Serogroup B Meningococcal Vaccine Approved But Awaiting CDC Recommendations

October 30, 2014 2 comments

This mMeningococcalonth another college student succumbed to a strain of meningitis that is not covered in the currently recommended meningococcal vaccine. In 2013 and 2014 outbreaks of serogroup B meningococcal disease occurred at Princeton University and University of California’s Santa Barbara (UCSB) campuses, prompting health officials to request special permission from the Food and Drug Administration to utilize a vaccine that is not currently licensed in the United States. More than 5,000 Princeton University students received the first dose of the MenB vaccine in December 2013, and more than 4,700 students received the second dose in February 2014. At UCSB, as many as 9,000 students received the first dose in February and March 2014 and more than 7,000 received the second dose in April 2014.

While some questioned the wisdom of using a vaccine that had yet to be licensed here in the U.S., clinical trials in other countries have shown that the same vaccine met safety and efficacy standards that cleared the way for licensure in the European Union, Canada, and Australia back in 2013. More than one million doses of the vaccine have since been distributed to over 30 countries where the vaccine was licensed, with little to no sign of serious adverse events. And, it has been determined that there have been no unusual patterns or occurrence of serious reactions reported among the students vaccinated here in the U.S.

Two different manufacturers (Pfizer and Novartis) have sought FDA approval of their MenB vaccines. Yesterday Pfizer received final approval and Novartis will be informed regarding the FDA’s decision in the next few months. In anticipation, the CDC’s Advisory Committee on Immunization Practices (ACIP), a group of medical and public health experts that develop vaccine recommendations to help control diseases in the U.S., has been receiving reports from their meningococcal subcommittee. This subcommittee is tasked with investigating the epidemiology of this disease and the results of the clinical trials. These reports become critical in helping the ACIP to ultimately vote on whether the vaccines will be recommended to the public once approved and under what parameters.

Of course, this will be no easy job. It’s important to understand that there are five main serogroups (“strains”) of meningococcal bacteria: A, B, C, Y, and W. The most common ones that cause disease in the United States are B, C, and Y. Our current U.S. meningococcal vaccine covers the A,C, Y and W strains, but not serogroup B. The strain prevalence often varies by country. For instance, Australia and Europe see far more cases of serogroup B than we do here in the U.S. However, in 2012, there were about 500 total cases of meningococcal disease in the U.S, and 160 of those cases were caused by serogroup B. According to a presentation made at today’s ACIP meeting, in the years spanning from 1998-2012 there have been an average of 50 cases of serogroup B meningococcal disease per year in 18-24 year olds. When factoring in the recent outbreaks, serogroup B now causes 40% of all meningococcal disease cases among 11-24 year olds.

While statistically speaking, an average of 50 cases a year may not sound like a lot, how can one quantify the number of deaths, and life-long disabilities caused by meningococcal disease that is considered acceptable?

Unfortunately, while meningococcal disease may not be highly prevalent, the disease can result in devastating consequences. Jessica MacNeil, who presented the epidemiology data on behalf of the CDC at this morning’s ACIP meeting, noted that there is a 12.4% fatality rate for serogroup B meningococcal disease.

A common outcome of meningococcal infection is meningitis, in which a bacterium infects the protective membranes covering the brain and spinal cord. Symptoms typically develop quickly and, in fatal cases, deaths can occur in as little as a few hours. In non-fatal cases, permanent disabilities can include hearing loss and brain damage. Another common outcome is bloodstream infection in which the bacteria enters the bloodstreams and multiplies, damaging the walls of the blood vessels and causing bleeding into the skin and organs. This type of infection is also very serious and again fatality can occur in as little as a few hours. In non-fatal cases, permanent disabilities can include amputation of toes, fingers, or limbs and severe scarring as a result of skin grafts.

Having the privilege of knowing some very courageous and inspirational survivors of meningitis, I would say that as a parent I want to do all I can to protect my children from this disease. Knowing that a vaccine is now licensed makes me eager to know how soon it will be available and what the ACIPs recommendations will be.

