Dengvaxia until 2015

Dengue fever symptomslooks clearer to me now, after my first article (link), the Senate hearing (link) and more research. After the 2012 SONA where President Aquino mentioned initial successes in dengue prevention, there were newspaper articles which mentioned a rise in dengue (link), doubting its success. What I wonder is if the increased spread of dengue is related to climate change and to rapid urbanization in the Philippines – with the slums that result, the stagnant pools of water you often have there and of course a population density that makes it easier for the mosquito to travel from person to person.

Phase 3 Tests

The development of Dengvaxia goes way back, but the two most important Phase 3 tests started in June 2011 – one in Asia and one in Latin America (link). CYD 14 (Asia) had over 10 thousand volunteers while CYD 15 (Latin America) had almost 21 thousand volunteers. The active phase of CYD 14 ended in December 2013, that of CYD 15 in April 2014, with Sanofi reporting the success of Phase 3 some months later (link). Phase 3 is needed to apply for approval. The Philippines played a key role in all three test phases (link): 3,500 children were from the Philippines, setting up clinical trial sites in Alabang, Muntinlupa City (Phase 1); Barangay Del Remedios in San Pablo City (Phase 2); and Barangay Guadalupe in Cebu City along with Barangay Del Remedios (Phase 3) with Dr. Maria Rosario Capeding, head of the Department of Microbiology of the Research Institute for Tropical Medicine (RITM)  – an agency of the Department of Health – playing a key role (link), including writing key scientific papers (link) and even experiencing how her own child got dengue (link). Seems the most important seroprevalence data came from San Pablo (link).

Since national data on seroprevalence (how many % of the population had virus exposure) did not exist, it was extrapolated to some areas where dengue is endemic (link). Some might consider this a doubtful methodology, but then again such authorities as Balik-Scientist Dr. Edcel Salvana have mentioned approximately 87% as the seroprevalence (see my previous article) and I see no reason to doubt that they are right, give or take a certain margin. He also writes (link) about why he sees the vaccine as good – if used properly. What is also important, however, is that the Phase 3 studies (link) included an active phase of follow-up for one year after the last dose of vaccine in the series (25 months from dose 1) and include a hospital-based follow-up period of four additional years. The follow-up phase for the Asian phase 3 study seems to have ended in November 2017.

A related research paper (with Dr. Capeding as a co-author) says that in the ongoing longer-term follow-up (from year 3 to year 6) to assess safety, we are monitoring the incidence of hospitalization for dengue as a surrogate end point for disease severity in order to evaluate a potential predisposition in vaccinated persons to increased severity of disease. I do wonder if there is a relation between the planned end of the follow-up phase and the warning by Sanofi not to vaccinate seronegatives (people without any virus exposure) anymore due to risk of severe dengue.

Getting Things Ready

In July 2014, then-Health Secretary Enrique Ona (link) sounded quite confident about the new vaccine (link) and the hope then was that it would be out by July 2015. The success of the Latin American study was announced by Sanofi on Sept. 3, 2014 (link). President Aquino met with Sanofi representatives on Nov. 9, 2014 (link) which was pretty soon after these events, then a year later in Paris on Dec. 1, 2015 when he was there for the Climate Change Conference – a meeting that was openly mentioned in the Philippine press (link), not done stealthily as some are insinuating.

There also was a dinner in Paris in May 2015 (link) involving ex-Secretary Garin and Sanofi, and before that Sanofi submitted papers for Philippine FDA requirements in January 2015 (link). Mexico, Brazil and the Philippines (link) approved the vaccine in December 2015. The end of December brought a number of events which were seen as rushed, which President Aquino in the hearing explained as being in order to get things done in his term, saying the new administrations often lose time in the beginning, and also explained why budget maneuvers were needed (link).


Now for Questions

Assuming the best (which I do now after having seen how Aquino acted at the hearing) there are still a number of questions. There were still some years of observation being conducted, who knew about this and who was (not) informed including possible risk factors, if already known then? As for monitoring, Dr. Melgar who was with the DOH when the program started has this to say (link): 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. Sounds properly done.

Dr. Salvana would be the right person to ask on seroprevalence, and on why certain extrapolations were considered OK. I am satisfied with that for now, what I computed in my previous article still stands – those who WILL get sicker should be few. And I believe Aquino didn’t know the science.

What one knows

depends on eyes, ears and brain – and on their human and man-made extensions, meaning the people who inform and educate you. We all know about the information overload modern social media brings with the world practically spilling into our brains, including all sights and sounds. What more is a President constantly subjected to a barrage of information? So he needs his people. To filter what is important and what is not, to give him what he needs to be able to make decisions. What if they mislead him? He has to counter-check if possible. Mayors in cities have it much easier.

It is I think possible to get an intuitive feel for a city. Mayor Duterte may have known Davao in and out, therefore being instinctively able to tell bullshit from truth. At national level it isn’t that easy. Spurious drug lists have shown the limits of an intuitive, seat of the pants approach to governing. At national level and even more in specialized areas, one may need to have additional sources. Seems that the Presidential Management Office would have specialists (link), even if I am not sure if they are used as extensively and as focused as the staff of Germany’s Federal Chancellery (link) which has the job to (translated from German) obtain and keep ready the information the Chancellor needs for his/her work. Its divisions mirror related ministries and directly contact them for detailed information: Division 1 for interior and justice, Division 2 for foreign, defence and development affairs, Division 3 for social, health, labor, infrastructure and social matters, Division 4 for financial and economic matters, Division 5 for Europe and Division 6 for intelligence matters. With a nerve center like that, no need to rely only on Ministers – who are also politicians after all.

