Dengue Vaccine: A Clear Example of Why it Must be the Parent’s Choice

Updated: March 15, 2018

Sanofi will decide shortly whether to seek regulatory approval for its dengue vaccine Dengvaxia in the United States and remains committed to the medicine despite a health scare in the Philippines, a senior executive said on Wednesday.” – Reuters 3/8/2018

If you follow the (below) chronology of the Philippines’ dengue vaccine fiasco, in which the drug maker (Sanofi) rushed to market to be first, convinced top level government officials to buy the product, and then 800,000 Filipino schoolchildren were injected, and 14 died, you will see in front of you a clear example of why vaccines should NEVER be mandatory for school.

These tragic circumstances are precisely why philosophical vaccine exemptions were enacted into state immunization laws in the first place, and should be protected at all costs.

The whole situation, as one Steemit contributor wrote, is “damning condemnation and a horrifyingly cautionary tale about how greed, ambition and hubris can lead to catastrophic tragedies.”

The government and the drug maker deny any connection.

As with all other vaccines, the risks associated with Denvaxia were fairly known, if not scientifically well understood, before launch – and since vaccine is an artificial intrusion into the immune system all of them are “unavoidably unsafe” to some extent.

Sanofi predicts to lose 100 million euro – peanuts for them. What of the children given the vaccine which was produced in Vero cells using recombinant DNA technology (genetic engineering)? Vero cells are a “continuous” line of green monkey cells.

 In mass vaccination programs, the sad fact is that some children will be sickened and die from the product. The medical-pharmaceutical industry takes this as cost of doing business, but never factors these losses in to the cost effectiveness calculations they present. Parents everywhere should always have the choice and never be faced with loss of their child’s institutional education if they decide not to take the risk.

As a side-note: Unwitting Vermont volunteers were compensated $3000 so their bodies could be used for the UVM vaccine research trial. I wonder how they all are doing?

~Jennifer Stella

 

 

Dengue Vaccine News Chronology –  2013 through 2018

Jan 22, 2018 – Former Health Secretary Enrique Ona faced the Senate blue ribbon committee for the first time on Monday, January 22, where he slammed the Aquino administration’s implementation of the now-controversial P3.5-billion dengue vaccination program. https://911ph.com/2018/01/22/ex-doh-chief-ona-says-he-would-not-have-okd-dengue-vaccine/

First they said it looked like measles, now they ask… Does immunity after Zika virus infection cross-protect against dengue?

Jan 24, 2018 – Shocker:: After deaths, illness & #disease from their dengue vaccine in the Philippines, drug maker presents “cost effectiveness” conclusion~!! https://www.sciencedirect.com/science/article/pii/S0264410X17316638

Jan 22, 2018

Ex-DOH chief Ona says he would not have OK’d dengue vaccine

Jan 18, 2018 – 5 more deaths linked to Dengvaxia for referral to UP-PGH http://northboundasia.com/2018/01/18/5-deaths-linked-dengvaxia-referral-pgh/

Jan 17, 2018 – Sanofi agrees refund for unused ‘killer’ anti-dengue vaccine: The French pharmaceutical giant denied the refund was related to safety issues, but was instead meant to improve ties with Philippine health authorities. http://nismagazine.com/2018/01/17/sanofi-agrees-refund-for-unused-killer-anti-dengue-vaccine.html

Jan 16, 2018 – “The findings of the forensic pathologists are consistent with severe dengue or dengue shock syndrome” https://www.rappler.com/nation/193439-philippines-deaths-vaccine-row-consistent-dengue

Jan 1, 2018 –  Was Aquino’s P3.5B purchase of the dengue vaccine the worst case of corruption ever? 

 http://www.manilatimes.net/aquinos-p3-5b-purchase-dengue-vaccine-worst-case-corruption-ever/367353/

Jan 11, 2018
MANILA – Public Attorney’s Office (PAO) probes death of 6th child dead after newly launched dengue vaccine http://news.abs-cbn.com/news/01/11/18/pao-probes-death-of-5th-child-who-received-dengue-vaccine

Jan 1, 2018
DOH to check on reported Denvaxia dengue vaccine deaths” – Dec 21, 2017… 

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

Jan 1, 2018 


- Worst of 2017: Sanofi’s Dengue vaccine launch turns into nightmare; stock prices plunge, Takeda now… 

https://pharmaphorum.com/news/sanofis-dengue-vaccine-triumph-turns-nightmare/

Dec 23, 2017 
- “Forensic team examines body of girl vaccinated with Dengvaxia” https://newsinfo.inquirer.net/954425/forensic-examination-pao-dengvaxia-dengue-vaccine-anjielica-pestilos

Dec 23, 2017 – Bataan girl died of dengue after vaccination: VACC http://news.abs-cbn.com/news/12/07/17/bataan-girl-died-of-dengue-after-vaccination-vacc

Dec 7, 2017 – Father seeks justice for daughter who died of dengue 6 months after Dengvaxia shot | News | GMA News Online http://www.gmanetwork.com/news/news/nation/635711/father-of-student-who-died-after-getting-dengvaxia-shot-wants-justice/story/#undefined.gbpl.uxfs.uxfs

