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Probe of vaccines buy sought

A LADY lawmaker has sought a congressional investigation into the National Dengue Prevention and Control Program of the Department of Health of what she described as “hasty and impulsive” approval of dengue vaccines.

Nueva Ecija Rep. Estrellita Suansing also wants an inquiry into the parallel allotment of P3 billion from available funds to buy the vaccines to boost the country’s dengue efforts by vaccinating one million Grade 4 pupils in public schools.

She said the purchase of the P3-billion dengue vaccines is apparently not included in the General Appropriations Act of 2015. 

“Hence, the source of fund might not have undergone the scrutiny of the House of Representatives where an appropriation must originate as mandated by the Constitution. Consequently, there is an urgent need to review the purchase of vaccines and the sources of funds to determine if government standards on accountability and transparency were followed,” said Suansing.

Suansing, in filing House Resolution 480, urged the House committee on health to review the processing and registration of the dengue vaccine, including the contract to purchase from Sanofi Pasteur; examine relevant research and studies on the efficacy and safety of the vaccine; and propose remedial measures that promote public safety.

Suansing said: “The DoH must enlighten the House of Representatives about the seemingly hasty and impulsive approval of the dengue vaccines and allotment of P3 billion from available funds to purchase the vaccines aimed at supposedly boosting the country’s dengue efforts by vaccinating a target of one million Grade 4 pupils in public schools, the first mass dengue vaccination in the world. 

“The actual procurement was delegated to the Philippine Children’s Medical Center and the Purchase Order was issued on March 9, 2016.”

Suansing said in the meeting of the Strategic Advisory Group of Experts in Geneva, Switzerland in April 2016, the results of review done by the group was presented. 

The review showed Asian children, who had their first vaccination when they were two to five years old, demonstrated a statistically significant increased risk of hospitalized dengue, she said.

She said the vaccination program was administered only to children nine years old and above.

Suansing said: “An estimated 489,000 Grade 4 pupils in Central Luzon, Calabarzon and the National Capital Region had received the first dose of vaccine early this year and are set to receive their second dose from October to December 2016. 

“Thus, the necessity to examine if there were procedural lapses in the approval of the dengue vaccine or any violations of existing laws, rules or regulations that endangered the lives of the school children.”

Suansing, chairperson of the committee on ecology, said there have been serious and highly significant doubts in the scientific community about the safety of the Dengvaxia vaccine. 

Only last April,  two pupils, one in Bataan and the other  in Muntinlupa City, who had been inoculated reportedly died after receiving the first dose of the vaccine.

“Based on a Resolution dated July 21, 2016 of the Dengue Expert Panel, composed of independent and uninvolved experts convened by the Secretary of Health, the first dose of dengue vaccine immunization to be administered to Grade 4 pupils should be immediately stopped and only the 489,003 pupils who have been immunized or given the first dose will be given the second and third doses,” she said.

Suansing said there were concerned sectors that stressed the need to determine if there were any adverse effects of the vaccine and the postponement of the vaccination program would pave the way for a more rigid monitoring and parallel research to ascertain its safety and efficacy.

Suansing said: “The Congress of the Philippines is the bulwark of freedom and democracy as enshrined in the Constitution. As such, it must ensure that public funds are utilized intelligently and efficiently. 

“The utilization of P3 billion for the purchase of a vaccine that apparently increases the risks of its more life threatening form in the long term and may be potentially harmful to our children is a senseless squander of public funds.”

She added: “In the spirit of checks and balance between the branches of government, a congressional investigation must be conducted to determine why the DoH under the previous administration hastily and knowingly entered into an agreement or contract that might have been grossly disadvantageous to the government. 

“Moreover, it is but fitting that an investigation be immediately carried out on the mysterious deaths of the two pupils after they were inoculated not only to give justice to them and recommend the prosecution of offenders but more importantly to prevent future deaths.”

Suansing said there was a need to review the system of approving drugs for use by the consumers among the different agencies concerned such as the Food and Drug Administration (FDA), the Formulary Executive Committee (FEC) and the DoH.

This is to determine if there are institutional overlaps in their mandates and autonomy as separate government entities and establish possible conflicts of interest in the processing and registration of the dengue vaccine, she said.

She added: “There is an urgent need to determine if there is a direct correlation between the death of the two pupils and their inoculation with the first dose of dengue vaccine. 

“If such, the national government must immediately stop its further implementation and stop its expansion to other regions throughout the country to ensure the safety of our pupils. 

“Moreover, if there is fraud on the part of the vaccine supplier, such agreement or contract entered into by the government and the supplies immediately rescinded.”

French pharmaceutical company Sanofi Pasteur developed the first dengue vaccine. 

The first dengue vaccine called Dengvaxia reportedly underwent 20 years of extensive clinical trials and medical research involving over 40,000 patients. 

This live attenuated vaccine has been licensed by several dengue epidemic countries in Latin America and Asia including the Philippines.

Dengue haemorrhagic fever is considered and recognized as one of the most extensively spread mosquito borne viral disease that has affected many Filipinos through the years. 

It is common among tropical and sub tropical countries like the Philippines and is transmitted through Aedes aegypti mosquito bite. 

According to the World Health Organization, over 400 million people are infected every year. 

Hence, the WHO targets the prevention and reduction of mortality and morbidity resulting from the dengue disease by 2020.

In the Philippines, dengue is a primary public health concern due to the significant increase and upward trend of cases and the rising number of dengue-related deaths, Suansing said. 

The regions mostly affected by dengue are the Calabarzon, Central Visayas, Central Luzon, Northern Mindanao and Soccsksargen.

Topics: National Dengue Prevention and Control Program , Department of Health , dengue vaccines , Nueva Ecija Rep. Estrellita Suansing , congressional investigation

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