How one leads

Could it be that Aquino relied too much on his Cabinet members alone? A second opinion is good not only when one goes to doctors privately! It may be even more crucial in matters of state. The fact that ex-Secretary Garin now seems to have connections to the other side is a bit interesting. Somewhat like how PNPs Napenas was a candidate for an opposing party in the 2016 elections. Trust, but verify is usually better. And even a highly efficient apparatus can be sidelined at times, as was shown recently by the controversy in Germany regarding the herbicide glyphosate (link).

Another possibility is what I sense – that Aquino tends to push through with things he wants to do, at some point no longer reconsidering. That is a very Filipino trait which his successor also has, as in the Philippines, too much reconsidering can make one lose respect. The other side dislikes it, yes. But there is to me not much evidence of significant counter-indications known at that time, at least in a form understandable to laymen or managers. Specialists speak in details, managers think in terms of consequences, that gap must always be bridged whether in IT – my field – or elsewhere.


My personal opinion

There are terms like “lighthouse customer” for those who adopt a certain product first. Sometimes vendors (in any industry including mine) manage to make lighthouse customers pay normal prices. Other customers negotiate a deal which fairly considers their role in being one of the first to buy. Possibly the Philippines bought too many vaccines to soon at a slightly too high price. Asking for a refund is a maximum demand Sanofi will probably not accede to. But maybe a rebate as not all things were really made clear, since around 800 thousand kids will have to be monitored and a few, hopefully very few, may have to be hospitalized, is an idea. Sanofi does not want the PR damage from a long public conflict – nor does the Philippines want to look like a backwater where they accuse foreign firms of witchcraft. There are many ways forward. But let us look at 2016-2017 next.

Irineo B. R. Salazar
München, 15 December 2017

13 thoughts on “Dengvaxia until 2015

  1. https://www.philstar.com/headlines/2018/04/11/1805043/bb8R7Mssp9CTjvuT.01

    MANILA, Philippines — Sen. Panfilo Lacson on Wednesday said that it is difficult to believe that former President Benigno Aquino III was capable of committing graft, hours after a Senate panel report damned the former leader for the mess created by an anti-dengue vaccine program started during his administration.

    According to the draft report of the Senate blue ribbon panel chaired by Sen. Richard Gordon, Aquino was guilty of “malfeasance, misfeasance and nonfeasance” in the mass vaccination of Dengvaxia among children in several regions where dengue cases were on the rise.

    In a strongly-worded report, Gordon accused the former leader of simply not caring as many parents were losing sleep over worries on the health of their children given dengue shots.

    Gordon also raised ethical questions over the meeting Aquino had with vice presidents of Sanofi Pasteur, the French pharmaceutical firm that manufactures the anti-vaccine shot.

    Lacson, who worked with Aquino at the Senate and later at the presidential palace, came to the former president’s defense in a social media post.

    “Having worked closely with ex-Pnoy (Aquino) both in the Senate and Malacañang, it is difficult for me to believe that he was capable of committing graft and corruption,” he said on Twitter.

    Aquino appointed Lacson to take charge of the rehabilitation of areas devastated by Super Typhoon Yolanda (Haiyan) in 2013..