Dec 27, 2016 – Meanwhile, in the Philippines…Senate probes dengue vaccine program… 

http://cnnphilippines.com/news/2016/12/07/senate-probes-dengue-vaccine-program.html

Apr 27, 2016 – Dengue vaccine trial in Philippines: one coincidental death out of 200,000 

http://outbreaknewstoday.com/philippines-dengue-vaccine-update-200000-kids-vaccinated-362-adverse-events-details-on-child-death-28455/

Apr 5, 2016 – Safety of dengue vaccine questionable, schoolchildren serve as guinea pigs https://web.archive.org/web/20160917091555/http://interaksyon.com:80/article/126028/who-stays-out-of-dengue-vaccine-controversy
(this one has been taken down but thanks to the internet archive you can still read it.)

Mar 22, 2016 – There is a “clinical similarity and serological cross reactivity of dengue fever and measles”? You don’t say…… https://academic.oup.com/jtm/article/19/4/268/1816028

Feb 11, 2016 – “Crop-Sprayed Villages regarding Dengue-Zika, microcephaly…” http://www.reduas.com.ar/wp-content/uploads/downloads/2016/02/Informe-Zika-de-Reduas_TRAD.pdf

Jan 21, 2016 – Dengue vaccine only gives patients 47% protection… http://www.freemalaysiatoday.com/category/nation/2016/01/21/dengue-vaccine-only-gives-patients-47-protection/

Jan 14, 2016 – More


 dengue vaccines: aluminum, novel adjuvants, GMOS, what could possibly go wrong?… http://www.denguevaccines.org/subunit-and-inactivated-vaccines/
‬

Jan 6, 2016 – More


 than 1 million nine-year-old Filipino children to become part of dengue vaccine experiment ‪#CDCwhistleblower…

http://thepinoy.net/?p=10557

Dec 23, 2015 – Sanofi gets green light from Philippines FDA 
http://www.moneycontrol.com/news/business/companies/sanofi-gets-philippines-approval-to-market-dengue-vaccine-1054775.html?classic=true

Jul 16, 2014 – “We cannot solve the dengue problem with a vaccine alone, especially not with this vaccine…” http://www.dw.com/en/experts-see-flaws-in-promising-dengue-fever-vaccine-candidate/a-17789632?maca=en-rss-en-all-1573-rdf

Sept 8, 2016 – Dengue vaccine could make things worse: ‘We should be careful in considering where and how to use this vaccine’ http://outbreaknewstoday.com/dengue-vaccine-could-make-things-worse-we-should-be-careful-in-considering-where-and-how-to-use-this-vaccine-24652/

Dec 22, 2015 – Vaccine: Not good enough for Singapore (2014)…

http://www.straitstimes.com/singapore/health/new-dengue-vaccine-not-effective-enough-for-singapore-vivian-balakrishnan

Nov 24, 2014 – Clinical similarity and serological cross reactivity of dengue fever and measles -… https://www.ncbi.nlm.nih.gov/pubmed/22776393

Jul 16, 2014 – Vaccine “not equally good for all four subtypes of dengue viruses, and that could be dangerous.”… http://www.dw.com/en/experts-see-flaws-in-promising-dengue-fever-vaccine-candidate/a-17789632?maca=en-rss-en-all-1573-rdf

Mar 25, 2014 – Sanofi bets big on dengue vaccine despite poor performance…. https://seekingalpha.com/news/1643013-sanofi-bets-big-on-dengue-vaccine?isDirectRoadblock=false

Oct 18, 2013 – More newsflash: Did you know that clinical signs and symptoms of dengue are similar to those of measles…?… https://www.ncbi.nlm.nih.gov/pubmed/1486671

Aug 12, 2013 – Someone asked what UVM is offering for that immune system experiment / dengue vaccine trial. Here is your answer: $3000 (see pic above).

Aug 4, 2013 – Blockbuster Sanofi Dengue Vaccine Marketing Begins:… https://www.bloomberg.com/news/articles/2013-08-04/sanofi-dengue-bid-seen-as-2-6-billion-hit-or-major-flop

July 12, 2013 – I suspect that dengue is about to become *more* widespread, *more* deadly, and *vaccine preventable*… https://in.reuters.com/article/us-sanofi-dengue-vaccine/sanofi-starts-dengue-vaccine-production-to-keep-lead-over-rivals-idINBRE96B0D120130712

June 22, 2013 – Vaccine Maker Sanofi is in full Pre-Launch phase of Marketing Campaign for Dengue Vaccine… https://www.pharmaasia.com/2013/06/sanofi-pasteur-supports-3rd-asean-dengue-day/3/

March 5, 2013 – Have you heard anything about the vaccine for dengue fever being tested here in VT? Based on quick research, it is a trial for a vaccine to be used for “biodefense” http://globalbiodefense.com/2012/11/28/army-dengue-vaccine-trial-supported-by-state-university-of-new-york/; (which may mean they may be willing to tolerate a higher rate of adverse reactions). The vaccine was developed at NIH and began phase I in 2010.

