New ACIP Recommendations for Meningococcal, Influenza and HPV Vaccines
Mar 10, 2015
written by: Amy Pisani, MS, Executive Director, Every Child By Two
The Advisory Committee on Immunization Practices (ACIP) conducted an abbreviated meeting on February 26, 2015 due to the threat of a winter storm in the Atlanta, Georgia region. The ACIP, which consists of 15 voting members who have expertise in vaccinology, immunology, healthcare and public health, makes recommendations to the Centers for Disease Control and Prevention (CDC) regarding vaccinations approved for use by the Food and Drug Administration (FDA). The recommendations pertain to the timing and intervals of vaccines which are included on the childhood, adolescent and adult immunization schedules. At this February meeting, the ACIP conducted three important votes which altered or created new recommendations for meningococcal vaccine, influenza vaccine and HPV vaccine.
Meningococcal Serogroup B Vaccine
Two new vaccines to protect against meningococcal serogroup B, which has been spreading through college campuses in recent years, were recently approved by the FDA. The Trumenba vaccine is developed by Pfizer Pharmaceuticals and requires three doses and the Bexsero vaccine has been developed by Novartis Vaccines and Diagnostics requiring two doses. The ACIP has previously recommended one dose of MCV4 vaccine at ages 11-12, and a booster at age 16 to protects against the A, C, W and Y strains of meningococcal bacteria Nearly 80% of teens between the ages of 13 and 17 have received at least one dose of the MCV4 vaccine, which is fairly remarkable considering the fact that it is recommended, but not mandated for use within states nationwide. However, because of the complicated nature of the virus, the new meningococcal serogroup B vaccine would require a separate series of shots, in addition to those recommended for MCV4 vaccine.
The serogroup B strain of meningococcal is considered the most common cause of meningococcal disease among adolescents here in the U.S. with a fatality rate of 12 percent in 11-19 year olds and 17 percent in 20 year olds over the last 14 years. While the number of meningococcal cases have declined since 1996, many advocates believe that the aggressive nature of this disease, which often kills or maims it’s victims within hours, necessitates a broad recommendation for the vaccine. However, the ACIP discussion at the February meeting was limited to recommendations for those at high risk for serogroup B infection, with a follow up vote anticipated at the upcoming June meeting where the Committee will review data and make a determination on whether to recommend the vaccine for a broader population. Authors note- added June 2015: At the June ACIP meeting the following recommendation was made “A serogroup B meningococcal (MenB) vaccine series may be administered to adolescents and young adults 16 through 23 years of age to provide short term protection against most strains of serogroup B meningococcal disease. The preferred age for MenB vaccination is 16 through 18 years of age.”
Several advocates traveled to the meeting to provide their testimonials. These included parents of those lost to the disease as well as survivors who have suffered amputations and serious life-long health consequences of this invasive disease. Dr. Mary Ferris, who helped lead efforts to contain the 2014 meningococcal outbreak at University of California’s Santa Barbara campus, provided compelling testimony regarding the impact of the outbreak on the university. Ferris noted that four cases, one of which led to the amputation of a student, spread panic throughout the campus and the local community. Students were banned from volunteering at the on-campus daycare and attempts were made by the local community to close the campus entirely. Dr. Ferris urged the Committee to consider the broadest recommendation
“which would protect the students prior to their arrival on campus”. She noted that they “would have much preferred to avoid this type of disaster and do not wish to relive it in the future”.
Seth Ginsberg, President of the Global Healthy Living Foundation, read the written testimony of Dr. Neal Raisman, a former college president whose son Isaac was killed by meningitis in 2005. Dr. Raisman’s testimony urged the Committee to
“endorse the FDA labeling for individuals 10-25 years of age…..without a broad recommendation, those who cannot afford the vaccine will succumb to the disease, while those with the means to pay will thrive.” Without ACIPs recommendation, Mr. Ginsberg continued, “insurance companies and Medicaid will not cover the costs of the vaccine, and leaving the poor without coverage is opposed to everything we stand for here in the U.S.” He continued, “death rates (from meningococcal) are so high, please understand the depth of our heartache and please act now so that other people and their families do not join our ranks”.
Carl Buher, testifying on behalf of the National Meningitis Association urged the Committee to consider the lasting effects of the disease on both the victims and their loved ones. He described the challenges faced by fellow survivors such as Samantha, who has had to endure more than thirty surgeries in thirty-seven years; and Kyla who lost both legs and most of her fingers and has gone through a dozen surgeries in the past six years to separate and lengthen her thumb, or Blake who survived meningitis at age 18 and learned so much as a dialysis patient before he got his transplant that he was inspired to become a dialysis nurse. Carl himself was attacked by the serogroup B strain at age 14 and lost three of his fingers and both of his legs below the knee. For survivors there may also invisible scars such as a loss of cognitive function, hearing and vision. He noted that
“On top of the medical challenges, living post-infection can affect one’s finances for a lifetime as it requires constant medical attention, missed work, and the costs to retrofit homes, purchase prosthetics, wheelchairs” and so forth.
