Categories

December 2017
M T W T F S S
« Nov    
 123
45678910
11121314151617
18192021222324
25262728293031

Up to 200 Filipino children risk severe dengue

Aedes Aegypti Mosquitoes (26444925321)based on three numbers: 730K vaccinated, 87% previously infected (link) and 2 of 1000 risk (link) of severe dengue according to Sanofi among those vaccinated but not previously infected: “The increased risk identified from the new analysis translated to two additional cases of ‘severe dengue’ out of 1,000 previously dengue-uninfected people vaccinated over five years of follow-up,” the company said in an emailed statement. Certainly not good, but a far cry from the panic in a video (link) by “major blogger” Sass Rogando Sasot implying that 700 thousand kids were at risk.

Who said what

997 children got sick after vaccination (link) say a Philstar headline – in the article it says that the Department of Health (DOH) reported that between March 18, 2016 and Aug. 20 of the same year, there were 997 “adverse events following immunization, 30 of which were considered serious cases that needed hospitalization.” The 30 serious cases included two deaths. But the DOH said these “were not related to the immunization program,” which was launched in early 2016. Other cases are claimed outside the DOH statistics, and insufficient monitoring is alleged.

There is also a difference between articles that claim WHO recommended Dengvaxia (link) and clarifications by WHO itself that it (linkdid not include a recommendation to countries to introduce the dengue vaccine into their national immunization programs. Rather, WHO outlined a series of considerations national governments should take into account in deciding whether to introduce the vaccine, based on a review of available data at the time, along with possible risks. Among other things recommending to vaccinate in areas with over 70% dengue exposure.

When what happened

Who published its position on the dengue vaccine in July 2016, based on a preliminary advice by an expert group from April 2016. The Philippines started vaccinating in April 2016 (link) – ignoring or setting aside opinions like those of UP College of Medicine Prof. Dr Antonio Dans, who warned that while the vaccine could reduce the number of dengue cases, it could later increase the disease’s severity, a phenomenon known as “antibody- dependent enhancement” – or Dr. Anthony Leachon who said the DOH should first wait for the WHO study – which came out in July 2016.

Further doubts Dr. Leachon had were also about long-term safety (link) especially with previously non-infected persons. Studies in September 2016 (link and link) and articles in CNN (link) and Voice of America (link) in late 2016 also mentioned those risks, but the DOH under a new administration continued the program (link) while having doubts on efficacy. There was a Senate hearing in December 2016 (link) but it seems it was more about the way the program was funded.  The decision to end the program after the third round of vaccination was taken in May 2017 (link).

Still, it seems that 67 thousand kids in the Central Visayas got vaccinated in August 2017 (link). Other countries like Malaysia (link, June 2016) and India (link, Oct. 2016) were more reluctant – even in April 2017 (link) and November 2017 (link). Brazil was the other country that vaccinated, the observations from there are going to be interesting. Sanofi was right to pull the brakes in late November 2017. Imagine if, let us say 20 million Filipinos had been vaccinated at a prevalence of 80% – that would have been 0.2% of 20% of 20 million at risk of severe dengue, meaning 8000.


Science and Risk

ICE4 FrontA major derailment happened in Eschede in 1998 (link) when the German speed train or ICE was hardly a decade old. A train derailed and folded together at high speed due to wheel fracture (link). 101 people died, tabloids reported scenes of horror. Yet no witch-hunts. Causes (link) were analyzed and consequences (link) – also legal ones – were decided upon. The program was not stopped, instead ICE model 1 was improved, later new models came out, new routes were built. This Friday, the Munich-Berlin route (link) shall cross 623 km in about 4 hours. Using ICE 4 (link) trains.

A book I read (link) mentions how the aircraft industry and airlines improved a lot of things by analyzing black boxes from airplane crashes and other incidents – but mentions issues in introducing similar measures in medicine. I wonder if the touch of arrogance attributed to the medical profession in the book also applies to the pharmaceutical industry. Many circles also accuse the pharma industry using third world countries as guinea pigs. But only a modern, evidence-based approach will help prove what is true. And pin down possible accountability. 

Capulet and Montague

There will probably be a hearing in aid of legislation at the Philippine Senate – once again. Which I do not expect much from. The usual political stuff, names of Presidents and Health Secretaries. VACC loudly claiming deaths NOW from last year (link) added to the fray, hardly looking credible.

Better not just allege deaths without proof as in hard evidence. Sanofi might go for an international case. Not like the De Lima case or the wannabe impeachment against Sereno. Real lawyers will be needed – like Sereno for Fraport or Carpio for ITLOS. The kind of talent the country hates (link).

One should also see that around half of the vaccinations were during the Aquino administration, the other half during the Duterte administration. Finding out the entire truth will be a long process – if the Filipino public is really interested in the truth and not just own emotional or group needs.


