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Meningococcal Disease: How to Be Sure Your Teens Are Fully Protected

September 18, 2018 2 comments

Guest Post By Lynn Bozof, President, the National Meningitis Association

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This post was written by an extraordinary woman who passed away only days ago. Lynn spent the last phase of her life fighting to ensure that mothers, fathers, siblings and family members would never suffer the devastation of losing a child to a disease called meningitis. Many parents are now aware of this disease, and that is in large part due to the tireless advocacy and educational efforts of Lynn, and the many families who support the work of the National Meningitis Association.  The entire vaccine community will miss you dearly Lynn.  Every Child By Two  promises to remain steadfast in our shared goal to save others from this terrible disease.


 

 

As a parent, it’s no surprise that the busy lives of teenagers can leave little wiggle room between school schedules, homework, and numerous extra-curricular activities. It’s hard to believe we’re already only a few weeks away from Thanksgiving break. Those off days from school are the perfect time to check in with your child’s healthcare provider to make sure they’ve received all recommended vaccines to prevent against deadly diseases – including meningococcal disease.

In 1998, I lost my son Evan Bozof to meningococcal disease – commonly referred to as bacterial meningitis. Evan was a vibrant, healthy teenage athlete, but within a month my husband and I watched this terrible disease attack every part of Evan’s body and ultimately take his life. No one had ever told me that there was a vaccine available that might have prevented it.

Ever since then, I’ve made it my mission to spread awareness of bacterial meningitis and encourage parents to get their children vaccinated. As we head into the colder months, here is everything you should know about this disease and the vaccines available to prevent it.

 

What is Meningococcal Disease?

 

Meningococcal disease is a rare but potentially deadly bacterial infection involving the inflammation of the membranes (meninges) surrounding the brain and spinal cord. The disease strikes quickly and can lead to devastating complications if your teen has not been fully vaccinated.

Of those who contract meningococcal disease, 10 to 15 percent die from it. Among those who survive, as many as 20 percent live with permanent disabilities, such as brain damage, hearing loss, loss of kidney function or limb amputations. Vaccinations offer the best protection against meningococcal disease.

Symptoms and Progression: What is Important to Know

 

Meningococcal disease is often misdiagnosed, as early symptoms resemble those of other illnesses such as the flu. They may include sudden high fever, headache, nausea, vomiting and exhaustion, and can progress into sensitivity to light, abnormal skin color or rash, with the most extreme symptoms being confusion, delirium or loss of consciousness.

Symptoms of meningitis advance incredibly quickly. Within 24 hours, patients can go from being entirely healthy to near death.

 

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What You Should Know About Vaccination Options

 

There are two vaccines available to prevent against the five major strains of bacteria (A, C, W, Y and B)that cause meningococcal disease. The MenACWY vaccine protects against four strains, while the MenB vaccine protects against the fifth.

The Centers for Disease Control and Prevention (CDC) recommends the MenACWY vaccine to all adolescents at age 11-12, with a booster at age 16.

The MenB vaccine was recommended for permissive (aka Category B) use among those age 16-23 – with preferred vaccination between 16 and 18 – by the CDC in 2015. Older adolescents and young adults can decide, in collaboration with their doctors, whether they’d like to receive the MenB vaccine. Nearly MenACWYevery insurance plan covers the MenACWY and MenB vaccines, and adolescents without insurance can get vaccinated at little to no cost.

The NMA believes that all adolescents should be vaccinated against meningitis B, as it is the strain most commonly linked to outbreaks on college campuses. Vaccination is always the best method of meningitis prevention.

For a full list of those recommended by the CDC for meningococcal vaccination, please visit the CDC website.

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Why Teens Are Most at Risk

 

Meningitis is a rare disease, but once it strikes it can prove deadly within a matter of hours. Teens and young adults are the group most at risk because they often live in close quarters – like a dormitory – and tend to share beverages more often than adults or young children.

In the winter of 2016, three cases of meningitis occurred at the University of Santa Clara. The year before, the University of Oregon experienced a six-month meningitis outbreak that infected seven students and left one dead.

