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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!

 

 

 

 

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.

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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Shingles Vaccine is the Silver Lining of Turning 50

April 19, 2018 9 comments

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Turning fifty is a milestone most people would rather avoid.  

Not me.  

After watching both my 73-year-old mother and my 18-year-old daughter suffer with shingles, I would do almost anything to avoid it. And last year, when a new and more effective shingles vaccines was licensed by the FDA, and recommended by the Advisory Committee on Immunization Practices (ACIP) for people age 50 and older, I began looking forward to my 50th birthday.

You see, now that I’ve witnessed shingles up close and personal, I am eager to prevent it and I feel compelled to encourage everyone to as well.  And here’s why…

Vaccination is the Only Way to Prevent Shingles

You can’t avoid shingles by washing your hands or avoiding sick individuals.  The only means of prevention is through vaccination.

That’s because shingles isn’t your typical contagion. It’s a virus, but not the kind that is spread from person to person through coughing or sneezing. It’s actually a virus (the herpes zoster virus), that is caused by another virus, (the varicella-zoster virus, more commonly known as chickenpox).

Over the past two years I’ve watched as both my mother and my daughter have suffered with shingles, and I’ve learned a few things along the way.   

Shingles Pain Is Excruciating, Debilitating and Can Be Long Lasting

ShinglesImageThe rash then developed into fluid-filled blisters that would break open, ooze out and eventually crust over.  She had to be careful to keep the rash covered and wash her hands frequently since she didn’t want to infect my newborn niece who was living in the same home at the time. Since my niece had not yet received her varicella vaccine, she was not immune to the virus and would be at risk of developing chickenpox.  As a premature infant, that could have been extremely dangerous for her.   Read more…

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…

Some Things You Outgrow as an Adult. Vaccines Aren’t One of Them.

August 17, 2017 1 comment

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Did you know that vaccines are recommended for people of all ages?

Even if you were fully vaccinated as a child, the protection from some vaccines you received can wear off over time and you may need a booster. There also are specific vaccines that you may need as you get older based on your age, job, lifestyle, travel, or other health conditions.

Below are 5 reasons adults need vaccines:

 

1) Every year, thousands of adults in the U.S. suffer serious health problems, are hospitalized, or even die from preventable diseases.

Much of this could be avoided if more adults received their recommended vaccines. While most adults recognize the need for childhood vaccinations, many adults simply don’t realize that vaccines are recommended to protect against diseases like whooping cough, hepatitis A and B, pneumococcal disease, shingles and influenza.

The latest data from the Centers for Disease Control and Prevention (CDC) shows that vaccination rates for adults are extremely low (National Health Interview Survey, 2014).

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Higher vaccination rates could help avoid the many cases of vaccine preventable diseases that adults suffer with each year.  For example, in 2015 there were about 27,000 cases of invasive pneumococcal disease and 3,300 deaths among adults. In 2016, there were more than 15,000 cases of whooping cough reported to the CDC.  Additionally, there are about 1 million cases of shingles and millions of cases of influenza that occur each year in the U.S.

2) Certain health conditions can put adults at greater risk of complications if they do get sick. 

As we go through life we’re often diagnosed with certain health conditions that put us at increased risk for complications from diseases such as pneumonia and influenza.  This includes conditions such as heart disease, asthma, chronic obstructive pulmonary disease (COPD) and diabetes. Even if we feel we have those conditions under control, it is best to get vaccinated to prevent an illness that can complicate these conditions and cause severe illness, hospitalization or even death.

3)  Adults are more likely to contract certain diseases.

As we age, we also become more likely to suffer with diseases such as shingles or pneumococcal disease.  That is why adults 65 and older are recommended to receive one or more pneumococcal vaccines, and those 60 years and older should get a shingles vaccine.

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Read more…