DrVirgo
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CDC Issues New Guidelines for Meningococcal Vaccination
Laurie Barclay, MD
RESOURCE CENTER
July 13, 2007 — The Advisory Committee on Immunization Practices (ACIP) of the US Centers for Disease Control and Prevention (CDC) has issued new recommendations calling for meningococcal immunization with conjugate vaccine of all adolescents 11 to 18 years of age. The new guidelines were presented at the ACIP meeting last month and will be published in an upcoming issue of the Morbidity and Mortality Weekly Report.
On July 12, a media telebriefing concerning the new guidelines was presented by the National Foundation for Infectious Diseases (NFID), a nonprofit organization aiming to educate the public and healthcare professionals about preventable and treatable infectious diseases, in collaboration with CDC and the National Meningitis Association (NMA).
"The conjugate vaccine is safe and effective and should be given to all adolescents 11 to 18 years of age, as well as to other recommended groups, and [the] vaccine can be given throughout the year," said Tom Clark, MD, a medical epidemiologist at the CDC's National Center for Immunization and Respiratory Diseases. "The conjugate vaccine should confer longer-lasting immunity and could even interrupt transmission of disease in the population if enough people are vaccinated."
Simplified Meningitis Immunization Recommendations
This teleconference highlighted the ACIP's simplified meningococcal disease immunization recommendations, which have expanded from 3 specific adolescent groups to all individuals aged 11 to 18 years; an epidemiologic perspective of meningococcal disease and why adolescents and young adults are at increased risk; and a personal account of the devastating effect meningococcal disease can have on families.
"Meningococcal disease is a difficult illness for healthcare providers to diagnose and treat for a number of reasons," Dr. Clark said during the press conference. "First, it's not very common and can be difficult to diagnose in its early stages. When it does occur, it's very serious and often deadly because it can progress so rapidly, killing an otherwise healthy person in just a day or 2.
"Additionally, meningitis cases often result in heightened public awareness and concern and may require expensive and time-consuming public health responses," Dr. Clark continued. "All these factors serve to underline the need to prevent meningococcal disease rather than waiting to treat it."
Meningococcal disease is the most frequent cause of bacterial meningitis in infants, children, adolescents, and young adults in the United States. Of the approximately 2800 cases of meningococcal disease in the United States each year, more than 60% are in individuals aged 11 years or older.
The impetus behind the expanded recommendations was the growing recognition that adolescents 11 to 18 years of age are at increased risk for contracting meningococcal disease. Lifestyle factors typical in older adolescents that may facilitate disease transmission include direct contact with infected persons, often through kissing; crowded living conditions such as those in college dormitories; and active or passive smoking.
"This was the first adolescent vaccine, and we knew there were others coming," said Carol Baker, MD, NFID President, and professor of pediatrics and molecular virology at Baylor College of Medicine in Houston, Texas. "We really wanted to build a platform for routinely vaccinating the 11- to 12-year-olds with the recommended vaccines, and now we have 3 recommended vaccines for girls in this age group and 2 recommended vaccines for boys."
Vaccination Groups Identified
After the quadrivalent meningococcal polysaccharide diphtheria toxoid conjugate vaccine (MCV4; Menactra, Sanofi Pasteur) became available in the United States, the ACIP in May 2005 recommended routine vaccination of:
* Adolescents during their 11- to 12-year-old healthcare visit;
* adolescents upon high school entry (15 years of age), if they were not previously vaccinated with MCV4;
* college freshmen living in dormitories, if not previously vaccinated with MCV4;
* other adolescents and college students who wanted to lower their risk for meningococcal disease; and
* groups in whom vaccination with the polysaccharide vaccine was previously recommended, such as persons with anatomic or functional asplenia, military recruits, certain international travelers to regions with hyperendemic or epidemic meningococcal disease, microbiologists routinely exposed to Neisseria meningitidis isolates, and patients with terminal complement deficiency.
The 2005 recommendations to limit vaccination to specific groups of adolescents and adults at high risk were in part based on concerns regarding vaccination supply. As the increased vaccine supply permitted (about 2 million extra doses were available in early 2007), the recommendations were expanded to include all adolescents and additional age groups, and vaccination against meningococcus is now recommended for everyone aged 11 to 18 years. The newer conjugate vaccine may be given up to age 55 years, and the polysaccharide vaccine may be given to children 2 to 10 years of age.
Previously, the vaccine was typically administered in August or September before high school or college entry, but now the recommendations are that immunization should take place anytime during the year. This should help alleviate any mismatch between supply and demand resulting from seasonal use of the vaccine, according to Dr. Baker.
"It is anticipated that there will be abundant supply, but for those that are not entering college and haven't been immunized before, there is no reason to have vaccination only before school starts, because this disease actually peaks in the winter and early spring," Dr. Baker said. "Vaccination should occur at any health care visit.... We're really trying to get the message out to immunize all year round, both to protect the child and to make sure that supply is not mismatched by just immunizing at 1 time of the year."