Increasingly, colleges have begun mandating that students receive the second dose of the MenACWY vaccine – as well as the MenB vaccine – prior to matriculation. The NMA fully supports these efforts and believes that the best path to meningococcal prevention is complete vaccination.

 

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About one in ten people carry meningococcal bacteria in their nose or throat without showing any signs or symptoms of the disease. These people can unknowingly transmit the bacteria to others.

 

Putting It into Perspective

 

It’s normal for kids and teens to think they’re invincible and not see the importance of getting vaccinated. Caitlin Brison was a high school senior when her doctor asked at her routine checkup if she wanted to receive the second meningitis vaccine. Not wanting another needle, Caitlin said no. That decision ultimately came back to haunt her.

In college, Caitlin contracted a severe case of bacterial meningitis that ultimately led to months of dialysis, as well as memory loss and physical therapy to re-learn how to walk. Several years later, she received a kidney transplant. Caitlin says she can still remember that day in the doctor’s office like it was yesterday. “My first question was ‘Do I have to have it?’’’ she says. “He said no, so then I said no, and that was a big, big mistake.”

Cases like Caitlin’s serve as a reminder to parents and adolescents to think about the big picture when it comes to vaccination. A small prick in the arm is nothing in comparison to kidney failure, loss of arms or legs, or any of the other debilitating after- effects that survivors of meningitis often must manage for the rest of their lives. Listening to survivors talk about their long and painful paths to recovery illustrates not only the horror of meningitis, but the importance of vaccines as prevention.

If I had known that there was a vaccine available to prevent against bacterial meningitis, my son might still be alive today. The NMA continues to advocate for the broadest possible vaccine recommendations from the CDC so that other families don’t have to experience the truly devastating impact of meningococcal disease.

 

Where Can I Find More Information?

 

Following are additional resources that provide more information about meningococcal disease and prevention methods, including vaccination:

 

 

 

 

Fifty and Fabulous, But NOT Fully Vaccinated

August 29, 2018 3 comments

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By Amy Pisani, Executive Director, Every Child By Two

As the 2018 National Immunization Awareness Month comes to an end, with a focus on adult vaccines this week, I look back on the three personal milestones I have reached over the summer and thought about how much my resolve to ensure that people are aware of the need to vaccinate at every stage in life has been strengthened. As many people are aware, vaccines are critical to ensuring the health of babies, and as our children grow older they continue to need booster doses of certain vaccines as well as other vaccines to protect them against different diseases. But did you know that vaccines are recommended for people of all ages?

Every year in the U.S., thousands of adults become seriously ill, and many even die, from vaccine-preventable diseases. Even if you received vaccines as a child, your immunity can wear off over time. You may also be at risk of different diseases depending on your age, job, lifestyle, travel, or chronic health conditions.  As I am now in the midst of several life changes, my perspective on vaccines for adults of all ages has also naturally shifted.

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Sending my fully vaccinated son off to college this past week was my most recent life-changing milestone.

I’m proud to say that while I was making sure my son was up-to-date on all his vaccines throughout his preteen and teen years, I was also encouraging dozens of my friends and family members to protect their children from influenza (flu) and cancer-causing HPV through immunizations.  More recently, as my friends and I prepared to send our kids off to college, I urged them to make sure their children received both vaccines against meningococcal disease (MenACWY and MenB), a dangerous, and sometimes deadly, disease that has taken the lives of too many young adults, which we discussed at length in last week’s blog post.

My second big milestone was becoming Fifty and Fabulous. 

 

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Turning 50 means that, in addition to my annual flu vaccine and my one-time Tdap vaccine, it’s now time to also protect myself against the shingles virus. As the big day approached I started noticing signs at the local pharmacies regarding a shortage of shingles vaccine (Shingrix®).  I sent photos of the signs to my coworkers, joking that I didn’t know what I would do with myself on my birthday, knowing that I couldn’t pop into my doctor’s office or pharmacy to get vaccinated as I planned on my big 5-0 day.