  2. https://www.facebook.com/jozy.acosta/posts/10155543124713585

    Dengvaxia is not fatal. People don’t die from Dengvaxia. They die when they contract severe dengue and don’t get treated for it. That was the case before Dengvaxia and that is the case now.
    Vaccines – any vaccine – are not magic potions. They all have a small proportion where they will fail and that proportion is indicated in the literature. If you fall in that proportion and contract the disease you were vaccinated against, you’re supposed to seek medical help. Just because you got the vaccine doesn’t mean you can assume the symptoms will go away on their own – once you have the disease, you have the disease. Get treated. (Or pressure DOH to level-up on providing medical access to the poor. We should be doing that anyway. For all diseases. Regardless of administration.)
    What Dengvaxia does is increase the incidence of severe hospitalization among those who were not previously exposed to dengue. There are three things here:
    1. Not previously exposed (sero-negative). I’m not sure if this means simply being exposed to the virus (the virus is always present in dengue-prevalent communities in our tropical climate) or if it refers to actually having dengue. Even if it’s the latter, the incidence of dengue in the Philippines, particularly where the dengue vaccination program was rolled out, is very high – WHO gave a parameter of 70% incidence in choosing the communities, which they say the Philippines complied with. Which means that the incidence of sero-negatives, conversely, is quite low.
    2. Severe hospitalization. Not deaths, hospitalization. Severe hospitalization can still be treated. Dengvaxia does not cause deaths. The onus is on the DOH to ensure that medical help is provided to those in poor communities when needed. This is true with or without Dengvaxia. Worth examining: how does the incidence RATE of severe hospitalization among sero-negatives compare to the overall incidence rate in severe hospitalization among all who were vaccinated, sero-negatives and sero-positives alike? I would hazard a guess that it is way below what it was pre-Dengvaxia.
    2. Increase the incidence. This means that not all of the sero-negatives who were vaccinated and contract the disease will experience severe hospitalization, just more of them than usual. Note that not even all vaccinated sero-negatives will contract the disease – Dengvaxia doesn’t cause dengue either.
    Why is Dengvaxia important?
    A) Our mortality rate from dengue is so high. The incidence is also high. When properly administered – i.e. only to those who are sero-positive – the benefit far outweighs the risk. Again, no vaccine is foolproof.
    B ) The benefit to sero-positives is multiplied when you consider that repeat infections of dengue increases the chance of hemorrhagic dengue fever, which has a higher mortality rate than other forms of dengue. Vavvinating against repeat infections of dengue, which is what Dengvaxia does, will prevent this.
    I’m not saying that deaths due to dengue (not due to Dengvaxia) are unimportant because the true incidence is likely low. I’m saying that a) the benefits far outweigh the risk and vastly more lives will likely be saved than put at risk, b) the risk can be managed by restricting administration to sero-positives, and c) the risk is severe hospitalization, which will not lead to death if properly treated.
    It’s sad that there are deaths, if true (again, not due to Dengvaxia but due to non-treatment of the symptoms caused by Dengvaxia). But what we could have with Dengvaxia is far preferable to the mortality rate we have without it. In medicine, nothing is 100% foolproof.
    An unfortunate result of this brouhaha is that parents are now refusing to vaccinate their children from any disease. Down the line, we may be faced with epidemics not just of dengue but also of measles, polio, whatnot.
    We need to end the hysteria. A lot of lives are at stake, not due to Dengvaxia but due to the withholding of it. We, including the DDS, need to go beyond our political biases and actually, really think of the children.
    I previously wrote on Dengvaxia. That touched a little on the political aspect. Here it is. (It assumed that everyone was aware of the then-newly discovered contraindication for sero-negatives because it was heavily in the news at that time. If that isn’t clear, clarifying it now.)
    https://m.facebook.com/story.php?story_fbid=10155368490493585&id=672663584
    Tigil na natin to. Let’s focus on the true ills besetting the nation.

  3. http://opinion.inquirer.net/110536/dengvaxia-facts-1 – Peter Wallace:

    “And for the opportunistic lawyers, Dengvaxia doesn’t cause dengue; it just, in the rare worst case, means that a seronegative person may suffer as much as a seropositive person who had not been vaccinated. If a society where the risk of dengue is high, like the Philippines, is not inoculated, 4.8 per 1,000 people are likely to suffer from a severe case. A fraction will die; the others will recover.

    The present controversy concerns the impact of a mosquito bite causing dengue in someone who’d been inoculated with Dengvaxia but not previously had dengue (seronegative). Among those who have had dengue (seropositive), there was a reduction of about four cases of severe dengue per 1,000 persons vaccinated. In seronegative people, there is higher risk of hospitalization from dengue and severe dengue (DHF grade I and II). These are the same symptoms an unvaccinated seropositive person would suffer if bitten a second time. The number remains much the same. Some 4/1,000 may suffer a severe case. This is about the same risk level as in people who had dengue in the past but are not vaccinated — 4 versus 4.8 per 1,000.”

  4. http://www.philstar.com:8080/headlines/2017/12/21/1770455/doh-check-reported-dengvaxia-dengue-vaccine-deaths

    MANILA, Philippines — The Department of Health (DOH) insisted yesterday there were no deaths related to Dengvaxia and that surveillance teams had been deployed to look into any report of dengue or severe dengue infection due to the vaccine.

    The families of two 10-year-old girls – one from Bataan and another from Quezon City – claimed the children died after getting vaccinated with Dengvaxia in school.

    Health Secretary Francisco Duque III gave assurance the agency does not ignore any possible death or severe dengue related to the controversial vaccine. But DOH Undersecretary Herminigildo Valle said they already investigated the two deaths that were being blamed on Dengvaxia and found that these were unfounded claims.

    Assisted by the Volunteers Against Crime and Corruption (VACC) and the Public Attorney’s Office (PAO), the parents of Christine Mae de Guzman of Bataan and Anjielica Pestilos of Quezon City faced the media on Tuesday and detailed how the two girls died months after being injected with the anti-dengue vaccine.

    It turned out the children have underlying conditions, like heart ailment, that led to their deaths, according to the DOH..

    • http://www.sunstar.com.ph/cebu/lifestyle/2017/12/19/bad-science-dengvaxia-controversy-580524

      THE ongoing Senate hearing on Dengvaxia may be described—outside clear political undertones in its initiation—as offering a potential breakthrough in the way the public health sector is being organized in the country. I am referring to the redefinition of the Bureau of Food and Drugs (Bfad) from an attached agency in the Department of Health to an independent bastion of scientific oversight in the country, as suggested by Antonio Dans of the Philippine General Hospital. Such independence is required to balance the policymaking power of the Department of Health, which, in the case of Dengvaxia, had leaned toward the financial and away from sound science. Moreover, the new Bfad will have the adequate budget to perform the seroepidemiological studies that dengue expert Scott Halstead had recommended. There were already signs of uncertainty in the efficacy of Dengvaxia before its distribution. First, the Formulary Executive Council did not recommend a mass vaccination of Dengvaxia. Second, Halstead already raised caution on vaccinating children without clear exposure to any serotype of the dengue virus. Third, there was no clear data-based long-term protection associated with the vaccination (the clinical trial was only then on its third year). The endemicity and growing cases of dengue, however, demanded some urgency of action. The problem with the uncertainty in the science of Dengvaxia was that uncertainty can either be positive or negative. It can be about negative efficacy as Halstead estimated. Please take note that this “negative efficacy” is only a “theoretical risk” because it had not been studied. Conversely, it can also be positive because Dengvaxia may still be able to deliver the promises made about it.

