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SOURCE: Press and Public Affairs Bureau

House resumes inquiry on dengue vaccine
28-November-2016, 09:13:04 AM

The House committee on health has invited former Health Secretary Janette Garin as a resource person in the continuation on Tuesday of its inquiry into the efficacy and safety of the Department of Health’s school-based immunization of Tetravalent Dengue Vaccine for purposes of protecting public health and welfare, after two pupils who received the first dose of the vaccine died last April.

The inquiry is being done on the basis of House Resolution 444 filed by Rep. Angelina Tan, M.D. (4th District, Quezon) and HR 480 by Rep. Estrellita B. Suansing (1st District, Nueva Ecija) with the following objectives: look into the DOH’s. National Dengue Prevention and Control Program; review the processing and registration of the dengue vaccine, including the contract to purchase from French pharmaceutical company Sanofi Pasteur; examine relevant research and studies on the efficacy and safety of the vaccine; and propose remedial measures to promote public safety.

Rep. Rodante D, Marcoleta (Party-list, SAGIP) said during the committee’s earlier hearing that Garin is a credible resource person in relation to the two resolutions. “The former DOH Secretary was very much involved, it would not be right to exclude her from the invitees,” said Marcoleta.

Tan, committee chairperson, said the DOH under the past administration assured the public about the safety and use of the dengue vaccine, Dengvaxia, the world’s first-ever dengue vaccine which was developed by Sanofi Pasteur.

Tan said Health Secretary Paulyn Jean Rosell-Ubial has recently put the dengue vaccination program on hold pending another round of medical review and in view of reports that Dengvaxia has less than 50 percent protection against dengue serotypes 1 and 2, which are the most common circulating serotypes in the country.

”The initial dose of dengue vaccine was administered to selected public school students in pilot regions using Dengvaxia developed by Sanofi Pasteur, the vaccines division of Sanopfi, the world’s largest company producing human vaccines,” said Tan in her resolution.

Tan said that a Sanofi report cited that more than 489,000 students were vaccinated up to July, of which 928 cases were reported as ‘adverse events’, out of which 27 were classified as serious events that included two deaths, which are coincidental and not associated with the vaccine.

The DOH has launched the School Based Immunization Program in April 2016 and administered the first dose of the vaccine to Grade 4 students or school children aged 9 years old and above in regions of the country, with the highest number of dengue cases specifically those from the National Capital Rregion (NCR), Calabarzon and Central Luzon.

Tan said the World Health Organization Strategic Advisory Group of Experts (SAGE) on Immunization has recommended the use of Dengvaxia, which has been licensed by Mexico, Philippines, Brazil, El Salvador and Paraguay for use in individuals 9 to 45 years of old (9 to 60 years old in the case of Paraguay) living in dengue-endemic areas.

“The DOH's launching of the program to vaccinate school children in select public schools drew the ire of public health advocates, healthcare workers, academics, and civic organizations that questioned the apparent haste in the vaccination of children amidst the pendency of the vaccine's pre-qualification and completion of the study on patients, particularly on the phenomenon of antibody dependent enhancement or ADE where dengue virus antagonize the hosts' antibodies to enhance its viral load and disease severity,” said Tan.

Meanwhile, Suansing said there have been serious and highly significant doubts in the scientific community about the safety of the first dengue vaccine called CYD-TDV (Dengvaxia). Suansing said only last April, two pupils, one in Bataan and the other in Muntinlupa City who were inoculated, reportedly died after receiving the first dose of the vaccine.

“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 there is such, then the national government must immediately stop its further implementation and 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 supplier should be immediately rescinded,” said Suansing.

Based on a resolution dated July 21, 2016 of the Dengue Expert Panel, which is 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 had already been immunized or given the first dose will be given the second and third doses according to Suansing.

Suansing said the Grade 4 students are set to receive their second dose of the vaccine from October to December this year.

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

In the meeting of the WHO SAGE in Geneva, Switzerland in April 2016, Suansing said the results of review conducted by the group was presented. Among the findings was that those children aged two to five years old first vaccinated in Asia, there is a statistically significant increased risk of hospitalized dengue in the vaccine recipients. The vaccination program was administered only to children nine years old and above.

“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,” said Suansing.

The lawmaker said the DOH also 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, according to Suansing.

“The purchase of the dengue vaccines in the total amount of P3 billion is apparently not included in the General Appropriations Act (GAA) of 2015. Hence, the source of funds might not have undergone the scrutiny of the House where an appropriation must originate as mandated by the Philippine 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.

Garin earlier told the committee that those who should have been invited to the inquiry are the real experts who were part of the program implementation. “They should be part of this investigation so that once and for all, everything will be cleared,” she said.

Garin also expressed the belief that President Duterte, whom she has known when he was still a mayor, supports such programs with services to be delivered to the poorest and those who need them most.

“Shall we allow that vaccines would only be for the rich? I thought it is universal healthcare that we are espousing. What is accorded the rich should also be given to poor patients when government can afford to buy it at a very reasonable and discounted price. Rich people get vaccinated easily after 10 years. It’s the poor people’s turn,” said Garin.