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CA Medical Board Takes Action to Protect Children’s Health: Dr. Bob Sears Placed on Probation

By Amy Pisani,  Executive Director, ECBT (mother of two fully vaccinated teenage boys)

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Last week, the Medical Board of California ordered a 35-month probation for Dr. Bob Sears, an Orange County pediatrician who is best known for hawking an “alternative” vaccination schedule for young children, promoting the unproven theory that vaccines cause autism, and being a champion for parents who seek to claim exemptions from school vaccination requirements.

The revocation of Dr. Sears’ medical license was stayed by the Medical Board, which allows him to continue practicing medicine, as long as he follows certain requirements of his probation including taking Board-approved medical education and ethics classes, and allowing a Board-approved monitor to watch and report on his medical practices. Through this disciplinary order, the Medical Board is providing Sears with a clear warning against future misconduct.

The overall charges against Sears include gross negligence and repeated negligence in his care and treatment of a patient (a child called J.G), and failure to maintain adequate and accurate records. The formal accusation brought by the Executive Director of the Medical Board of California Kimberly Kirchmeyer provides specific examples of Sears’ departures from the medical standard of care, “which require that a physician who is evaluating a patient for possible reaction to vaccines obtain a detailed history of the vaccines previously received as well as the reaction that occurred. Based on that information the physician should provide an evidence-based recommendation for future immunizations.” The accusation continues “the respondent was grossly negligent and departed from the standard of care in that he did not obtain the basic information necessary for decision making prior to determining to exclude the possibility of future vaccines leaving both the patient, the patient’s mother, and his future contacts at risk for preventable and communicable diseases.”

Forbes’ contributor Tara Haelle, who has been following this case against Dr. Bob Sears since last year, noted that:

“the charges involve much more than writing a vaccine exemption letter. According to the accusation, Sears failed to test the same toddler for neurological problems after the child was hit on the head with a hammer and failed to investigate alleged vaccine reactions that, if they did occur, would have been life-threatening. He also prescribed garlic for the child’s ear infection despite there being no evidence of its effectiveness. Such departures from the medical standard of care prompt questions about what other ways Sears might be practicing negligently beyond this complaint.”

Ms. Haelle’s latest Forbes article offers insight into Dr. Sears’ extensive history of anti-vaccination practices and advocacy efforts:

“When physicians practice this type of substandard care, it places children’s lives at risk. Dr. Sears’ bias against vaccines flies in the face of overwhelming evidence of the safety and necessity of timely vaccinations,” Amy Pisani, MS, executive director of Every Child By Two told me.

“With notoriety comes great responsibility. Dr. Sears’ promotion of his ‘alternative vaccine schedule’ has helped perpetuate the myth that vaccines are not safe for children, which is shameful,” Pisani said. “This ruling should send a strong message to providers that the practice of medicine must be based on evidence, not anecdote, and signing vaccine waivers without medical necessity is not an acceptable practice.”

Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law, details the legal ramifications of Sears’ probation and offers insight into Sears’ past actions in a recent Skeptical Raptor post 

Like many moms, I was an avid follower of the advice of Dr. Bill Sears, the father or Dr. Bob Spears and the well-known pediatrician who offered advice to parents on child rearing and attachment parenting. Over the last decade, it has been very disturbing to see Dr. Bob using his father’s name and the Sears Parenting Library to sell his books, which contain inaccurate vaccination information and fuel parents’ fears about vaccines. Dr. Bob Sears’ “alternative” vaccination schedule, which encourages parents to either skip or delay recommended vaccines for their children, is dangerous and ignores the importance of following the Centers for Disease Control and Prevention’s (CDC’s) recommended schedule.

The CDC sets the U.S. immunization schedules for children, teens and adults based on recommendations from the Advisory Committee on Immunization Practices (ACIP). The ACIP, which is made up of medical and public health experts, carefully considers many factors, including the safety and effectiveness of vaccines, before recommending a vaccine for use. As a result, the CDC’s recommended childhood immunization schedule (from birth to 18 years old) is the ONLY vaccination schedule for children and teens that is rigorously tested for safety and effectiveness. No “alternative” or “non-standard” schedule has ever been tested. The CDC’s recommended schedule is also endorsed by the leading medical groups including the American Academy of Pediatrics (AAP) and the American Academy of Family Physicians (AAFP). The vaccines in the schedule are carefully timed to provide protection to children when they are most vulnerable to diseases, and when the vaccines will produce the strongest response from their immune system.

Learn more about how the vaccine schedule is determined and why it is never okay to delay a child’s vaccines.

 

Advisory Committee on Immunization Practices June 2018 Meeting Update

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The Advisory Committee on Immunization Practices (ACIP) held their second of three annual meetings at the Centers for Disease Control and Prevention (CDC) in Atlanta, GA last week.  ECBT staff took advantage of the opportunity to view the meeting via webcast, and strongly encourage members of the public to take advantage of this technology in order to gain a better understanding of the deliberations that take place to ensure the ongoing safety and effectiveness of the vaccines licensed for use in the U.S.

