Dengvaxia’s FDA Priority Review: Is the global health community settling on a Dengue vaccine?

The Food and Drug Administration (FDA) announced on October 30th that Dengvaxia’s, Sanofi Pasteur’s dengue vaccine, file has been accepted for priority review within the regulatory agency. With this announcement, the FDA will ensure that a decision will be declared on approval in the United States within six months for the world’s first licensed vaccine protecting against this flavivirus. While this declaration by the FDA displays an improved pragmatic approach to addressing neglected tropical diseases (NTDs), this vaccine has created controversy throughout the global health community. This vaccine is licensed in twenty countries to date and implemented into country wide vaccination programs. However, the concerns accompanying this recombinant, live, attenuated, tetravalent dengue vaccination have led to a discontinuation of this technology with a loss of confidence in several nation states. The Philippines, the first country to complement their vaccination program with this vaccine, has even instructed Sanofi to reimburse the $70 million the country spent to vaccinate 830,000 children. This has caused many global health experts to doubt the impact this vaccine can have throughout the world – causing many to wonder if the global health community is settling on a dengue vaccine.

The dengue virus is estimated to cause 400 million infections each year spanning each of the World Health Organization’s (WHO) regions. This arbovirus belongs to Flaviviridae family and is spread to humans through the bite of an infected female Aedes aegypti mosquito and to a lesser extent from the Aedes albopictus species. The dengue virus has four unique serotypes, DEN-1, DEN-2, DEN-3, and DEN-4, which has caused an effective vaccine to be eluded for centuries. When a person is infected with one certain serotype, the person gains life-long immunity to that serotype. However, if that person contracts a different serotype, it increases the risk of the person developing severe dengue. This phenomenon is called antibody-dependent enhancement (ADE) which allows the different serotype to enter cells more efficiently due to the previously created antibodies from the initial serotype. The symptoms that dengue causes depend on primary or secondary infection. Primary infection results in an acute febrile illness that is typically cleared by the immune system within seven days, while secondary infection can lead to dengue hemorrhagic fever or dengue shock syndrome causing serious morbidity and mortality. The dengue virus currently has no approved treatments – highlighting the importance of an effective and safe vaccine for children and adults alike.  

The significant setbacks for Dengvaxia first arose when Sanofi Pasteur released interim studies concerning children aged 2 to 16 receiving the vaccine who were seronegative. This information was released on November 29, 2017 and revealed that among dengue-seronegative participants, recipients had increased rates of hospitalization for virologically confirmed dengue (VCD) and severe VCD in the vaccine group than in the group not administered the vaccine. These risks were significantly elevated in patients who were aged 2 to 8 years of age and became evident earlier than those aged 9 to 16 years of age. When this data became available, it led to the Strategic Advisory Group of Experts on Immunization (SAGE) of the WHO to reconvene and update their guidance on Dengvaxia. On April 18, 2018, SAGE recommended that for countries considering implementing Dengvaxia, every individual should be screened to determine their serological status with only seropositive persons receiving the vaccine.

The flavivirus genus includes other NTDs including the Zika virus, Japanese Encephalitis, West Nile Fever and Yellow Fever in addition to the Dengue Virus. The symptoms of each these ailments can present almost identically, especially in their milder forms, seeming almost flu-like in nature. When considering these identical disease presentations and the WHO’s recommendation to prescreen individuals for Dengvaxia, health care professionals must turn to dengue serological testing to ensure best practice – if the vaccine is accidentally given to a person with, for example, the Zika virus with no previous case of dengue due to a misdiagnosis from medical history, this would increase the risk of morbidity and mortality if dengue was contracted subsequently. The gold standard for serological testing is isolation and characterization of the virus, like PCR; however, this typically takes six or more days to receive the results and can be burdensome with it’s cost on a public health care system. A more common approach is enzyme immunoassay (ELISA) which is cost effective and less time consuming. However, in areas where two or more of the aforementioned flaviviruses exist, there is IgG cross reactivity between the viruses causing false positives for the dengue virus when ELISA is used. This often rules out the use of ELISA due to a common vector, Aedes aegypti, being able to spread two or more of these viruses within the same zone. Since the dengue virus is endemic throughout the developing world, dedicated health care professionals in these areas often don’t have funds, technology, or training in order to utilize the gold standard, PCR, in dengue testing — further highlighting the health disparities that exist on this earth. This leaves a major barrier to giving proper care to a large portion of humanity including administering this vaccine safely.

