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Posts Tagged ‘vaccines

Science Policy Around the Web – April 25, 2017

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By: Eric Cheng, PhD

Photo source: pixabay.com

FDA

FDA Nominee Gottlieb Tackles Vaccines, Trial Design at Hearing

The President’s nominee to head the FDA, Scott Gottlieb, MD, sat before lawmakers for his confirmation hearing before the Senate’s health committee. Gottlieb, a hospitalist and former FDA official, was questioned on many controversial topics on health.  On the topic of vaccines and autism, Gottlieb said, “I think we need to come to the point where we can accept ‘No’ for an answer, and come to the conclusion that there is no causal link between vaccinations and autism.”

On the topic of double-blind randomized trials as the “gold standard” for medical treatment research, Gottlieb was more cautious. He believed that there are more “opportunities to modernize how we do clinical trials in ways that aren’t going to sacrifice on the gold standard of safety and effectiveness. Perhaps there are ways to think of clinical trial constructs that don’t require the tight randomization that current clinical trials do.” What this suggests is a push towards more adaptive trials that would allow researchers to review results before a study’s endpoint and would allow changes to treatment groups in a study, which is in contrast to traditional randomized controlled trials.

Another less controversial but popular topic in the hearing was on opioid abuse. Gottlieb believed that opioid abuse is “a public health emergency on the order of Ebola and Zika” and that bolder steps will be needed to address this issue.

The committee will vote on whether to move Gottlieb’s nomination to the Senate floor after the Senate returns in late April from a 2-week recess. (Joyce Frieden, MedPage Today)

Healthcare Policy

Trump Administration Still Plans to Undo Parts of the ACA, Tom Price Testifies

Health and Human Services Secretary Tom Price made one thing clear during his testimony to the House appropriations committee: “The administration is still intent on dismantling parts of the Affordable Care Act even if Republicans lack the votes to rewrite it.”

Price discussed how, as the Health and Human Services Secretary, his department could scale back several federal mandates that include “essential benefits” in coverage to make insurance plans cheaper. He did not say if the administration will continue to provide cost-sharing subsidies for insurers, which has been a topic of discussion on items to change in the Affordable Care Act. However, removing subsidies will bring “significant premium increases,” said Michael Adelberg, a health-care principal at FaegreBD Consulting. He predicts that the removal of these subsidies will cause some insurers to drop out while the remaining insurers will seek rate increases to compensate.

Regardless of these discussions, the individual mandate remains in place with Price telling the panel, “So long as the law’s on the books, we at the department are obliged to uphold the law.” (Juliet Eilperin and Mike DeBonis, Washington Post)

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April 25, 2017 at 9:53 am

Science Policy Around the Web – April 21, 2017

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By: Rachel F Smallwood, PhD

Source: pixabay

Scientific Awareness

Earth Day and the March for Science

This Saturday, April 22, is Earth Day and the day scientists have chosen to hold demonstrations in the name of science. The March for Science primary demonstration will be held in Washington, D.C., with over 500 satellite events in other locations around the world. According to their website, the goal of the marches, rallies, and teach-ins is to “defend the vital role science plays in our health, safety, economies, and governments.” In a time where there has been increasing disregard and disdain for sound scientific research, scientists and science enthusiasts are passionate about raising awareness of the importance of scientific research and the funding and support of that research. Many scientists are also hoping to clear up commonly held stereotypes and allow people to see the diversity in scientific careers and that careers can be collaborative, interesting, and enjoyable.

There are those, however, who disagree that these demonstrations and events are the way to bolster funding and awareness. The March for Science professes to be non-partisan, but there are some who see it as a chance to protest against President Trump and his controversial views and statements on various scientific matters. Those who oppose the march feel that there could be unintended consequences for speaking out against a political figure or party, and many believe science should remain objective and not politicized in general. There are many supporters of the march who agree that science should remain politically unbiased but are further motivated to march given the recent budget proposals that would significantly cut funding to the National Institutes of Health and the Environmental Protection Agency.