The CDC sets the recommended immunization schedules for people of all ages in the U.S. based on recommendations from the ACIP. The ACIP establishes, updates and continually evaluates all the vaccine recommendations that are made in the United States for infants, adolescents and adults. These guidelines are considered the gold standard among healthcare providers. The ACIP consists of 15 voting members, 8 ex officio members and 30 non-voting representatives who participate voluntarily. In addition to the three meetings per year, which are open to the public, ACIP members serve on various work groups that are active throughout the year. Work groups review the latest studies on specific vaccines (including safety and efficacy reports), in order to provide recommendations to the larger committee.

Last week the ACIP voted on recommendations for influenza (flu) and anthrax vaccinations, and discussed HPV, mumps, shingles (herpes zoster), Japanese encephalitis, and pneumococcal vaccines. Votes and highlights from the discussions are detailed below.

 

Influenza (Flu) Vaccination Discussion and Vote

It will come as no surprise to our readers that the flu virus hit a brutal blow to people of all ages during the very severe 2017-18 flu season in the U.S., striking at nearly the same time nationwide.

 

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Influenza A (H3N2) was the predominant circulating strain and this year the effectiveness of the vaccine against this strain was approximately 24% (similar to the previous flu season). Effectiveness against the influenza A (H1N1) strain was 65% and 49% against the influenza B (Yamagata) strain.

 

 

 

Now the good news – vaccination reduced flu-related visits to healthcare providers (outpatient) by 40% among all people ages 6 months and older. Among adults, the vaccine reduced outpatient visits and hospitalizations by 22%.

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The ACIP listened to vaccine safety reports provided by representatives from the Food and Drug Administration (FDA), vaccine manufacturers, and the vaccine safety surveillance systems in the U.S. – the Vaccine Adverse Event Reporting System (VAERS) and Vaccine Safety Datalink (VSD) which is a collaboration between CDC and nine healthcare organizations that began in 1990 and analyzes up to 10 million immunization records per year to ensure ongoing safety.  After an extensive review of the safety of this season’s flu vaccines, the ACIP confirmed that there were no vaccine safety signals of concern including anaphylaxis, narcolepsy and Guillian-Barre Syndrome, each of which received increased scrutiny due to a number of news and anecdotal reports in recent years.

The ACIP approved the following influenza recommendations for the 2018-19 season:

Everyone 6 months of age and older should be vaccinated with any licensed, age-appropriate influenza vaccine (IIV, recombinant influenza vaccine [RIV], or LAIV), as indicated. No preference is given for any one vaccine over another. In its February meeting, the ACIP once again recommended LAIV (the nasal spray vaccine known as FluMist) for healthy, non-pregnant people 2 through 49 years old during the 2018-19 season. This recommendation was made after ACIP reviewed effectiveness data presented by the manufacturers of FluMist.

Of Note: The Redbook Committee of the American Academy of Pediatrics, who typically endorses the recommendations of the ACIP, have stated a preference for the flu shot (IIV or RIV) over the nasal spray vaccine (LAIV), recommending that pediatricians only give the nasal spray as a last resort. This decision by the AAP is not without controversy as it may lead to confusion among parents and their providers. ECBT Board Member Dr. Paul Offit recently created a Medscape video explaining why he agrees with the ACIP’s decision to recommend the use of FluMist in children based on the effectiveness data.

 

Pneumococcal Vaccination Discussion

Two pneumococcal vaccines are currently recommended for all adults over the age of 65 – one dose of pneumococcal conjugate vaccine (PCV13) with a booster dose of pneumococcal polysaccharide vaccine (PPSV). ACIP is re-examining whether PCV13 should be routinely recommended for otherwise healthy older adults. Some experts believe the childhood recommendations for routine vaccination with PCV13 is sufficiently lowering the disease burden in adults by reducing the circulation of the disease in communities. In data presented to the ACIP, however, it seems there are persistent disparities in the rate of pneumococcal disease and vaccine uptake  pneumoacip062018

among minority populations and those in poverty, which puts into question whether it would be wise to eliminate the vaccine recommendation for adults.  The ACIP will continue to deliberate the data and have continued discussions into 2019.

 

Anthrax Vaccination Discussion and Vote

The anthrax vaccine is currently approved for use by the FDA for 18-65 year olds, and is usually given to select populations of adults (i.e. military). As the Department of Health and Human Services (HHS) and CDC review their plans for responding to an anthrax “mass event”, they have asked ACIP to offer guidance on how best to use the vaccine in the event of emergency. Specifically, they asked ACIP whether the anthrax vaccine would be equally effective and safe if they had to administer the vaccine in fewer or smaller doses to ensure there was enough vaccine for everyone affected.  Also under consideration was the utilization of different types of needles to be used in the event of a needle shortage. The current vaccine is given subcutaneously, not intramuscularly, like typical vaccines. Intramuscular needles are therefore more readily available.

After reviewing the data, the ACIP agreed unanimously that reduced dosing would still save lives, as would offering the vaccine intramuscularly instead of subcutaneously. There was no data, however, on whether reduced doses given intramuscularly would be equally effective. The Committee also offered their recommendations on the duration of antimicrobial treatment following vaccination. There is a new intramuscular anthrax vaccine on the horizon which may help federal agencies better plan for a possible emergency situation.