      The missing link in this bad science, from the side of the Philippines, was the lack of at least one seroepidemiological study to ascertain that a target community for mass vaccination had really been exposed to the dengue virus. This mistake exposes the reality that the Philippines is far from being evidence-based in its public health practice. If blaming is the game, everyone, from educators to policymakers, can be blamed for that.

      What policymakers can do to improve our public health situation is to demand that decisions made must be evidence-based, and not resting on some mental inferences based on uncertain grounds.

    • https://www.facebook.com/walden.bello/posts/10155437348179332?pnref=story

      CORPORATE CRIME+POLITICAL AMBITION+VINDICTIVE AGENDA+SELF PROMOTION = THE SANOFI CIRCUS
      On the Sanofi dengue vaccine (Dengvaxia) scandal, I doubt that any corruption or corporate payoff was involved. But there certainly was negligence and command responsibility on the part of the Aquino administration given the fact that in 2015, the Sanofi deal was probably the most important decision to be made by the Department of Health that year and certainly the biggest budget item for a commodity purchase. That Sanofi would lobby then President Aquino and then Secretary of Health Janet Garin to make special visits to their offices in Paris should have tipped them off to the fact that the Philippine contract was a very, very big deal for the company, and that they should have exercised special caution and looked very closely at all aspects of the deal, especially the results of testing.
      With former Secretary Garin, the situation is a bit more complicated. I worked with her on the Reproductive Health Bill when she was Assistant Majority Leader in the House of Representatives, and I think she was instrumental in getting it through the House, and I continue to praise her for this. She is a medical professional, but she is a politician first and foremost, and in her last incarnation as Secretary of Health, it is likely that political ambition influenced her approving the Sanofi deal. That she could point to solving the dengue problem as a feather in her hat on her way up to even higher appointive or elective office could have been the factor that made her disregard the advice of the DOH Formulary Executive Council not to seal the deal with Sanofi until all the key test results were in that would clear the vaccine as safe.
      I think that had Dr Enrique Ona remained in office as Secretary of Health instead of being eased out by Aquino because he was not part of the barkada, this would not have happened. Ona was a real professional, who stuck to the straight and narrow. Sanofi was, in a way, another negative consequence of the fraternity style of governance that plagued the Aquino years.
      Having said that, I think that Secretary Aguirre and Senator Gordon have opportunistically politicized the issue in a very unhelpful way to advance the vindictive agenda of the Duterte administration and their own careers. Gordon will use any issue to promote himself and his ambitions. An inveterate attention-getter, he’s the kind of guy who would not be able to attend a funeral without wishing to be the corpse. There is a strong case for an independent commission to be established to get to the roots of the matter.

      https://www.facebook.com/walden.bello/posts/10155445243729332?pnref=story

      ON THE DENGUE VACCINE SCANDAL 2
      In my post two days ago, I said that it was probably political ambition rather than corruption that motivated former Health Secretary Garin to approve a massive purchase of the vaccine without its being fully tested. Now I am not so sure. Why else would her congressman husband attend a budget hearing to urge her successor as DOH chief to order another batch of the drug? Why act as a sales agent for Sanofi? This is what happens when you make loyalty instead of proven professional integrity the basis for making appointments to sensitive positions and remove real professionals like Dr Enrique Ona to make room for them. I resigned from Congress to protest this barkadismo that was the Achilles Heel of the Aquino administration. But I take no joy in again being proved right.

      https://www.rappler.com/thought-leaders/191626-hinggil-sa-dengvaxia-dengue-vaccine

      by Sylvia E. Claudio

      OPINYON] Hinggil sa Dengvaxia

      Sinubok kong isuma ang impormasyon mula sa mga mapagkakatiwalaang eksperto at institusyon. Layunin ko pong maibsan ang pagkabahala at pag-aalala ng mga pamilya.’

      Balitang-balita ngayon ang tungkol sa bakuna laban sa dengue. Marami ang nababahala, lalo na ang mga nabakunahan.
      Marami at salusalungat ang impormasyong naibibigay sa mamamayan tungkol sa bakuna.

      Marami po sa impormasyon ay mali. Sa aking palagay, may iba’t-ibang dahilan. Isang dahilan ay ang pagkawalang-bahala ng ilang media na mali-mali ang nirereport dahil hindi nila iniintindi o inaaral ang datos at impormasyon.

      Isa pa dito ay napulitika na nang husto ang isyung ito kaya’t nabibigyan na ng maling interpretasyon ang mga datos at pangyayari tungkol sa programa ng gobyerno.