With the addition of rapid, accurate dengue test for the serological status of individuals that is in the pipelines (although no estimate of how soon it will be developed has been released yet), this vaccine will certainly find its niche in the global health society. However, this niche will exclude an enormous percentage of humans that would benefit from a safe and effective dengue vaccine. Those individuals that are currently seronegative and those who don’t have access to well-funded public health care system will continue to be at risk for developing the fatal consequences of the dengue virus. Global health leaders need to continue to promote and demand a vaccine that will ensure protection for a greater majority of people. Although this vaccine will serve some well, health care professionals must not settle until the dengue virus and each neglected tropical disease is properly addressed.

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An emerging threat of “digital pandemics”- lessons learned from the anti-vaccine movement

SeymourHeadshotGuest blogger: Brittany Seymour, DDS, MPH

During the 20th century alone, the world experienced a larger gain in life expectancy than in all the previously accumulated history of humankind. This triumph has been dubbed one of the greatest achievements in global health and is largely attributed to the 20th century success of vaccines. However, a digital assault (one that began with autism but has ballooned to numerous other concerns) regarding the safety and importance of vaccines has permeated the Internet. Anti-vaccine sentiments, derived from this study – now retracted – perpetuated by celebrities such as Jenny McCarthy and Kristin Cavallari, and other concerned citizens, have gone viral. A “digital pandemic” is underway, and like a game of telephone, the truth has morphed, facts were lost in translation, and the story of vaccines today boggles the mind. Public acceptance and trust in their safety and utility has waned. Regions of the world, including the United States, are experiencing their worst disease outbreaks in nearly two generations (IOW since the invention of the associated vaccines), and many of these are attributed to exemptions from the recommended vaccine schedule. As rotavirus vaccine inventor (and recipient of death threats due to his pro-vaccine work) Paul Offit describes it, every story has a hero, victim, and villain; in this story gone viral, Jenny McCarthy is the hero, the children the victims, which leaves one role for public health experts: the villain.

More recently, is public health at the forefront of yet another digital assault, susceptible once again to the label of villain? Last month, a study with known limitations was released naming fluoride as one of six newly identified developmental toxins in children. Ironically, this followed the American Dental Association’s announcement only two weeks prior that it has changed its longstanding guidelines for the use of fluoride in young children, recommending an increase in fluoride exposure before the age of two years old, as compared to the former recommendations. Yet, within a matter of hours from the release of the study, the story of fluoride as a new threat to normal child development created a flood of posts on Twitter (just search #fluoride) and was covered in popular media news stories for CNN,USA Today, Forbes, and Time. These news sources alone generated over 54,000 views and shares over social media by the end of the weekend. Does fluoride share the same vulnerabilities as vaccines?

To many public health experts, these stories trigger bewildering thoughts. How is it possible that such misguided health information can spread so far so fast, painting public health experts as villains? Is there a way we can reverse our role in this story and emerge the heroes? Lessons learned from the vaccine story provide insights into an emerging threat of digital pandemics and the power of social media as the medium. Public health is encountering an unfamiliar menace, a rising global pandemic of rapid and unrestricted information transfer.

In today’s global society undergoing tremendous technological advances, new and emerging media modalities are greatly affecting health by influencing policy decisions, direction of philanthropic aid, and individual health behaviors. No doubt, due to the power of handheld technology and online social networking,social media and “citizen journalist”have played a role in propagating potential detriment to what is revered as one of public health’s greatest triumphs (vaccines). Thomas Patterson explains that information accuracy is becoming obscured, “The internet is at once a gold mine of solid content and a hellhole of misinformation.” As Nicco Mele illustrates, the internet makes David the new Goliath, where citizens are capitalizing on the power of social media’s velocity and reach, disarming the traditional gatekeepers of information quality.

Even when presented with corrective information, it’s no wonder the public continues to be confused, and concerned, about potential dangers of our intentional public health interventions. But what triggers a digital pandemic, and where is the threshold between an outbreak of bad health information versus a true online pandemic wrought with content persuasion? In a world of expanding voices sharing health information online through social media, how can we ensure that the cream still rises to the top and the public is making health decisions based on the most accurate information possible?These are the big “opportunity” questions we as public health experts need to be addressing under our responsibility to keep today’s citizens, their children, and our societies healthy.