The ACIP made the following recommendations:

The intramuscular route of administration may be used if the subcutaneous route presents clinical, operational, or logistical challenges that may delay or prevent effective vaccination.

  • Should there be an inadequate supply of anthrax vaccine available for Post Exposure Prophylaxis (PEP), either 2 full doses or 3 half doses of AVA may be used to expand vaccine coverage.
  • In immunocompetent individuals 18-65 years of age, antimicrobials given in conjunction with vaccine may be discontinued at 42 days after the first vaccine dose or 2 weeks after the last vaccine dose, whichever comes later.

 

Japanese Encephalitis Vaccination Discussion

The cell culture-derived Japanese encephalitis vaccine (JE-VC) is both safe and effective, but given how few U.S. travelers contract the disease, ACIP is re-evaluating their recommendations. They are in the midst of re-evaluating the cost effectiveness of the vaccine and whether their recommendations should be more targeted. ACIP will continue deliberations at a future meeting.

 

Mumps Vaccination Discussion

Mumps outbreaks continue to crop up throughout the nation. From late 2016 through 2017, there were 56 outbreaks, which included 3,914 cases, and in 2018, there have already been 30 outbreaks, including 1,415 cases. The ACIP previously recommended the use of a 3rd dose of mumps virus-containing vaccine (MMR) for people identified at increased risk during a mumps outbreak. img_0681.pngDuring the June, 2018 ACIP meeting, the CDC provided guidance for public health officials to assist them on the use of a 3rd dose of MMR vaccine during an outbreak, including identifying groups of people at risk for acquiring mumps during an outbreak; assessing transmission in the settings to determine if groups are at increased risk; and how to implement a 3rd dose recommendation.

 

Shingles (Herpes Zoster) Vaccination Discussion

In October 2017, ACIP made recommendations for a new recombinant zoster vaccine (RZV) called Shingrix. The vaccine is recommended for the prevention of shingles and related complications for adults 50 years of age and older. It is also recommended for adults 50 and older who previously received zoster vaccine live (ZVL), and it is preferred over ZVL for the prevention of shingles and related complications.

GSK, the manufacturer of Shingrix, reported to the Committee that it is increasing the number of doses available due to high demand and shipping delays.  They are also continuing to study the safety and effectiveness of the vaccine.  The CDC also continues to monitor shingles vaccine coverage and vaccine supply. As it does with all vaccines, the CDC is using U.S. safety surveillance systems – VAERS and VSD – to monitor the shingles vaccine (RZV). VAERS is a passive system that is not designed to determine if a vaccine caused a health problem, but does help to detect unusual or unexpected patterns of adverse events that might indicate a possible safety problem with a vaccine. The CDC reported that were 680 reports to VAERS between October 20, 2017 and April 27, 2018, and the majority concerned females. There were no unusual patterns or unexpected adverse events. 48 (7%) of reports involved co-administration with 1 or more other vaccines, and the most commonly reported side effects from RZV were injection site pain and pyrexia (fever).

The CDC also reported to ACIP about VSD monitoring of the shingles vaccine.  The staff of the  VSD conducted vaccine safety studies based on questions and concerns raised from the medical literature and reports to VAERS. As of May 31, 2018, 37,303 total doses of RZV were administered at the participating VSD sites. The VSD monitoring for RZV includes high priority short-term outcomes (GBS, anaphylaxis, and acute myocardial infarction); lower priority short-term outcomes for descriptive analysis (gout, local and systematic reactions); and longer-term outcomes (potential immune-mediated diseases). Evidence of safety and effectiveness of shingles vaccine in immunocompromised is currently being reviewed.

The CDC has created a number of resources for RZV. For providers, the CDC developed a report published in MMWR on vaccine administrative errors, a Continuing Medical Education program (CME) called “You Call the Shots”, a Medscape video, web pages, webinars/conferences and fact sheets. For the public, the CDC created a vaccine information statement (VIS) on the RZV, web pages and a fact sheet.

Human Papillomavirus (HPV) Vaccination Discussion

In October 2018, the FDA is expected to complete a review of scientific studies to determine whether 9-valent HPV vaccine (GARDASIL®9) is safe and effective for use in adults ages 27 to 45. The vaccine will continue to serve as a prophylactic to prevent new infections, and is not expected to prevent progression of the disease among those who already have a HPV infection. The ACIP is also simultaneously reviewing the evidence that has been sent to the FDA and will determine whether to recommend the vaccine if and when the FDA approves the vaccine for use among mid-aged adults. Factoring into the ACIP decision will be the fact that the overall population-level benefit will be lower among mid-aged adults than among younger populations. This is due to the fact that this

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population may have already been exposed to HPV and thus already have an infection, or have immunity against some strains of the disease. In addition they tend to have fewer new sex partners and have several other factors that will make the vaccine less beneficial (but not without merit) for this older group than for those ages 11-12, who can be vaccinated prior to exposure.

The ACIP’s HPV work group is also continuing to review data in consideration of “harmonizing” the schedule for males and females so that both populations would be recommended up to the age of 26 instead of up to age 21 for males and up to age 26 for females and will report back to the full ACIP at a future meeting.