      Dahil dito, sinubok kong isuma ang impormasyon mula sa mga mapagkakatiwalaang eksperto at institusyon. Layunin ko pong maibsan ang pagkabahala at pag-aalalang ng mga pamilya. Heto po ang mga itinatanong ng mga pangkaraniwang tao at ang mga kasagutan.

      Tanong: Safe ba ang bakuna laban sa dengue?

      Sagot: Opo, kung tama ang paggamit. Halos lahat ng gamot at iba pang teknolohiya sa medisina ay mapanganib kung hindi tama ang paggamit.

      T: Ano ang tamang pamamaraan ng paggamit ng bakuna laban sa dengue?

      S: Ayon po sa World Health Organization:

      Ang bakuna ay dapat ibigay sa mga komunidad kung saan higit sa 70% ng populasyon ay nagkadengue na.
      Hindi bababa nang 9 na taong gulang ang babakunahan.
      Tatlong beses dapat ibibigay ang bakuna.
      T: Sinunod ba ng Department of Health ang utos ng WHO tungkol sa tamang paggamit ng bakuna?

      S: Opo. Ayon sa WHO noong Disyembre, 5, 2017: “WHO acknowledged mid-April 2016 that these conditions appeared to be met in the 3 regions of the Philippines in which the dengue vaccination effort was already ongoing at that time.”

      T: Kahit po safe ang bakuna, epektibo ba ito?

      S: Opo. Paulit-ulit po itong sinabi ng WHO. Kung tungkol po sa Pilipinas, pakipanood na lang ang video kung saan sinabi ni Dr Gundo Weiler ng WHO na mababawasan ang bilang ng maoospital dahil sa pagbibigay ng bakuna dito sa Pilipinas. Sinabi po niya ito noong Apirl 2016 nang sinusuri ang programa ng DOH.

      T: Bakit po sa imbestigasyon sa Senado tungkol po sa bakuna, iba-iba po ang sinasabi ng mga eksperto?

      S: Likas po sa agham, lalo na sa medisina, ang pagkakaiba-iba ng opinyon ng mga eksperto. Nguni’t hindi po ibig sabihin na pareho lamang ang timbang ng kanilang mga opinyon. Ang karamihan po ng eksperto at ang karamihan ng pag-aaral tungkol sa bakuna laban sa dengue ay nagsasabing ito ay ligtas at epektibo. Kaya po mayroong World Health Organization, ang internasyonal na institusyong kinikilala ng lahat ng gobyerno at siyang nagbibigay ng payo sa mga gobyerno tungkol sa mga tamang patakaran tungkol sa kalusugan.

      Dapat intindihin ng lahat na pinahahalagahan ang mga kritiko dahil nakatutulong ang kritisismong maging maayos at masinop ang pagtuklas at paggamit ng gamot. Ngunit hindi nangangahulugang tama ang lahat ng kritiko. At kung narinig ninyo ang isang eksperto sa Senado na nagsabing “kami lang ang tama,” ‘yan na po ang indikasyon ninyong huwag magtiwala sa kanila. Sa totoo lang, kahit sinong diumano’y ekspertong nagsasabi na sila lang ang tama, lalo na’t salungat sila sa WHO at karamihan ng ibang eksperto, di sila dapat pagkatiwalaan.

      T: Hindi ba nag-report ang mismong manufacturer na may problema pala ang bakuna nila?

      S: Noong November 29, 2017, nag-report ang Sanofi Pasteur, ang manufacturer ng bakuna, batay sa 6 na taon nilang pag-monitor sa mga nabakunahan, na mas mataas ang posibilidad na maospital ang mga nabakunahang hindi pa nagkakasakit ng dengue.

      Subali’t inulit nilang nagbibigay ang bakuna ng “significant, durable protection from dengue” para sa mga taong nagkasakit na ng dengue bago mabakunahan.

      Ayon sa datos, sa grupong minonitor na nagkasakit na ng dengue bago mabakunahan, nababawasan ang mga naospital at nagkaroon ng severe dengue. Ganito rin para sa mga taong hindi pa nagkaka-dengue bago mabakunahan sa loob ng dalawang taon. Nguni’t simula nang ikatlong taon matapos mabakunahan, sa bawa’t 1,000 kataong hindi pa nagkaka-dengue bago mabakunahan, maaaring madagdagan ng 5 katao ang maoospital at dalawang katao ang magkaroon ng “severe” dengue.

      T: Ang ibig ba sabihin nito ay nagkamali ang WHO at ang DOH? Hindi po ba dapat inalam lahat ng posibleng problema bago inaprubahan ang bakuna?

      S: Hindi. Ang WHO mismo ang nag-utos sa Sanofi Pasteur na magmonitor pa sa epekto ng gamot. Mahaba ang proseso ng pagtuklas at testing ng bagong gamot. Ang pinakahuli nito ay ang pagmonitor kung ano ang magiging epekto kapag ang isang gamot ay ginamit na ng maraming tao o sa mahabang panahon. Kahit kasi anong ingat sa testing, hindi naman talaga malalaman ang lahat habang hindi pa ito nagagamit ng maraming tao sa pangmatagalan. Paminsan minsan, kailangang ipa-recall ang isang gamot na inaprubahan na dahil napakalubha pala ng side effects na nakikita matapos itong ipagamit na sa lahat. Nguni’t sa kaso ng bakuna sa dengue hindi naman ito pinare-recall. (BASAHIN: FDA orders market pullout of Dengvaxia vaccine)

      Sa totoo lang nagsabi ang ang Ministry of Health ng Brazil, isa pang bayan kung saan marami ang binigyan ng bakuna, na kahit naglabas ng dagdag na warning ang Sanofi Pasteur, itutuloy pa rin nila ang pagbibigay ng bakuna. Bibigyan lamang ng paalala ang mga hindi pa nagkadengue na huwag na munang magpabakuna.

