Managing Dengvaxia Miscommunication Through Risk

Managing Dengvaxia

Miscommunication

Through Risk

Management Plan by Via Zareena Bulda and Naomi Maraviles National Change Organization

LETTER OF TRANSMITTAL

Via Zareena Bulda Block 18 Lot 54 Willow Street, Antel Grand Village, Bacao 2, General Trias, Cavite 4107

Dr. Francisco Duque III Department of Health Secretary San Lazaro Compound, Tayuman, Sta. Cruz, Manila, Philippines 1003

March 3, 2018

Dear Dr. Francisco Duque III,

Attached to this letter is a report for the risk management development plan for the Dengvaxia controversy. The report is based on the findings and an overall report produced by the National Change Organization.

The communication plan solely focused on giving alternative solutions to the victims of the Dengvaxia, by producing paper materials to be disseminated nationwide like brochures, leaflets, and posters containing general information, frequently asked questions, and contact details. The organization also aims to propose a partnership with the government to conduct seminars and require a task force in all hospitals, both public and private, to help and attend to the needs of the victims.

After a thorough observation and investigation, the National Change Organization assures that the communication plan can help and guide the victims.

If you have any questions or want to discuss this matter further, we can be reached at the above addresses, at (0955) 915 0366 and (0905) 511 3919, or at [email protected] and [email protected].

Sincerely,

Via Zareena Bulda

Abstract This report focuses on informing the readers about the general information about Sanofi Pasteur, one of the largest companies in the world that specialize in vaccines; Dengvaxia, the anti-dengue vaccine that was created to save millions of lives; and alternative solutions that the National Change Organization came up with to address the issues related to Dengvaxia in the Philippines. Sanofi Pasteur was able to complete the necessary stages before being able to distribute the vaccines to 11 countries which are the Philippines, Mexico, Brazil, El Salvador, Costa Rica, Paraguay, Guatemala, Peru, Indonesia, Thailand, and Singapore. Months after the distribution, a paper by the World Health Organization was released and they ordered that governments should further look into the possible effects of Dengvaxia because it may be ineffective and unsafe to individuals who have never had dengue. Months after the Department of Health’s school-based immunization program, up to 40 cases of children’s deaths have been linked to Dengvaxia. The Senate has filed cases against the government officials who were involved in the implementation of the program, and they are under investigation. This caused confusion amongst the public and mistrust towards the government. The National Change Organization offers alternative solutions to resolve the controversy, which include dissemination of paper materials nationwide such as brochures, posters, and leaflets, social media platforms for announcements, possible partnership with the government to be able to conduct seminars and forums, and partnership with public and private hospitals nationwide to have a task force that will address the concerns of the vaccinated individuals.

List of Figures

Figure 1: Distribution of Global Dengue Risk ...... 13 Figure 2: Overview of Sanofi Pasteur ...... 14

Table of Contents Letter of Transmittal ...... 2 Abstract ...... 3 List of Tables ...... 4 Executive Summary ...... 6 National Change Organization ...... 6 Business Mission ...... 6 Business Goals and Objectives ...... 6 Introduction to the Report ...... 7 About Dengvaxia ...... 7 Statement of the Problem ...... 9 Significance ...... 10 Scope and Limitations ...... 10 Purpose ...... 10 Objectives ...... 11 Introduction to Dengvaxia ...... 12 Dengue Fever ...... 12 Dengvaxia Vaccine ...... 12 Timeline ...... 14 Related Events ...... 17 Effects of Dengvaxia Vaccine ...... 19 Incidents ...... 19 Effects and Impacts ...... 20 National Change Organization’s Risk Management Plan ...... 21 Risk Management Plan Goals and Objectives ...... 21 Mitigation of Problem ...... 22 Strategies ...... 22 Attainability ...... 23 Benefits of the Dengvaxia Risk Management Plan ...... 23 Conclusion ...... 24 Conclusion ...... 24 Recommendations ...... 25 Appendices ...... 27 List of Sources ...... 28

EXECUTIVE SUMMARY

NATIONAL CHANGE ORGANIZATION National Change Organization, widely known as the NCO, is one of the top non-profit organizations in the Philippines. Established last January 1, 2018, the organization continues to grow up to this day with the expectation of rapid expansion in the risk communication industry.