Galileo and Newton

The modern world is too complex for the petty village mentality on show in Filipino politics, the lack of getting the big picture. India seemed to have dealt with Dengvaxia way more maturely – but then again they send rockets into space (link). How could one deal with this in a rational manner?

200 kids are at risk, if one is to believe a certain set of numbers. What is the solution? First – monitor things. Senator Hontiveros wants that to happen in form of a database (link). Possibly, measures from this experience could be used to improve health monitoring in the Philippines.

Second – all lab data on present alleged cases (link) should be gathered in a transparent manner. Just in case there really was negligence on part of Sanofi, it can be proven in an auditable way. There is a certain self-discipline needed here, as Filipinos very often lack objective attitudes.

The Big Picture - The Noun ProjectThird – look at the big picture. Few newspapers, few experts, few leaders in the Philippines are good at that. Data is not information is not knowledge is not wisdom. This Rappler timeline (link) of what happened locally is at least information. Knowledge? We know a little, need to learn more.

In some papers I read about 3.5 billion being for vaccines only. In some I read it was for the vaccines and the entire program including monitoring for five years. Some state that monitoring was insufficient in the beginning. How was the experience in Brazil? And the more cautious countries?

India wanted to make own tests with monkeys before starting, later on Assam state decided to make a random test to check for at least 70% prevalence before going for vaccination. Malaysia wanted to wait for fourth phase tests. All in the sources quoted above. Where is the best balance?

Finding scapegoats is too easy as well – especially if the issue could be caused by weak institutions with systemic problems (link) that go beyond individual leaders. Maybe Dengvaxia could be an opportunity to learn and reform some things? There is a lot of ground to be covered I think.

Irineo B. R. Salazar
Munich, 6 December 2017

39 comments to Up to 200 Filipino children risk severe dengue

  • https://pr.ricmais.com.br/dia-a-dia/noticias/vacina-contra-a-dengue-podera-custar-ate-r-13463-no-parana-diz-anvisa/

    ..A Agência Nacional de Vigilância Sanitária (Anvisa) definiu, na segunda-feira (25), o preço da dose da vacina da dengue no Brasil. No Paraná, a Dengvaxia poderá custar até R$ 134,63 na rede privada de saúde..

    134.63 BRL = 2,065.01 PHP (per dose of Dengvaxia, according to this Brazilian source)

    • http://www.saude.pr.gov.br/arquivos/File/ManualVacinaDengue03032017.pdf

      ..A Dengue é considerada pelo governo brasileiro como um importante problema de saúde pública. Atualmente as medidas de controle de vetor não têm sido suficientes para a redução do número de casos da doença. Novos casos têm sido notificados no país todo e a maioria dessa população vive em áreas de médio a alto risco para a doença. O Brasil é o primeiro país em número de casos notificados anualmente e somente no ano de 2015, foram registrados 1.649.008 casos prováveis de dengue no país. Entre as semanas epidemiológicas 10 e 17 de 2015, foram notificados mais de 100.000 casos todas as semanas. De acordo com o boletim epidemiológico da semana 52 de 2015, foram confirmados 1.569 casos de dengue grave e 20.329 casos de dengue com sinais de alarme, enquanto no mesmo período de 2014, foram confirmados 764 casos de dengue grave e 8.436 casos de dengue com sinais de alarme. Foram confirmados 863 óbitos por dengue, o que representa um aumento no país de 82,5% em comparação com o mesmo período de 2014, quando foram confirmados 473 óbitos. Entre o grupo de 9 a 45 anos, 1.112.048 casos foram notificados, com 315.233 confirmados laboratorialmente, o que representa que 66% do total de casos em 2015 ocorreram na faixa etária que poderia se beneficiar com a vacina contra dengue (BRASIL, 2016)..

      ..Entre agosto de 2015 e até o dia 19 de julho de 2016, foram notificados no estado do Paraná
      144.936 casos suspeitos de dengue, com 55.260 confirmados, 31.682 por laboratório, sendo 51.583 casos autóctones e 3.677 casos importados. Destes, 62.059 foram descartados (PARANÁ, 2016). Dentre esses casos foram identificados: 751 casos de dengue com sinais de alarme, 92 casos de dengue grave, 61 óbitos confirmados, gerando uma incidência média de 462,09 casos por 100.000 habitantes. É considerada situação de epidemia pelo Ministério da Saúde a incidência igual ou superior a 300 casos por 100.000 habitantes..

  • http://www.gmanetwork.com/news/news/nation/223701/philippines-ranks-4th-in-asean-wide-dengue-incidence/story/ June 7, 2011

    The only way to prevent dengue virus transmission is the removal of the breeding places of disease-carrying mosquitoes, according to Lee Suy of DOH.

    “Vessels containing clear and stagnant water should be emptied regularly. Dengue-carrying mosquitoes lay their larvae in clear and stagnant water such as those found in flower vases, pails, soft drink bottles, cans, and drums,” Lee Suy said.