      T: Kaduda-duda ba na sinimulan ng gobyerno ang pagbabakuna nang dalawang buwan bago lumabas ang guidelines ng WHO?

      S: Habang lumabas ang guidelines ng WHO nung July 2016, ibinatay nila ito sa statement noong April 2016 ng sarili nilang mga eksperto, ang WHO Strategic Advisory Group of Experts on immunization (SAGE). Minabuti ng gobyerno na simulan nang maaga dahil tuwing Abril tumataas na ang mga kaso ng dengue sa Pilipinas.

      T: Nabalitaan ko na sinabi ng WHO mismo na hindi raw nila nirekomenda ang bakuna para sa national immunization program ng Pilipinas.

      S: Totoo po iyon. Hindi nila inirekomendang lahat ay bakunahan. Sa halip ay inirekomenda nilang bigyan ng bakuna ang ilang piling lugar. ‘Yon po ang ginawa ng DOH.

      T: Ang bakuna ba mismo ang nagiging sanhi ng dengue?

      S: Mahalagang linawin na hindi nanggagaling sa bakuna ang sakit na dengue. Galing ito sa kagat ng lamok na may dengue virus.

      T: Paano ko malalaman kung nagka-dengue na ako o hindi?

      S: Marami sa atin ang nakakseguro na tayo ay nagka-dengue na dahil na-diagnose tayo ng doktor o naospital tayo.

      Nguni’t higit na marami ang nagkaka-dengue na hindi man lamang napansin na nagkaimpeksyon na pala sila. Sa sakit na ito, ang pangalawang impeksyon ang mapanganib. Kaya’t nirekomenda ng WHO na sa mga lugar na ayon sa pagsusuri ay 70% o higit pa ang nagka-dengue ibigay na ang bakuna sa lahat.

      T: Dapat ba akong magpabakuna kung sigurado akong nagka-dengue na ako?

      S: Opo. Iyon pa rin ang rekomendasyon ng WHO at karamihan ng mga eksperto.

      T: Kung hindi ako nakakaseguro na nagka-dengue ako, may test ba na makapagsasabi kung nagkasakit na nga ako?

      S: Walang mabisa at abot-kayang test na makapgsasabi kung nagkasakit ka na dati o hindi pa. Ang mga ginagamit na test ngayon ay mabisa lamang kung kasalukuyan kang may sakit.

      T: Dapat bang isinugal ang buhay ng kahit iilan lamang kahit magdadala ito ng kabutihan para sa higit na marami?

      S: Ayon sa report ng Sanofi Pasteur walang ni isang namatay sa mga nagkaroon ng side effects at lahat naman ay gumaling. Wala pa talagang naiulat na namatay dahil sa bakuna. Ayon pa sa mga eksperto, hindi dapat ikatakot ang salitang “severe dengue” na ginamit ng Sanofi Pasteur dahil ang pamantayan nila para tawaging “severe” ang side effects na nakita nila ay hindi nangangahulugan ng tipo ng dengue na humahantong sa kamatayan.

      T: Nabakunahan ang anak ko at hindi namin alam kung nagkasakit na siya ng dengue o hindi. Dapat ba akong mabahala?

      S: Hindi lahat ng bata sa Pilipinas ang binigyan ng bakuna. Kung isa kayo sa mga pamilyang nakatira sa lugar na pinili ng DOH na bakunahan, malamang ay nagkasakit na nga ang inyong anak ng dengue at, sa gayon, mabibigyan siya ng dagdag na proteksyon.

      Ayon sa report ng Sanofi-Pasteur sa mga nabakunahan na hindi pa nagkakasakit, may .05% na dagdag na panganib na maospital, at 0.2% dagdag na panganib na magkaroon ng severe dengue.

      T: Ano ngayon ang dapat gawin ng mga nabakunahan?

      S: Pareho naman ang dapat gawin ng lahat ng mamayan kahit nabakunahan o hindi. Dapat mag-ingat pa rin sa kagat ng lamok, lalo na sa mga lugar na naka-epidemic o kilalang may dengue. Kasama na dito ang paggamit ng kulambo, at paglinis sa mga naimbak na tubig na maaaring pagpugaran ng lamok.