In all seriousness, what does it mean to be offered protection against shingles at age 50, rather than having to wait until age 60, which was the starting age for the previously recommended shingles vaccine called Zostavax®? For starters, Zostavax®, while a good vaccine, only reduced the risk of shingles by about 50% and protected against long-term nerve damage (PHN) by about 67%.  The newer vaccine, Shingrix®, which was approved by FDA in 2017, offers a 97% reduction in your chances of getting shingles and 91% reduction against long-term nerve damage. And, since the Shingrix® vaccine offers longer-lasting protection against shingles and its complications, it is now recommended by the CDC for all healthy adults age 50 and older (even if you got the Zostavax®, vaccine before).

So what is shingles and why am I among the 1 in 1,000 people in the U.S. who are at risk of getting this virus? Shingles is a painful rash of blister-like sores caused by the varicella zoster virus – the same virus that causes chickenpox. After you’ve had chickenpox, the virus lies inactive in nerve tissue near your spinal cord and brain. Years later, the virus may get reactivated causing shingles to develop. The most common complication of shingles is postherpetic neuralgia (PHN). People with PHN have severe pain in the areas where they had the shingles rash, after the rash clears up. The pain from PHN usually goes away in a few weeks or months; however, for some people, the pain from PHN can last for years.shingles

Luckily, Millennials and future generations will be spared the misery of both chickenpox and shingles due to development of the chickenpox (varicella) vaccine, which was recommended for routine use in the U.S. in 1995.  However, being a child of the late sixties, and one of five girls in my household, you bet I caught the chickenpox!  While it is usually a mild disease in children, prior to the routine use of the chickenpox vaccine in the U.S., approximately 11,000 children were hospitalized and about 100-150 children died each year due to serious complications from chickenpox.

Back to my fifty, fabulous and fully vaccinated plan, AND my third milestone

 

Unfortunately, my plan to be fully vaccinated on my 50th birthday didn’t go as planned.  The Shingrix® vaccine is still out of stock in both my doctor’s office and my pharmacy. But I plan to get it as soon as it becomes available again. While I know I should keep my anxiety at a minimum, I truly don’t want to end up as one of the four out of 1,000 people in my age cohort who thought she was invincible, waited to get vaccinated, and ended up with a debilitating, but preventable case of shingles. Practice what you preach definitely needs to be added to Every Child By Two’s official mission statement! Which brings me to my third exciting milestone this month – I celebrated over two decades as the Executive Director of Every Child by Two, which has by far been one of the greatest priveleges of my life (next to raising my wonderful boys).

Paying for the Shingles Vaccine Is Complicated

 

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As a vaccine advocate, I am incredibly dismayed to know that not all adults will have as easy of a time paying for the shingles vaccine as I will. I am lucky that my current health plan will cover 100% of the cost of my vaccine, but others, including those on Medicare Part D may not be as fortunate. As I await the end of the shingles vaccine shortage, I have hardened my resolve to be an even louder advocate alongside partners such as the Adult Vaccine Access Coalition (AVAC), a group that strives to prevent the deaths of over 50,000 adults from vaccine-preventable disease (VPDs) every year in the U.S. AVAC also seeks to put an end to the enormous economic burden caused by treating adults who contract VPDs, and works to ensure fair and equitable vaccine coverage for older Americans (like me). Stay tuned for my personal shingles vaccination photo op, hopefully in the near future!

 

 

 

 

Meningitis B and Your College Student: Preventing the Call

This important post is being published to highlight Preteens & Teens Week during National Immunization Awareness Month.  Please take the time to talk to your child’s healthcare provider to make sure he or she is up-to-date on all recommended vaccines. (A version of this post was originally published on Shot of Prevention on February 14, 2018.)

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Emily and the Stillman family after her high school graduation.

Emily was a 19-year-old college student when she called home complaining of a headache. Thirty-six hours later, she passed away due to serogroup B meningococcal disease (also known as meningitis B). Emily was able to donate six of her organs, together with bones and tissue, to save the lives of five others.