Not surprisingly, there will also be scientists working at the March for Science. Sociologists from the University of Maryland will be conducting surveys of march attendees. Their goal is to learn more about the people who protest in support of science: their motivations, work backgrounds, and political activism levels. They hope to better understand our current political culture and attitudes about science, as well as see what kind of impact these demonstrations have in the future. (Adam Frank, NPR)

Vaccination

California Vaccination Rate Hits New High after Tougher Immunization Law

Following an outbreak of measles in Disneyland in late 2014, California passed a law that abolished the right for parents to refuse to have their children vaccinated based on personal beliefs. The students enrolling in kindergarten for the 2016-2017 academic year were the first that this law applied to. Comparing this year to the previous, vaccination rates increased from 92.8 percent to 95.6 percent, making this California’s highest year for vaccination rates since the new set of requirements was instated fifteen years ago. This rate is considered high enough to prevent measles transmission which, after being eliminated in 2000, has reemerged as a risk due to an increase in parents exempting their children from receiving vaccinations because of personal beliefs.

California still has a number of at-risk students and residents, however. These requirements have only been in place for the current school year, meaning older class years still have many students whose parents opted to not vaccinate them based on personal beliefs. There are even more unvaccinated adults who were already through school before the current set of requirements. California is still being vigilant to protect the unvaccinated. An unvaccinated high school student in Laguna Beach contracted measles earlier this month, and the school quickly moved to identify other unvaccinated students in the school and bar them from returning until it could be assured that transmission would not occur. The Centers for Disease Control and Prevention (CDC) provide a recommended schedule for vaccination of children (and adolescents and adults) who have no health contraindications. To provide the maximum resistance to measles, a highly contagious disease, the CDC recommends vaccinating between 12-15 months and again between 4-6 years of age. It will likely take some time before the long-term effect of the new law can be observed. (Lena H. Sun, The Washington Post)

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Science Policy Around the Web – April 14, 2017

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By: Leopold Kong, PhD

Fatty foods: By Lucasmartin2 (Own work) [CC BY-SA 4.0], via Wikimedia Commons

Health Policy

Banning Trans Fats in New York Prevented Thousands of Heart Attacks

In an effort to lower the incidence of heart disease, the leading cause of death in the United States, the FDA will prohibit food manufacturers from using trans fats next summer. FDA’s decision was based on decades of research linking trans fat consumption with increased risk of heart disease. A study published this Wednesday in JAMA Cardiology provided further support for the ban. Using data from the New York State Department of Public Health, collected from 11 counties where trans fats restriction was recently implemented, the researchers showed a statistically significant decline in heart attack (7.8%) and stroke (3.6%) events since then. “The most important message from these data is that they confirm what we predicted — benefit in the reduction of heart attacks and strokes,” said the lead author, Dr. Eric J. Brandt, a fellow in cardiovascular medicine at Yale. “This is a well-planned and well-executed public policy.” With the rising cost of health care in the United States, the FDA’s long awaited trans fat ban is urgently needed to lighten the public health burden. (Leah Samuel, STATNews)

Vaccine Research

The Human Vaccines Project, Vanderbilt and Illumina Join Forces to Decode the Human Immunome

Rapidly evolving viruses such as HIV and Hepatitis C have been difficult targets for traditional vaccine development, in which inactivated viruses or viral proteins are used as vaccine components. Despite the success of small molecule therapeutics against HIV and Hepatitis C, an effective vaccine remains the most cost effective solution to curb the global pandemics caused by these viruses. Scientists now seek to optimize vaccine candidates based on a deeper understanding of host-pathogen interactions using multidisciplinary approaches, ranging from protein engineering and evolutionary biology to immunology and genetics. To facilitate these sophisticated efforts, the Human Vaccines Project, an international public-private collaboration, was established. A major initiative of the project, the Human Immunome Program, is led by Vanderbilt University Medical Center. Now, Illumina has joined the collaboration to help decipher the genetic features of the immune system, or the “immunome,” using cutting edge sequencing technology. DNA sequences from immune cells during infection may capture how the immune system adapts to viruses, providing guidelines for vaccine design. “Successfully defining the human immunome will provide the foundational knowledge to usher in a new era of vaccine, diagnostic, and therapeutic development,” says Gary Schroth, vice president for product development at Illumina. Greater understanding of the immunome may also lead to more effective cancer vaccines. (Human Vaccines Project)

 

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Science Policy Around the Web – March 7, 2017

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By: Allison Dennis, BS

Synthetic opiates

Opioid Crisis

Keeping up With the Synthetic Opioids

At the center of the opioid crisis is an ever-expanding class of would-be-regulated drugs, exploited for their ability to produce morphine-like effects. Opioids, including morphine, heroin, and oxycodone interact with the opioid receptors found on the surface of our nerve cells to trigger feelings of euphoria, and block pain. Unfortunately, these substances can adversely affect the respiratory rhythm generating area of the central nervous system, resulting in respiratory depression, effectively disrupting the body’s instincts to breathe.