ECBT will keep you informed on this and other deliberations of this important committee.  

Learn more about each of these vaccines and the diseases they prevent on the Vaccinate Your Family website and Facebook page.

 

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With School Vaccine Exemptions on the Rise, What Can Be Done to Protect Our Students?

June 12, 2018 1 comment

Today, PloS Medicine published a study that examined the increase we are seeing across the country in philosophical exemptions to school vaccine requirements, also known as personal belief exemptions.

According to the authors, 12 of the 18 states that allow philosophical exemptions have seen an increase in parents choosing to exempt their children from one or more vaccines. As a result, several metropolitan areas are at risk of an outbreak of disease, such as measles, similar to the one we saw originate at Disneyland in Anaheim, California three years ago.

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The Washington Post notes that the study “characterized many rural counties, as well as urban areas, as ‘hotspots’ because their high exemption rates put them at risk for epidemics of measles, whooping cough and other pediatric infectious diseases.

Amy Pisani, Executive Director of Every Child By Two/Vaccinate Your Family, expressed concern about what is known as the “community protection threshold” by stating, 

“It’s alarming to see the rise in exemption rates across this country, putting communities at greater risk. Parents need to understand that timely vaccines are critical to protecting children’s health and should be at the top of the family’s to-do list.”

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While the study reveals some interesting data points, there’s little information as to why it appears that parents are increasingly claiming exemptions for their children.

In most states, the school vaccine exemptions tend to be elevated in a handful of communities, as opposed to a general rise in exemptions throughout the state.  It appears that more research needs to be done to better inform public health policymakers regarding the underlying reasons parents are exempting their children from school required vaccines.

In the meantime, some of the states with the highest levels of exemptions have passed legislation to make nonmedical exemptions more difficult to obtain. For example:

  • In Washington state, a law was passed that required parents to have their exemption form signed by a health care provider.
  • In Oregon, parents have the option of watching an online module on the dangers of not vaccinating or getting a form signed by a health care provider.

While both states saw an immediate and encouraging reduction in the number of exemptions claimed, it appears that these policies have not been effective over time and exemptions are once again on the rise.

Tightening laws and policies clearly does not keep those parents who are intent on seeking exemptions from obtaining them. But how about eliminating nonmedical exemptions?

After the 2014-2015 measles outbreak in California, the state legislature decided to eliminate all nonmedical exemptions. Again, one year after the law was passed exemption rates fell dramatically and, most importantly, vaccination rates rose well above community immunity thresholds, thus better protecting communities against disease outbreaks.

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But what will the future hold?  Will parents who have philosophical reasons to avoid vaccines for their children find ways to obtain medical exemptions?

Initial data suggests that may be the case. According to an article in JAMA, the California medical exemption rate reflected a three-fold increase following the introduction of the law, from 0.17% to 0.51%. According to the article’s authors,

“Some vaccine-hesitant parents may have successfully located physicians willing to exercise the broader discretion provided by SB 277 for granting [medical exemptions]…If true, this practice would be inconsistent with the recommendation from the American Academy of Pediatrics to reserve [medical exemptions] for children having contraindications.”

In the coming years, public health partners may have a better sense of whether eliminating nonmedical exemptions can sustainably increase vaccination rates and protect our communities against dangerous vaccine-preventable diseases. We will also be looking to additional studies to learn how many parents are choosing exemptions because they have true personal objections to vaccinations, or because they don’t view vaccination as a priority among their long back-to-school lists.

In the meantime, it’s important to help state legislators and the public understand what has been tried to-date and what are the most promising policy paths forward. 

Here are some ways that you can be informed and help to inform others:

  • Consider sharing Vaccinate Your Family’s fact sheet on the impacts of exemption legislation with your local lawmakers to remind them of their role in strengthening our defenses against vaccine-preventable disease.
  • Check out Vaccinate Your Family’s 2018 State of the ImmUnion report to learn more about federal policies that aim to protect our families and communities from dangerous diseases.
  • Help ensure children are better informed about how diseases develop and how vaccines work with the immune system by sharing specially designed science curricula from The Vaccine Maker’s Project with school nurses and science teachers at your local elementary, middle or high schools.
  • Find out more about the vaccination rates in your state and community by contacting your local schools, public health department or reviewing the latest CDC vaccination coverage reports.
  • Stay informed about the latest immunization news and research by following Vaccinate Your Family’s Facebook, Twitter and Instagram accounts, subscribing to this Shot of Prevention blog and sharing the information we discuss on these channels with your social contacts.

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Together we can work to ensure that students get the protections they deserve in their schools and communities.

Rise in Vaccine Hesitancy Related to Pursuit of Purity: A Conversation with Professor Larson

This article was originally published in Horizon magazine by Gary Finnegan. It is being republished  to provide much needed perspective on the issues pertaining to vaccine hesitancy around the world.

 

The rise of alternative health practices and a quest for purity can partly explain the falling confidence in vaccines which is driving outbreaks of preventable diseases such as measles, according to Heidi Larson, professor of anthropology, risk and decision medicine at the UK’s London School of Hygiene & Tropical Medicine. She is working to understand the causes of vaccine hesitancy in order to devise ways of rebuilding trust.

