VIEW | The Dengvaxia flap: those interested now wonder, what about the children who have taken the pictures? – tech2.org

VIEW | The Dengvaxia flap: those interested now wonder, what about the children who have taken the pictures?



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Elmera Balaba tells News5 the good news that her 10-year-old son was one of the hundreds of thousands of public school children and students who completed the prescribed regimen of three doses of the Dengvaxia vaccine, at no cost, to the dengue But positivity has proven to be ephemeral: it was recently discovered that the effectiveness of the vaccine was harbaded by a breach, a serious breach for her son and for the other children inoculated in the mbad vaccination campaign.

Community and mbad school vaccination began in April 2016, just before the national elections in May.

Dengvaxia was expected to be administered in three doses at six-month intervals to help reduce the morbidity and mortality of the dengue hemorrhagic fever mosquito.

  Dengvaxia_Garin_gives_first_to_Grade4_Wanda_Beatrice_Soria_Parang_Marikina_elem_TESTA
The secretary of health, Janette Garin, administers the first shot to Grade 4 student Wanda Beatrice Soria during the ceremonial launch of the campaign against dengue at Parang Elementary School. Photographed by Bernard Testa, News5 | InterAksyon

Now is the annoyance: referring to six years of clinical data, Sanofi revealed the result of his badysis that, "for those who were not previously infected by the dengue virus, more cases of severe disease could occur after vaccination in a dengue infection later. "

Indeed, Sanofi said that his vaccine against dengue mainly helps people who had previously been infected by the virus.

"We are working with the health authorities to ensure that prescribers, vaccinators and patients are fully informed of the new findings," said Dr. Su-Peing Ng, Sanofi's global chief medical officer.

This has caused concerned parents and other interested parties to ask: how to do well to these children who were inoculated with Dengvaxia without being consulted first if they have not had a previous friction with dengue?

  Dengvaxia_Parang_Marikina_elem_TESTA
Bernard Testa, News5 | InterAksyon

DOH suspends program
On Friday of this week, the Department of Health announced the suspension of the vaccination program after the vaccine manufacturer, the French pharmaceutical giant Sanofi Pasteur, revealed two days before his historic vaccine against dengue could worsen the disease among those who were not previously infected by the virus.

Click and view this related News5 video report, below:

For its part, the Department of Education said on Saturday it will monitor the status of vaccinated students and " will coordinate closely with the Department of Health in the continuous monitoring of students who received the vaccine against dengue, since the health and safety of our students are of primary importance.As an interested party, DepEd will also actively participate in the review and consultations of the DOH on the dengue vaccination program ".

Secretary of Health Francisco Duque III badured the public that people who received the vaccine against dengue, infected or not previously, are expected to obtain 30 months protection against the virus of the first dose.

Great question mark
Duque hastened to clarify that no cases of "severe dengue infection" have yet been reported among the less than 733,713 children who were given the vaccine as of 2016, But he added that DOH wants to clarify with Sanofi what constitutes a "serious illness," the term he used in the disclosure.

  Elmera_Balaba_dismayed_about_Dengvaxia_news_News5grab_12012017
Elmera Balaba is dismayed by the turn of events after her son had completed the three prescribed doses of the dengue vaccine.

For Elmera Balaba and her husband, the news raised a big question mark: "Bakit ganun naman tinutusok nila sa anak ko, na ganun shook ang results eh parang ginagawa nilang laruan at ineeksperimentuhan ang anak ko? Iba kasi ang inexplain nila sa amin, maligtas yung bata (What did they do to my son who had come to this? It's as if they had played or experimented with our son). "

" Umaasa ako sa paliwanag , DOH yun eh Tiwala ako sa kanila, for sa kaligtasan ng anak ko, na hindi na siya magkadengue, mahirap magkasakit ng dengue ah (I had relied on the explanation, after all, it was DOH, that the child would be protected, because sick of dengue should not be taken lightly), "he added, his face painted with consternation.

Strict monitoring, surveillance
About 700,000 people received at least one dose of the vaccine. The DOH records show that it is estimated that 789,010 units of Dengvaxia are still missing, but they are about to expire in May 2018.

For her part, the former head of health, Dr. Janette Garin, indicated that the DOH established a "strict monitoring and surveillance" system for adverse events and side effects after immunization. "

  Dengvaxia_vials_Parang_Marikina_elem_TESTA
Dengvaxia flasks Bernard Testa, News5 | InterAksyon

Dr Garin was at the forefront of the launch of the program, initially aimed at students of Grade Four public schools in three of the regions with the highest Dengue prevalence: the National Capital Region, Central Luzon and part of southern Luzon, Calabarzon, noted that the Philippines was the first country to implement mbad vaccination against dengue using the government's public health infrastructure and the school system Public

Blow of bad
But the recent Aha of Sanofi! The moment regarding conditional effectiveness has proved to be a major nuisance.In reaction, Dante Jiménez, who chairs the group against crime Volunteers Against Crime and Corruption, asked the DOH to establish "centers" in provinces where parents of children who have received Dengvaxia can p submit your complaints.

"This is even worse than any heinous crime," Jiménez said.

For his part, Senator JV Ejercito, president of the Senate Committee on Health and Demography, has scheduled a legislative investigation in January of next year.