      Higit na mahalaga, kung may mga sintomas ng dengue, kumonsulta agad sa doktor. – Rappler.com

      Si Sylvia Estrada Claudio ay isang doktor ng medisina na doktorado din ng sikolohiya. Bilang isang ordinaryong manggagamot na ilang dekada nang bumababad sa mga mahirap na pamayanan nakasanayan na niyang ipaliwanag ang mga sinasabi ng mga eksperto sa ordinaryong mamamayan. Higit po niyang tinututulan ang walang galang na pagtrato ni Sen. Dick Gordon sa mga testigong na sa aking pananaw, ay hindi sumasang-ayon sa kanyang mga hinala at akala. Sa pagkakilala niya sa loob na maraming taon sa mga eksperto tulad ni Dr. Kenneth Hartigan Go at ni Dr. Julius Lecciones, tapat po sila sa kanilang propesyon. Wala pong naitutulong sa mamayan kapag ang isang panig lamang ng mga eksperto, yaong panig pa na sinusuway ang opinyon ng karamihan, ang binigyang daan sa isang imbestigasyon. Humihingi po siya ng patawad kung nagbabanggit siya ng mga pangalan ng ilan. Mahirap po kasing panoorin ang paninira sa mga mabubuting tao.

    • https://www.rappler.com/nation/191497-rappler-talk-janette-garin-dengue-vaccine-dengvaxia

      (Interview)

      https://newsinfo.inquirer.net/953048/rep-richard-garin-denies-pressuring-ubial-to-buy-more-dengavaxi

      Iloilo Rep. Oscar “Richard” Garin Jr., an ally of President Rodrigo Duterte and husband of former Health Secretary Janette Garin, denied on Saturday that he pressured former Health Secretary Paulyn Rosell-Ubial to buy more of the controversial Dengvaxia vaccine and allocate budget for it in 2018.
      “It is the work of Congress to scrutinize budgets submitted to it by departments such as the DOH [Department of Health] and for projects to be implemented in the different congressional districts,” Garin said in a statement.
      He said records of the budget hearings “will speak that I only asked her if it is true that some children in NCR [National Capital Region] will only receive two doses [of the vaccine] and [if they] will pay for the third dose.”

      ..Representative Garin pointed out in his statement that he was not a member of the Commission on Appointments (CA).

      http://www.philstar.com/headlines/2017/12/14/1768362/who-issues-new-recommendation-dengvaxia

      MANILA, Philippines — The World Health Organization has issued a new recommendation that Dengvaxia should not be administered to people who have not had dengue before.

      The WHO said Dengvaxia “prevents disease in the majority of vaccine recipients but it should not be administered to people who have not previously been infected with dengue virus.”

      http://newsinfo.inquirer.net/953095/dengue-vaccine-dengvaxia-sanofi-pasteur-benigno-aquino-iii-noynoy-aquino-florencio-abad-butch-abad-paquito-ochoa-doh-department-of-health-jv-ejercito

      “If we’re going to talk of command responsibility, I think President Aquino has liability,” Ejercito said in a radio interview Saturday..

      I have to be honest, I am not a fan of President Aquino. I disagree with many of what was done during his administration. But his integrity, President Aquino is still honest. But I can’t say the same thing about his men,” Ejercito said.

    • http://www.interaksyon.com/doh-execs-in-dengvaxia-mess-still-have-access-to-docs-can-cover-up-misdeeds-experts-warning/

      MANILA – Even while lawmakers are conducting separate inquiries into the P3.5-billion Dengvaxia fiasco, officials should move quickly to stop “an ongoing cover-up” among Department of Health officials involved in the Aquino-era dengue immunization program who could prevent the incumbent DOH secretary from getting to the bottom of the scandal, a public health expert warned at the weekend.

      “Imperfect science cannot conceal what is perfectly clear: people got greedy. Sanofi Pasteur is the manufacturer and supplier of Dengvaxia. DOH is the contracting party. Even without the ‘bad science’ issue, there were apparent red flags in the procurement and delivery of the new vaccination services,” Dr. Francisco Salcedo Cruz, who had testified in two hearings of the joint Senate Blue Ribbon and Health committees, said in a statement sent to media outlets Saturday.

      http://www.philstar.com/headlines/2017/12/14/1768373/pcmcs-p1.15-b-dengvaxia-funds-remain-intact-says-coa

      MANILA, Philippines —
      X

      A portion of the funds allocated by the Department of Health to the Philippine Children’s Medical Center (PCMC) for the mass implementation of the previous administration’s dengue immunization program remains intact and was in fact deposited to high-yielding accounts, a Commission on Audit report shows.

      Based on the COA’s audit report on the PCMC, as of Dec. 31, 2016 the state hospital has a total of P1.865 billion “cash and cash equivalent” that remains intact – P1.03 billion of which is under “special high yield savings deposits,” P833.234 million under “cash on hand and in banks” and P2.084 million under “time deposits.”

      https://www.rappler.com/newsbreak/inside-track/173280-health-secretary-paulyn-ubial-record-of-flip-flopping

      Prior to heading the Department of Health (DOH), Ubial was assistant secretary when the P3.5-billion dengue vaccine program was approved during the Aquino administration.

      On July 18, 2016, the newly appointed DOH chief Ubial signed a resolution recommending the deferment of the program, saying the vaccines are not proven safe.

      She also earlier told the House of Representatives panel deliberating the 2017 budget that “a panel of experts convened by the DOH revealed the dengue vaccine has potential health risks.”

      But on September 28, 2016, she issued a Certificate of Exemption for the vaccine, Dengvaxia, so it could still be used despite her earlier flagging of certain issues.

