have undergone Congressional scrutiny, as the purchase was not included in the General Appropriations Act (GAA) of 2015, according to Suansing.

    During the hearing, Dr. Tony Leachon, an independent health advocate and member of the Dengue Expert Panel convened by the DOH, said they recommended last July the temporary stoppage of the program until a further study is done to determine if there is a direct correlation between the death of two pupils and their inoculation with the first dose of dengue vaccine.

    Leachon said the dengue vaccine program had misplaced priorities, procedural lapses, and conflicts of interest. He offered some legislative initiatives for congressional consideration.

    Leachon questioned how a P3.5 billion fund was allocated for a single vaccine when the entire vaccination program of the DOH totaled P3 billion. He pointed to procedural lapses in the dengue vaccination program, the evident conflict of interest in the members of the formulary executive community, and the supposed bloating/overpricing of the particular drug.

    Leachon detailed the timeline of the DOH dengue vaccination program, starting from the meeting between the former president Benigno Aquino III and Sanofi representatives during the Climate Change Summit in Paris on December 2, 2014, then the Food and Drug Administration’s (FDA) approval on December 22, and subsequently the Formulary Executive Council (FEC) defense of the economic study on January 17, 2015.

    This was followed by the signing of the purchase request for two million doses despite the absence or inclusion of the drug in the national drug formulary for the use of public funds on January 21, 2015 and the purchase order made to Zuellig on the same day despite the grant not yet being approved by the Philippine National Drug Formulary (PNDF).

    This was followed by the approval of the budget allotment on January 25, 2015, the approval of the FDA by then-Health Secretary Janette Garin, the actual purchase order on March 9, and the actual purchase and the start of the program last April, despite calls from the scientific community for a more lengthy study first to ensure the safety of the beneficiaries.

    Dr. Antonio Miguel Dans, another health advocate who represented the Philippine College of Physicians (PCP) and National Academy of Science and Technology (NAST), supported the move to suspend the dengue program pending further investigation and until the safety, cost-effectiveness, and preparedness of the recipient students are assured.

    Nela Charade Puno, FDA Executive Director, said that based on their investigation, while the papers are complete, they found what appeared to be a deviation from the usual protocols during the FDA’s approval of the vaccine, under the watch of past officials.

    Health Undersecretary Dr. Gerardo Bayugo, however, maintained that the necessary protocols have been followed and family consent was secured before the vaccine was administered to pupils.

    Rep. Harry Roque (Party-list, Kabayan) asked for a backgrounder of the dengue vaccine called CYD-TDV (Dengvaxia) from Sanofi Pasteur representatives. He also made sure of the resource persons’ competencies relative to the matter to determine whether or not their views and opinions can be considered as factual and based on broad studies and research.

    Sanofi Pasteur representatives Gerrard Paez and Anh Wartel appreciated the venue given to them by the committee to air their side, as they welcomed questions from lawmakers. They admitted that while they have conducted extensive research and attested to the safety and efficacy of their product, the Philippines was their first attempt at a dengue vaccination program on a massive scale and the first-ever worldwide.

    The committee heard the views of other invited resource persons from the medical industry and related government agencies, who disclosed their ties with Sanofi Pastuer. This will determine if there was conflict of interest on their part.

    Due to lack of time, Tan set another hearing on December 12 to tackle other matters relative to the dengue vaccination program. Garin and other resource persons are expected to give their views on the issue.

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