Formed by Via Zareena Bulda and Naomi Joy Maraviles, BS Technical Communication graduates of Mapua University, in hopes of making relevant changes in the country. NCO aims to serve, help, and reach out to the needs of the people of the Republic of the Philippines by providing alternative solutions to resolve countless issues and controversies.

Business Mission One of the organization’s biggest achievements is that they were already able to provide alternative solutions, in partnership with the city of Manila, to reduce poverty in the urban areas.

New Services The organization is beyond prepared to introduce their alternative solutions to resolve the Dengvaxia controversy:

Paper Materials: NCO will be designing and disseminating leaflets, brochures, and posters nationwide that contains general information, frequently asked questions about Dengvaxia, and contact details that vary depending on location.

Seminars and Forums: NCO will collaborate with the government to conduct seminars, entitled “Magandang Kalusugan Para sa Magandang Kinabukasan,” and forums that will open opportunities for a thorough face-to-face interaction.

Dengvaxia Task Force/Groups: NCO will propose a partnership with the government and hospitals, both public and private, for the implementation of task groups that will help the patients with illnesses linked to Dengvaxia.

Disease/post marketing Surveillance System: NCO will encourage the government to implement this system that will analyze and observe a drug and vaccine for the succeeding months after licensure.

Business Goals and Objectives Short-Term Goals: To provide quality service to the Filipino people. Long-term Goals: To consistently provide help and alternative solutions to resolve national issues.

INTRODUCTION TO THE REPORT

About Dengvaxia

One of the biggest issues in the Philippines today is the

severity of the effects of Dengvaxia to the youth that have

never been diagnosed with dengue in the past. Dengvaxia was Dengvaxia is manufactured by created by Sanofi Pasteur, a French company, and they Sanofi Pasteur distributed the said vaccine all around the world, especially

those within the areas with a high number of dengue cases—in

hopes of saving millions of lives. It was first registered in

Mexico last December 2015.

Dengvaxia, also known as the CYD-TDV, is a live Dengvaxia, also known as the CYD- recombinant tetravalent dengue vaccine that has been evaluated TDV, is a live recombinant as a 3-dose series on a 0-6-12 month schedule in Phase III tetravalent dengue clinical studies. It has been registered for use in individuals 9- vaccine 45 years of age living in endemic areas (WHO, 2017). Dengue,

on the other hand, is a mosquito-borne flavivirus disease that Dengue is mosquito-borned has spread to most tropical and many subtropical areas (WHO, disease prevalent in tropical areas 2017).

In the Philippine setting, the dengvaxia issue created

7 quite a stir, for victims included public school(s) students, young children, and adolescents. Most victims were shot free (provided by the government), meanwhile, some were asked to pay for the vaccine by their own doctors. Months after they were vaccinated, a lot of reports came to the attention of the government, stating that the said vaccine had a lot of side effects especially to those who were not diagnosed with dengue in the past.

It started the year 2014 when former president Benigno Aquino III started meeting with

Jean-Luc Lowinski, the Sanofi Pasteur Vice President in Asia, in Beijing, China. The government then negotiated with the company and bought 3.5-billion Philippine peso worth of vaccines (CNN, 2018). As of 2018, the Public Attorney’s Office (PAO) has filed cases against former Health Secretary Janette Garin, former Undersecretary Kenneth Uy, and other health officials for not reassuring the level of safety and efficacy of the vaccines. Senate Blue Ribbon committee chair Richard Gordon has also suggested filing a case against Aquino and former government officials (CNN, 2018).

In a statement by Sanofi Pasteur (CNN, 2018), of the 800,000 students that were injected with the Dengvaxia vaccine, 10% are experiencing severe illness. These children that are having diseases have no recorded history of ever having former dengue infection. According to a press release by Sanofi Pasteur (2017), the manufacturer of Dengvaxia, the vaccine has different effects on patients based on prior dengue infection. Furthermore, the press release centers on the long-term effectiveness and safety of the vaccine to patients considering whether they have had past dengue infection. The company discovered that for those who had dengue before, the vaccine continues to be beneficial for the protection against dengue fever (Sanofi, 2017).

However, severe illness is anticipated for those patients that were not previously infected with dengue (Sanofi, 2017).