Brittany Seymour is an Instructor on Global Health at the Harvard School of Dental Medicine’s Department of Oral Health Policy and Epidemiology and the Inaugural Harvard Global Health Institute Fellow. Her research includes interdisciplinary global health curriculum development and pedagogy, capacity strengthening for oral health delivery systems in resource-challenged regions, and digital information transfer and impacts on health.

Global Health Weekly News Round-Up

Politics and Policies:

  • The Food and Drug Administration has announced that it will begin exercising its authority given under a 2009 law, power to regulate cigarettes and other tobacco products that they believe pose public health risks.
  • In an effort intensify campaign to publicize new health insurance options and to persuade consumers, the White House is recruiting mayors, county commissioners and other local officials.

Programs:

  • A health check program has been launched in Accra, in order to reach out to the people of Ghana who are challenged with non-communicable diseases (NCDS), in an affordable and effective way.
  • The United Kingdom (UK) is starting a rotavirus vaccination program to protect the babies from infection which causes diarrhea, vomiting, abdominal pain, fever and dehydration.
  • Ben & Catherine Ivy foundation grants more that $9 million for brain cancer research.

Research:

  • To help avert 3 million AIDS deaths by 2025, the World Health Organization (WHO) through its guidelines is recommending the patients the start medicine at earlier stage of the deadly disease.
  • According to global Diabetes attitudes, wishes and needs 2 study one in five people with diabetes feel discriminated against them because of their condition. About 16% people suffering from this condition are at risk of depression.
  • According to the United Nations Program on HIV/AIDS (UNAIDS), Ghana cuts new HIV infections among children by 76% since 2009. It states that one three in ten children in need of treatment have access to it.
  • A report released by the United Nations state that Nigeria has highest number of children with HIV/AIDS virus in the world. It states that the incidence rate has not increased much but the increase in the prevalence rate has remained stagnant.
  • According to the scientists, new World Health Organization (WHO) test- based approach against malaria does not work everywhere. There must be a hard diagnosis before the disease is treated.
  • According to the research results published in the Journal of Infectious diseases, infant rotavirus vaccine is effective against this disease in Ghana. Results showed a significant response in parameters of efficacy, safety and immune impact of vaccine.
  • A study published in the journal’ Diabetologia’, ethnicity should be considered while making guidelines for physical activity. They state that south Asians need more exercise than white Europeans to reduce diabetes risk.
  • According to a research review published in BMJ, high consumption of fish reduces risk of breast cancer by 14%. It replenishes the body with all omega 3 essential fatty acids which can only be acquired from external sources as body cannot manufacture it.
  •  In a study published in Cell Transplantation journal, type 2 diabetes patients who receive self-donated bone marrow stem cells require less insulin. According to the scientist’s good glycemic control appeared as a critical factor in the transplanted and non-transplanted control group.
  • A study indicates that consuming more than 2-3 standard alcohol drinks per day is linked to deadly digestive tract cancers including mouth, throat, larynx and esophageal. They also warn of risk of bowel, breast and prostate cancers.
  • The scientists have found out that the patients of Crohn’s disease also have a virus – enterovirus in their intestines as compared to those who did not have this disease. It also said that the genes associated with the onset of this disease are vital for the immune response against this virus.
  • According to the researcher’s malaria parasite are full of iron which they cannot digest nor can excrete them. Their invention- hand-held battery operated malaria detector will use the power of magnets to detect them.

Diseases & Disasters:

  • Reports state that Lusaka (Zambia) records approximately 185 new HIV/ AIDS infections every day. It has high prevalence rate of 20.8 percent as compared to the other districts of Zambia.
  • The cholera epidemic in the Democratic Republic of the Congo claims lives of 257 people. Lack of proper sanitation and clear water are stated to be the main cause of the outbreak.
  • Polio outbreak in Somalia jeopardizes global eradication. Before this there was no case of this disease for more than five years. This outbreak is reported in its early stages and WHO experts see more cases coming in next few weeks.
  • A report released by Greenpeace suggests that a Chinese herbal medicine contains a variety of pesticides. It is increasingly accepted in the western countries for medicinal use.
  • Reports have shown a new trend of HIV infection among the youths of Manipur (India). Unsafe sex practice has been indicated to be the major mode of HIV transmission among them.
  • According to the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA). Diclofenac, a common painkiller raises the risk of heart attack and stroke among the patients with serious underlying heart conditions.
  • Health officials are warning that tularemia cases are on rise in New Mexico. Four cases have been so far been reported.
  • Japan and Poland are facing epidemic of rubella. Travel warnings have been issued by the Centers for Disease Control and Prevention for the pregnant females visiting these countries.