    • http://www.officialgazette.gov.ph/2014/07/18/dengue-vaccine-successfully-tested-possibly-ready-for-release-july-2015/

      (July 18, 2014) Secretary of Health Enrique T. Ona explained that 56.5% efficacy means that more than half of the subjects did not get dengue compared to the group that did not receive the vaccine.

      The study also showed that after three doses, the vaccine reduced the possibility of a subject developing dengue hemorrhagic fever by 88.5%, according to the World Health Organization (WHO) criteria. Also during the observation period, a 67% reduction in the risk of hospitalization due to dengue was observed.

      Ona added that the study on the dengue vaccine efficacy was performed in five Asian countries, namely Indonesia, Malaysia, Thailand, Vietnam, and the Philippines. The said study involved 10,275 children (2-14 years old). In the Philippines, there were 3,500 children coming from Cebu and San Pablo.

      • http://newsinfo.inquirer.net/237507/dengue-cases-in-philippines-up-by-16 (July 27, 2012)

        Most of the cases centered in Metro Manila with 11,476. This was followed by Calabarzon with 7,265 and Central Luzon with 7,044.

        Sharp rises in dengue incidence were also recorded in the Zamboanga Peninsula from 687 last year to 2,250 (227 percent) this year; Bicol from 576 to 1,369 (137 percent); the Davao region from 1,724 to 4,078 (136 percent), and Western Visayas from 1,634 to 3,668 (124 percent).

        • http://www.philstar.com/headlines/2015/10/07/1508028/dengue-cases-nearing-100000-mark-doh (October 7, 2015.)

          ..The provinces of Bulacan and Cavite have declared a state of calamity in their respective areas due to the rising number of dengue patients and deaths brought about by the disease.

          Sen. Nancy Binay called for an inquiry into the increasing number of dengue cases in the country..

          • http://outbreaknewstoday.com/philippines-reports-more-than-200000-dengue-cases-in-2015/

            The “preliminary” final numbers are finally out and the Philippines saw an increase in dengue fever of nearly 65 percent in 2015 compared to the prior year. Through Dec. 31, the archipelago reported 200,415 suspected cases of dengue, including 598 deaths…

            ..In the past 50 years, the incidence of dengue worldwide has increased 30-fold, largely as a consequence of the growth of cities and increased travel…

          • https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4222740/

            “..The numbers of dengue disease cases being reported were highest in the most populated urban areas, such as NCR [25], [28], [29], [35]–[40]. However, the incidence of dengue disease per 100,000 population varied by year and by region. The dengue disease incidence rates per 100,000 population were highest in the NCR in 2000, CAR in 2001, Region VI in 2002, Region VII in 2007, Region XI in 2003, 2004, 2008 and 2009, and Region XII in 2005 and 2006 (Table S4) [25], [29]. Incidence rates for 2010 and 2011 were not available. However, in 2010, the highest number of cases by region was in Western Visayas (Region VI; 17,593 cases; 84 deaths; CFR 0.48%) [36]. In 2011, the highest number of cases by region was in NCR (15,427 cases; 93 deaths; CFR 0.60%), and the NCR area with the highest number of cases was Quezon City (4611 cases; 32 deaths; CFR 0.69%) [36]. The highest numbers of fatal dengue disease cases were in the NCR in 2001, 2003, 2004, 2005, and 2006 (121, 148, 131, 185, and 345 cases, respectively) [28]. By contrast, in 2002, the region with the highest number of fatal dengue disease cases was Central Visayas (Region VII; 107 cases) [28]…

            ..Few studies show any analysis of the seroepidemiology of dengue…In a prospective study of children admitted with fever without a clear focus to St Lukes Medical Centre in Quezon City, Metro Manila, from January 1999 to December 2001, 71.4% had dengue (confirmed by IgM and/or RT-PCR) and 1/3 had DHF [47], [48]. Furthermore, in another prospective fever surveillance study of patients with a mean age of 18 years admitted to San Lazaro Hospital, in Manila, Luzon, 87% of those with fever without a clear focus of infection had dengue, 7% of the cases were primary dengue infections (determined by IgM/IgG ELISA) [43].”

      • http://cnnphilippines.com/news/2017/12/09/Dengvaxia-DOH-Sanofi-Garin.html

        “What is obvious is there is collusion between the Philippine government headed then by the secretary of health Garin and the manufacturer of the vaccine Sanofi Pasteur,” Former Health Undersecretary Ted Herbosa said on the sidelines of a forum on Saturday.

        He belied Garin’s claim on Friday that he and Garin’s predecessor, former Health Secretary Enrique Ona, were aware of the government’s plan to administer Dengvaxia through a school-based dengue immunization program in 2016.

        “We never contemplated on using the dengue vaccine kasi experimental pa siya…Ibig sabihin nun hihintayin mo ‘yung final result of the study. Pagkatapos nun, mahaba po ang proseso ng drug development,” Herbosa said.

        [Translation: “We never contemplated on using the dengue vaccine because it’s experimental….This means you have to wait for the final result of the study. What follows is a long process of drug development.”]