The issue regarding Dengvaxia stems from the failed communication between the

Philippine government agencies and (1) the manufacturer, and (2) the Filipino citizens that were immunized with the vaccine, which caused a panic. The alarm was not contained and was further generated when the previous and present administration in the Philippines shifted the blame to one another (CNN, 2018). The current administration accusing Aquino’s administration for rushing the purchase of the vaccines that led to not having all the information regarding the product (Cupin, 2018). The Philippine government is also claiming that Sanofi Pasteur did not disclose all the necessary information, especially the risks, to them and the public, which the pharmaceutical company denied (Santos, 2018). Moreover, there was an evident misinformation to the public about the vaccine (Cupin, 2018).

Nation Change Organization (NCO), striving to resolve this miscommunication, produced a communication plan with local and national government partnership. This partnership will hold campaigns and seminars in barangay communities that will educate the public, especially the families that were immunized with Dengvaxia. Furthermore, NCO will collaborate with public and private hospitals, such as Philippine General Hospital (PGH) and

Philippine Children's Medical Center (PCMC), for the implementation of task groups that will entertain and help those patients with illness linked to Dengvaxia.

Statement of the Problem

Public school students were required to be vaccinated by a dengue vaccine that was meant to save lives--the Dengvaxia vaccine. They will be given shots on a 0-6-12 month schedule, but months after, instead of seeing improvements and positive effects, the vaccines placed the lives of the victims in great danger and risk. National Change Organization aims to help the victims by guiding them on what to do, where to go, and who to look for whenever they

9 want to. With the help of our government, NCO also aims to well-inform the public, victims and non-victims, on how to know if a vaccine (or a medicine, in some cases) is safe or not.

Significance

The Dengvaxia controversy is one of the biggest issues in the society for months after the victims were vaccinated, they were only able to find out the side effects and the limitations of the vaccine. A thorough investigation and series of tests were not done by the government, and it is causing panic among the public and distrust towards the government.

Scope and Limitations

This report focuses on the Dengvaxia controversy within the Philippines. The other ten countries that were distributed with the Dengvaxia vaccine by Sanofi Pasteur are briefly discussed but are not included in the recommendation of this report because: (1) there were no reports of problems encountered with the vaccines, and (2) these countries have different laws and procedures in their society compared to the Philippines. The audience for this report is the

Filipinos that were injected with Dengvaxia, regardless of age. Furthermore, this report only focuses on one vaccine, which is Dengvaxia. Therefore, the recommendations of this report is not applicable to other vaccines that were withdrawn from distribution or encountered the same problems.

Purpose

This report intents to provide a detailed information regarding the Dengvaxia vaccine and ways to mitigate the problem. Moreover, the purpose of this report is to motivate the government into doing campaigns that are more approachable that will reach a wider audience. The risk management plan presented will provide the government – both local and national – with information on how to effectively implement seminars that will help those citizens that were

10 affected. The people that were injected with the vaccine, and their families, will benefit from this because they will be educated on every information that they need to know about the situation.

Ultimately, this report will help contain the panic and alleviate the citizens’ uncertainties about the vaccine.

Objectives

National Change Organization aims to reach out to, help, and educate the victims of

Dengvaxia by proposing a partnership with the government to conduct seminars on how to handle the issue and to require both public and private hospitals nationwide to help the

Dengvaxia victims. NCO will be giving out brochures and leaflets containing general information about the vaccine and contact details of the nearest hospitals (within particular areas), government, and non-government organization(s). Furthermore, the organization encourages the government and public hospitals to implement a task group that will help and prioritize patients that are immunized with Dengvaxia, and implement a disease surveillance system.

INTRODUCTION TO DENGVAXIA

Dengue Fever

Dengue virus causes mosquito-borne disease mostly in

390 million people tropical countries. According to the World Health Organization are infected with (2017), an estimate of 390 million people are infected with the said dengue fever virus each year. Furthermore, for more than 128 countries, WHO

added that 3.9 billion people are at risk of getting the disease.

Symptoms of dengue may include severe headache, muscle and joint pain, high fever, vomiting, and possibilites of skin rashes and Symptoms of bleeding complications. The threat of dengue can complicate even dengue may include severe more and develop to a dengue hemorrhagic fever and dengue shock headache, muscle and joint pain, high syndrome, which, in some cases, causes death. fever,and vomiting According to WHO (2017), treatment for dengue fever has

no specifics yet. However, in early 2016, a new vaccine is first

introduced which will prevent dengue fevers.