Emily’s mother, Alicia Stillman, who graduated from Arizona State University, returned to Arizona after founding The Emily Stillman Foundation to honor her late daughter’s life. She shared the story of how Emily contracted meningitis B and her family decision to donate Emily’s organs. She also explained the work she is doing to help educate others about the availability of serogroup B meningococcal vaccines (MenB) in the United States and to encourage organ donation. She spoke with Debbie McCune Davis, Director of The Arizona Partnership for Immunization (TAPI), who is leading the effort to increase awareness of the approved vaccine and who is working with the universities in Arizona to promote the Off to College education campaign.

Together these two women share a message of hope, as they work to save lives and prevent serogroup B meningococcal disease by educating parents, students, educators and medical professionals across Arizona and the nation.

Alicia: I always felt I was living a blessed life. I enjoyed motherhood. I had three beautiful children, a wonderful husband, and a successful career. I believed I was doing everything right to raise healthy, independent children, as I sent each one off to college.

My middle daughter Emily had a fabulous first year away at a small liberal arts college in Kalamazoo, Michigan. In 2013, she was well into the second semester of her sophomore year when she called home one evening, complaining of a headache. Thinking it was from lack of sleep, I advised her to take some ibuprofen, and to touch base with me in the morning. Little did I know that was to be the last time I would ever hear my Emily’s voice.

The call the next morning wouldn’t come from my Emily, but rather from the Dean of the college. She told me my daughter had been admitted to the hospital during the night with bacterial meningitis, that she was very sick, and I needed to get there as soon as possible. I remember insisting that this was not possible because even at that time, I knew she had received “the meningitis shot”.  In fact, I even remembered that before she left for college, she had received a meningitis booster. What I did not yet know at that time was that the vaccine she had received (MenACWY) only protected her against 4 of the 5 common serogroups of meningococcal disease. I had no idea that there was a strain (serogroup B) she was not protected against because a vaccine for that strain was not even available in the United States at that time.

Less than 36 hours later I said goodbye to my baby. My beautiful girl that I had promised to always protect and take care of was gone. As I said goodbye to her on that cold February morning, I told her that I would be ok…and that I would figure this out.  I would make sure this could not happen to other people.

Debbie: Stories like Alicia’s couldn’t be prevented in the U.S. when Emily Stillman was infected with meningitis B and lost her life to the disease, but they are today. In October of 2014 and January of 2015, the FDA approved licensing for two different vaccinations to protect against serogroup B meningococcal disease. Soon after that, the CDC’s Advisory Committee on Immunization Practices (ACIP) recommended that college students talk with their doctors about the meningitis B vaccine (MenB).

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Off to College TAPI’s campaign to educate college students and their parents about vaccinations needed before school.

In Arizona, our Board of Regents (the governing board of our state university system) took quick action to recommend all incoming freshmen get the vaccine.  There had been outbreaks in the PAC 12 schools and Arizona wanted to promote healthy campuses. We, at TAPI, worked with the universities, their medical directors and all of our professional medical organizations including osteopaths, pharmacists, nurses, and pediatricians to put forth a unified message and raise awareness.

Alicia: I live my promise to my Emily every single day with my work at The Emily Stillman Foundation. Before the vaccine was approved in the U.S., I discovered the vaccine was available in Canada. We took busloads of families across the Detroit/Windsor border into Canada to get the MenB vaccine. We met with the Food and Drug Administration (FDA) and many members of Congress to urge the fast tracking of the licensing process. I testified at the CDC and encouraged ACIP to grant a firm recommendation to protect our adolescents and young adults. I set up vaccination clinics locally to provide the vaccine before medical practices were willing to hear about it. I speak nationally, working with colleges, medical practices, and parents to raise awareness to this hideous disease, its symptoms, and the vaccinations now available to prevent it. I won’t stop until the MenB vaccine is on the required list, and is available to all people.  Only then will my promise to my Emily be fulfilled. 

Debbie: Today, we at TAPI are taking it a step further…we don’t want kids to wait until they’ve moved into their dorms to receive their vaccination. We are working with high schools, parents groups, physicians, athletic departments and more to promote Vaccinate Before You Graduate here in Arizona. We want this to become part of the college prep routine—take your college entrance exams, turn in your transcripts, apply for scholarships, choose your school, order your cap and gown and vaccinate.