        Over 40,000 volunteers participated in the Sanofi Pasteur dengue vaccine clinical study program in three phases in 15 countries in Asia, including the Philippines. A total of 29,000 volunteers received the vaccine. In 2014, Dengvaxia successfully completed phase III clinical studies to evaluate if the vaccine was effective.

      • https://www.reuters.com/article/sanofi-bribery/former-sanofi-employees-convicted-of-bribery-in-germany-idUSL6N0M01V620140303

        (March 3, 2014) A German court convicted two former employees of Sanofi-Aventis on bribery charges 10 months ago and imposed a fine on the French drugmaker last year, prosecutors said on Monday following a newspaper report.

        The court’s ruling also resulted in a 28 million euro fine for Sanofi. A spokeswoman for Sanofi-Aventis Deutschland GmbH confirmed the company had to pay that sum in connection with the case against the two former employees.

        “For Sanofi the matter is closed,” the spokeswoman said, referring to the Winsen court’s rulings. She added the company had cooperated with authorities during the investigation and had since further tightened its compliance system.

        • http://www.manilatimes.net/aquinos-p3-5b-purchase-dengue-vaccine-worst-case-corruption-ever/367353/ (WARNING – TIGLAO ARTICLE, use judgement in reading…)

          WAS there corruption on a massive scale, with former President Aquino 3rd earning hundreds of millions of pesos in dirty money from his administration’s purchase of Sanofi’s dengue vaccine Dengvaxia?

          If indeed it was a case of corruption, it would be among the biggest ever for a single corrupt deal, as just 10 percent of the P3-billion cost of the one million dosages of the vaccine purchased—without any bidding and through secret negotiations—is P350 million. It could have been likely more, considering that Sanofi’s $70 million sale to the Aquino administration gave it the much needed financial and advertising boost for a vaccine it had developed at a cost of $1.8 billion, yet which it could sell only $20 million worth in two years of aggressive marketing.

          • https://www.reuters.com/article/us-sanofi-dengue-philippines/philippines-to-seek-refund-of-59-million-from-sanofi-amid-vaccine-risk-idUSKBN1E2106

            MANILA (Reuters) – The Philippines will seek the return of 3 billion pesos ($59 million) it paid French drugmaker Sanofi for a dengue vaccine used to immunize hundreds of thousands of children that Sanofi has said could worsen the disease in some cases.

            “We will demand the refund of the 3 billion (pesos) paid for the Dengvaxia and (demand) that Sanofi set up an indemnification fund to cover the hospitalization and medical treatment of all children who might have severe dengue,” Health Secretary Francisco Duque told reporters on Friday.

            The Philippines last week suspended a national immunization program after Sanofi’s recent findings that there was a risk of severe dengue occurring in previously uninfected people who were inoculated with Dengvaxia. Manila also halted sale of the vaccine in the country and has ordered a probe into the matter.

            Duque said the number of children, ages 9 and above, inoculated with Dengvaxia has risen to about 830,000 from an initial estimate of nearly 734,000 after further verification by the Department of Health.

            The state program, which was launched in 2016, cost 3.5 billion pesos and Duque earlier said the government has already paid 3 billion pesos to Sanofi.

  • https://www.reuters.com/article/us-sanofi-dengue/trouble-mounts-for-sanofi-dengue-vaccine-over-safety-concerns-idUSKBN1DY26Y

    ..Brazil confirmed it already had recommended restricting use of the vaccine to those previously infected with dengue but had not suspended it entirely.

    Brazilian health regulator Anvisa, in an emailed statement to Reuters, said it had not received any reports of vaccine recipients dying or falling more severely ill because of the drug. It does not know how many people have received the vaccine in Brazil since its 2015 approval..

    ..“As far as we know, as far as we are made aware, there are no reported deaths that are related to dengue vaccination,” said Ruby Dizon, medical director at Sanofi Pasteur Philippines.

    A Philippine health official said the deaths of three children who received Dengvaxia, reported by a non-government organization, were not related to the vaccine.

    Nearly 734,000 children aged 9 and over in the Philippines have received one dose of the vaccine as part of a program that cost 3.5 billion pesos ($69.54 million)…

    • https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5355209/ 2013 May 28

      Current WHO guidelines recommend that safety assessment of dengue vaccines should include follow-up of dengue-vaccinated and control subjects for at least 3–5 years after completion of primary vaccination in Phase II and Phase III trials [4], [20]. Evidence from settings with different mosquito transmission intensities will be desirable as boosting from natural infection and different circulating serotypes and genotypes may impact on vaccine safety.