Global Health Weekly News Round-Up

Politics and Policies:

  • Swaziland has launched a new national framework to eliminate new HIV infections among children by 2015 and keep their mothers alive.
  • According to a report Pakistani politicians have pledged for health and education of their people.
  • A Texas Senate bill would revise the state’s end-of-life procedure.
  • Bloomberg’s campaign might close off the remaining means of access to cheap cigarettes and little cigars which make it easier for teenagers to experiment with smoking and progress to smoking regularly.

Programs:

  • World Bank has approved a concessionary loan of US $200 million to Sri Lanka to further enhance the quality of the health sector service.
  • §  Britain is going to launch a £179 million five-year healthcare program in the Democratic Republic of Congo which aims to reach about six million people.
  • The Food and Drug Administration (FDA) is planning to clamp down on the sale of non-iodized salt.
  • UNICEF has increased its support from four to ten districts in the Upper East region in Ghana to implement a 5 year child survival program known as the Essential Newborn Care (ENC).
  • A regional health agency has been launched in Kigali, Rwanda, East Africa aiming to facilitate and improve regional health sectors.
  • US AIDS agencies have begun their five-year effort with Malawi’s government to improve health care services for HIV/AIDS virus infected people.
  • Irish aids program helping African people suffering from HIV/ AIDS.
  • Niger’s first lady commits to stopping new HIV infections in children.

Research:

  • According to a study done by the scientists at Queen’s University, the risk of getting head and neck cancer can be reduced by 22% by taking a weekly or even monthly dose of over-the counter aspirin.
  • A study shows that climate change can worsen the public health threat of diarrheal disease in Botswana.
  • According to a global health study HIV/ AIDS and tuberculosis are two top killers among the people of Russia.
  • A study on a disease- konzo- indicate that its physical effects on body is accompanied by impairment of children’s memory, problem solving capability and their cognitive functions.
  • Scientists in United Kingdom have been successful in making a vaccine for foot-and-mouth disease. Since it is not made from live virus, its production will require no special containment.
  • United Nations analyst says that Tanzania might achieve millennium goal on maternal health.
  • Kenya Aids Research Coordinating Mechanism chairperson has called for teamwork in HIV/Aids research.
  • According to a study early detection of bowl cancer can help to prevent cancer. They say that those who participated in the screening program were the people who were the most easiest to treat.
  • A study says that a ‘new diagnostic test may be safe and easy screening method that could improve the prognosis of patients with pancreatic cancer through early detection’.
  • Study shows that obesity makes a person to exercise less.
  • According to a study elderly people who have many social interactions may live longer than those who are more socially isolated.
  • According to a NIH study pregnant women who experienced financial, emotional or other personal stress in the year before their delivery had an increased chance of having stillbirth.
  • A study by U.S. Centers for Disease Control and Prevention many mothers in U.S. start infants on solid foods earlier than experts recommend.
  • A study done by the scientists at Boston School of Public Health finds a link between childhood abuse and fibroids.
  • Researchers at Boston University School of Medicine say that improving levels of vitamin D in the blood via supplementation could help to fight disease by affecting gene expression and boosting the immune system.
  • Italian scientists say that people who suffer from migraines are more likely to have brain abnormalities at birth and some develop them over the course of time.

