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What Parents of Every Teen Should Know About Meningitis

The most important thing parents of teens need to know about meningococcal disease is that it can be very serious.  And by serious, we mean debilitating and often deadly.

Even with prompt medical treatment, about 1 in 10 people with meningococcal disease will die from it. Of those who survive, about 1 to 2 will have permanent disabilities such as brain damage, hearing loss, loss of kidney function or limb amputations.

The best thing parents can do to protect their children from meningococcal disease is to get them vaccinated against all of the preventable forms of the disease.

 What causes meningitis and meningococcal disease?

Meningitis refers to a swelling of the protective membranes that cover the brain and spinal cord.   While meningitis is commonly caused by a bacterial or viral infection, it can also be caused by injuries, cancer, certain drugs, and other types of infections.

Meningococcal disease is specific to any illness caused by the bacterium Neisseria meningitidis (also referred to as meningococcus or meningococcal meningitis).  These types of infections can cause meningitis, but can also cause bloodstream infections (known as bacteremia or septicemia).

It’s possible to have meningitis without having meningococcal disease, and it’s possibly to have a type of meningococcal disease that isn’t necessarily meningitis.  The specific cause of illness is important to identify because the treatment differs depending on the cause.

  • Bacterial forms of meningitis can be extremely dangerous and fast-moving and have the greatest potential for being fatal. The long-term effects of bacterial meningitis can include multiple amputations, hearing loss and kidney damage. Many, but not all, forms of bacterial meningitis can be prevented by vaccination.
  • Viral meningitis has similar symptoms to bacterial meningitis, but for the most part is neither as deadly nor as debilitating. There is no specific treatment available for viral meningitis, but most patients fully recover over time.
Meningococcal Disease Facts

Who is at risk?

While anyone can contract meningococcal disease, adolescents and young adults are among the population who have a higher risk for the disease due to their lifestyle factors.  For instance, the risk of meningococcal is higher for those who are living in crowded settings such as college dormitories, boarding schools, sleep-away camps or military barracks. Other factors that can raise the risk of infection include:

  • Attendance at a new school with students from geographically diverse areas
  • Irregular sleeping patterns
  • Active or passive smoking
  • Social situations where there is crowding
  • Moving to a new residence

How is it spread?

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 through the exchange of respiratory secretions during close or lengthy contact with someone’s saliva, such as through kissing or coughing, especially if they are living in close quarters.  Although meningococcal bacteria are very dangerous, they cannot live outside the body for very long.  This means that while contagious, the infection is not as easily spread as a cold virus.

How can it be prevented?

Currently, vaccination is the best defense against meningococcal disease. There are five major serogroups of meningococcal disease (A, C, W, Y and B). The three most commonly seen in the United States are B, C and Y, with one-third of all cases in the U.S. being of serogroup B.

In order to be protected against all the preventable strains of meningococcal disease, teens need to receive multiple doses of two different kinds of meningococcal vaccines.

Meningococcal Conjugate Vaccine (MenACWY):  Routine vaccination with the conjugate is recommended at age 11-12 to protect against serogroups A, C, W and Y. Adolescents should also get a vaccine booster dose at age 16.

Meningococcal Serogroup B Vaccine (MenB): This vaccine is recommended for people 10 years or older who are at increased risk for serogroup B meningococcal infections including:

  • People at risk because of a serogroup B meningococcal disease outbreak.
  • Anyone whose spleen is damaged or has been removed.
  • Anyone with an immune system condition known as “persistent complement component deficiency”.
  • Anyone taking a drug called eculizumab (Soliris).
  • Microbiologists who routinely work with N. meningitidis isolates.

The CDC also recommends permissive use of the MenB vaccine for adolescents and young adults age 16-23, with a preferred age of 16 to 18. A permissive recommendation means that it is at a doctor’s discretion whether they will recommend the vaccine to those who don’t fall into the categories listed above.  If a provider doesn’t feel the patient is at risk, they may fail to mention the availability of the vaccine.

This does not mean that a parent can’t request or receive the vaccine for their child.    

It’s critical that parents understand that serogroup B meningococcal disease is not only the most common cause of meningococcal disease in adolescents and young adults, but it has also cause several outbreaks on college campuses over the past few years.