In 2013, the U.S. Drug Enforcement Agency began to detect in confiscated supplies of heroin the synthetic compound, Fentanyl, which is 50 to 100 times more potent and carries a much higher risk of respiratory depression. The supply was traced to illicit online pharmacies in China, prompting Chinese officials to implement an export ban on fentanyl. Just as medical drug makers audition new compounds through structure-based drug design, illicit drug makers quickly modified the structure of fentanyl to produce furanyl fentanyl, temporarily circumventing the ban. This was followed by the production of the elephant tranquilizer, carfentanil. As of March 1, 2017, China has placed a ban on the sale and manufacture of these compounds along with acrylfentanyl and valeryl fentanyl.

However the dynamic that has emerged is a global game of whack-a-mole. Cutting off the global supply of fentanyl-derived compounds will require negotiations with individual governments to cooperate in their ban. Willing chemists in Mexico may already be setting up to fill the gap left by the ban in China. As each substance is entering the U.S. Drug Enforcement Agency’s radar, the list of designer fentanyls is expanding. The rotating portfolio of synthetic opioids has left local law-enforcement and coroners stumped as to how to test for drugs not-yet-known to their screens, leaving a critical lag in identifying local suppliers. (Eric Niler, Wired Magazine)

Influenza

Keeping up with the Neuraminidases

The H7N9 strain of bird flu may be gaining ground as a global threat to human health. On Monday, the U.S. Department of Agriculture confirmed the presence of a highly pathogenic H7 avian influenza strain in a flock of chickens in Lincoln County, Tennessee. The agency is hurrying to establish the neuraminidase protein type, or “n-type” of the virus. In combination with the H7 hemagglutinin type, an N9 would consign this virus to the class of influenza the WHO has described as “definitely one of the most lethal influenza viruses we have seen so far.”

First detected in China in 2013, the H7N9 strain has been the source of yearly epidemics of human infections. These infections are characterized by severe respiratory illness, which has lead to death in 40% of cases. Over 5 flu seasons, 1222 human cases of H7N9 flu have been confirmed. Most infections have been tied to direct exposure to poultry where the avian strain circulates, indicating that the virus is not currently suited for sustained person-to-person spread. However, the ability of these viruses to recombine, gaining new specificities, keeps public health officials watchful.

Following the first reports of H7N9 infections in humans in 2013, the U.S. Department of Health and Human Services amassed a 12 million-dose stockpile of H7N9 specific vaccines. However, the strains selected as the seeds for these vaccines may not adequately protect against the particular H7N9 virus circulating now.  The U.S. CDC is currently evaluating the need to update its vaccine stockpiles in addition to recommending inclusion of H7N9 in next year’s seasonal flu vaccine. Many researchers are hoping to circumvent these concerns with the development of a universal vaccine, protective against all known flu strains. (Helen Branswell, STATnews)

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Written by sciencepolicyforall

March 7, 2017 at 9:02 am

Containing Emerging and Re-emerging Infections Through Vaccination Strategies

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By: Arielle Glatman Zaretsky, PhD

Source: CDC [Public Domain], via Wikimedia Commons

           Throughout history, humans have sought to understand the human body and remedy ailments. Since the realization that disease can be caused by infection and the establishment of Koch’s postulates, designed to demonstrate that a specific microbe causes a disease, humans have sought to identify and “cure” diseases. However, while we have been successful as a species at developing treatments for numerous microbes, viruses, and even parasites, pure cures that prevent future reinfection have remained elusive. Indeed, the only human disease that has been eradicated in the modern era (smallpox) was eliminated through the successful development and application of preventative vaccines, not the implementation of any treatment strategy. Furthermore, the two next most likely candidates for eradication, dracunculiasis (guinea worm disease) and poliomyelitis (polio), are approaching this status through the use of preventative measures, via water filtration and vaccination, respectively. In fact, despite the recent pushback from a scientifically unfounded anti-vaxxers movement, the use of a standardized vaccination regimen has led to clear reductions in disease incidence of numerous childhood ailments in the Americas, including measles, mumps, rubella, and many others. Thus, although the development of antibiotics and other medical interventions have dramatically improved human health, vaccines remain the gold standard of preventative treatment for the potential of disease elimination. By Centers for Disease Control and Prevention [Public domain], via Wikimedia Commons