Why would people opt out of recommended vaccines?

‘Most people have their recommended vaccines but many do not. In some cases, people are missing out on immunisation because they cannot access vaccines. But there is a growing and concerning trend that shows people with access and education are saying “no thanks”. This is a real challenge because it’s driven by belief and it’s difficult to change people’s minds when they have decided that they don’t want or need a vaccine.’

Our 2016 study in 67 countries found that Europe was the most sceptical region in the world.

Heidi Larson, London School of Hygiene & Tropical Medicine, UK 

What are the specific reasons people give when declining to immunise their child?

‘Sometimes there are concerns about vaccine ingredients, usually based on a misinterpretation of the science. There is misinformation circulating online about, for example, some compounds that contain metals. But there are also strong underlying beliefs linked to religion, philosophy and politics. In the US, some states allow philosophical exemptions from mandatory vaccination – although California repealed this opt-out option after a major measles outbreak in Disneyland.

‘One of the biggest lessons of our research is that you can never assume what’s in people’s mind nor assume that simply explaining science can change their opinion. People’s reasons for rejecting vaccines could stem from a bad experience at a healthcare facility, general distrust in the government, in medicine or in industry – it’s a real mix but you have to understand their reasons if you are to address concerns and prevent outbreaks of preventable disease.’

How is the decision to vaccinate political?

‘Vaccines are regulated, recommended and sometimes mandated by government or public authorities. In the US, researchers have looked at values-based vaccine rejection. Two major values can be seen: purity and liberty. For some, the idea of government influence over health is unacceptable.’

People need more support to maintain confidence in vaccines, says Dr Heidi Larson. Image credit - Jon Spaull

People need more support to maintain confidence in vaccines, says Dr Heidi Larson. Image credit – Jon Spaull

Do all countries and cultures share the same concerns about vaccines?

‘Ten years ago, the answer was no. We saw distinctions between the UK, where a (now withdrawn) 1998 research paper incorrectly linked the MMR (measles, mumps and rubella) vaccine and autism, and France, whose main vaccine concern was suspected – albeit unproven – links between Hepatitis B vaccines and multiple sclerosis. The UK public was generally not worried about Hepatitis B and the French public was unconcerned about MMR. Now, because information is shared rapidly online and online translation tools are freely available, rumours and myths spread more quickly.’

Does the public expect medicines and vaccines to carry zero risks?

‘Vaccines are different from medicines – they are preventative and given to healthy people. If you are sick, your attitude to intervention and risk is much different. In addition, vaccines are often recommended for people who are most vulnerable – children and pregnant women. Vaccination is, by its nature, somewhat invasive as most vaccines are given by injection, and this provokes an emotional reaction such as fear and anxiety. Indeed, one of the unhelpful trends we notice is that images of needles are commonly used in media coverage about vaccines – you rarely even see a person in the picture.’

Can information fix ‘fake news’?

‘We will always need public communication, but that alone will not fix things. I’m not a great believer in hitting rumours on the head by myth-busting or debunking falsehoods. We need to be more sophisticated and to build strong transnational networks to pick up rumours and misinformation early and surround them with accurate and positive information in support of vaccination.’

Through your Vaccine Confidence Index, you have surveyed opinion on vaccines in 67 countries. What did you find?

‘We came up with a systematic approach to measuring vaccine hesitancy through repeated global surveys. One of the reasons the issue of vaccine reluctance and refusal has not been addressed in any comprehensive way is that it was seen as complex and too fuzzy to measure. It was written off as “not fact” and perceived to be propagated by those who are ignorant, rather than recognising that, fact-or-not fact, these perceptions impact on vaccine uptake and risk disease outbreaks. Our 2016 study in 67 countries found that Europe was the most sceptical region in the world – France was the least positive about vaccines. Now we are planning to rerun the survey in Europe to see if recent devastating measles outbreaks – which have killed 50 people in Europe (since the beginning of 2016) – may have changed minds.’

There were 1,346 cases of measles in Europe in 2008 and 19,570 cases in 2017. Image credit - Horizon

There were 1,346 cases of measles in Europe in 2008 and 19,570 cases in 2017. Image credit – Horizon

How can this information be used to reduce preventable deaths?

‘First you need to understand what’s driving a decline in vaccination rates and only then can you come up with an appropriate response. The needed intervention will vary depending on whether the problem is vaccine supply or access to vaccines, inadequate awareness of disease risk, concern over vaccine safety risks, including ingredients, or general distrust in authority.’

How can people be persuaded that vaccines are safe and what role can research play?

‘Two of our biggest projects are EU-funded initiatives aimed at understanding drivers of vaccine confidence and developing interventions to build trust. One – EBODAC – focuses on trust building and community engagement around recruiting participants into Ebola vaccine trials in Africa, including investigating the evolution and impacts of negative rumours, such as those that led to the suspension of two Ebola vaccine trials in Ghana.

‘Another is the ADVANCE consortium where we are developing a consistent and coordinated approach to assessing vaccine benefits and risks, including more open and coordinated access to relevant data. For example, if a concern is raised about a particular vaccine, we need to be able to determine whether the rates of a reported adverse event are any different among those who are not vaccinated.’