Dengvaxia Vaccine

CYD-TDV, also known and sold as Dengvaxia, is developed Dengavia is the first by the French pharmaceutical giant Sanofi Pasteur. It is among the dengue fever first dengue vaccine in the world (Tomacruz, 2017). The purpose of vaccine the vaccine is to prevent dengue fevers in people, especially those that are located in an area where dengue is predominant – such as

Asia and Latin America. It was first released to be commercialized in late 2015 and early 2016 in 11 countries: Mexico, the Philippines, Brazil, El Salvador, Costa Rica, Paraguay, Guatemala, Peru,

Indonesia, Thailand, and Singapore (Reuters, 2016). The distribution of dengue risk among endemic countries can be seen in Figure 1.

Figure 1. Distribution of Global Dengue Risk (Simmons CP et al, 2012). Retrieved from http:// www.paho.org/hq/index.php?option=com_docman&task=doc_view&gid=25879&Itemid=270& lang=en

When the vaccine became available for purchase and distribution, it was partially effective. This means that the other effects of the vaccine is not yet discovered and is under other trial and clinical phases. On the 29th of November 2017, Sanofi Pasteur released a finding about the vaccine that puts a negative image to the company and Dengvaxia. The findings, as mentioned at the introduction, was that the vaccine can have more risk to people without prior dengue infection.

In regards to the information released by the Dengvaxia manufactures, the World Health

Organization recommended that the vaccine should only be used in areas where dengue fever and risk is highly suitable (see Figure 1). Along with that, Sanofi Pasteur advised the public to limit the use of the vaccine to those who had prior dengue infection. Subsequently, the immunization program of Philippine government was put into halt to further investigate the situation.

Who is Sanofi Pasteur? Sanofi Pasteur is the largest vaccine company in the world that is entirely dedicated to the production of vaccines. Every year, the company produces more than one billion doses of vaccines. Sanofi Pasteur focuses on saving lives from vaccine-preventable diseases, such as cholera, dengue, hepatitis A and B, influenza, rabies, and tetanus. Claiming to have saved two to three million lives every year because of the vaccinations.

Figure 2. Overview of Sanofi Pasteur

Timeline

Dengvaxia has already been a priority of the government since 2014, the same year when the vaccine successfully completed its two parallel Phase III clinical studies that compared the safety and effectiveness of the new treatment. Along with nine other countries, the Philippines supported the creation and the distribution of the vaccine.

On June 2015, former Health Secretary Janette Garin negotiated with Sanofi Pasteur to reduce the cost of the vaccines to be able to accommodate the huge number of possible vaccinees. Garin submitted a proposal on December 2015 to the Budget Department to buy three million Dengvaxia vaccines, which was later on approved and the Budget Department issued a

3.5 billion Philippine pesos Special Allotment Release Order to Garin's office to purchase the vaccines, making it the first vaccine to be licensed for the prevention of dengue in Asia.

On February 11, 2016, the Philippines, under Health Secretary Janette Garin, hosted the nationwide launch of Dengvaxia.

The World Health Organization (WHO) called for more studies into the vaccine, saying

Dengvaxia may increase the risk with those who are seronegative (pertains to people who have not yet had dengue) at the time of their first vaccination. Regardless, Garin issued a 3 billion

Philippine pesos disbursement voucher to the Philippine Children’s Medical Center to fund the

14 purchase of the vaccines, who issued its purchase order to Zuellig Pharma, the distributor of

Dengvaxia.

On April 4, 2016, the government kicked off its school-based dengue immunization program worth 3.5 billion Philippine pesos.

On July 2016, Health Secretary Paulyn Ubial temporarily suspended the school-based dengue immunization program and ordered that only the approximately 489,000 pupils who received the first dose would take the two remaining doses.

Despite all the studies against the vaccine, the department resumed the program on

September 2016. As a result, the House of Representatives examined the allegedly anomalous purchase of the vaccines on November 2016, and the Senate launched its own investigation into the vaccines because it was approved without congressional approval and the project cost was too big.

A year later, Sanofi Pasteur announced the results of new clinical data analysis, which found that Dengvaxia is more risky for people not previously infected by the virus, and this resulted to a tremendous public outrage.

Following Sanofi Pasteur's announcement, Dr. Francisco Duque III ordered the temporary suspension of the dengue vaccination program. Duque said that 733,713 children from

Central Luzon, Region IV-A, and Metro Manila were vaccinated, and about 70,000 children have not had dengue yet, causing panic and fear among the vaccinees.