Just this summer, before my oldest daughter headed to college, I made sure she had her meningococcal booster (which covers the A, C, Y and W strains). However, with the ongoing outbreaks in university settings, I worry that she is not yet protected against the serogroup B strain. But it’s not just about my college-aged daughter. I have four others I want to protect. And I know lots of parents who would want to do the same. Unfortunately, there are many parents who don’t realize that the current meningococcal vaccine leaves their children susceptible to the serogroup B strain. And even some parents who are not aware of the current vaccine and the fact that it is recommended for all children between the ages of 11-12, with a booster shot at age 16. This is why I’ve been following the ACIP’s discussion of the new serogroup B vaccine for some time.

It appears that at the February 2015 ACIP meeting the committee will be discussing the use of MenB vaccine in persons 10 years of age and older for those with high-risk medical conditions, microbiologists and to address ongoing outbreaks. There is a planned vote on recommendations specifically for high risk groups. Then, at their upcoming June and October 2015 meetings, they will review the evidence for recommending the vaccine for expanded target groups, while also reviewing the economic and impact analysis.

While today’s ACIP presentation resulted in many answers, it also prompted more questions for me:

Does the prevalence of the serogroup B strain necessitate a vaccine recommendation for all children, or just for those people considered high risk? And, knowing that there have been, on average, about 50 cases per year in the 18-24 age group, will this age group be considered high risk?
Since 1/3 of the cases of MenB are among college students, will college students be considered in the high risk category? If so, aren’t we missing the opportunity to protect the remaining 2/3 of 18-24 year olds who appear to also be at risk, though not attending college?

Additionally, if the vaccine is recommended only for use in high risk and outbreak situations, it’s quite possible that a severe case or death will have to occur before the outbreak recommendation is implemented.  In those instances, how will immunization efforts be coordinated in response to these outbreaks? In the cases of Princeton and UCSB, the universities paid for and facilitated mass vaccination clinics. Will the universities be expected to take responsibility, or will parents need to coordinate the receipt of the vaccine for their children independently?

While the current adolescent schedule includes meningococcal vaccine that is administered initially between the ages of 11-12, followed with a booster dose at 16 along with their Tdap booster and HPV vaccine series, the new MenB vaccine will be administered as a separate vaccine requiring multiple doses for optimal immunity. How will this additional vaccine be incorporated into the current immunization schedule and what steps will be taken to ensure parents and providers are aware of the changes to the schedule? At today’s meeting, Cynthia Pellegrini, a current member of the Adolescent Immunization Working Group, urged the committee to make a recommendation that aligns with the current adolescent schedule, prompting me to consider just how complicated the delivery of vaccines can be with the varied age recommendations.

Even though one of the MenB vaccine has been approved, there are still some questions as to how parents can get their children vaccinated prior to formal ACIP recommendations.  I plan to continue to follow the ongoing discussions of the MenB vaccine and the ACIP’s efforts to prevent additional cases of such a debilitating disease. If you have further questions for consideration, please add them to the comments below so we can work to address them in follow-up posts.

Fascinating Report on the Advisory Committee on Immunization Practices

October 28, 2014 2 comments

Time and again I hear people on social media criticizing our immunization practices here in the United States.  Often they make suggestions that vaccine recommendations are made arbitrarily and without careful consideration.  Some even go so far as to suggest that vaccine recommendations are made for the sole purpose of lining the pockets of pharmaceutical companies.

My purpose in contributing to this blog has always been to inform people about immunizations and the various professionals and non-profit organizations working to ensure that timely immunizations are available to protect U.S. citizens from serious and often debilitating diseases.  What I’ve learned is that many people fail to recognize the great efforts that are made by the Advisory Committee on Immunization Practices (ACIP)mmwrhead.  This committee consists of many dedicated immunization experts who are given the immense responsibility of providing external advice to the CDC and the Secretary of the U.S. Department of Health and Human Services (DHHS).