Meningococcal Disease Symptoms Often Nonspecific
Early symptoms of meningococcal disease are typically nonspecific and resemble those of influenza. However, the disease is rapidly progressive and may be fatal within 48 hours, even in a previously healthy young person. Meningitis is most common; meningococcemia is less common but more severe. Symptoms may include high fever, headache, muscle pain, stiff neck, confusion, nausea, vomiting, exhaustion, and a purple or brown rash that rapidly spreads and changes in appearance.
Although meningococcal disease has a high mortality of 10% to 14%, with 11% to 19% of survivors left with long-term disabilities such as hearing loss, brain damage, cognitive impairment, renal failure, or limb amputations, most cases are potentially vaccine preventable. Results of 1 study suggest a mortality rate as high as 25% in adolescents.
Lynn Bozof, NMA executive director, described her personal experience with meningococcal disease when her previously healthy, active 20-year-old son died from it while a junior in college. His illness began with what he thought was a migraine, progressed to intensive care unit treatment within hours, resulted in amputation of all 4 limbs, and ended in death 26 days later.
"Had we known about the vaccine, my son would have been immunized, and he would be alive today," Ms. Bozof said. "The CDC's new recommendations are very encouraging to me because they encompass all adolescents and leave no question about who should be vaccinated or when the vaccine should be given."
Although most meningococcal disease cases in US adolescents and young adults are caused by strains B, C, and Y, there is no vaccine available for type B meningococcal disease. Nonetheless, about 75% of meningococcal disease cases in US adolescents and young adults are attributed to 4 of the 5 strains (A, C, Y, and W135), and the meningococcal conjugate vaccine, as well as the older polysaccharide vaccine, protects against these 4 strains.
Association With Guillain-Barré Syndrome
Although the conjugate vaccine is said to be safe, a possible association between Guillain-Barré Syndrome (GBS) and vaccination with MCV4 was first reported in October 2005. A total of 8 cases were reported through February 2006, but a causal relationship was not proven, and the CDC recommended continuing use of MCV4 for persons for whom vaccination is recommended.
"We conduct surveillance for any adverse events reported with any vaccines, and we follow them with the meningococcal conjugate vaccine as well," Dr. Clark told Medscape. "There have been rare reports of GBS associated with Menactra, which have been published in the Morbidity and Mortality Weekly Report.
"We continue to recommend the vaccine for adolescents because when those GBS cases do occur, they have resolved," Dr. Clark continued. "There's nothing that we have found to be causally related to the vaccine.... The only change to the recommendation has really been that anybody with a prior history of GBS should discuss with their doctor the risks and benefits of the vaccine before getting it."
In December 2005, the Global Advisory Committee on Vaccine Safety also recommended no change in MCV4 vaccination policies. However, the CDC did recommend that information concerning the GBS investigation should be shared with adolescents and caregivers before MCV4 vaccination, and Sanofi Pasteur and the US Food and Drug Administration updated the Menactra vaccine package insert to list previous GBS as a contraindication and to provide a warning of the temporal relationship between GBS and MCV4.
Additional preliminary data from the Vaccine Safety Datalink Project (VSD; a surveillance collaboration of the CDC with 8 US managed care organizations) did not identify any other GBS cases in MCV4 recipients, but the CDC acknowledged that the ability of VSD to detect rare health events such as GBS is limited. Further controlled studies of GBS after MCV4 are being planned.
The most common adverse events associated with the vaccination are redness, pain, and swelling at the injection site, lasting 2 days at most, and syncope related to the needle stick.
Vaccine Costs
The cost of the newer conjugate meningococcal vaccination itself is about $82, and there is also an administration fee. Most insurance providers will cover the cost, and uninsured children may be eligible through the Vaccines for Children program to receive the vaccine at no cost, although they will still have to pay the administrative fee.
Published analyses, as well as ongoing updates by the CDC, suggest that the cost to prevent 1 death through meningococcal vaccination is on the order of $100,000 to $200,000.
"It's a little bit different than cost-saving vaccines, but then if you look at the societal benefits, it really becomes a decision that's compelling to make," Dr. Clark told Medscape.
The CDC has estimated that vaccinating the entire population recommended to be vaccinated, — all adolescents between 11 and 18 years of age — would prevent about 100 cases of meningococcal disease.
"The more kids that actually get this vaccine in the recommended adolescent age group, the more likely herd immunity is to kick in, and the cost-benefit changes in a very positive way," Dr. Baker told Medscape.
The media telebriefing was supported by an unrestricted educational grant to NFID from Sanofi Pasteur, the maker of Menactra. The 3 speakers report no relevant financial relationships.
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