The FDA suspended the sale and distribution of Dengvaxia, and started monitoring 40 cases of children who became ill.

The Health department called for a refund of the 3.5 billion Philippine pesos it paid for the vaccines, adding it has created a task force to further investigate the program. That same day, the

Senate announced that they will again investigate the dengue vaccination program.

The Senate started its investigation into the Dengvaxia issue on December 11. Before the start of the hearing, former Health Secretary Enrique said Garin was solely responsible for the

Dengvaxia purchase. Aquino attended the Senate hearing on the vaccine program and claimed that no one advised him against obtaining the vaccines.

Year 2018, Sanofi Pasteur said it has complied with international and local laws and regulations. The Public Attorney's Office conducted an autopsy on five dead children that were vaccinated. Dr. Erwin Erfe, director of the PAO Forensic Laboratory, said that according to their findings, signs, symptoms, and the deaths occurred within six months after the victims’ last

Dengvaxia vaccine, while the Philippine General Hospital (PGH) experts' panel reported that out of 14 autopsies they conducted, three died due to complications of dengue. Two of those three dengue deaths could possibly be related to Dengvaxia failure.

Health Secretary Francisco Duque III announced to the public that Sanofi Pasteur has refunded 1.16 billion Philippine pesos worth of unused vaccines at an event in San Fernando,

Pampanga. He also sent a letter to Sanofi Pasteur formally requesting for a full refund of all the used and unused vaccines.

Sanofi Pasteur turned down the Department of Health's demand to refund used vaccines, and the request to financially support hospitalized vaccinated children. The PAO filed a civil case against Sanofi Pasteur, distributor Zuellig Pharma, Garin, former Undersecretary Kenneth

Uy, and other health officials who were in office when they implemented the program in undue haste even if the product has no proven safety and efficacy and for failing to release all the

16 relevant information about the vaccine's risks, and Senate Blue Ribbon committee chair Richard

Gordon said he may recommend the filing of charges against former President Aquino. PAO is seeking at least 4 million Philippine pesos in damages.

Related Events

The controversy regarding the Dengvaxia vaccine is not a new occurrence in the medical field. There are many cases in the past wherein a manufacturer will discover years later, after the approval of a specific drug, that the medication has long-term side effects – such as severe illness or death. Approved medicines and vaccines that are eventually being withdrawn from production is similarly a common incident. An example is Sibutramine, also known as Reductil or Meridia, which is an appetite suppressant or a medicine for weight loss that was withdrawn worldwide in

2010 (Department of Health, Australian Government, 2010). In the Philippines, products that have sibutramine are no longer permissible for circulation because of “increased risk of heart attacks and strokes” (Santos, Inquirer, 2014).

There was an event in 1998 to 1999, however, that is thoroughly related to the Dengvaxia controversy. On August 1998, a vaccine that protects infants against rotavirus diseases was certified by the United States Food and Drug Administration, called the rotavirus vaccine or

RRV-TV (Delage, 2000). Weeks later after receiving an RRV-TV injection, there were 15 reported cases of infants having intussusception – a section of the intestine folding that causes abdominal pain and vomiting (Delage, 2000). Moreover, the intussusception was verified for all

15 patients with three months of the median age, and more than half receiving surgery. This resulted in the postponing of distribution of RRV-TV, and the manufacturer voluntarily terminated the vaccine allocation altogether (Delage, 2000).

The essential information about this event is not only the immediate accountability action

17 by the manufacturer, Wyeth-Lederle Vaccines, but the “postmarketing surveillance” (Delage,

2000) of the vaccine program operation. Postmarketing surveillance is a system that different US government agencies implement after a product is released to observe the after effects of a product. Through this system, the health groups in the United States was able to identify that weeks after the immunization, the risk of intussusception increases despite the information not being known before the accreditation of the vaccine (Delage, 2000). In Canada, they have an active postmarketing or disease surveillance system, called the Immunization Monitoring

Program ACTive (IMPACT) [Scheifele, et al., 1993]. They have an active surveillance system because this gives their country the complete and necessary information that they need regarding any specific product that is under analysis (Scheifele, et al., 1993).