Recently, there have been numerous outbreaks of emerging or reemerging infectious diseases. From SARS to Ebola to Zika virus, these epidemics have led to significant morbidity and mortality, and have incited global panic. In the modern era of air travel and a global economy, disease can spread quickly across continents, making containment difficult. Additionally, the low incidence of these diseases means that few efforts are exerted to the development of treatments and interventions for them, and when these are attempted, the low incidence further complicates the implementation of clinical trials. For example, though Ebola has been a public health concern since the first outbreak in 1976, no successful Ebola treatment or vaccine existed until the most recent outbreak of 2014-2016. This outbreak resulted in the deaths of more than 11,000 people, spread across more than 4 countries, and motivated the development of several treatments and 2 vaccine candidates, which have now reached human trials. However, these treatments currently remain unlicensed and are still undergoing testing, and were not available at the start or even the height of the outbreak when they were most needed. Instead, diseases that occur primarily in low income populations in developing countries are understudied, for lack of financial incentive. Thus, these pathogens can persist at low levels in populations, particularly in developing countries, creating a high likelihood of eventual outbreak and potential for future epidemics.

This stream of newly emerging diseases and the re-emergence of previously untreatable diseases brings the question of how to address these outbreaks and prevent global pandemics to the forefront for public health policy makers and agencies tasked with controlling infectious disease spread. Indeed, many regulatory bodies have integrated accelerated approval policies that can be implemented in an outbreak to hasten the bench to bedside process. Although the tools to identify new pathogens rapidly during an outbreak have advanced tremendously, the pathway from identification to treatment or prevention remains complicated. Regulatory and bureaucratic delays compound the slow and complicated research processes, and the ability to conduct clinical trials can be hindered by rare exposures to these pathogens. Thus, the World Health Organization (WHO) has compiled a blueprint for the prevention of future epidemics, meant to inspire partnerships in the development of tools, techniques, medications and approaches to reduce the frequency and severity of these disease outbreaks. Through the documentation and public declaration of disease priorities and approaches to promote research and development in these disease areas, WHO has set up a new phase of epidemic prevention through proactive research and strategy.

Recently, this inspired the establishment of the Coalition for Epidemic Preparedness Innovations (CEPI) by a mixed group of public and private funding organizations, including the Bill and Melinda Gates Foundation, inspired by the suggestion that an Ebola vaccine could have prevented the recent outbreak if not for the lack of funding slowing research and development, to begin to create a pipeline for developing solutions to control and contain outbreaks, thereby preventing epidemics. Instead of focusing on developing treatments to ongoing outbreaks, the mission at CEPI is to identify likely candidates for future outbreaks based on known epidemic threats and to lower the barriers for effective vaccine development through assisting with initial dose and safety trials, and providing support through both the research and clinical trials, and the regulatory and industry aspects. If successful, this approach could lead to a stockpile of ready-made vaccines, which could easily be deployed to sites of an outbreak and administered to aid workers to reduce their morality and improve containment. What makes this coalition both unique and exciting is the commitment to orphan vaccines, so called for their lack of financial appeal to the pharmaceutical industry that normally determines the research and development priorities, and the prioritization of vaccine development over treatment or other prophylactic approaches. The advantage of a vaccination strategy is that it prevents disease through one simple treatment, with numerous precedents for adaptation of the vaccine to a form that is permissive of the potential temperature fluctuations and shipping difficulties likely to arise in developing regions. Furthermore, it aids in containment, by preventing infection, and can be quickly administered to large at risk populations.

Thus, while the recent outbreaks have incited fear, there is reason for hope. Indeed, the realization of these vaccination approaches and improved fast tracking of planning and regulatory processes could have long reaching advantages for endemic countries, as well as global health and epidemic prevention.