As mothers and as experts – one from a heart-breaking loss, and one as a professional who works tirelessly to prevent disease – we urge you to enjoy these moments with your child.  However, as you are giving them that final send off, smoothing the bedding on their dorm bunk, stocking snacks and toiletries, telling them to study hard and have fun (but not too much fun), asking them to be safe, be sure to also give them the tools to stay healthy. Make sure they have their boosters, that they are up-to-date on all vaccination and be sure your health professional has given your child protection from all strains of meningitis, including meningitis B. If your child has already started that journey and is off to college, check with the student health services at their school for information about vaccine availability on campus. Do it for your child, do it for yourself and do it for Emily.

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Watch this video from the Meningitis B Action Project to learn more about MenB in 90 seconds

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Alicia Stillman lives in West Bloomfield, Michigan with her husband of 29 years, Michael. In addition to her angel daughter Emily, she has two live children – Karly, 25, and Zachary, 21. Alicia holds an MBA in Management Accounting, and is the Accounting Director for a multi-state law firm. She is the Co-Founder and Director of The Emily Stillman Foundation, founded in 2014 in memory of her late daughter Emily. The Foundation has a trifold mission to raise awareness for and encourage organ and tissue donation, to educate about meningococcal disease as well as all vaccine-preventable diseases, and to advocate globally for all health and wellness issues. Most recently, Alicia partnered with Patti Wukovits to co-found the Meningitis B Action Project. Alicia can be reached through the Foundation at emilystillmanfoundation@gmail.com.

McCune DavisDebbie McCune Davis has served as Director for The Arizona Partnership for Immunization, better known as TAPI, since February 1996. She was an elected member of the Arizona Legislature, serving from 1979 until 1994 and again from January 2003 until her retirement in January 2017, serving in both the House of Representatives and the Arizona State Senate. In her local community Debbie serves on numerous committees and task forces, working to improve the health status of women and children in Arizona. She has established a reputation for being a knowledgeable advocate for maternal and child health and childcare issues. In 2012 she was recognized for her advocacy by the Children’s Action Alliance in Phoenix and Every Child By Two in Washington, DC. Debbie also served on the Board of Directors of the American Immunization Registry Association and she volunteers her time as a member of the planning committee of the National Conference on Immunization and Health Coalitions. She is married to Glenn Davis and has a blended family of 5 children and 3 grandchildren. More information about TAPI may be found at www.whyimmunize.org.

Learn More

Vaccinate Your Family

National Meningitis Association

Meningococcal Vaccination for Preteens and Teens: Information for Parents (CDC)

CDC’s Recommended Immunization Schedule for Preteens and Teens (En español)

 

How Do We Know Vaccines are Safe?

August 15, 2018 8 comments

Vaccinate Your Family_MomGrandmaLittleGirlToo often, we hear misinformation about vaccines and their safety. Some people claim that they are not tested for safety before being licensed and recommended for use in people in the United States. Others say that vaccines are not held to the same safety standards as drugs, when in fact they are held to a higher standard. And some others wrongly proclaim that vaccines are not monitored for safety after they are licensed by the U.S. Food and Drug Administration (FDA) and recommended for the public by the Centers for Disease Control and Prevention (CDC), as they are unaware of the strong vaccine surveillance systems we have in place in the U.S.

The United States has the safest, most effective vaccine supply in its history.

Below, we offer an overview of how vaccines are tested and monitored for safety and effectiveness:

Clinical trials

Vaccines are one of the most thoroughly tested medical products available in the U.S. Before a vaccine can be considered for approval by the FDA, a vaccine manufacturer must show it is safe and effective through clinical trials. Developing a new vaccine begins with exploratory stage and pre-clinical stage before advancing to three stages of clinical trials. Together, this scientific process can take over a decade and cost millions of dollars. The FDA then examines these studies and determines whether a vaccine is safe, effective, and ready to be licensed for use. The FDA only licenses vaccines that have data that shows that the vaccines’ benefits outweigh the potential risks. If there is any question about the data, or any holes in the data, the FDA will request further studies before approving the vaccine.