Diseases and Disasters:

  • According to the reports about two people have died due to infection of a new strain of Avian flu in China.
  • UNICEF warns that 2 million children in Central African Republic are without basic supplies.
  • United Nations has been forced to delay desperately-needed food-aid to nearly 300,000 people in Guinea Bissau as it has so far received no donations to support its operation.
  • According to the United Nations reports about 240,000 Pakistani children have missed their UN sponsored polio vaccinations due to the security concerns in the country’s tribal regions.
  • According to the reports, skin lightening is popular among the females in Senegal despite of health concerns over the product.
  • Reports show that the public health centers in Tanzania do not have enough medicine and hospital supplies.
  • Clusters of vancomycin resistant enterococci cases in Kowloon Central Cluster (KCC), in Queen Elizabeth Hospital, Hong Kong have been reported.
  •  Visitors urged to stay away from Beaumount Hospital Dublin due to flu outbreak, according to the reports.
  • The health officials of Australia have become alarmed after the report of first death from XDR-TB- drug resistant tuberculosis.
  • According to the reports, more than 7,000 people might have been exposed to HIV and or hepatitis in Oklahoma dentist’s office.

 

IH News Global Health Weekly News Round-Up

Politics and Policies:

  • The government of Australia is preparing to soon offer a 20-minute HIV test in Melbourne. It has yet to decide which clinics will offer the test.
  • The National Population Commission has announced that China has planned to improve county-level family planning services.
  • Regulations have been issued by the government of Indonesia to bear graphic photographic warnings on the cigarette packets.
  • The United Nations has allowed Bolivia to return to the United Nations main anti-narcotics treaty and has given its approval on chewing the coca leaf.
  • Twelve nations have signed a new United Nations treaty which aims to counter the illegal tobacco trade.
  • New York City (U.S.) hospitals will adopt new guidelines that will forbid emergency room doctors to give out more than three days’ worth opioid painkillers to the patients.

Programs:

  • Pfizer Inc. has included its pneumococcal conjugate vaccine to expand its pediatric immunization program in Tanzania.
  • UNICEF calls for cessation of child recruitment in the Central African Republic. More than 300,000 children have been affected by the violence which has led to their limited access to education and health facilities.
  • US$176 million announced by IMF and World Bank for debt relief for the Union of the Comoros. It will help the country to fight poverty and improve health and education facilities.
  • European Union gives EUR 16million support to Ghana. This money will support the implementation of the Millennium Development Goal (MDG) Accelerated Framework and Country Action Plan developed to combat maternal mortality.
  • $25 million has been awarded by Abt Associates for a three-year malaria prevention project in Kenya.
  • The FCC has launched $400 million heath care development fund with an aim to create and expand telemedicine networks.

Research:

  • According to a study published in the British Journal of Psychiatry there is a relationship between mental health and spirituality.
  • According to the Journal of Infectious Diseases, nosocomial transmission responsible for XDR-TB outbreak in South Africa.
  • A study identifies the chances of infection (co-infection) with another disease when a person is infected with a disease.
  • A study published in the Journal of Neurosurgery Pediatrics, climate can be the reason for a neurological condition, hydrocephalus in children in Uganda.
  • Number of new annual cases of HIV/AIDS cases in India has dropped by 57 percent in the last decade.
  • A study published in J Neurol Neurosurg Psychiatry links loneliness with higher chances of dementia or memory loss.
  • Researchers have identified role in obesity and diabetes. They have found that blocking the expression of gene TRIP-B2r  in mice protects them against obesity and insulin resistance.
  • A report published by Natural News states that children who are vaccinated according to the CDC recommended schedule are five times more likely to develop diseases as compared those who are not.
  • According to the findings of a report, among all rich countries, people of U.S.  live unhealthy and shorter lives.

Diseases and Disasters:

  • The Flu has surpassed an ‘epidemic’ threshold in the United States. It is widespread in all except the three states of US.
  • According to The New Times survey, there is a severe drug shortage in Kigali hospitals (in Rwanda).
  • The World Health Organization (WHO) yellow fever has killed about 171 people in Darfur (Sudan).
  • Top U.N. Aid officials warn food crisis in two isolated southern states of Sudan. People of South Kordofan and Blue Nile have been feared dying of malnutrition and disease.
  • According to the officials, about 80 people have died in Bangladesh due to cold-related diseases like respiratory problems, pneumonia and cough.
  • People in Beijing have been warned of extremely hazardous air quality. The density of PM2.5 particulates has reached 700 micrograms per cubic meter in many parts of city.
  • Sri Lanka’s Ministry of Health has warned the public of possible outbreak of Leptospirosis (rat fever) in flood affected areas.
  • According to the health authorities, Barbados has recorded an increase in dengue cases since the last year.
  • Paraguay has confirmed reports of outbreaks of dengue in the north and east of the country. It has declared a national epidemics alert.