Recently I read a detailed and fascinating MMWR report, written by Jean Clare Smith, MD, Alan R Hinman, MD, and Larry K. Pickering, MD, which summarizes the evolution of the ACIP over the past 50 years. I felt it was rather timely, given the fact that later this week the ACIP will meet once again, to discuss a variety of immunization related items. Read more…

Join Amanda Peet in the Fight to End Polio on World Polio Day

October 24, 2014 11 comments

Written by: Amanda Peet, Every Child By Two Vaccine Ambassador

Shot@Life035Last summer I traveled to Kenya as part of a UN Foundation/Every Child By Two delegation to ensure access to vaccines throughout the globe.  While there, our delegation traveled to a remote village to meet a little boy named Job Alphonse, who had recently contracted polio along with his sister and brother.  Sadly, Job’s mother confided that she had not vaccinated her children at the guidance of her former spiritual leader.  While three of her children had contracted polio, only Job’s case had caused permanent paralysis in his legs.

The community health nurses and UN staff explained that the family’s cases had galvanized Kenyans to conduct intense vaccination efforts to stop the spread of the disease in what was once a polio-free country.

amandavaxIt was heartwarming to meet families throughout the country who are truly grateful for the life-saving vaccines provided to their children, as well as the dedicated community volunteers who walk for miles to ensure that not one child is left without protection.  Witnessing these efforts truly solidified my commitment to raising awareness of the need to support global vaccination efforts.

Today, the vast majority of the world is polio-free. Nearly 80 percent of all polio cases are concentrated in just one country: Pakistan. The two other remaining polio-endemic countries – Afghanistan and Nigeria – continue to show progress. Nigeria has decreased polio cases by 87 percent and Afghanistan has recorded fewer than 10 cases of this devastating disease.

Tonight I am proud to be taking part in Rotary’s World Polio Day Livestream Event at 6:30 PM CST. During the event, viewers will receive an update on the status of polio eradication, featuring Global Polio Eradication Initiative partners, celebrity ambassadors, polio survivors and special guests.

Please join me tonight to learn how we can all take action to help eradicate this disease from the face of the earth!

Rotary_World Polio Day_graphic

Are Doctors’ Vaccine Recommendations Motivated By Profits?

October 22, 2014 58 comments

DrZibnersThis guest post has been written by Dr. Lara  Zibners, in response to comments we’ve received on our Vaccinate Your Baby Facebook page.

“How can I trust the vaccine recommendations that I get from my doctor?  After all, isn’t she the one making money off all of these shots?”

Have you ever heard this concern or something like it? How many parents do you know who are leery of a doctor’s vaccine recommendations because they think the doctor is simply motivated by profits?

MoneyThe idea that pediatricians are colluding in some giant immunization scam that is designed to fund their fancy vacation homes and expensive watches is a concern for some.  But could it be true? Does your pediatrician look at your child, pinch those pudgy thighs and inject vaccines against life-threatening illnesses while dreaming of a new car?  It’s a pretty disgusting thought, isn’t it? The idea that your child’s doctor could have a financial incentive to encourage vaccination is an upsetting one. One that would understandably get your panties in a twist, right?

Well, my friends, relax. You can unwind your knickers because it’s simply not true.

Now, let me start by telling you that this is not a discussion of physician salaries as a whole. (Although I will point out that pediatricians are the 2nd lowest ranking physicians by salary in the United States.) Or whether they deserve a salary that averages in the low six figures. (Even though that’s after the usual investment of 40,000 hours of training and $300,000 in expenses). We’re not going into those topics today but instead we’re going to focus on one specific question: do pediatricians make money from immunizations?

And the answer is “No.” Despite what some people think, vaccines aren’t the cash cow everyone seems to think they are.

It’s estimated that it takes 35 office visits and costs around $2500 to fully vaccinate a child through age 18. But providing immunizations goes beyond just providing the vaccine. There are plenty of additional costs. These include direct costs such as vaccine purchase, storage, staff time to handle, oversee and administer the vaccine, as well as indirect costs such as insurance against vaccine loss. Read more…

Which Do People Fear More? The Flu or Flu Vaccine

October 16, 2014 190 comments

CDC Flu Ambassador Badge FINAL 2014-2015Yesterday was the day I had been anxiously anticipating for well over a month.  I took my kids to the local senior center to get our flu shots at the county flu vaccination clinic.