What is the future of this field?

‘We need to do a better job in schools, helping children to understand essential concepts about how immune systems work to fight disease and how vaccines help build our body’s own protection against infection. Medical school curricula also need to focus more on vaccination, including how to engage with patients who have questions about vaccines.  Health authorities need more capacity to respond to vaccine confidence issues, not just by debunking myths, or just providing facts, but by understanding what is driving the concerns, where they are coming from and surrounding them with positive, informed people. The majority of people still believe in vaccines, but they need more support to sustain their confidence.’

If you liked this article, please consider sharing it on social media.

 

 

Five Important Reasons to Vaccinate Your Child

April 23, 2018 2 comments

Every parent wants to do what’s best for their children. However, when parents are bombarded by conflicting messages, it can be a struggle to try to determine what is best.  Every decision – from the type of car seat to purchase, to how to soothe a fussy child – elicits a variety of opinions.  But when it comes to protecting our children from dangerous and sometimes deadly diseases, parents should rely on evidence based information from trusted sources.  

In honor of National Infant Immunization Week 2018, we’ve outlined some of the top reasons experts give for immunizing for your child, along with trusted sources where parents can get more information:

 

1.) The diseases we can prevent through immunization are dangerous and sometimes deadly.  

The 14 different diseases that we can now prevent through vaccination had once injured or killed thousands of children in the U.S. each year. Today, we may hardly ever see these diseases, but the fact remains that these diseases still exist and can be extremely dangerous, especially to children.

Take polio as an example. Polio was once America’s most feared disease, causing death and paralysis across the country.  Thanks to vaccination, the U.S. has been polio-free since 1979.  But small pockets of polio still exist in Afghanistan and Pakistan, and the threat to your child may just be a plane ride away.  (Read Judith’s polio story.)

There are lots of other vaccine preventable diseases that we see more frequently here in the U.S., such as flu, measles and pertussis.  So far during the flu season, over 150 children have died from flu.  And in the past few years, we’ve seen a resurgence of measles.  Back in 2014, there was an outbreak involving 667 cases of measles in 27 states. Another large multi-state outbreak linked to an amusement park in California occured in 2015 involved 147 people. And more recently, an outbreak in MN resulted in the hospitalizations of a dozen children.

Learn more about the 14 different diseases we can prevent through vaccination with this interactive eBook which includes a description of each disease, its symptoms and an explanation of how the disease can be prevented through immunization. 

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2.) Vaccines are safe and effective. 

Vaccines today are the safest they’ve ever been. Of course, parents are bound to hear stories from people on the internet claiming that their children were injured by vaccines.  Since it is extremely difficult to validate these stories, parents should rely on evidence based information when making conclusions about the safety of vaccines.

It is important to acknowledge that vaccines do come with a risk of side effects. However, since vaccines are administered to almost every child in the U.S., they undergo an enormous amount of safety surveillance and scrutiny by scientists, doctors, and healthcare professionals.  The most common vaccine side effects are minor and include redness or swelling at the site of the shot, which is minimal compared to the pain, discomfort, and risk of injury and death from the diseases these vaccines prevent. Serious side effects following vaccination, such as severe allergic reaction, can happen, but are extremely rare.

Considering the dangers of the diseases we are trying to prevent, the benefits of vaccines far outweigh the minimal risk of side effects.

This video, as well as others available on our Vaccinate Your Family Facebook page, address some of the most common safety questions parents have about vaccines.  

 

3.) Childhood vaccines contribute to the community immunity that helps keep everyone free from disease.  

Some vaccines are not administered until a child is 2, 6 or 12 months of age.  Some vaccines even require multiple doses before a child receives optimal immunity.  Prior to being fully vaccinated, these infants remain vulnerable to diseases that can be particularly dangerous for infants.   Read more…

How Flu Strains are Selected for the Seasonal Flu Vaccine Each Year

March 14, 2018 5 comments
SereseMarotta_FamiliesFightingFlu-300x300by Serese Marotta, Chief Operating Officer of Families Fighting Flu 

 

The Centers for Disease Control and Prevention (CDC) recommends that everyone ages 6 months and older, with rare exception, get an annual flu vaccine. But did you ever wonder how the flu strains are selected for the seasonal vaccine every year?

A lot more goes into the decision than you might think!

Seasonal flu vaccines contain three (trivalent) or four (quadrivalent) flu strains. Because flu is a complex, dynamic virus that is constantly changing, there are more than 100 monitoring centers in over 100 countries located across the globe that monitor flu activity on a year-round basis to identify which flu strains are circulating.

These centers receive and test thousands of influenza virus samples from patients. They then send representative virus samples to five World Health Organization (WHO) Collaborating Centers for Reference and Research on Influenza, located in Atlanta, GA (i.e., the CDC); London, United Kingdom; Melbourne, Australia; Tokyo, Japan; and Beijing, China. The surveillance data gathered from these samples, along with other information, are used to make a recommendation on which flu strains should be included in the upcoming year’s seasonal flu vaccine.

