Archive

Posts Tagged ‘MenB vaccine’

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

March Madness Requires Both Shots To Defeat Meningococcal Disease

This guest post was provided by the National Meningitis Foundation (NMA) and first appeared on their Parents Who Protect blog.  

 

As our obsession with basketball’s March Madness has progressed to the Final Four, our efforts to encourage “both shots” in the fight against meningococcal disease remain at center court.

While March is a time when basketball steals the headlines, it’s also a time when meningococcal disease steals our children.  In fact, while meningococcal disease can strike at any time of year, the number of cases peaks in the winter and early spring. Unfortunately, for many National Meningitis Association (NMA) members, such as the member of Moms on Meningitis (M.O.M.) and Together Educating About Meningitis (T.E.A.M), March is a time when we remember those we lost to meningococcal disease.

And there have been plenty of others who never got their “shot” at life.  

NMA March Madness Infogram

The higher incidence of meningococcal disease in March can be seen in the headlines of the last few years.

In March 2014, a Drexel University student died after visiting Princeton University, which was nearing the end of an outbreak that impacted eight students. In 2015, the University of Oregon was battling an outbreak of meningococcal disease with two additional cases appearing in March. In 2016, students at both Penn State and Rutgers University were hospitalized with meningococcal disease in March. This year there were cases on three college campuses by mid-March: Wake Forest UniversityOld Dominion University, and Oregon State University. There has also been an outbreak, at an elementary school in Virginia.

To rise to the challenge of this other recurring “March Madness”, we must increase our efforts to raise awareness of meningococcal disease and its prevention.

There are two kinds of vaccines that students need to be protected from meningococcal disease, the MenACWY vaccine and the MenB 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 (MenACWY).
  • CDC recommends permissive use of meningococcal vaccination against serogroup B at ages 16-23, with a preferred age of 16 to 18 years (MenB). (Click here for more information.)

It’s important that students remain vigilant and be able to recognize the symptoms of meningococcal  disease including headache, fever, stiff neck, and a purplish rash, so that you can promptly seek medical attention.

SOTI_Mening_FB.png

This March, let’s get on the ball and take “both shots” to prevent the other March Madness.

The National Meningitis Association is a nonprofit organization founded by parents whose children have died or live with permanent disabilities from meningococcal disease.  Their mission is to educate people about meningococcal disease and its prevention.  To stay informed about meningococcal disease and how to prevent it, follow The National Meningitis Association on Facebook and Twitter and be sure to subscribe to their Parents Who Protect blog.

 

 

Make Sure Your College Student Has These Shots Before Returning To Campus

iStock_000078067721_Double.jpgTeens and young adults have a tendency to believe they’re completely invincible.  But their lifestyle – which often involves high levels of stress, inadequate amounts of sleep and close living quarters – can put them at an increased risk of certain infections such as flu, mumps, meningitis and HPV.  As students return to class after winter break, they’re  reunited with classmates, roommates, and professors who may have been exposed to infectious diseases during their travels to other states or other countries.

While it’s impossible to prevent every cough and sniffle, parents can help protect their kids by ensuring they’re up-to-date on all their recommended vaccines.

So what are all the vaccines that are recommended for teens and young adults?  

And wouldn’t they be required for school anyway?

Vaccine requirements vary by state and don’t necessarily include all the vaccines that the CDC recommends. Therefore, as winter break come to an end, parents should review their students’ immunization records and arrange for them to get any missing shots before they return to class.

Here are a few of the diseases that students should be protected against.

Influenza

Influenza is a dangerous viral infection that causes hundreds of thousands of hospitalizations and thousands of deaths each year in the U.S., even among health people of all ages.  For the best protection, the CDC recommends that everyone over the age of 6 months receive an annual influenza vaccine.

animated-young-adults

Unfortunately, while flu vaccination rates are typically the highest among children, rates tend to drop among teens and young adults. If your college student hasn’t already received their annual flu vaccine it’s not too late.  Bring them to their healthcare provider or local pharmacy to get them protected before they return to campus. Although it can take up to two weeks to develop antibodies post-vaccination, flu season often extends well into Spring, so students will benefit from protection for many months to come.