Four monitoring systems 

After a vaccine is licensed for use in the U.S., there are four systems in place that work together to help scientists monitor the safety of vaccines and identify any rare side effects that may not have been found in clinical trials. Even large clinical trials may not be big enough to find very rare side effects. For example, some side effects may only happen in 1 in 100,000 or 1 in 500,000 people. Second, vaccine trials may not include certain populations like pregnant women or people with specific medical conditions who might have different types of side effects or who might have a higher risk of side effects than the volunteers who got the vaccine during clinical trials.

Vaccine Adverse Events Reporting System (VAERS)

VAERS is a passive reporting system. That means it relies on individuals to report vaccine reactions. Anyone can report a reaction or injury, including healthcare providers, patients and patients’ representatives, such as caregivers or attorneys. The system is co-managed by the FDA and the CDC. However, it is important to note that VAERS data alone can’t be used to answer the question, “Does a certain vaccine cause a certain side effect?” This is because adverse events reported to VAERS may or may not be caused by vaccines. There are reports in VAERS of common conditions that occur just by chance after vaccination. Further investigation may find no medical link between vaccination and these conditions. Instead, the purpose of VAERS is to see if unexpected or unusual patterns emerge, which may indicate a vaccine safety issue that needs to be researched further.

The Vaccine Safety Datalink (VSD)

Established in 1990, VSD is a collaboration between the CDC’s Immunization Safety Office and eight health care organizations across the country. It conducts studies based on questions or concerns raised from the medical literature and reports to VAERS. In addition, when new vaccines are recommended or if changes are made in how a vaccine is recommended, VSD will monitor the safety of these vaccines.

The Clinical Immunization Safety Assessment Project (CISA)

CISA, which was created in 2001, is a national network of vaccine safety experts from the CDC’s Immunization Safety Office, seven medical research centers and other partners. CISA addresses vaccine safety issues, conducts high quality clinical research and assesses complex clinical adverse events following vaccination. CISA also helps to connect clinicians with experts who can help consult on vaccine safety questions related to individual patients.

The Post-Licensure Rapid Immunization Safety Monitoring System (PRISM)

PRISM is a partnership between the FDA’s Center for Biologics Evaluation and Research and leading health insurance companies. It actively monitors and analyzes data from a representative subset of the general population. PRISM links data from health plans with data from state and city immunization information systems (IIS). PRISM has access to information for over 190 million people allowing it to identify and analyze rare health outcomes that would otherwise be difficult to assess.

These four post-licensure monitoring systems have been able to address several important issues related to vaccines and their safety, including:

The Department of Health and Human Services (HHS) and its agencies, health insurance companies, scientists, healthcare providers, and other public health and medical groups are all dedicated to ensuring people of all ages are protected against serious infectious diseases by a safe, effective supply of vaccines.

Supercharge Your Kid’s Cancer Fighting Power

July 18, 2018 2 comments

By: Jennifer Zavolinsky, Director, Outreach Initiatives, ECBT

Kids having fun with mumIt’s hard to believe how quickly the summer is rushing by. The July 4th holiday is in the rearview mirror and stores are already putting their summer clothes on clearance. So now is a good time to start thinking about what you need to do to prepare your kids to go back to school.

Are You the Parent of an 11- or 12-Year-Old? 6-reasons-listicle-05

Make sure your preteen gets the three vaccines that protect against whooping cough (Tdap), meningococcal disease (MenACWY) and HPV cancers (HPV).

We can reduce the risk of our children getting certain cancers later in life by helping them make healthy choices now, including eating a healthy diet, staying away from tobacco, wearing sunscreen and being physically active. We can also help prevent most HPV cancers with just two shots of the HPV vaccine.

HPV vaccination helps prevent six types of cancers caused by the human papillomavirus (HPV) in both men and women including cervical, vaginal, vulvar, anal, penis and throat cancers. Every year in the United States, HPV causes approximately 32,000 cancers in men and women, and HPV vaccination can prevent most of the cancers from ever developing.