Meningococcal Disease on U.S. College Campuses, 2013-2017

Graphic compiled by the National Meningitis Association

The vaccine has been deemed safe by the FDA, and has been recommended by the CDC, so parents should feel comfortable getting the vaccine for their child, especially if they feel they are at risk of exposure.  If a child is attending college, parents may want to take the precaution of getting them vaccinated before they arrive on campus.  In the case of an outbreak, the vaccine will be recommended.  However, if your child is exposed before the outbreak is identified than it may be too late to benefit from the vaccine.

What are the symptoms and can it be treated?

The symptoms of meningococcal disease are the same for all of the serogroups.  Unfortunately, it is not easy for healthcare professionals to identify and diagnose the infection in its early stages and it’s often mistaken for the flu or other viral infections.  Symptoms tend to develop over several hours or over one or two days, and may include:

  • Sudden high fever
  • Severe headache
  • Stiff neck
  • Vomiting or nausea with headache
  • Confusion or difficulty concentrating
  • Seizures
  • Sleepiness or difficulty waking up
  • Sensitivity to light
  • Lack of interest in drinking and eating
  • Skin rash

Meningococcal disease can be treated with antibiotics, but treatment must begin early to be effective. Even if treatment is started as soon as possible, it might not prevent death or serious long-term complications such as hearing loss, brain damage, kidney disease or limb amputations.

Today we are grateful for moms like the ones featured in this video who are helping to raise awareness about the two available meningococcal vaccines for adolescents and young adults. May their stories help parents to make educated decisions about disease prevention.

Visit the following websites for more information on the dangers of meningitis and how it can be prevented.

Vaccinate Your Family – PreTeens & Teens Meningococcal Disease

National Meningitis Association

The Kimberly Coffey Foundation

The Emily Stillman Foundation

Meningitis Angels

Is Your College Student Protected from This Deadly but Preventable Disease?

December 21, 2016 1 comment

Parents often go to great lengths to help their children succeed in college.  What they may not realize is that their children often arrive on campus unprotected from a life threatening, yet preventable disease known as meningococcal serogroup B.  

Four women, known as the ‘MenB Strong Moms’,  became united on a mission to save others after their teen children died from meningococcal serogroup B before a vaccine was available to prevent the disease.  Through a special partnership between The Kimberly Coffey Foundation and The Emily Stillman Foundation, they produced the following Meningitis B Shatters Dreams PSA to educate young adults and their parents about the availability of the MenB vaccine and to encourage college kids to get vaccinated while home for winter break.

“Our kids have brought us together and their message is loud and clear in this PSA.” says Alicia Stillman, Director of The Emily Stillman Foundation.  “We don’t want parents to have to bury their children like we have, and we want kids to take it upon themselves to get protected and ask for the MenB vaccine.”

In the past few years, there have been outbreaks of meningococcal serogroup B on several U.S. college campuses.  This isn’t surprising considering that one out of ten people have the bacterium that causes meningococcal disease in the back of their nose and throat with no signs or symptoms of disease.  Additionally, typical teen behaviors, such as living in close quarters, hanging out in large groups, sharing drinks or utensils, and kissing, all increase the risk of meningococcal disease.

And when meningococcal disease strikes, it strikes quickly.  In fact, one in ten teens and young adults who develop meningococcal disease will die from it, sometimes within 24 hours.  Those lucky enough to survive will often suffer significant physical and mental disabilities, ranging from deafness, nervous system problems, brain damage, or loss of limbs.

While most teens receive the recommended meningococcal vaccine known as MenACWY at age 16, or prior to attending college, the MenACWY vaccine does not prevent the serogroup B strain.  Since this B strain accounts for approximately half of all meningococcal cases in the U.S. among those age 17-22, the MenB Strong Moms believe it is imperative that young adults and their parents understand the options for prevention.  Unfortunately, although the MenB vaccine has been licensed for over a year, many doctors are still not mentioning it to their patients and therefore, most parents and young adults don’t realize the vaccine exists. Read more…

I Want Parents to Know About the Additional Meningococcal Vaccine That Could Have Saved My Daughter

August 25, 2016 1 comment
This guest post has been written by Patti Wukovits, a Registered Nurse and Executive Director of The Kimberly Coffey Foundation, as part of National Immunization Awareness Month’s week-long focus on the importance of preteen and teen vaccination.