      Roque questioned this: “Ang tanong ko, may red flag ka na pala, bakit noong Secretary ka na noong September 2016, nagbigay ka pa rin ng Certificate of Exemption sa dengue vaccine? Atras abante siya.” (My question is: You already had red flags. Why did you issue a Certificate of Exemption in September 2016? You’re moving back and forth.)

      When confronted during a House hearing, Ubial apologized and said she had “forgotten” about the July resolution.

      Ubial also defended her issuance of a certification, saying she consulted with “experts,” as she had no expertise on dengue vaccines.

      “I deferred to the wisdom and the decision of the experts that recommend to me the action to be taken because I admitted that I am not an expert on the dengue vaccine. So, ‘yun po nangyari na (that’s what happened), every time we move forward in this initiative, we convene an expert panel so that based on the scientific and logical thinking of scientists and experts [we decided] what would be the next step to take in moving forward the dengue vaccination program,” she earlier said.

      The health department is already administering the 2nd of the 3 doses of the dengue vaccine to around 489,000 public school students (at least 9 years old) in Central Luzon, Calabarzon, and the National Capital Region.

      But Ubial, on May 5, said they would again stop the dengue vaccination program after the 3rd and final round of injections is administered, saying they have to wait for the results of the pilot testing.

      Roque questioned this: “Kung ito ay delikado sa kalusugan, dapat tinigil no matter what. Pero hindi pupuwede ‘yung minsan tuloy, minsan tigil. Ang nagiging epekto nito, natatakot ang taumbayan sa lahat ng forms ng vaccines, hindi lang sa dengue, kasi nga naman ‘yung Secretary of Health, hindi maintindihan kung tuloy or hindi tuloy.”

      (If this is dangerous to people’s health, this should have been stopped no matter what. It can’t be that it’ll push through, then it’ll be stopped. The effect of this is the public gets scared of all forms of vaccines, not just the one for dengue, because the Secretary of Health is unsure if it will continue or not.)

    • https://www.rappler.com/nation/191364-conflict-janette-garin-fec-dengvaxia-dengue-vaccine

      ..MANILA, Philippines (UPDATED) – Which group of experts should the Department of Health (DOH) chief believe in making key policy decisions?

      The issue became a hot topic on Thursday, December 14, as the Senate continued its probe into the now-suspended government dengue vaccination program, which used Sanofi Pasteur’s Dengvaxia vaccine.

      During the hearing, DOH secretary Janette Garin defended her decision to start vaccinating public school students in the National Capital Region, Central Luzon, and Calabarzon with Dengvaxia in April 2016.

      Senate blue ribbon committee chairperson Richard Gordon pointed out in the hearing that the Formulary Executive Council (FEC) – a panel of top Filipino experts that identifies which medicines and drugs the government may use and procure – never recommended mass use of Dengvaxia.

      “FEC, yes, they are experts in their own fields. But during that time, but even until now, in aid of legislation, your honor, tingnan po natin ang palagi pong paulit-ulit na conflict between FEC and the Department of Health. Dahil doon po sa batas nakasaad na dapat ang FEC pinapatawag ang departamento, ang mga internal and external experts,” said Garin.

      (FEC, yes, they are experts in their own fields. But during that time, since this is an investigation in aid of legislation, let’s look at the longtime conflict between the FEC and the Department of Health. Because the law states the FEC must call for the department as well as internal and external experts.)

      She said she had consulted other experts including DOH’s own program directors as well as Philippine Society for Microbiology and Infectious Diseases and Philippine Pediatric Society Incorporated, which advised her it would be safe to use Dengvaxia in the national immunization program.

      “Ang tiningnan po namin, hindi lang po ‘yong proteksiyon na 65.5% (We checked not just the protection rate 65.5%), but what was very important for us was the 80.8% reduction in hospitalization and the 90.2% reduction in severity,” said Garin.

      She said it “wasn’t true” that the vaccine’s safety and efficacy was being questioned, arguing that the Food and Drug Administration will not approve Dengvaxia’s sale in the country had it been otherwise.

      But the FEC members were not sold on the safety, efficacy, and cost-effectiveness of Dengvaxia when they met on January 7 and 25, 2016, and on February 1, 2016.

      Created by then President Fidel Ramos through Executive Order 49, the FEC is mandated to determine which drugs should be part of the National Formulary, a list of drugs that the government can buy and use..

      http://cnnphilippines.com/news/2017/12/06/DOH-more-than-800000-children-vaccinated-with-dengvaxia.html

      The 800,000-plus figure is an increase from the 733,000 individuals, mostly children from Metro Manila, Region 3, and Region 4 whom the health department said were immunized with Dengvaxia, under a program that cost the government P3.5 billion (US$ 70 million) for the vaccines alone.

      Earlier, the Health Department in Region 7 or Central Visayas said there are about 159,766 children that were given Dengvaxia in Cebu. It is unclear if the 159,766 children in Cebu are part of the 800,000 figure cited by Bayugo.

    • https://www.rappler.com/science-nature/life-health/122061-dengue-vaccine-available-philippines (February 11, 2016)

      Citing a local study done by a professor at the University of San Carlos in Cebu City, Dr Rose Capeding of the Research Institute of Tropical Medicine said the total annual disease cost of dengue was estimated at P16.7 billion.

      Although Santos refused to disclose the price of the vaccine, medical experts assured the public it will be “affordable and reasonable.”

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