HPV is a Common Virus that Infects Teens and AdultsHPV is a common virus

HPV is so common that most people will get the virus at some point in their lives. About 14 million people in the U.S., including teens, become infected with HPV each year. HPV is passed during intimate sexual contact. You can get HPV by having vaginal, anal or oral sex with a person who has the virus. And the virus can be passed even when an infected person has no signs or symptoms. Most HPV infections go away on their own without lasting health problems. However, there is no way to know which infections will turn into cancer. That is why it is important that all children get vaccinated against HPV.

Vaccines are for Prevention, Not Treatment

Since vaccines are for prevention, not treatment, they only work if given BEFORE coming in contact with a virus. That’s why you want to get your child vaccinated against HPV at 11 or 12 years old. In addition, scientific studies have shown that children have the best immune response to the vaccine at these ages. The HPV vaccine is given as a series of two shots, and the series should be completed by age 13.

HPV Vaccines Are Continuously Monitored for Safety

Like all vaccines recommended in the U.S., HPV vaccines are monitored on an ongoing basis to make sure they remain safe and effective. With approximately 100 million doses of HPV vaccine distributed so far in the U.S., data continues to show that HPV vaccines are safe, effective and give long-lasting protection.

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Make sure to ask your preteen’s health care provider about the HPV vaccine at his/her next appointment.

Commonly-Asked Questions

Are HPV vaccines safe?

Yes, numerous research studies have been conducted to make sure HPV vaccines are safe, both before and after the vaccines were licensed. Before the three HPV vaccines were licensed for use in the U.S. by the FDA, each went through years of testing in thousands of people through clinical trials. After being licensed, the CDC and FDA have continued to monitor the safety of the HPV vaccines through the three surveillance systems in the U.S. Over 100 million doses of HPV vaccines have been distributed in the U.S. so far and HPV vaccines continue to have a good safety record.

Like any vaccine or medicine, HPV vaccines can cause side effects, but the most common side effects are mild. They include pain, redness or swelling in the arm where the shot was given; dizziness; fainting; nausea; and headache. The benefits of HPV vaccination far outweigh any potential risk of side effects.

Does the HPV vaccine contain dangerous ingredients?

No, the HPV vaccine does NOT contain harmful ingredients. While HPV vaccines, like some other vaccines, do contain a small amount of aluminum in order to boost the body’s immune response to the vaccine, it’s important to realize that people are actually exposed to aluminum every day. Aluminum is commonly found in numerous food and beverages, water, infant formula and even breast milk. Aluminum-containing vaccines have been used for decades and have been given to more than 1 billion people without problems. The quantities of aluminum present in vaccines are low and are regulated by the FDA’s Center for Biologics Evaluation and Research (CBER). Learn more about the use of aluminum and other ingredients in vaccines.

If I vaccinate my preteen now, won’t the vaccine wear off by the time he/she goes to college?

No, if you vaccinate your child at age 11 or 12, he or she should continue to be protected against HPV through college. Studies continue to monitor how long the vaccine protects against HPV infections, and protection has been shown to last at least 10 years with no signs of the protection weakening.

If I give my preteen the HPV vaccine, won’t it be like giving them permission to start having sex?

No, there have actually been scientific studies that have looked at this issue, and they show that there is no correlation between receiving the HPV vaccine and increased rates of, or earlier engagement in, sexual activity.

My child is not sexually active. Why should I vaccinate him/her against HPV now?

Preteens should receive all recommended doses of the HPV vaccine series long before they begin any type of sexual activity. Even if your child delays sexual activity until marriage, or only has one partner in the future, he or she could still be exposed to HPV if his/her partner has been exposed to HPV. Studies have shown that the HPV vaccine is most e­ffective in preventing the virus, and therefore HPV cancers, when given at age 11 or 12.

Can HPV vaccination cause infertility?