EFFECTS OF DENGVAXIA VACCINE

Incident

Months after the school-based immunization program started

Vaccinated in the Philippines, numerous cases have been reported wherein individuals have vaccinated individuals have developed serious illnesses which developed serious illnesses which include internal bleeding, swollen internal organs, and severe dengue include internal after the three doses of the Dengvaxia vaccine. The Philippine bleeding, swollen internal organs, and General Hospital and the Public Attorney’s Office conducted severe dengue after the three doses of separate examinations and investigations on 14 children that showed the Dengvaxia the symptoms stated above. Although the findings of both groups vaccine contradicted each other, three cases linked with each other, meaning

that the three children had the same symptoms and cause of death.

Even with the investigations surfacing the news, it was later

Up until this day, announced on February 2018 that the deaths were not directly caused there are no concrete findings to by the vaccine, despite Health secretary Enrique Domingo confirm that the confirming that two of the three cases have been caused by the vaccine has a direct link to the vaccine (citing the PGH report). Up until this day, there are no deaths of the concrete findings to confirm that the vaccine has a direct link to the children deaths of the children.

Effects and Impact

The controversy caused a lot of people being afraid to be vaccinated by free vaccines provided by the government and other organizations. They were afraid that what happened with

Dengvaxia might happen with other vaccines as well. It caused a mistrust towards the government, since countless news have featured the hearing wherein former President Aquino admitted that no one has advised him to not obtain the said vaccines. The hearings also put emphasis on the fact that Sanofi Pasteur was not able to provide all essential information along with the release of the vaccines. They just announced months after the school-based immunization program has started that Dengvaxia is not safe and may cause other complications to individuals who have never had dengue.

NATIONAL CHANGE ORGANIZATION’S RISK MANAGEMENT PLAN

This section will provide the risk management plan for the

resolving the problem with the misinformed public with regards to

Seminar called, the Dengvaxia vaccine. Conducting a seminar, called “Magandang “Magandang Kalusugan Para sa Magandang Kinabukasan,” is the main approach Kalusugan Para sa Magandang for this plan. That will be supplemented with task force or groups Kinabukasan” within public and private hospitals, and a postmarketing surveillance system that is adapted from Canada.

The goal of the Risk Management Plan Goals and Objectives Dengvaxia vaccine The goal of the Dengvaxia vaccine risk management plan is risk management plan is to reach the to reach thos demographic that is in the external target group, such as parents, people the parents, people immunized with Dengvaxia, and other immunized with

Dengvaxia, and unaffiliated citizens. These people are to be educated on the other unaffiliated information that they need to know about the Dengvaxia vaccine, and citizens. make them aware of who are the people and agencies they can approach when they are experiencing problems in relation to the treatment. Objective is to The objective of this risk management plan is to convince develop a postmarketing different government departments into implementing a postmarketing surveillance syste, seminars, and task surveillance sytem, raise awareness towards the possible side effects force of the Dengvaxia vaccine, and persuade public and private hospitals

to 21 develop a task force or group that will help prioritize those patients that are immunized with the said vaccine. With the collaborative work of the National Change Organization, the Department of Heatlh, and other hospitals, these three objectives are to be accomplished in three months.

These objectives will be measured successful under evaluation, following a certain set of criteria.

Mitigation of Problem

In order to contain and ease the panic of Filipinos, it is necessary for NCO and various government agencies and hospitals to work together. Furthermore, the development of management strategies is essential for the success and efficacy of the risk management plan.

Strategies

According to the 2017 report released by Hootsuite and We Are Social Ltd. (Camus,

2017), Philippines is among the top three social media users for that year with Filipinos spending an average of 4 hours and 17 minutes per day on social media. These social media sites are mainly Facebook, Snapchat, and Twitter; therefore, NCO will utilize these online platforms to reach a wider and diverse demographic. Facebook and Twitter will be mainly used for seminar updates and posting of educational materials in a form of infographics or short videos. As for

Snapchat, it will be used for showcasing essential information in the seminars through short clips. Moreover, the seminars that will be conducted every 10th of the month in barangay sites will be supplemented with paper materials (brochures and leaflets). The latter strategy centers on families that do not have internet access, and therefore giving them a permanent copy of information that they need to know through these printed materials.

Along with the social media strategies, NCO will also utilize paper print materials, mainly brochures, that will be handed out in barangays and hospitals – private and public. There are two types of brochures that will be used: (1) invitational brochures, and (2) educational or

22 informational brochures. Invitational brochures are distributed to encourage the receivers to attend the upcoming seminar or events that will be hosted by the organization. While educational brochures includes the information about the vaccine and different emergency contact information. These will be disseminated by NCO volunteers in barangays, hospitals, and schools where the vaccination program happened.