To date Carl’s medical bills have far exceeded two million dollars. Carl compelled the Committee to make a broad recommendation, ending his testimony by stating that although
“we are all very different, there’s one thing we universally agree on. We don’t want anyone to have to go through what we went through – and what we deal with every day…when you look at the cost of prevention, I hope you’ll calculate how high the cost of survival is as well.”
In the end, ACIP voted to recommend either the complete two or three dose series (depending on which vaccine is selected) of the meningococcal serogroup B vaccine for those 10 years and older who are at increased risk for meningococcal serogroup B infection including: persons with persistent complement component deficiencies; persons with anatomic or functional aslpenia, microbiologists routinely exposed to isolates of Neisseria meningtidis; and persons identified to be at increased risk because of serogroup B meningococcal disease outbreaks (i.e. college students). In June, broader consideration will be given to determine whether the vaccine ought to be recommended to the entire population.
It is notable that the ACIP is constantly reviewing the data that supports their recommendations for vaccinations and influenza is one vaccine that requires “fresh” recommendations yearly. This is due to the fact that a new influenza vaccine is created each flu season based on the strains that are predicted to be most frequently circulating that season. For the 2014-2015 season, Influenza A (H3N2) viruses had been detected most frequently and therefore this strain was included along with other strains in this season’s vaccines. Unfortunately, about half of the H3N2 flu viruses that were analyzed by the CDC since October were of a different strain of the H3N2 virus than what was included in the vaccine, possibly reducing the effectiveness of the vaccine and it’s ability to prevent that particular strain of the virus.
As readers may recall, prior to the 2014-2015 season the ACIP reviewed available data that suggested that the Live Attenuated Influenza Vaccine (commonly known as the nasal spray or FluMist and also referred to as the LAIV vaccine) offered better protection than the shot for children ages 2-8 years of age. Therefore,the ACIP made a “preferential recommendation” for the 2014-2015 season that healthy children ages 2 – 8 years receive the nasal spray vaccine in place of the flu shot (IIV) when immediately available. However, after reviewing interim data from the U.S. Flu VE Network, it was determined that neither the shot nor the nasal spray worked particularly well against the H3N2 viruses this season, nor did the mist provide greater protection than the shot against the predominant strains. Although limited data suggested that the mist may be more effective against drifted H3N2 viruses, this did not seem to deter the Committee from changing their recommendation for the upcoming season. Therefore, the ACIP voted to recommend that all persons 6 months of age and older be vaccinated annually against influenza. Again, there will be no preference made for children to receive LAIV/mist vaccine over the IIV/shot.
HPV 9-Valent Vaccine
The FDA approved the new 9-valent HPV vaccine in December, 2014. The newly improved vaccine will protect against five additional strains of Human Papillomavirus (HPV), which will offer protection against fourteen percent of additional HPV cancers in women and five percent of additional HPV cancers in men. The Committee’s vote did not make a preference over the 2-valent, 4-valent or 9-valent vaccines. Instead the vote included wording suggesting that all females, aged 11 to 12 years of age, receive a three-dose series with either the 2-valent, 4-valent (if available) or 9-valent vaccine. Vaccination of males is recommended at 11 to 12 years of age with either 4-valent (if available) or 9-valent vaccine. Females aged 13-26 years, and males aged 13-21 years, who have not been vaccinated or have not completed the three-dose series, and males ages 22-26 are also included in the recommendation. (Please note that the use of the vaccine in males over 15 years would be considered “off-label” since the FDA license currently includes males aged 9-15. Data is currently under review by the FDA who may consider broadening their license in the future).
In addition to the wording above, the ACIP no longer suggests that females complete the entire HPV vaccination series with the same vaccine product, which allows for greater interchangeability of the new HPV-9 valent vaccine. The new recommendation states that
“when providers do not know which vaccine the female patient received previously, or are in settings transitioning to the 9-valent vaccine…for better protection against HPV 16 and 18, any HPV vaccine product may be used to continue or complete the series for females.” For males either the 4-valent or 9-valent vaccine “may be used to continue or complete the series.”
This careful wording may be necessary for the current time-frame to account for the availability of the new 9-valent vaccine and to allow providers time to prepare for the new recommendation. At the June, 2015 meeting the Committee will address the issue of revaccination of patients who have already received the full 4-valent series in order to offer protection against the additional five strains of the virus.
With the new vaccine even more lives can be saved, but only if public health advocates, parents and providers work together to ensure that boys and girls are protected against a disease that typically morphs into a deadly virus in adulthood. Every single year 14 million people will newly acquire HPV. Each year HPV continues to cause about 17,000 cancers in women and about 9,000 cancers in men. Cervical cancer causes nearly 4,000 deaths in women each year in the U.S. Low HPV vaccination rates are leaving another generation of boys and girls vulnerable to devastating HPV cancers. To learn more about how the CDC is working with healthcare professionals to prevent HPV please visit You Are the Key to Cancer Prevention.
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