No, there is no evidence that HPV vaccination causes fertility or reproductive problems. In fact, getting HPV vaccine, which protects against cervical cancer, can help ensure a woman’s ability to get pregnant and have healthy babies. For example, a woman who develops cervical cancer later in life due to HPV infection may require serious treatments that could leave her unable to have children. It’s also possible that treatment for cervical pre-cancer could put a woman at risk for problems with her cervix, which could cause preterm delivery or other problems. HPV vaccination can help prevent these complications.

Learn more about HPV vaccination at vaccinateyourfamily.org

 

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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American Cancer Society Announces Goal to End HPV Cancers

June 8, 2018 2 comments

It has been 12 years since the FDA approved the first HPV vaccine. To mark the occasion, the American Cancer Society has launched a public health campaign with one very ambitious goal – to eliminate vaccine-preventable HPV cancers.  

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Since the HPV vaccine has been proven to be so highly effective, experts and organizations in the U.S. and around the world are talking about how the vaccine can be used to eliminate HPV cancers, starting with cervical cancer. As one of the most respected cancer organizations in the world, the American Cancer Society is uniquely positioned to lead the fight against all HPV related cancers.

How do they plan to achieve this goal?

By using their Mission: HPV Cancer Free Campaign to increase HPV vaccination rates for preteens to at least 80% by June 2026, the 20-year anniversary of the FDA’s approval of the first HPV vaccine.

Considering the number of adolescents who are receiving other recommended vaccines, like the meningococcal vaccine, this objective seems both reasonable and achievable.

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However, in order for the vaccine to prevent any of the six HPV related cancers, such as cancer of the cervix, vulva, vagina, penis, anus, head and neck (also called oropharyngeal cancer), children need to be vaccinated before potential exposure. By getting children vaccinated as recommended, at 11-12 years of age, parents can help ensure the vaccine is administered before sexual activity begins, and when studies show children to have the most optimal immune response to the vaccine.

While the HPV vaccine has been shown to be both safe and effective, the unfortunate reality is that only about 40% of boys and girls in the U.S. are fully protected with the recommended 2 or 3 doses of HPV vaccine.  This is unfortunate because we know that 9 out of 10 adults will have an HPV infection at some point in their lifetime.

6-reasons-listicle-04Many of these HPV infections may eventually clear up on their own. However, the fact remains that some infections will develop into dangerous cancers years, or even decades, after initial exposure. While doctors routinely screen for cervical cancer, there are no recommended cancer screening tests for the other 20,000 cases of cancers caused by HPV infections each year in the United States. Considering that there are often no early symptoms of these cancers, many of these cases will go undetected until they have progressed to a late and dangerous stage.

This is why HPV vaccination is so important.  Preventing cancer is always better than treating it. 

 

So how can you help the American Cancer Society in their goal to end HPV cancers?

 

Parents:

Educate yourself about HPV and make sure the children in your life are vaccinated. Read some of the most common myths about HPV vaccine here and help to dispel these myths by sharing accurate and evidence-based information about HPV and HPV vaccination with your friends and family.

Learn more about HPV and HPV vaccination, by reviewing the informative new resources that have been developed as part of the American Cancer Society’s Mission:HPV Cancer Free campaign, to include the following:

Also, hear the stories of HPV cancer survivors and the providers who have cared for them to consider why prevention is critical in our fight to end cancer.

Clinicians and Health Care Providers:

Your strong recommendation is the biggest predictor of whether your patients will receive timely HPV vaccination. To ensure you are prepared to make the most of your discussions with your patients and their parents, check out the library of provider resources available on the National HPV Roundtable website. There is even a special suite of Clinical Action Guides tailored to six different professional audiences, to include:

  • Physician/Physician Assistant/Nurse Practitioner Guide
  • Nurse & Medical Assistant Guide
  • Dental Health Professionals Guide
  • Large Health Systems Guide
  • Office Team Guide
  • Small Private Practices Guide

The goal of the Mission: HPV Cancer Free campaign may be to increase HPV vaccination, but the purpose behind the goal is our ultimate motivator. With the HPV vaccine, we have the power to prevent cancer, and that is something that deserves a chance.  By uniting in this endeavor, we can change lives, save lives and make HPV cancer history.