While most Americans are worrying themselves sick over Ebola, I’m more concerned about the greater risk of influenza.  See, I’m no stranger to the fact that thousands of people die from iFlunfluenza each year. In fact, I’ve already read about several flu deaths being reported this season, to include a person from South Carolina and a child from North Carolina in just the past week though these deaths won’t get the media attention Ebola does.  And while the flu may not be widespread in my local area at this particular moment, it’s just a matter of time.  The flu arrives every year like a tornado on the midwestern plains.  Sometimes you get a little bit of a warning, but regardless of whether you see it coming, it inevitably hits towns, schools and workplaces, hurting and even in some cases killing those who are not protected from its wrath.

Unfortunately, because I’ve had a child diagnosed with H1N1, met parents who have lost their children, know friends who have lost their neighbors, and have personally known a previously healthy individual who succumbed to influenza in his early 30s, I have a healthy fear of the flu (no pun intended).  Yet, it never ceases to amaze me that reasonable and otherwise intelligent people continue to reject flu vaccinations because they are swayed by unfounded myths or the sting of a needle.

Yesterday I realized that while my children understand the importance of flu vaccination, many adults around them still do not.

Here are a few of the surprising things I heard in just one hour of the day:   Read more…

Concern Over Enterovirus D68 Amidst Death of Asymptomatic Child

October 7, 2014 16 comments

EV68-map-thmbThe United States is currently experiencing a nationwide outbreak of enterovirus D68 (EV-D68) associated with severe respiratory illness. From mid-August to October 6, 2014, there have been a confirmed total of 594 people in 43 states and the District of Columbia diagnosed with the infection and five of those patients have since died.  While the role that EV-D68 infection played in four of these deaths is still being investigated at this time, the latest fatality of a four-year old boy from New Jersey is confirmed to have been associated with EV-D68.  As more cases appear across the country, and more questions arise about the symptoms – or lack of symptoms in the latest fatal case – parents are understandably growing concerned. What is this unfamiliar virus that is threatening the health of their otherwise healthy children?

The truth is that there are more than 100 types of enteroviruses which are fairly common through the summer and fall in the United States. In general, a mix of enteroviruses circulates every year, and different types can be common in different years. It’s estimated that 10 to 15 million enterovirus infections occur in the United States each year resulting in tens of thousands of hospitalizations.

But what has drawn the public’s attention is that EV-D68 is extremely prevalent of all the types and is causing severe respiratory illness.  While the three strains of EV-D68 circulating this year are not new, and small numbers of EV-D68 have been reported regularly to the CDC since 1987, the number of confirmed EV-D68 infections this year is much greater than what has been reported in previous years.

It’s also important to realize that different enteroviruses can cause different illnesses, such as respiratory illness, febrile rash, and acute neurological diseases such as aseptic meningitis which results in swelling of the tissue covering the brain and spinal cord, encephalitis which results in swelling of the brain, and acute myelitis and paralysis. While severe respiratory illness has been the most common result of EV-D68 infection, the CDC is aware of two published reports of children with neurologic illnesses in confirmed patients with EV-D68 infection. This, of course, is concerning and has resulted in frequent alerts and updates from the CDC in regard to the spread and symptoms of EV-D68. Read more…

Five Reassuring Facts About Ebola

October 1, 2014 3 comments

Last night, as I sat in the airport waiting for to return home from the CDC’s National Immunization Conference in Atlanta, I caught a glimpse of CDC Director Dr. Thomas Frieden speaking at special press conference.   The news that an air traveler from Liberia was the first person to be diagnosed with Ebola in the United States seemed to attract quite a bit of attention among passengers waiting at the gate.  While it appeared that many people were listening to Dr. Frieden’s comments, I couldn’t determine if their blank stares were due to fear or disinterest.

Honestly, there has been so much media attention on the Ebola outbreak over the past few months that I’ve refrained from writing about it.  But now, in response to yesterday’s announcement of Ebola in the US, I feel it’s important to try to diffuse some of the fear and misinformation surrounding Ebola.  So, in my “glass is half-full” approach, I’d like to offer a few reassuring thoughts to consider.

The Reassuring News Read more…

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