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Written by sciencepolicyforall

January 26, 2017 at 9:47 am

Science Policy Around the Web – December 9, 2016

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By: Amy Kullas, PhD

Infectious Diseases

Current Mumps Outbreak is the Worst in Recent History

2016 has been the worst in recent history for mumps outbreaks. According to a report released by the Center for Disease Control (CDC), almost 4,000 cases of mumps have been reported. This number is almost triple the number of cases reported in 2015. Mumps symptoms include: puffy cheeks and a swollen jaw (due to swollen salivary glands), fever, headache, tiredness, and loss of appetite.

In prevention of mumps, the measles, mumps, and rubella (MMR) vaccine is ~88% effective when a person gets both of the recommended doses and ~78% effective when a person received a single dose. The mumps vaccination program began in 1967. Prior to this, mumps was considered a ‘classical’ childhood disease in the United States. Some clinicians say, “the efficacy of the vaccine wanes after 10 to 15 years.”

Though mumps outbreaks can still occur in vaccinated communities (particularly in close-contact settings like colleges), high vaccination rates aids to limit the size, length, and spread of the outbreak. This ongoing outbreak is hard-hitting college campuses. In fact, some universities have scaled back dining hall hours in addition to asking students to “cancel nonmandatory social gatherings” in an attempt to thwart the infectious disease. Other universities have begun to recommend and offer a third dose of the mumps vaccine to students. (Melissa Korn, The Wall Street Journal)

Vaccination

Antivaxers Meet with Trump

Andrew Wakefield, the orchestrator of the “anti-vaccine movement”, met with Donald Trump this past summer. This misguided movement began with a paper published in 1998 by the now discredited Wakefield in The Lancet. The authors claimed that 2/3 of children developed autism soon after receiving the measles, mumps, and rubella (MMR) vaccine. Though this study has been disproven numerous times and has been retracted, the impact still flows not only through the scientific community, but also into the general public. This is why the scientific community cringed when Trump appeared to be sympathetic towards their cause.

When parents refuse to vaccinate their children, they cite the belief that vaccines cause autism or state that vaccines are “unnecessary”. Vaccination is an extremely effective strategy for preventing infectious diseases. However, this strategy is only successful when the vast majority of individuals are immunized against a particular pathogen in order to offer some protection to individuals who are not medically able to receive the vaccine.

Wakefield stated, “For the first time in a long time, I feel very positive about this, because Donald Trump is not beholden to the pharmaceutical industry. He didn’t rely upon [drug makers] to get him elected. And he’s a man who seems to speak his mind and act accordingly.” While Trump has appeared to be interested and open-minded on vaccines, there are limits to what he can do to undercut vaccination policies. But the antivaxers remain hopeful that Trump will be a powerful ally who would trigger more of a cultural impact as opposed to passing laws. (Rebecca Robbins, STAT news)

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December 9, 2016 at 9:40 am

Eradicating global infectious disease: Two steps forward and one step back?

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By: Jessica Hostetler, PhD

Source: CDC

The world made some good progress recently toward controlling or eliminating several diseases. Such gains are often long and hard fought. Vaccines are often a primary tool for eliminating diseases, which makes the rise in vaccine scepticism in many developed nations all the more troubling and fears of disease resurgences and outbreaks all too real.

The good news for disease control started in July with the commendation from the World Health Organization (WHO) to India for its work in eliminating yaws earlier in May of 2016. Yaws, often described as a “forgotten disease,” is a chronic skin disease caused by the bacterium Treponema pallidum, which is closely related to the organism that causes syphilis. It affects primarily children in poverty-stricken, crowded communities in about 13 countries with limited access to clean water, sanitation, and healthcare and can lead to severe disfigurement if not treated. Yaws is treated by a single dose of oral (Azithromycin) or injected (Benzathine penicillin) antibiotic. India tackled yaws through a campaign spanning years. “Highly targeted awareness and early treatment campaigns in vulnerable communities enabled treatment of yaws cases and interruption of disease transmission,” said Dr. Khetrapal Singh, the WHO Regional Director for South-East Asia in a WHO July press release. The success in India as the first country to eliminate yaws under the 2012 WHO neglected tropical diseases (NTD) roadmap gives renewed momentum toward global eradication in the remaining yaws-endemic countries by 2020.