National Change Organization will follow a three-month plan that includes the proposal, execution, and evaluation stages. This three-month plan will utilize all three social media platforms mentioned and do site visits to accomplish the objectives and reach the target groups.

Attainability

Most of the people that will be managing the seminars and working for the materials that will be distributed are the staff of National Change Organization. There will be volunteers at the seminar events for every barangay. The speakers for the seminars will be from different companies and organizations that is a professional on the topic, which is Dengvaxia or health awareness. As for the task group and disease surveillance system, government officials and hospital administrators will be the ones to handle it, respectively.

Benefits of the Dengvaxia Risk Management Plan

There are several benefits to the ctizens and government agencies that will be provided by this risk management plan. The most evident benefit is that parents, people immunized with

Dengvaxia, and other citizens wil learn more about the risk of the Dengvaxia vaccine. Moreover, they will be aware of the possible symptoms that a person will encounter upon injection of the vaccine. On the other end, government agencies, such as the DOH, have the benefit of lessening the growing mistrust of the public and build a stonger foundation of public confidence towards the government. Generally, the panic and further damage can be contained and prevented.

CONCLUSION

Conclusion

Dengvaxia was created by the French company Sanofi

Pasteur, and they distributed the said vaccine all around the

world, especially those within the areas with a high number of dengue cases. They were positive about the confirmed effects

of Dengvaxia, but what caused numerous controversies that

resulted to government officials filing cases against one another National Change is that the company, along with the introduction of Dengvaxia, Organization ensures that great kept secrets that are essential, highly relevant, and must be results will be visible if the public will publicized for the safety of the public and the individuals that encourage, support, and help one will be vaccinated. The government officials who were another involved in the purchasing of the vaccines are also being

investigated, for a lot of people have claimed that they did not

conduct a thorough research regarding the vaccine, because if

NCO is open to all they did, everyone will be well-informed, and no lives will be types of concerns, put to risk. victims and non- victims National Change Organization aims to help the victims

by guiding them on what to do, where to go, and who to look

24 for whenever they need to. With the help of the government, NCO also aims to educate the public, victims and non-victims, on how to know if a vaccine is safe. NCO is also focused on resolving the issue in the Philippines before it goes beyond resolution.

The risk management plan and recommendations NCO have, if executed properly, may result to relevant changes that can resolve the underlying issues the controversy has brought to the Philippines. NCO ensures that great results will be visible if the public will support and help one another. The paper materials (brochures, posters, and leaflets), after dissemination, can help enlighten and well-inform the public. The seminars and forums, if a huge number of people will attend (in each area), will help both the public and the government and organization interact with and help each other through voicing out their own opinions and possible recommendations.

National Change Organization is open to all types of concerns, victims and non-victims, and it is ensured that the organization will help as much as possible. The proposed task force, with the help of the department of Health and all hospitals nationwide, can minimize the number of complications and fatalities related to the Dengvaxia vaccine. It is not only limited to medical help, but our medical staff can also help with the concerns of the people.

Once the risk management plan is considered successful, the organization is aiming to help the other countries that have the same or related controversy, and research on other issues and propose partnerships with international organizations and governments to broaden the zone of risk management strategies and help resolve countless issues that other nations are facing.

Recommendations

The risk management plan is limited to providing only alternative solutions which are paper materials, seminars and forums, and a task force that can attend to the needs of the victims.

National Change Organization recommends the following solutions that can be executed in the future by the government and other organizations:

1. A postmarketing surveillance that can be implemented by our government, spearheaded

by the Department of Health, that is similar to the system of the United States of America

and Canada wherein a drug or a vaccine undergoes observation after being released to

identify if the drug or vaccine has other effects (discussed in part II section B).

2. Immunization vaccine programs that can help disregard the effects of the Dengvaxia

vaccine to the victims. This solution will take a long time, for after the controversy,

people are now hysterical when it comes to vaccines. The government should ensure the

public that the immunization vaccines are safe by implementing the first recommendation

which will observe and identify the effects of the vaccine, and releasing all the

information to the public before the execution of the program.

3. A computerized vaccination record can be implemented by the government and hospitals,

and the records can be given to and viewed by schools and outside medical staff (e.g.

municipal/city nurses and barangay nurses) in particular areas in order to verify doses and

the dates.

Appendices

Appendix A: Request for Interview

List of Sources

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