Another news release here, from 2013, mentions VT…

Here is the public statement from UVM.… and here are the “protocols” for all of the Vermont trials, which leave out details like adjuvant, placebo, etc.

December 1, 2017

Philippines Suspends Dengue Shots After Drug Firm’s Warning

The New York Times Reports:

MANILA — The Philippines suspended its school-based dengue immunization program on Friday after the French pharmaceutical giant Sanofi warned that its flagship vaccine, Dengvaxia, had been found to pose health risks in people not previously infected.

The suspension came after health experts expressed worries about Sanofi’s announcement this week.

The company said further clinical studies had revealed that, in those who had previously had dengue, the vaccine could prevent repeat infection. But for those who had not had dengue, and were vaccinated and later became infected, “more cases of severe disease could occur,” Sanofi said in the advisory.

With more than 740,000 elementary school students in the Philippines having already received Dengvaxia vaccinations, the government decided to halt the program for the time being.

The Philippine health secretary, Francisco Duque, said the program would be “on hold while review consultations are on the way.” He added that the government would seek help from medical experts outside the Philippines, including from the World Health Organization.

Dengue is the most widespread mosquito-borne disease in the world, with nearly 400 million people infected every year. There are four dengue viruses, or serotypes, and most people who are infected recover and become immune to the first serotype they had. In some cases, a later infection with a different serotype can lead to a severe hemorrhagic fever. About 25,000 people die every year from hemorrhagic fevers arising from the disease.

Mr. Duque said that, with an average of 200,000 people infected with dengue every year in the Philippines, vaccination was “essential.” He said that the Department of Health would be stepping up its monitoring efforts to ensure public safety and that the department’s legal division was studying what to do with the Sanofi contract and how to deal with the hundreds of thousands of children who may have been put at risk.

Mr. Duque said that government officials had been asked to coordinate with community health experts to identify and monitor the children. He said a post-vaccination surveillance program would last for five years.

“I hope that this development will not in any way affect the expanded program of immunization because there are countless number of lives that have been saved,” Mr. Duque said, adding that 7 billion Philippine pesos, or about $140 million, had been budgeted for all government vaccination programs for the year, up from 340 million pesos in 2006.

He would not say when the program was likely to be restarted or what steps would be necessary to allow resumption.

“We need to go back quite a long way to really put the facts together,” Mr. Duque said. “Until that is available, we can’t answer all your questions with definitive responses.”

He said the vaccines that were now in stock would not be allowed to be sold unless the labels were changed to reflect the latest advisory.

Photo

 
Sanofi, manufacturer of Dengvaxia, said the drug posed a risk to people who had not previously been infected. CreditNoel Celis/Agence France-Presse — Getty Images 

Sanofi representatives in Manila were not immediately available to comment on Friday.

The Philippines became the first country in Asia to approve the commercial sale of Dengvaxia, in December 2015. Dengvaxia is the first dengue vaccine developed by Sanofi.

Health advocates in the Philippines first raised the alarm over Dengvaxia when the government announced in April last year that it would be used in the school immunization program despite the fact that it was a relatively new drug with possible unknown effects. But the government continued, budgeting about $70 million for the program.

The government has defended its use of the vaccine, saying that the treatment had undergone extensive studies and stressing that it was approved for use by the World Health Organization. The first hint that there could be something wrong was in April last year, when an 11-year-old boy with congenital heart disease died after receiving a Dengvaxia shot, but the government worked to distance the drug from the death.

Nancy Binay, a legislator in the Philippine Senate, said she was alarmed at the drug’s potential impact on public health and urged the health authorities and Sanofi to “launch a nationwide medical advisory and information drive” to contact parents whose children had been given Dengvaxia.

The recently released Sanofi medical report was “deeply shocking and disturbing,” Senator Binay said.

She said it was “sad” that the health department ignored the warnings about the lack of patient safety and research integrity in the Dengvaxia tests. “Safety should always be the paramount concern when it comes to any immunization program,” she said.

Senator Binay called on the pharmaceutical giant to explain what it meant when it warned of “severe disease.”

“We don’t want the warning to the public to come too little, too late,” she said. “Obviously, there were shortfalls and gaps in the vaccine’s safety profile, and I believe Sanofi is morally and ethically obliged to inform the public what severe diseases came out in their clinical tests.”

Dr. Anthony Leachon, an independent director at PhilHealth, a government medical insurance body, said the Philippine medical community had expressed alarm at the government’s use of the vaccine.

He said that as early as last year medical experts had told the government that there was “lingering uncertainty” about the long-term effects of the vaccine, but that their concerns had apparently been ignored.

“Evidence from manufacturer’s trials shows that there may be a paradoxical increase in the incidence of severe dengue beginning a few years after children are vaccinated, and possibly continuing for the rest of their lives,” Dr. Leachon said.

The clinical trials on the dengue vaccine were designed specifically to assess this “and sadly, this danger has been confirmed,” he said.

“Many parents, teachers and health care workers claim they were never fully informed about the benefits and potential side effects of the vaccine,” Dr. Leachon added.