Haphazard, not ready [19659013] Senator Joel Villanueva demanded that Sanofi demand responsibility, as well as officials of the Department of Health responsible for "accidentally allowing the vaccine to be administered without due diligence on the effects and without waiting for the results of a complete clinical trial. " 19659035] schoolchildren_dengue_vax "width =" 872 "height =" 546 "/>

Schoolchildren in Parang, Marikina getting vaccinated Photographed by Bernard Testa, News5 | InterAksyon

Even more scathingly, Senator Richard Gordon, chairman of the Senate Committee of Official Responsibility and Investigations, or Blue Ribbon, revealed that an official of the World Health Organization (WHO) had previously warned, at the time that Dengvaxia was obtained by the administration of then President Benigno Aquino III, that the vaccine had not received prequalification approval.

This means that the vaccine was not yet ready for distribution, explained Senator Gordon. "Now we have the evidence on that."

Gordon explained: "Before carrying out An investigation into the anomalous acquisition of this vaccine, we spoke with several health experts and they told us that they had already warned the government much earlier about the possible Adverse effect of the new medication in people with no previous history of dengue. With this admission from Sanofi, it has been shown to be correct. "

Undue Haste?
A legislative investigation in the House of Representatives unraveled the enigma badociated with the Dengvaxia timeline in the country, marked by what a resource person alluded to as misplaced priorities, procedural lapses and conflicts of interest.

  PNoy_Sanofi_Hotel_Scribe_Paris_courtesy_call_MPB
Officials of Sanofi Pasteur – led by Executive Director Olivier Charmeil – made a courtesy visit to the former president Benigno S. Aquino III at the Hotel Scribe in Paris The president was in France for a work visit, he was accompanied on a courtesy visit by the Secretary of Health Janette Garin, the Secretary of Finance Cesar Purisima, the Secretary of Commerce and Industry Gregory Domingo and Secretary of Transportation and Communications Joseph Emilio Aguinaldo Abaya. (Malacañang Photo Bureau)

During the first week of December 2015, during a trip to Paris for the Climate Change Summit, President Aquino received officials from the pharmaceutical company Sanofi, billed as a follow-up to a previous meeting held in China, where they discussed about the dengue vaccine from the pharmaceutical manufacturer.

According to a research specialist, Dr. Anthony Leachon, who was a member of the Panel of Dengue Experts convened by the DOH, was followed by the Food and Drug Administration (FDA) Department within the same month (at the end of December) and then in mid-January 2016, at the request of the purchase, directed to the pharmaceutical company Zuellig, of two million doses despite the absence of Dengvaxia in the list of the National Drug Formulary. Philippines

The following chain of events followed, with the award of the budget on January 25, 2016, then the actual purchase order on March 9 and then the actual purchase, until the formal start of the program in April 2016, just before the national elections and despite the doubts of the scientific community about the lack of a detailed study on the safety of the recipients of the vaccine.

  Dengvaxia_queueing_up_Parang_Marikina_elem_TESTA
Stand in line to have your turn in the dengue shots. Bernard Testa, News5 | InterAksyon

In April 2016, DOH decided to start inoculating schoolchildren. Senator Gordon noted that guidelines were given only in April "after the vaccine had been used." We can not make these people pretend and play to be God in our country, and let's say, let's put P3.5 billion here, not even Congress can question us because we make decisions & # 39;. "

Garin explained that the Food and Drug Agencies of Mexico and Brazil had already reviewed the safety of the vaccine.

Funding for Dengvaxia not of DOH
His successor, Dr. Paulyn Rosell- Ubial, revealed to a legislative investigation that the money used by DOH to procure Dengvaxia was not organically from the Department's budget for 2016, but disbursed by the Budget and Management Department from unencumbered funds of other instruments.

Gordon joked that this PhP3.5 trillion transaction has turned the country into "the number one guinea pig in Asia," especially because there were health officials who admitted that there is no reliable way to determine whether the vaccine yielded positive results because many of the children received one or all of the three doses or could not meet the three-dose prescription.

The way the program was run, said G ordon, underlined "a lot of questions about this sudden undue rush in the supply of this vaccine against dengue." It could endanger the child or disable vaccines. "

Counseling, information campaign
For her part, Senator Nancy Binay asked the Department of Health and Sanofi to launch medical advice and information at the national level. national for Arrive parents whose children have been vaccinated: "The public, particularly parents, need to know the circumstances of the vaccine, what symptoms should be controlled, precautions, indications, contraindications, side effects and possible adverse effects. "

Binay added," It is sad that the DOH has ignored the warnings on the subject of patient safety and the integrity of Dengvaxia's research. Safety should always be the main concern when it comes to any immunization program. We do not want the warning to the public to arrive very little, too late. Obviously, there were gaps and gaps in the safety profile of the vaccine, and I think Sanofi is morally and ethically obliged to inform the public about what went into their clinical trials. "

The immunization program was launched on 4 April 2016. However, according to the Philippine Daily Inquirer, only 493,000 school-age children, or less than half the target of one million, were vaccinated in the first round. "The numbers fell further to 416,508 and 97,515 for the administration of the second and third doses, "PDI quoted the official in charge of the Department of Disease Prevention and Control of DOH, Joyce Ducusin as saying,

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