      • http://amp-vaccinology.org/sites/default/files/upload/files/CYD-TDV%20Pharmacovigilance_Module%205%20-%20v2(16Dec2016)_Eng.pdf

        Countries should have a dengue safety crisis management plan in place well in advance, including:
        o A frequent, proactive, and transparent review of dengue surveillance data.
        o Ongoing analysis and interpretation of passive data.
        o Giving the public a balanced overview of CYDTDV safety.
        o Preparing clear and efficient guiding principles and plans for communication with the media.
        o Minimizing misuse of data by the media

        • http://pps.org.ph/wp-content/uploads/2017/04/Serological-Testing.pdf

          There is currently no national data documenting dengue seroprevalence in the Philippines.
          However, in one study involving 1,066 Filipino children aged 2-16 years, dengue seropositivity rates as determined by plaque-reduction sero-neutralization assay were found to increase with increasing age: 58% in those age 2-4 years, 74.9% in those 5-8 years, 88.5% in those 9-12 years, and 93% in those 13-16 years.9

          Subsequently, a prospective longitudinal cohort study conducted in Cebu City among 1,008 children and adults starting from age 6 months and older showed that >98.3% of all those > 15 years developed evidence of multi-typic dengue HAI antibodies during the 12-month study period.

          However, only 17.5% of dengue infections that occurred were symptomatic; 82.5% developed subclinical infection.10

          In the absence of population-based serologic data, the WHO suggests the use of epidemiologic information (incidence, morbidity and mortality rate among infectious diseases) as an indicator.

          • http://www.pidsphil.org/download/RECOMMENDATION-DENGUE-VACCINE-MAY2016.pdf

            A national dengue seroprevalence data is unavailable, except in two areas (Guadalupe, Cebu and San Pablo, Laguna), which showed 58% of children aged 2-4 years old, 75% of children aged 5-8 years, 89% of children aged 9-12 years old and 93% of children aged 13-14 years old, to be seropositive.1

            As part of a public health program, the Committee on Immunization suggests the following:

            1. Enhance the surveillance system that integrates epidemiological, entomological,
            environmental , clinical and laboratory data to include seroprevalence data.

            2. Disseminate information, education and communication materials on dengue vaccination
            for healthcare workers and the public.

            3. Provide enhanced training for healthcare workers on administering the vaccine, including cold chain management, the informed consent process as well as surveillance for Adverse Events Following Immunization (AEFIs).

            4. Emphasize the importance of coordinated strategies for dengue control, including vector control, adequate case management, and community programs to prevent transmission of dengue virus.

            5. Conduct a cost effectiveness study, utilizing local prevalence rates, facility utilization rates, and social costs, in order to justify and prioritize a long term dengue vaccination program.

  • http://www.gmanetwork.com/news/news/regions/635705/tarlac-student-suffers-from-severe-dengue-after-receiving-dengvaxia-shot/story/ – this thread is only for the severe dengue cases… (as always please take whatever is published with a grain of salt in this scrapbook approach)

    A student in Tarlac is suffering from severe dengue after she was immunized with the world’s first dengue vaccine, Dengvaxia.

    According to a report on Unang Balita on Thursday, while the student’s condition was improving, she is still confined in a hospital in Pampanga.

    The student had completed the three doses of Dengvaxia and had not been had dengue before.

    Meanwhile, another student was hospitalized due to dengue in Talisay City. She also received Dengvaxia shots and had no previous history of dengue.

    A Grade 5 student in Mariveles, Bataan was reported to have died of dengue in October last year.

    (does anyone know IF and WHERE this is centrally documented – IF EVER it is..)

  • additional comments from FB:

    1. why is the Philstar report about sicknesses starting from mid-March 2016 when vaccinations started in April 2016? (yes, that should be clarified – when did test phase 3 end?)

    2. 200K cases per year in the Philippines were mentioned (I would be happy to see sources)

    (plus of course local and international groups that approved of the vaccine)

    … the picture is getting bigger and rounder..