PattiAndKimberlyCoffey

As a mother and a nurse, I was vigilant in having both of my children up-to-date on all recommended vaccinations, including meningococcal vaccination. I was under the common misconception, as many parents are, that the meningococcal vaccine that my daughter received would fully protect her from meningococcal disease, when in fact, it didn’t protect her against meningitis B. The meningococcal vaccine (MCV4) only protects against four of the five common groups (ACWY), leaving adolescents and young adults vulnerable to meningitis B. Meningitis B is a type of bacterial meningitis, also known as meningococcal disease, which is a potentially fatal bacterial infection that can kill a healthy person within 24 hours.KimberlyCoffey

When my daughter Kimberly Coffey died in 2012 from bacterial meningitis, a vaccine was not available to protect her. But since 2014, meningitis B vaccination has been available in the United States. Kimberly was a perfectly healthy 17-year-old high school senior, and I believe she would be alive today if meningitis B vaccination had been available to her.

I established The Kimberly Coffey Foundation in Kimberly’s honor to educate other parents and health care providers about meningitis B, also known as MenB.

It’s critical that parents know that MenB vaccination is now available, and that without requesting MenB vaccination in addition to the common meningococcal vaccine (MCV4), their child will not be fully protected against meningococcal disease and MenB.

The Kimberly Coffey Foundation has partnered with Pfizer on the National Meningococcal Disease Awareness Survey to gain a better understanding of parents’ knowledge of meningococcal disease and its available vaccines.  This 2016 survey revealed that nearly 4 out of 5 parents didn’t know their child wasn’t fully immunized against the five common groups of meningococcal disease unless they had two meningococcal vaccines (MCV4 and MenB).

The bottom line is this – without adding MenB vaccination, we are going to lose more lives. There will continue to be more college outbreaks, especially since MenB has been responsible for several recent college outbreaks in the United States.  According to data released by the CDC, MenB currently accounts for approximately 50% of meningococcal disease in the United States among persons aged 17-22 years old. MenB vaccination is available for individuals ages 10-25, and public health insurance and most private insurance plans provide coverage.  However, your child’s provider may not mention it.

I want parents to have the knowledge to request MenB vaccination, in addition to the meningococcal vaccine, so that their children can potentially be fully protected against this devastating disease.

As a mother who lives every day with the heartache of not seeing my beautiful daughter live the full life she deserved, I know only too well how important MenB vaccination is. My daughter Kimberly’s life was one too many lost to this terrible disease.

KimberlyCoffeyFoundationLogoI will be Kimberly’s voice as I continue to promote awareness of meningococcal disease, which includes MenB. I don’t ever want another parent to experience what I have. And more important, I don’t want another person to experience what Kimberly did when she battled for her life.

Kimberly contracted MenB two years too early—two years before the MenB vaccine was made available.  She didn’t have the protection of the MenB vaccination, but your children can. Please protect your children – because YOU can.

 

For more information about meningitis B and the MenB vaccine, please visit the Kimberly Coffey Foundation at www.kimberlycoffeyfoundation.org.

 


Every Child By Two (host of the Shot of Prevention blog) welcomes guest blog posts on a variety of vaccine related issues.  The views and opinions expressed in these guest posts do not necessarily represent the views of the Every Child By Two organization.

Meningococcal Disease Killed My Child, But a New Vaccine Means it Doesn’t Have to Kill Yours

August 2, 2016 2 comments

Me head and shoulderThis guest post was written by Neal Raisman, PhD, to highlight the threat of meningococcal disease in the U.S. as part of Vaccinate Your Family’s “State of the ImmUnion” campaign.

My son Isaac was a very healthy 26-year-old who worked out every day and took great pride in how and what he ate. On September 24, 2005 he called home from college to tell his mother he had a terrible headache and felt lousy. Since he complained of chills and a fever, my wife and I thought he was suffering with the flu and told him to get some sleep and drink lots of fluids. He called again to report that the headache was even worse and he felt even sicker. Again, his mother re-assured him that it was probably the flu.

IsaacLittle did we know at that time, but Isaac did not have the flu.

What he had was serogroup type B meningitis and it was quickly eating at his body and brain.

He died soon after that call with his mother. It wasn’t until later that night that I was able to get into his apartment where I found his body. This is the last photo that was ever taken of our son.

Isaac had received a meningitis vaccine before college, but back in 2005, the only meningococcal vaccine available was one that covered the serogroup strains of A, C, W and Y.  At that time there was no vaccine to prevent the B strain that killed our son.

But there is now.

I’m sharing our story today so that every mother and father will know that serogroup B meningococcal disease kills and maims without mercy.