More good news followed on September 5th with the announcement from WHO that Sri Lanka is now free of malaria. It is a large turnaround from the historical burden of the disease which was as high as 5 million cases per year in the 1930’s followed by a highly successful elimination program resulting in only 17 recorded cases in 1963. However, due to multiple factors, potentially including “human migrations, asymptomatic parasite-carriers, vector-reintroduction, behavioural changes in the vector and the emergence of drug and insecticide resistance,” cases soared again to half a million or more cases per year in the 1970s and 1980s. With a renewed focus on global malaria elimination in the 2000s, Sri Lanka has become a remarkable success story. As laid out in the WHO September press release, Sri Lanka’s strategy for elimination included targeting the parasites and the mosquitoes transmitting them through “mobile malaria clinics in high transmission areas” to give “prompt and effective treatment,” which reduced disease transmission and the parasite reservoir. Work such as this requires large teams of people for “effective surveillance, community engagement and health education.” But given Sri Lanka’s proximity to India, where malaria is still endemic, active surveillance for newly introduced cases will be essential to keep the disease at bay.

On September 27th, 2016, the Pan American Health Organization (PAHO) certified that the region of the Americas is free from endemic measles. This news isn’t strictly “new” as the last locally transmitted case of measles in the Americas occurred in Venezuela in 2002. Certification as being disease-free is a long process, however, and the Americas continued to experience over 5000 imported measles cases between 2003 and 2014, necessitating careful documentation to ensure local transmission had ended. Measles is a highly contagious virus and causes fever and a characteristic rash. It can lead to severe symptoms including “pneumonia, brain swelling and even death.” This is a historical success, but the WHO reports that measles still caused over 100,000 deaths globally, mostly children, in 2014. Continued vigilance and worldwide vaccination compliance are needed to maintain gains and reduce the disease where it still spreads endemically.

Such good news represents decades of hard work from international organizations, national governments and NGOs and many field workers on the ground. These efforts represent the best of humanity in working to alleviate suffering and eradicate disease. One of the primary tools in the fight against infectious diseases remains the development and mass administration of vaccines. In the US, vaccination skepticism has been growing for years on the heels of a now-retracted study in The Lancet in 1998 that proposed a link between the Measles-Mumps-Rubella (MMR) vaccine and the development of autism. While there is no evidence that vaccinations or vaccine ingredients cause autism in any way, the paper caused lasting damage to the public perception of vaccinations. A recent study examining American Academy of Pediatrics Periodic Surveys from 2006 and 2013 reports that while most parents no longer cite autism as a reason for avoiding vaccines for their children, many are now avoiding vaccinations because they are “unnecessary.” An increasing number of pediatricians (up from 6% in 2006 to 11% in 2013) report always dismissing patients for “continued vaccine refusal” citing both a lack of trust in the physician-patient relationship and concern for other patients as primary reasons. Non-compliance with vaccinations is largely viewed as the driver behind an outbreak of measles in and around the Disneyland resort in California in 2014-2015 as 67% of those with infections (who were vaccine eligible) “were intentionally unvaccinated because of personal beliefs.” Vaccination rates in some California communities had fallen below the level required for protection of the population; this spurred a controversial tightening of regulations requiring vaccinations for all public-school educated children with no exemption for religious or personal beliefs.

The international news is even more concerning with a recent global survey (with a commentary in Science) looking at attitudes toward vaccination showing that 41% of respondents from France and 31% of respondents from Japan disagreed with the statement that vaccines are safe. Russia had the highest scepticism about the importance of vaccines at 17%. The survey notes that “Countries with high levels of schooling and good access to health services are associated with lower rates of positive sentiment, pointing to an emerging inverse relationship between vaccine sentiments and socio-economic status.” The WHO reports that vaccines prevent 2-3 million deaths per year from diphtheria, tetanus, pertussis (whooping cough), and measles, but that as many as 1.5 million children under the age of 5 died from vaccine-preventable diseases in 2008. Vaccine-scepticism and outbreaks from vaccine non-compliance represent an alarming and avoidable threat as we aim to eliminate vaccine-preventable diseases from the world. As a perspective by Dr. Douglas S. Diekema in the New England Journal of Medicine notes, we must set a high goal in the US and globally to improve childhood vaccination rates through increased and free access to vaccines, but also swift rebuttals of unbalanced or incorrect reporting on vaccinations. The physician-patient relationship may offer the best opportunity to educate and “influence the vaccine-hesitant.”

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October 21, 2016 at 9:34 am

Posted in Essays

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