Mumps

Mumps may not be considered “common” in the U.S. thanks to a 99% decrease in mumps cases once mumps vaccination began in 1967, but there have been several mumps outbreaks on college campuses in the past year, and approximately 4,258 cases across 46 states and DC in 2016.

screen-shot-2017-01-04-at-3-47-00-pm

This shouldn’t come as much of a surprise when you consider that crowded environments, such a large classes and dormitory living can all contribute to the likelihood of outbreaks.  Also, since mumps is spread primarily through saliva, coughing and sneezing, teen behaviors such as kissing or sharing plates, utensils, cups, lipstick or cigarettes, are all factors that can increase the likelihood of transmission. Read more…

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 from June Meeting of Advisory Committee on Immunization Practices

June 30, 2016 1 comment

Original Title: BLDG21_0023.jpg

Three times a year a specialized group of medical and public health experts meet to review scientific data related to vaccine safety and effectiveness. 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. Health insurance coverage of vaccines is based on these recommendations and the ACIP guidelines are considered the gold standard among healthcare providers.

Last week, in their second meeting of 2016, the ACIP discussed cholera, meningococcal, hepatitis, influenza, RSV and HPV vaccines, as well as the safety of maternal Tdap immunization and the laboratory containment of Poliovirus Type 2.  

Below you will find a recap of the highlights of the June 2016 ACIP meeting to help keep you informed of the latest ACIP recommendations and considerations. 

Influenza Vaccine

The most significant and somewhat surprising decision that occurred during last week’s ACIP meeting was that the Committee voted in favor of an interim recommendation that live attenuated influenza vaccine (LAIV), also known as the nasal spray flu vaccine, should not be used during the 2016-2017 flu season. 

The vote followed an extensive review of data investigating the effectiveness of the nasal spray flu vaccine over the past three flu seasons.  The data showed vaccine effectiveness for nasal spray vaccine among children 2 through 17 years during 2015-2016 was only 3% effective (with a 95% Confidence Interval of -49-37%). In comparison, flu shots had a vaccine effectiveness estimate of 63% against any flu virus among children 2 through 17 years (with a 95% Confidence Interval of 52-72%). This estimate clearly indicates that while no protective benefit could be measured from the nasal spray vaccine in this past season, flu shots provided measurable protection in comparison.

The disappointing vaccine effectiveness data for the nasal spray vaccine during the 2015-2016 season follows two previous seasons (2013-2014 and 2014-2015) that also showed poor and/or lower than expected vaccine effectiveness for LAIV.  (More information about past LAIV VE data is available here.)

child_h1n1_flu_shotWhile it’s disheartening to see data suggesting that the nasal spray flu vaccine did not work as well as expected, the data did suggest that flu shots did perform well and offered substantial protection against influenza this past season. Some patients prefer the nasal spray flu vaccine due to an aversion to needles and may be disappointed in this vote. However, the action taken by the ACIP  emphasizes the important role they fill in continually measuring and evaluating vaccine effectiveness.  Only after a thorough review of the latest scientific data and discussion among the Committee do they decide to alter vaccine recommendations to ensure that they are in the best interest of the public’s health.

ACIP continues to recommend annual flu vaccination, with either the inactivated influenza vaccine (IIV) or recombinant influenza vaccine (RIV) for everyone 6 months and older and the CDC expects that there should be no shortage of injectable vaccines.  However, it should be noted that with the ACIP vote the nasal spray flu vaccine should not be used during the 2016-2017 season and therefore should not be offered by providers or clinics and will not be covered under the Vaccines For Children (VFC) program.

Cholera Vaccine

A vote was taken to recommend the vaccine for people traveling to high risk areas. 

For more information about cholera visit the CDC travel page here and for up-to-date travel alerts that address various destinations and diseases, we recommend visiting Passport Health’s travel alerts here.

Meningococcal Vaccine

The first part of the discussion of meningococcal vaccines was a consideration of the data on the serogroup B vaccine Trumenba.  This particular vaccine is currently administered on a three dose schedule, however Pfizer’s Dr. Laura York indicated during her presentation that the FDA has approved both a 2 and 3 dose schedule based on the data showing both schedules to be considered safe and effective.  While immunity data suggests that the 3 dose schedule may confer slightly greater immunity over longer periods of time, the 2 dose schedule would be considered optimal in the case of an outbreak or when it is important to confer rapid immunity.   The committee will be reviewing more data on the duration of immunity and the safety of a 2 dose versus 3 dose schedule at the October meeting, before a formal recommendation is made for persons at increased risk, for use during outbreaks or for all healthy adolescents. 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.