Not every person infected will die like Isaac.  Sometimes victims will live in a brain-dead coma.  Some will lose limbs.  Now that I know how quick and devastating this disease is, I must caution parents to do everything they can to protect their children before it is too late.

In 2014, nine years after we lost Isaac, the FDA approved the first vaccine to prevent the serogroup B strain of meningococcal disease.

In order to offer the most complete protection from all the preventable strains of meningococcal disease, this MenB vaccine needs to be administered in addition to the MenACWY vaccine that is already on the recommended immunization schedule.

While the current burden of disease appears to be low, there have been outbreaks of serogroup B meningococcal disease at U.S. colleges that have resulted in loss of limbs and loss of life.  Following FDA approval, it is customary for the Advisory Committee on Immunization Practices (ACIP) to evaluate the data and determine whether the vaccine should be added to the recommended schedule.   With FDA approval, the safety of the vaccine was not in question, however the ACIP felt it was necessary to continue to review data pertaining to vaccine effectiveness, duration of effectiveness and impact of the vaccine on carriage and herd immunity.  Therefore, the initial ACIP decision was to make a routine recommendation for individuals at highest risk of disease and in outbreak situations, while recommending that those in the 16-23 year age range “may be vaccinated to provide short term protection against the strain”. This is what is known as a “permissive” or “Category B” recommendation.

In the beginning, there was speculation that due to this “Category B” recommendation, that not all insurance companies would cover the cost of the vaccine.  However, as a condition of the Affordable Care Act (ACA), all health plans must start covering any recommended vaccine (even Category B) with no out-of-pocket costs when provided by an in-network healthcare provider.  Health plans have until one year after the effective date of the recommendation to comply, so it is possible that some patients won’t be covered until their plan renewal, which may occur more than a year after the October 2015 recommendation was made. However, public health partners nationwide continue to report that providers (including Vaccine For Children providers) are not universally stocking the vaccine, nor making strong recommendations for its use. In addition, although the majority of health plans are covering the cost, some may not be following ACA guidelines, which can be quite ambiguous. Some may be covering the cost of the vaccine for one category of recipients (i.e. high risk) but not those who “may” be vaccinated.

As a parent of a child who died from meningococcal disease, I still worry that this ambiguous recommendation is leaving our children unprotected.

A vaccine is now available to prevent the B strain that my son died of.  Yet this limited recommendation means that many doctors won’t be discussing the availability of the vaccine, and many parents won’t know that the vaccine is available.  Worse yet, many parents may wrongfully believe their child is fully protected from all the preventable meningococcal strains when their child receives the MenACWY, which is not accurate.

So now we are left wondering, what is the benefit of the serogroup B meningococcal vaccine if parents aren’t aware that it is available or believe they can’t afford it?  How many lives will be lost due to the current policy?  And what will it cost to stop letting young men and women be horribly maimed or die?

Read more…

One Mother’s Mission to Save Lives And Prevent Meningococcal Disease

July 25, 2016 1 comment

imagesAfter losing her son Evan to meningococcal disease, Lynn Bozof’s life became a mission to prevent other families from experiencing similar tragedies. She has since co-founded the National Meningitis Association (NMA), to help educate people about the dangers of meningococcal disease. In this special State of the ImmUnion post, Lynn addresses some of the most common questions parents have asked her about meningococcal disease and the ways it can be prevented.  

How would you describe the current “State of the ImmUnion” for meningococcal disease? How many cases of meningococcal disease are there in a typical year?  Are enough people protected?

In the 14 years since NMA was founded, vaccination rates have climbed steadily while disease incidence has declined. Although we are pleased with this progress, there is much more work to be done to strengthen the State of the ImmUnion.

Annually, there are approximately 800-1200 cases of meningococcal disease in the United States. As an organization comprised of survivors and families who have lost children to this devastating disease, we at NMA know that one case is too many.

While the Centers for Disease Control and Prevention (CDC) routinely recommends meningococcal vaccines beginning at age 11-12, one in five U.S. teens are not vaccinated as recommended and one-third of those who get the first dose don’t go on to get their booster dose. This leaves adolescents unprotected as they enter some of their most vulnerable years.

What can parents do to protect their families from meningococcal disease?

Evan_BozofAs a parent who lost my college-age son, Evan, to meningococcal disease, I urge all parents to make sure their child is vaccinated. Vaccination offers the best protection against this disease, and parents should understand that to be fully vaccinated against meningococcal disease, your child should receive two kinds of meningococcal vaccines.

