The WHO Strategic Advisory Group of Experts (SAGE) on Immunization is still reviewing the evidence for the dengue vaccine in question and yet to consider major issues such as vaccine safety, vaccine efficacy, disease burden, programmatic suitability, and cost-effectiveness.
WHO-SAGE is yet to discuss the specified dengue vaccine (CYD-TDH) in April 2016, after which it will provide recommendations to the WHO Director-General on the same and recommendations for use.
Yet here we are with national health authorities ready to treat our grade-school kids like lab animals and guinea pigs!?
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| Photo provided by the Zuellig Pharma Corp. shows laboratory specialists inspecting the dengue vaccine during the launching and press conference at the company laboratories in Parañaque yesterday. EDD GUMBAN |
Philstar reports:
The world’s first ever dengue vaccine is now available in the country, and doctors in several private hospitals are providing the vaccine against the potentially deadly dengue virus, the Pediatric Infectious Disease Society of the Philippines (PIDSP) reported yesterday.
Chit Santos, Sanofi-Aventis Philippines country manager, said the first shipment of dengue vaccine has arrived in the country and is ready for the market.
“The shipment arrived last week and we have already distributed the vaccine to some private medical practitioners so children can visit their doctors and get the dengue vaccine,” Santos reported.
Santos said the Philippines is the first country in the world to have access to the vaccine, although Mexico was the first to have it licensed for the market.
The Food and Drug Administration (FDA) approved the distribution of the dengue vaccine in the country last December.Yet we find the following facts from the World Health Organization (WHO) website:
Status of vaccine development
The first dengue vaccine, Dengvaxia (CYD-TDV) by Sanofi Pasteur, was first registered in Mexico in December, 2015. CYD-TDV is a live recombinant tetravalent dengue vaccine that has been evaluated as a 3-dose series on a 0/6/12 month schedule in Phase III clinical studies. It has been registered for use in individuals 9-45 years of age living in endemic areas.
Questions and answers on CYD dengue vaccine
The WHO Strategic Advisory Group of Experts (SAGE) on Immunization is currently reviewing the evidence for CYD-TDV and will advise WHO on a policy position for CYD-TDV. Key considerations include vaccine safety, vaccine efficacy, disease burden, programmatic suitability, and cost-effectiveness.
It is expected that SAGE will discuss CYD-TDV at its April 2016 meeting and will then provide recommendations to the Director-General, WHO on the public health utility and any recommendations for use.
There are approximately five additional vaccine candidates under evaluation in clinical trials, including other live-attenuated vaccines, as well as subunit, DNA and purified inactivated vaccine candidates. Additional technological approaches, such as virus-vectored and VLP-based vaccines, are under evaluation in preclinical studies.
SAGE Working Group on Dengue Vaccines and Vaccination
Challenges to vaccine development
Infection by one of the four dengue virus serotypes has been shown to confer lasting protection against homotypic re-infection, but only transient protection against a secondary heterotypic infection. Moreover, secondary heterotypic infection is associated with an increased risk of severe disease. This and other observations suggest an immunopathological component in dengue pathogenesis, which is referred to as immune enhancement of disease.
Due to these dengue-specific complexities, vaccine development focuses on the generation of a tetravalent vaccine aimed at providing long-term protection against all virus serotypes. Additional challenges are posed by the lack of an adequate animal disease model and the resulting uncertainty around correlates of protection. In spite of these challenges, vaccine development has made remarkable progress in recent years, and the current dengue vaccine pipeline is advanced, diverse and overall promising.
WHO activities
The WHO Initiative for Vaccine Research (IVR), in collaboration with a wide range of partners, aims to facilitate the development and future introduction of safe, effective and affordable dengue vaccines. Activities focus on the following main objectives:
Identify knowledge gaps and research needs related to the development, evaluation and implementation of dengue vaccines.
Build scientific consensus and develop guidance on the evaluation of dengue vaccines.
Review and evaluate the evidence base for policy recommendations related to the introduction and use of dengue vaccines.
Develop guidance on vaccine implementation, including introduction strategies.
Then what could be behind the Philippine government's rush for distribution of this vaccine?
Report from CNN Philippines:
The government has a P3.5 billion budget for the dengue immunization, and the DOH said it will work towards getting approval for funding.
DOH Spokesperson Dr. Lyndon Lee-Suy explained, "We need to come out with a good documentation ng lahat ng nangyayari so we can appeal it sa susunod na budget hearing para maipasok at dapat tuloy-tuloy ito."
[Translation: We need to come out with a good documentation of all events so that we can make an appeal on the next budget hearing, so they can include it and make sure the funds continue to come in.]
DOH: Vaccine has side effects
Health Secretary Janette Garin earlier said the agency would get a discounted price for the vaccine that would be used in the vaccination program starting March.
The DOH will begin vaccinating Grade 4 students in public schools in Metro Manila, and in Southern and Central Luzon. The vaccine will be given in three doses, with six-month intervals.
Health authorities said the vaccine will have side effects, including fever, headache, muscle pain, weakness, redness and swelling.
Take a break from the election fever. Think abut this one and what it could do to our children - and maybe even their would-be children!
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