Contrary to popular belief, the flu vaccine is not just based on last year’s flu viruses. Three general sources of information are considered in the selection of flu strains for the seasonal flu vaccine:

 

  • Surveillance data represents information gathered from the influenza monitoring centers that collect virus samples from patients. Experts use this information to determine which flu strains are circulating and where.
  • Laboratory data refers to antigenic characterization of the flu viruses in a laboratory, which simply means the identification of specific molecular structures on the influenza virus that are recognized by our immune systems and elicit an immune response. The antigen is the “invader” (i.e., in this case, the flu virus) that causes our immune systems to launch an attack through the formation of specific antibodies. Antibodies are what our bodies produce following flu vaccination so that it’s properly “armed and ready” to recognize and fight that specific flu virus if and when we’re exposed.
  • Genetic characterization of flu viruses may also be considered in the selection of vaccine strains. This refers to “mapping” of the genetic codes that make up each flu strain, which allows the experts to monitor changes in circulating flu viruses.
  • Data from clinical studies on vaccine effectiveness are also considered.

With this robust amount of data in hand,  the WHO then meets twice per year to make a recommendation for flu vaccine strains for the upcoming season: once in February to recommend flu strains for the Northern Hemisphere seasonal flu vaccine, and again in September to recommend flu strains for the Southern Hemisphere seasonal flu vaccine. But it doesn’t stop there! Each country then considers the WHO recommendation, reviews the available information, and makes their own decision on which flu strains to include in their country’s seasonal flu vaccine.

In the U.S., once the WHO makes their recommendation for flu strains for the upcoming year’s seasonal flu vaccine, an advisory committee from the U.S. Food and Drug Administration (FDA) meets in February or March to review the WHO’s recommendation and supporting information and vote on the final selection of flu strains. The role of the FDA is an important one, because once the flu strains are selected, the FDA produces materials in their laboratories that are critical for actually producing the flu vaccines. For instance, the FDA provides vaccine manufacturers with the seed viruses and the potency reagents needed to ensure that flu vaccines made by one manufacturer are similar to those made by another. The FDA also conducts quality control measures by ensuring that batches (referred to as “lots”) of flu vaccines released by the manufacturers meet appropriate standards and reflect the correct genetic composition.

Following the selection of flu strains for the seasonal vaccine and receipt of the appropriate materials and information from the FDA, private sector manufacturers begin the process of making the vaccines. All flu vaccines in the U.S. contain the same flu strains, i.e., the flu vaccine available in New York contains the same three or four flu strains as the vaccine that’s available in California. And it’s important to remember that all flu strains (influenza A or B) can be potentially dangerous, regardless of an individual’s health status, and are capable of causing serious illness, hospitalization, or even death.

Influenza is a vaccine-preventable disease that has the ability to affect all of us around the world, which is why it remains such a pressing global public health issue. Seasonal flu vaccines may not be perfect, but given the complexity of flu viruses and their ability to change and mutate frequently, the U.S. does have a solid, scientifically-based approach for flu vaccine development. While much research and development is being done for a universal flu vaccine, the possibility of this technological advancement is still many years off.  In the meantime, let’s not forget all the hard work and research that goes into helping to protect us with the currently available seasonal flu vaccines. And if you’re wondering “why bother” with a flu vaccine that may be substantially less than 100% effective, let’s remember that something is better than nothing, especially when it comes to your life or the life of a loved one.

More in-depth information on how flu strains are selected for the seasonal flu vaccine every year are available from the CDC and FDA


FFF logo_R copyAbout Families Fighting Flu:  Families Fighting Flu (FFF) is a national, nonprofit, 501(c)(3) volunteer-based advocacy organization dedicated to protecting the lives of children and families by helping to increase annual influenza vaccination rates, especially among children 6 months and older and their families.  Our members include families whose children have suffered serious medical complications or died from influenza, as well as healthcare practitioners and advocates committed to flu prevention.  In honor of our children, we work to increase awareness about the seriousness of influenza and to reduce the number of hospitalizations and deaths caused by the flu each year.

Updates from the Advisory Committee on Immunization Practices February Meeting

March 6, 2018 2 comments
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Photo Credit: James Gathany, Centers for Disease Control and Prevention

The Advisory Committee on Immunization Practices (ACIP) held its first meeting of 2018 on February 21st and 22nd.  The Committee consists of a panel of immunization experts that advise the Centers for Disease Control and Prevention (CDC).  Part of their charter is to continually evaluate new data and update or change vaccine recommendations as warranted. 

The agenda for the February 2018 meeting included presentations pertaining to several different diseases and vaccines, to include hepatitis, influenza, anthrax, HPV, pneumococcal, meningococcal and Japanese encephalitis.

A overview of the meeting is provided below, with details on presentations in the order they occurred: 

Hepatitis B

The committee voted unanimously to approve a non-preferential recommendation for a new Hepatitis B vaccine (Dynavax’s HEPISLAV-B™) to their list of recommended vaccines for adults 18 years and older against infections caused by all known subtypes of Hepatitis B.

This vote came following the presentation of data showing that the new two-dose vaccine generates a more rapid and higher antibody response than the standard 3 dose vaccine.