There are five major serogroups of meningococcal disease: A, C, W, Y and B.

MenACWY Vaccine:  The Centers for Disease Control and Prevention (CDC) recommends meningococcal vaccination against serogroups A, C, W and Y for all children at 11-12, with a booster at age 16.

MenB Vaccine: After the FDA approved this vaccine in 2014, the CDC made a permissive recommendation for children ages 16-23, with a preferred age of 16 to 18 years.

Because it behaves somewhat differently, the B serogroup was not included in the ACWY vaccine, and it took longer for scientists to design an effective vaccine.

Today, nearly half (43 percent) of all meningococcal disease cases among U.S. teens and young adults are caused by serogroup B. Since MenB is a relatively new vaccine, and not routinely recommended, many parents and healthcare professionals remain unaware of this vaccine. This is particularly concerning since it’s the most common cause of meningococcal disease in adolescents and the cause of several outbreaks on college campuses in recent years. This is why we urge parents to have a conversation with your child’s doctor to ensure your child is fully vaccinated.

My doctor never mentioned a separate vaccine for serogroup B?  Why is that?

While the MenACWY vaccine has been routinely recommended since 2005, the MenB vaccine received FDA approval in 2014. That is not to say this is a “new” vaccine. The MenB vaccine has been used in other countries for many years already, and safety and efficacy data from these countries has been extensively reviewed by the CDC’s Advisory Committee for Immunization Practices (ACIP). After FDA approval in the U.S., the Committee gave this vaccine a permissive or “category B” recommendation. Unlike a routine recommendation, this recommendation puts more responsibility on parents to request the vaccine, which is why it is important to be proactive and ask your doctor about it.

Are there certain people who should be particularly concerned about meningococcal disease?  How easily does it spread?

Vaccines are recommended for adolescents and young adults because they are at higher risk of contracting meningococcal disease.

The following factors increase the risk of disease: being an adolescent or young adult, spending time in large crowds like parties or dorms, and participating in behaviors like kissing or sharing drinks. But, anyone at any age can contract it.

Other people who are at higher risk for the disease include:

  • Infants under 1 year of age
  • People living in crowded settings like college dorms or military barracks
  • People living with HIV
  • Those with persistent complement component deficiency or anatomic or functional asplenia
  • People traveling to certain areas outside the U.S. such as the meningitis belt in Africa
  • Laboratory personnel who are routinely exposed to meningococcal bacteria
  • Those who might have been exposed to meningococcal disease during an outbreak

Meningococcal disease is contagious. It is spread through the exchange of respiratory secretions during close contact such as kissing, sharing drinks or coughing on someone. Although meningococcal bacteria are very dangerous, they cannot live outside the body for very long. This means the infection is not as easily spread as a cold virus. 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.

Of those who contract the disease, 1 in 10 will die and 2 in 10 will suffer from long term complications, including deafness, brain damage, or limb amputations.

StateoftheImmunion_Mening_FB

My child was required to get a meningitis vaccine before middle school. Is she still protected or does she need a booster?  If so, when should she get one?

Read more…

Highlights of the Latest Meeting of the Advisory Committee On Immunization Practices

February 26, 2016 4 comments

Three times a year a specialized group of medical and public health experts meet in Atlanta to review scientific data related to vaccine safety and effectiveness. Although most people are probably unaware that these meetings occur, this is not some clandestine group.  Far from it actually.  Meeting dates and proposed agendas are available in advance, all meetings are open to the public and available via webcast, public comments are accepted, and past meeting notes and slide presentations are accessible online.

What amazes me is that the 15 voting members, 8 ex officio members and 30 non-voting representatives of this group participate voluntarily.  In addition to the three meetings per year, members serve in various work groups that are active all year long.  Work groups  review the latest studies on specific vaccines, as well as the safety and efficacy of those vaccines, in order to provide recommendations to the larger committee.

They work hard and take their responsibilities very seriously.  And they should, because this group, known as The Advisory Committee on Immunization Practices (ACIP), has an enormous responsibility.  They establish, update and continually evaluate 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 and health insurance coverage of vaccines is based on these recommendations.