  • https://www.facebook.com/edselmaurice.salvana/posts/10204286812445997

    So I’m going to stick my head out because I feel there is a lot of confusion going around on the dengue vaccine again. This is my interpretation of the Sanofi release. For the record, I am an infectious diseases physician who deals with dengue on a daily basis. I am not a trained epidemiologist, but I do have some research expertise. I do not work for Sanofi and have never received any money from them. The reason I am speaking up is because I feel this vaccine has been demonized and that the ones who would benefit from it may not take it because of the uncertainty surrounding the interpretation of the recent statement.
    1. First of all, the vaccine was never meant to be given to seronegatives, based on the understanding that it would set up the antibody dependent enhancement (although there was no cytokine evidence of this in the severes). That is why it is only for use in high prevalence countries.
    2. There is a proliferation of igm and igg dengue test kits in the market which are meant for diagnosis of active dengue, not necessarily past dengue infection where the titers are much lower. The best test will be an elisa done in a proper hospital or research lab. The vast majority of lateral flow rapid assays done by diagnostic labs are not designed to detect past infection in someone who does not have active dengue. Therefore, there is no readily accessible reliable way for a physician to diagnose past infection in someone who does not have dengue. If the test is positive then it is useful, but if it is negative it is not certain.
    3. The statement reiterated the efficacy of the vaccine up to 6 years, and this is a good thing. If you have started the series, you probably should complete it otherwise you wont get the full benefit. We need to emphasize this because people may not complete their vaccination because of the uncertainty.
    4. We are talking of a safety SIGNAL, not a statistically significant harm. This is why they used the word “could harm” versus definitely harms. No one has died from this. But lots of people have died from dengue. You decide which is a bigger problem and if your risk of getting dengue is higher you should take the vaccine within the recommended parameters. Put another way, we are talking about definite benefit versus possible harm.
    5. I agree this should not have been used immediately for mass vaccination until after SAGE released its recommendations. Whatever DOH’s reason for going ahead with it, they will have to explain. However this should not discredit the scientific evidence that the vaccine works when used correctly. Based on the seroprevalence studies in the Philippines, the seroprevalence of at least one dengue infection is above 90% in those ages 12 and above. And if you have had at least one episode of dengue (like me), you should absolutely not hesitate to get the vaccine. The vaccine decreases the risk of severe dengue in this group of people by about 90% for sure. Statistically significant.
    Bottom line, this is a GOOD vaccine when used correctly. Talk to your doctor if it is appropriate for you. Only you can make decisions about your health, but you need to make an informed decision.

    • https://www.facebook.com/jozy.acosta/posts/10155368490493585

      With all the misinformation and politicking about the dengue vaccination program, it’s time to set the record straight.
      1. DOH’s dengue vaccination program was not administered prior to the drug Dengvaxia’s approval for sale.
      Dengvaxia had passed three of four phases of clinical trials. Passing Phase 3, typically the most expensive, time-consuming and difficult phase, means the drug company can already apply for approval to market the product, which Sanofi did and which it obtained.
      Phase 4, called post-marketing suveillance, is in-market monitoring conducted AFTER the drug has already been approved for consumer sale, to determine such things as long-term effects, contraindications in unstudied segments, new uses, dosage adjustments, etc. This is where the Philippines came in and it was not alone – a total of 11 countries approved it for use (source: Rappler), with Mexico licensing it in December 2015 (source: WHO).
      WHO had recommended it for use in areas where data “indicate a high burden of disease”.
      While the regional WHO office responsible for the Philippines clarified that it never recommended use of the drug in national immunization programs, it did “outline a series of considerations national governments should take into account in deciding whether to introduce the vaccine” and notes that the Philippines met those conditions in the three regions where it was initially rolled out. (Source: WHO Western Pacific Region Dec. 5 2017 statement.)
      It’s worth noting that one of those parameters – high proportion of at least 70% of the community already previously exposed to the disease – significantly reduces the risk factor of the vaccine.
      2 Is PNoy to blame?
      Much has been said about who is to blame for the dengue vaccine uproar – the PNoy admin for approving ithe program or the Duterte admin for continuing it despite initially deciding against it, resulting in over half of the 700k+ vaccinations happening during Duterte’s term.
      I would hazard a guess that PNoy’s people did a risk-benefit assessment and made a judgement call, given the gravity of the disease here and the WHO endorsement. The Duterte administration had an opportunity to discontinue the implementation. It’s possible that the current officials didn’t do so because they arrived at the same conclusion that PNoy’s people did.
      The entire finger-pointing is unproductive. Simply put, officials of both admins made the same decision based on information available to them at the time.
      Perhaps the better questions are: How many are at risk and is the risk worth it vis-a-vis the number who were protected? Can we manage that risk? Can Sanofi be enlisted in helping manage that risk?
      3. The drug is not lethal. It does not merit the shrill accusations of genocide nor the facial contortions of not-newsworthy bloggers.
      Dengvaxia increases the severity of expressions of dengue among those who were not previously exposed to dengue and contracts it after being vaccinated. Nothing I read says that it increases susceptibility to the disease nor mortality from it if treated as indicated.
      In fact, in its updated FAQs, WHO maintains that “the vaccine significantly protects against hospitalized and severe dengue” in individuals previously exposed to dengue, and still recommends its use among those who have been previously exposed, emphasizing that this narrowed application is a precautionary and interim measure pending a full review. (Nevertheless, on a country level, WHO supported the precautionary suspension of the vaccination program in the Philippines.)
      Time, money and energy are better spent on managing the risk among those affected. Unfortunately, data does not exist on who these might be, precluding any preemptive action. The most we can do is do what we’ve always done – treat dengue patients the best we can (this time, hopefully with the assistance of Sanofi given their role in this mess).
      The bright spot is that the risk uncovered by the new information can actually be effectively controlled by simple blood-testing and taking of medical histories.
      4. It does not cost P9 a pop.
      Here is where we venture into fake news troll territory.
      Sonza, fact check naman. But you know what’s needed before fact-checking? Logic. It’s that nagging feeling that signals to you that something is not quite correct, and gives you that compulsion to dig deeper.
      Think about it. You’re a drug company in the business of making mega-bucks. You have a patent for a formulation that is the first and so far the only vaccine against a disease that affects millions of people worlwide. Wouldn’t you try to make truckloads of money off of it while you still have a monopoly of the market, to pay for the millions you spent on decades of research and development, not to mention the millions more you’ll spend sending doctors to expensive junkets?
      A troll sent me a meme showing a site where Dengvaxia is purportedly sold at the equivalent of nine pesos a dose, whereas the PNoy admin bought it at P1000. Oh wow, millions pocketed by PNoy!
      But wait. Sanofi, the patent owner, is not listed as the seller. Could Astellas Pharma India, the alleged seller, be an authorized reseller?
      A cursory search for the company unearths a warning from them on unscrupulous persons unlawfully using their name to sell drugs online (it does not mention trolls using it to generate fake news, alas). It states that the only drugs they sell are listed in their site. The list does not included Dengvaxia.
      Sigh. Sabi nga nila, walang maloloko kung walang tanga. Ay, ako pala nagsabi nun.
      Ang mas malala, yung pinamukha na sayo ang katotohanan pero todo depensa ka pa rin sa fake news mo. Walang vaccine sa katangahan. Double sigh.