Hepatitis B is a viral disease of the liver that can become chronic and lead to cirrhosis, liver cancer and death. The hepatitis B virus is 50 to 100 times more infectious than HIV, and transmission is on the rise. In 2015, new cases of acute hepatitis B increased by more than 20 percent nationally and 850,000-2.2 million persons are estimated to be living with infection in the U.S.

Since there is no here is no cure for hepatitis B, vaccination is our best chance at preventing the disease. While about 90% of people are infected during infancy, in adults, hepatitis B is most often spread through contact with infected blood and through unprotected sex with an infected person. Some individuals who are especially susceptible include those who are immunosuppressed or living with diabetes. The CDC recommends vaccination for those at high risk for infection due to their jobs, lifestyle, living situations and travel to certain areas.

The Working Group summary suggested that this new vaccine option is likely to improve vaccine series completion and result in earlier protection, which is especially beneficial in persons with anticipated low adherence such as injection drug users.  Additionally, the improved immunogenicity in populations with typically poor vaccine response such as the elderly, diabetics and those on dialysis, is promising.  The ACIP will continue to review post-marketing surveillance studies and additional data to ensure safety and cost-effectiveness considerations.

Hepatitis A

The committee voted unanimously to pass three recommendations pertaining to Hepatitis A.

  • Hepatitis A vaccines should be administered for post-exposure prophylaxis for all persons 12 months of age or older.
  • Hepatitis A vaccine or immune globulin (IG) may be administered to persons 40 years of age or older, depending on the providers’ risk assessment.
  • Hepatitis A vaccine should be administered to infants age 6-11 months of age traveling outside the US when protection against hepatitis A is recommended. This recommendation takes into consideration the fact that infants under 12 months who will be traveling internationally will typically also need an MMR vaccine.  Since Hepatitis A immune globulin and MMR vaccine should not be administered simultaneously, these children should receive a single dose of HepA vaccine. It’s important to note that infants should then complete the full, 2 doses of MMR and HepA vaccines at 12 months of age as recommended.

Influenza

The Committee heard five presentations specific to influenza.

The first two were reports of current season data; one detailing flu surveillance, the other providing early influenza vaccine effectiveness data.

According to the update, the majority of circulating flu strains are similar to those contained in the 2017-2018 vaccine.  The only virus clearly showing antigenic drift was the B/Victoria lineage viruses which represents less than 1% of circulating viruses.  So far this season, influenza A (H3N2) has been dominant, with influenza B activity starting to increase more recently. Activity has been the highest we’ve seen since 2009, and while final severity can’t be determined until the end of the season, hospitalization rates and mortality could be similar to or exceed those send during the severe 2014-2015 season.

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Based on data from 4,562 children and adults with acute respiratory illness enrolled during November 2, 2017–February 3, 2018, at five study sites, the overall estimated effectiveness of the 2017–18 seasonal influenza vaccine for preventing medically attended, laboratory-confirmed influenza virus infection was 36%. The percentage differs by age group and by virus.  A detailed report can be found here.

The most notable news out of the Committee last week was the vote to restore the live attenuated influenza virus (LAIV) vaccine as an option for the 2018-19 season. LAIV is commonly known as the nasal spray flu vaccine or by its brand name, FluMist This renewed ACIP recommendation offers FluMist as one of several vaccine options for non-pregnant people who are 2-49 years of age during the 2018-2019 season, but does not indicate any preference for FluMist over injectable flu vaccines.

While FluMist has not been recommended for the past two flu seasons due to reduced effectiveness against the H1N1 flu strain in children, the Committee heard three presentations specific to LAIV vaccine efficacy in children prior to taking a vote on future recommendations for LAIV.  The first reported on the efficacy of Fluarix Quadrivalent in children 6-35 month of age. Another presented the results of a randomized trial of a new H1N1 LAIV strain in U.S. children. The third was a review LAIV in children 2-17 years of age.  

The possible root cause of the poor effectiveness of LAIV against H1N1 was discussed and poor replication of the H1N1 selected strain was thought to be the likely problem. A new strain selection process is now in place in cooperation with the Food & Drug Administration (FDA) and it suggested that the antibody responses of the latest reformulated version of the quadrivalent vaccine, which includes the new 2017-18 post-pandemic 2009 H1N1 LAIV strain (A/Slovenia), will perform significantly better than what was previously observed when the vaccine included the 2015-16 post-pandemic LAIV strain (A/Bolivia).  Immunogenicity and viral shedding data in small trials supported this notion, but no efficacy data is available at this time.

The Committee was therefore forced to a vote using only the science available to date. There was a lively discussion among members who expressed various concerns. While flu vaccine effectiveness is a serious issue, some committee members expressed concern that they may be holding FluMist to a higher standard than other influenza vaccines, yet all have efficacy challenges from year to year.  Other members were concerned with how the vaccine may perform in an H1N1 dominated season. Until the vaccine is used, further effectiveness assessments are performed, and a prominent H1N1 year occurs, a certain level of uncertainty will remain.

While members voted overwhelmingly (12-2) to reinstate LAIV on the immunization schedule, a second vote to give other flu vaccines a preferential recommendation over LAIV failed (11-3).  So, while the ACIP will not indicate a preference for any one type of flu vaccine over another, the public will ultimately determine whether there will be high uptake of this particular vaccine next season. Read more…