Original Title: BLDG21_0023.jpgIf you’ve ever attended a meeting or tuned in to a live webcast, you know how thorough they are in their investigation of the science that is the driving factor behind every recommendation they make.  Earlier this week, in their first meeting of 2016, ACIP members discussed a variety of vaccines to include HPV, meningococcal, influenza and Japanese encephalitis, as well as Zika virus. For those who were unable to attend the meeting or tune in via webcast, I would like to provide a brief recap of the major discussion items.

HPV Vaccination: 

The discussion focused on the ongoing review of data comparing the immunogenicity of human papillomavirus (HPV) vaccine after a 2 dose schedule versus a 3 dose schedule. 

As early as June 2014, the ACIP began reviewing data for 2 dose bivalent and quadrivalent HPV vaccines.  The World Health Organization has been recommending a 2 dose schedule since 2014 for children starting the series before age 15 and most other countries who primarily administer bivalent or quadrivalent HPV vaccines are already using a 2 dose schedule.  These 2 dose schedules are recommended in foreign countries for use with the bivalent and quadrivalent vaccines.  Here in the U.S. the ACIP began recommending the 9-valent HPV vaccine, which provides protection from additional strains of HPV in February, 2015.  Vaccination with 3 doses was recommended at that time.

In evaluating the possibility of reducing the number of doses from 2 to 3 here in the U.S., the ACIP reviewed data on the immunogenicity of a 2 dose versus 3 dose HPV vaccination schedule to determine whether a different schedule could provide similar, acceptable levels of protection in the months and years following vaccination as compared to what is expected with a 3 dose schedule. The Committee reviewed three studies comparing 2 doses versus 3 doses of the bivalent HPV vaccine, three studies comparing 2 doses versus 3 doses of quadrivalent vaccine (one from Canada, one from Mexico and a large trial from India), and preliminary findings from a ongoing study of 9-valent vaccine that is expected to continue for two more years.

Each study was conducted slightly differently and provided an extensive amount of data to consider. For instance, some studies differentiated between the timing of the doses, (such as 0, 6 month dosing and 0, 12 months dosing versus the 0, 6, 12 month interval that is currently recommended).  Some studies also accounted for differences in gender, ages of administration of doses (for instance, young girls versus older women and girls versus boys).  There was even data that differentiated between the seroconversion rates at different intervals after vaccination and among the antibody titers for the different HPV types.

The data appears to suggest that a 2 dose schedule may be a consideration moving forward.  However, the ACIP’s HPV Work Group still needs to evaluate all the data in greater detail before they can present their recommendations for further discussion and approval by the entire ACIP Committee at a future meeting.

The Committee still needs to consider that completion of a 2 dose regimen would be important since the effectiveness of a single dose is known to be lower.  Currently,  completion rates for the 3 dose regimen remains suboptimal and there would be even less flexibility in a 2 dose regimen.  Additionally, the duration of protection from a 2 dose 9-valent vaccine has not been determined, but is currently undergoing investigation.  This type of data will likely need to be evaluated in comparison to a 3 dose schedule before proceeding with a change of recommendation.

A study released earlier this week suggests that we may be witnessing a herd effect with HPV vaccine.  Despite only 40% of girls and 22% of boys being vaccinated, the rate of HPV infections among young women has plummeted by two-thirds since the introduction of the vaccine.  Before altering the current recommendations, the Committee may also want to consider the comparative herd effect in a 2 dose versus 3 dose schedule.

It was noted that  the vaccine manufacturer is seeking FDA approval of a 2 dose 9-valent HPV vaccine, which should be determined within the year.  In the meantime, if the ACIP were to recommend a 2 dose schedule before the FDA review is complete, the recommendation would be considered off label. Although some may question an off label recommendation, the ACIP has made other off label recommendations when sufficient evidence suggests it is reasonable to do so.

Meningococcal Vaccine: 

The ACIP reviewed several post-approval studies of meningococcal serogroup B vaccine  to further evaluate the vaccine’s safety and efficacy profile.  Additionally, the Committee was presented with data from a mass immunization campaign that occurred in response to a large meningococcal serogroup B outbreak in Quebec, Canada.  There was also discussion pertaining to a possible increased risk of meningococcal disease among HIV infected persons.

As background, it was noted that the ACIP issued a recommendation for meningococcal serogroup B vaccine in 2015 following FDA licensure.  Prior to the licensure of the vaccine, the FDA approved special use of the vaccine in response to outbreaks of the disease on various college campuses.   While both the ACIP and the FDA have previously reviewed the efficacy and safety data available from pre-licensure vaccine trials, and from the use of the vaccine in many countries that have licensed and administered the vaccine ahead of the U.S., the Committee will continue to review post-approval studies to ensure the vaccine’s safety and efficacy.