      • https://www.facebook.com/sylvia.claudio.5/posts/10155125784722014?pnref=story

        Dengue Vaccine
        Here is what the initial accusations were: that the dengue vaccine has been used by the administration of Garin/Pnoy (or the Ubial/Duts, depending on political camp) to place people in danger mainly because the vaccine is unsafe. In truth the vaccination program was started under the Pnoy administration and continued under PDuts. Sorry na lang yung mga tao na may political agenda na “everything Pnoy is horrible and PDuts is the anti-Pnoy.”
        It seems clear to me that they were in compliance with the WHO recommendations at that time, same compliance now in stopping the vaccines for review.
        I do not know what your politics are around the WHO but medical treatments are always contested and I follow the WHO. Call me conservative that way.
        Some people now ask, “show us the data that you were actually following WHO recommendations that it be used in endemic populations.” I suggest you talk to the DOH epidemiology unit who are also competent professionals. As it is, whole populations are panicking because you make accusations about “show us the data”.
        The other accusation is that the drugs are overpriced. That one is yet to be proven. What I know is that people like Gwen Garcia held the DOH budget hostage if they did not implement the vaccine. (See the Pinoy Ako Blog for “resibo”.)
        People accuse me of politicising all the time. As a rebellious sort whose rebelliousness got super validated by being an academic from UP, I am indeed always critical and this has been true whoever sits in Malacañang.
        But part of being critical is holding your “banat” until you get the facts.
        Find out please if Sanofi lobbied and unduly influenced people like Garcia who from all indications has flip-flops on the issue. Regardless of the science of the vaccine, this would not be right.
        Find out if the government paid more for the vaccines. In this regard my sources in DOH are talking with 2 mouths which is always part of the DOH game. But I trust so far those who say this did not happen. I am open to a contrary finding because one journalist I trust says otherwise.
        In the meantime, I suggest we inform ourselves better before we panic people with our certainties which turn out to be maybes.

        • https://www.facebook.com/sylvia.claudio.5/posts/10155128069787014?pnref=story

          More on the dengue vaccine by Junice Junice L. Demeterio Melgar
          Let us do the math on the risks of the Dengue vaccine.
          The seropositivity level, which is an indication of a population’s exposure to dengue, was in the range of 89-98%, based on tests made in San Pablo City. This value was extrapolated to apply to the endemic areas in NCR, Region 3 and a few other places where the vaccine was introduced. WHO requires a minimum level of 70% seropositivity as basis for doing vaccination. The vaccine would be risky to the seronegative population, i.e. those who were not exposed to dengue.
          Applying the WHO’s maximum at-risk value of 30% to the 700,000 population of children vaccinated, there would be 210,000 at elevated risk of severe Dengue. The additional actual severe Dengue, according to Sanofi’s latest estimate,would be 2 per thousand. 210,000 X 2/1000 is 420. So 420 is the number of cases that the health system is expected to handle at severity levels 1 and 2, out of a 4 point scale. Sanofi has said there have been no deaths and no severity level 4.
          Obviously, we need to monitor the 210,000 at risk and take care of the additional 420 who are estimated to present with severe dengue.
          But let us also remember that 70% of the 700,00 population, or 490,000, will benefit from the protection of the vaccine.