This week, the Committee reviewed four safety and immunogenicity studies, all of which demonstrated a high proportion of individuals who achieved a high consistency of response across the studies.  The safety profile seemed consistent with the safety data at licensure and phase three studies confirmed that the vaccine elicits bacterial responses that correlate to protection against the four most prevalent strains circulating in the U.S., as well as 10 additional strains.  The data continued to demonstrate broad protective response when used for both outbreak control and prevention of endemic disease.

Additionally, there was a review of a mass immunization campaign following a significant outbreak in Quebec, Canada.  The data suggests direct protection during 18 months following vaccination with 100% vaccine effectiveness observed among the 47,115 vaccinated people and two cases among two unvaccinated adults.  There was additional data presented on the safety profile and observational evidence pertaining to adverse events such as pain and fever post injection.

The meningococcal vaccine discussion also suggested that there is a growing body of evidence that supports an increased risk of meningococcal disease among HIV-infected persons.  This is of particular interest since the ACIP doesn’t currently include HIV-infected persons on the list of people at high risk.  This is largely due to evidence that suggests that the meningococcal vaccine offers suboptimal vaccine response and duration of protection among this particular demographic of HIV-infected persons.  In contrast, the American Academy of Pediatrics does in fact recommend MenACWY vaccine for HIV infected persons ages 2 and up.  So, while the Meningococcal Work Group seems supportive of adding a recommendation to include HIV infected persons, they will continue to review additional data and will report back to the full Committee at a future meeting.

During the public comment period of the meeting, Lynn Bozof from the National Meningitis Association, raised the concern that the public is having difficulty locating MenB vaccine.  She provided anecdotal evidence that her member families seeking MenB vaccination for their children have had to make up to five calls to providers to gain access to the vaccine.  She feared that less motivated families would simply give up.  She asked that the ACIP consider the ramifications of their permissive Category B recommendation for MenB vaccination, which in her opinion does not carry the strength of a full Category A recommendation.

ACIP’s current recommendation as posted on the CDC website states that “Teens and young adults (16 through 23 year olds) may also be vaccinated with a serogroup B meningococcal vaccine (Bexsero® or Trumenba®), preferably at 16 through 18 years old. Two or three doses are needed depending on the brand.”  “Preteens, teens, and young adults should be vaccinated with a serogroup B meningococcal vaccine if they are identified as being at increased risk of meningococcal disease.”  This is quite different than the Category A recommendation for the vaccine to prevent the A,C,W and Y strains of meningococcal.  The recommendation states that “all 11 to 12 year olds should be vaccinated with a single dose of a quadrivalent (protects against serogroups A, C, W, and Y) meningococcal conjugate vaccine (Menactra® or Menveo®)”.   The small differences in recommendation types can make a big difference in the number of individuals who are offered the vaccine, have access to the vaccine and ultimately get vaccinated.

Influenza Vaccine: 

There were two significant discussions pertaining to influenza vaccine.  First, the CDC announced that based on interim vaccine effectiveness data it appears that getting a flu vaccine this season has helped reduced the risk of having to go to the doctor because of flu by 59%.  Additionally, data suggests that there is a very low rate of adverse reaction to flu vaccine in people who have egg allergy and that since the same reactions occur at the same rate in non-egg-allergic people, the ACIP will be removing egg allergy warnings for influenza vaccination. 

The influenza surveillance data from this season indicates that influenza activity in the U.S. has been lower this season than in the last three seasons, and that there is a good match between the most common circulating viruses (A (H1N1) and B) which may explain why the vaccine is offering significant protection this season.  It was also noted that there have been 13 pediatric deaths this season.

The Committee also learned that among the 73.7 million children in the U.S., 1.3% or approximately 958,100 children have some type of egg allergy.  Current flu vaccine recommendations for those with allergy to egg are quite extensive, including a long algorithm which must be considered by vaccine administrators.  The recommendation that children be monitored post vaccination or seek the advice of an allergist may result in parents avoiding influenza vaccine all together for their children.  However, this may no longer need to be the case.

In the review of 27 published studies involving flu vaccine and egg allergy, most studies included patients with history of severe anaphylaxis with egg ingestion. These patients tolerated the vaccine without any serious reactions such as respiratory distress or hypotension.  While there was a very low rate of minor reactions such as hives and mild wheezing, these reactions occurred in non-egg-allergic people at the same rate.  Similarly, there was a one in one million chance of anaphylactic reaction to flu vaccine among egg-allergic people, which is the same rate in response to flu and other vaccines in non-egg-allergic people.  The research suggests that there haven’t been serious reactions to flu vaccine in people with egg allergies because flu vaccines contain minimal egg ovalbumin and therefore are unlikely to cause a reaction in egg-allergic people.  In fact, it was demonstrated that the manufacturers have actually over-estimated the amount of egg ovalbumin contained in both the IIV (injected) and LAIV (live attenuated/nasal) vaccines.

Based on the Committee’s review of this data, the ACIP voted to remove the precautions about IIV and LAIV flu vaccine for people with a history of egg allergy.  The ACIP Influenza Work Group was tasked with developing the exact wording of the recommendation post-meeting, which will be approved for the 2016-2017 season.  Stay tuned for the exact recommendation changes.

Japanese encephalitis vaccine:

The ACIP reviewed data on the current recommendation for travelers to receive Japanese encephalitis vaccination.  Studies regarding the safety of the vaccine and duration were presented to the Committee and it was determined that there was insufficient data to spur the inclusion of a booster (2nd) dose of the vaccine.  The latest data will however be included in an upcoming MMWR and further considered at a future meeting.

Zika Virus:

The Committee was given an overview of the international efforts to quell outbreaks of the Zika virus and develop a potential vaccine to protect against future infections worldwide.  Collaboration among global experts was similar to the impressive response to the Ebola outbreaks and the conversation regarding the potential for a future vaccine was encouraging.

While this recap offers a glimpse into the type of considerations that the ACIP addresses and the extensive amount of research they regularly review, these highlights do not go into the length necessary to recount the entire meeting.  If you should be interested in seeing the slide presentations made to the Committee, simply check for the slides to be updated here within the next week or two.  If you should have questions, please let us know in the comments below and we will do our best to address them.  Additionally, by subscribing to this Shot of Prevention blog in the upper right corner of the page you can ensure that you will receive notice of ACIP updates and meeting recaps in the future.

How My Vaccinated Daughter Died From Meningitis and What I’m Doing About It

February 2, 2016 8 comments
This is a guest post, written by Alicia Stillman, Director of the Emily Stillman Foundation.  One of the missions of the Foundation is to raise awareness of meningococcal disease and the various vaccines that are now available to prevent it.    

February 2, 2013 my life changed forever.  I was told my beautiful and healthy nineteen year old daughter no longer had any brain activity, and that she would die.  Those words will forever haunt me.  There is no preparation, no training, and no practice for what was to come.  The loss of a child is like none other.  It is the wrong order. When you lose a child, a piece of you dies as well.

EmilyStillman

Emily was a sophomore at Kalamazoo College when she tragically contracted bacterial meningitis.  On February 2nd, 2013, Emily passed away with her family by her side.  Emily was able to donate 6 of her organs to 5 recipients, along with tissue and bones to countless others.

On January 31, 2013 my middle daughter Emily called home from college, and mentioned she had a headache.  I thought she was possibly coming down with the flu.  She thought it may be from lack of sleep.  We decided she would take Motrin and go to bed.  Several hours later she woke up to increased pain and was taken to the hospital where she was treated for a migraine.  It was not until hours later that the medical professionals realized they may be looking at meningococcal disease, and performed a lumbar puncture to confirm.

The entire two hour drive to the hospital I begged the medical professionals to double check the results.  Since I knew my daughter had been vaccinated against meningitis, I did not believe it was possible for her to have that disease.  I feared that something else would go untreated, and I wanted them to heal her.

When I arrived at the hospital, Emily was already unconscious as they prepared her for a craniotomy to relieve the swelling in her brain.  When the nurse took me to see her, she asked if I wanted them to call clergy.  That was the first time I actually realized the seriousness of this disease.  I did not understand how this could be happening.  My daughter only had a headache.  She was vaccinated.

Within 30 hours from the onset of her headache, my daughter was brain dead.  Her life was over.  We decided Emily would want to be an organ donor.  She was able to save five lives with six organs, and countless others with her bones and tissue.  She was a hero.

StillmanFamily2As I said goodbye to my sweet daughter in that hospital bed, I made her a promise.  Read more…