          • https://www.facebook.com/sylvia.claudio.5/posts/10155128120632014

            More again from Junice L. Demeterio Melgar:
            There is currently a lot of anxiety regarding the possible “severe effects” of the dengue vaccine in kids given the vaccine in dengue-endemic areas. I was with the Family Health Office of the Dept. of Health in 2016 when the program was started and supported the initiative despite the criticism of some sectors that the vaccine had not been tested enough for safety and that it was too expensive. My own reasoning then -and until now – is that the benefit to public health is greater than the cost. Since then, I know that the Family Health Office and the Epidemiology Bureau of the DOH have been doing due diligence in monitoring all adverse effects from the beginning. As far as I know there have been no “severe” complications nor deaths directly attributable to the vaccine. The Secretary of Health has recently stopped the vaccinations and ordered a thorough review of the impact. Let us support that. But I appeal to fellow health workers to help stop the panic and the anti-vaccine paranoia that will put more people into greater harm.
            Below is the statement from the Brazilian Minister of Health who has deemed it safe and wise to continue with the Dengue vaccination in the localities where endemic dengue was harming and killing citizens prior to the vaccine.
            ———————————————————————————
            Press release of the government of Brazil released Nov 30
            NOTE – DENGUE ANVISA VACCINE
            The Secretary of State for Health will maintain the offer of the vaccine against dengue in the 30 municipalities defined to receive the campaign since 2016. The Anvisa Note, released on Wednesday, 11/29/17, does not interfere with the strategy adopted in Paraná following criteria:
             Anvisa’s statement was motivated by the official notification of the production company, which continues to monitor vaccination results not only in Brazil, but also in other countries that are using the product.
             The decision of the Government of Paraná to adopt the vaccine was based on consistent epidemiological data, following recommendations of the World Health Organization, academic societies and the release of ANVISA. Thus, the campaign was directed only at 30 endemic and epidemic municipalities. 82% of the cases registered in Paraná, 91% of the serious cases and 87% of the dengue deaths in the State, which faced consecutive epidemics, recorded a large number of cases.
             Since 80% of the cases of first dengue infection are asymptomatic, that is, the person does not identify the disease, even those who did not have the diagnosis and live in endemic cities may have had contact with the virus, which reinforces the decision of Paraná to vaccinate in the selected municipalities.
             Scientific evidence clearly demonstrates that the vaccine does not cause dengue and all identified cases of adverse events have been fully recovered with routine treatment.
             Paraná vaccinated 300,000 people against dengue fever in three stages of the campaign: August / September 2016, March / April 2017 and September / October 2017. The State Department of Health monitors those vaccinated in the 30 municipalities that received the campaign and did not report any serious adverse reactions. Only minor local reactions were reported.
             In addition to surveillance for adverse reactions, in which no serious reaction has been reported, the Government is conducting cross-monitoring between vaccinates and new confirmed cases of dengue. Since August 2016, when the vaccination campaign against dengue was defined, 1061 cases of dengue fever in Paraná and no deaths from the disease were confirmed, and only 40 people vaccinated were notified with mild dengue fever without laboratory confirmation, only clinical suspicion. This represents 0.01% of the total vaccinated. In the previous epidemiological period, between August 2015 and July 2016, Paraná registered 56,351 cases and 63 deaths from dengue.
             Effectiveness and safety studies of the vaccine are being carried out in the 30 municipalities that received the campaign. In addition to technicians from the State Department of Health, they participate in the professional studies of the Federal University of Paraná (UFPR), the Pequeno Príncipe Hospital in Curitiba, representatives of the Ministry of Health, Pan American Health Organization (PAHO), Sabin Institute and Santa Casa de São Paulo and University of São Paulo (USP).

  • http://opinion.inquirer.net/109289/whats-stake-dengue-vaccine#ixzz50Wl7SAUr – Gideon Lasco

    The debate over the dengue vaccine is nothing new in the medical community, but it is far more complex than how it is being presented in popular discourse. In the first place, there is actually broad consensus—based on existing data — that the vaccine has benefits among those who’ve had previous dengue and risks among those who haven’t. Doctors also know that every intervention has risks and benefits, and it’s a matter of weighing them — a very difficult task, especially when dealing with large populations, ever-changing medical knowledge, and a particularly complex virology.

    The disagreements lie in whether risks were fully considered at the time the decision was made (critics, citing the haste and lack of prior World Health Organization endorsement, claim they weren’t), whether the economic cost of P3 billion and medical risks justified a mass vaccination program (Sanofi, citing its own research, says the cost of vaccinations is less than the hospitalizations they would prevent), whether vested political and pharmaceutical interests were involved, and whether, in light of new evidence, the program should be continued. Fortunately, the Department of Health seems to be taking a prudent course by suspending the vaccination program and calling on experts to adjudicate the matter…

  • karlgarcia

    In the Philippines it is hard to say who had a previous nfection.

    http://www.philstar.com/headlines/2017/12/05/1765469/dengvaxia-still-beneficial-sanofi

    “…
    important to note, however, is that it depends on which country you might be in. It’s sometimes not easy to really identify who had a previous infection because we saw three out of four cases can have no symptoms,” she said.”

Leave a Reply

You can use these HTML tags

<a href="" title=""> <abbr title=""> <acronym title=""> <b> <blockquote cite=""> <cite> <code> <del datetime=""> <em> <i> <q cite=""> <s> <strike> <strong>