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.
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.)
While 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.
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.
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…
HPV is such a common virus that nearly all sexually active individuals will contract the virus at some point in their lives.
It’s estimated that 79 million people (about 1 in 4) are currently infected with human papillomavirus (HPV) and about 14 million people become newly infected each year in the U.S. alone. Yet, there is no cure for HPV and in some cases the virus will develop into cancer years, or even decades, after initial exposure. This results in about 270,000 people who are diagnosed with HPV-related cancers in the U.S. each year to include cancers of the cervix, vulva, vagina, penis, anus or throat.
While the CDC currently recommends that parents get their sons and daughters the HPV vaccine series between the ages of 11-12 to prevent future cases of HPV and HPV-related cancers, the reality is that many people are already infected and are spreading the virus to others.
Good News For Those Already Infected
Mayumi Nakagawa, M.D., Ph.D. from the University of Arkansas for Medical Sciences (UAMS) is researching a new vaccine that is designed to cure HPV, cause pre-cancerous lesions to disappear, and provide future protection against HPV. Following the success of the vaccine’s phase I trials, Dr. Nakagawa is now continuing with stage II trials with the support of a $3.5 million grant by the National Institutes of Health (NIH), over the next five years. Read more…
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.
If 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.
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.
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.
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.
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.
Every Child By Two is pleased to welcome Linn to our social media team. Linn is a student intern who will be sharing her perspectives on vaccines with us through the eyes of a PhD candidate. We hope you enjoy her first piece of the summer.
The HPV vaccine is recommended for all girls and boys ages 11-12.
This vaccine has the potential to prevent 70% of all cervical cancers and 90% of genital warts.
Why then is there such a low rate of vaccine uptake?
Only about 1/3 of girls aged 13-17 have been fully vaccinated and less than 14% of boys are fully vaccinated.
One study looked to identify the barriers to uptake of HPV vaccine and found that it was not the lack of perceived risk or vaccine safety that kept parents from vaccinating their children, but the perception that it would increase risky sexual behavior in adolescents even though there is no evidence that this will occur.
As a young student, I remember learning about the HPV vaccine in high school. HPV was a sexually transmitted disease that was relatively unknown, but we learned that the vaccine would prevent certain cancers and genital warts. The knowledge that I gained about the ability for this vaccine to prevent these potential diseases prompted me to learn more about the HPV vaccine and increased my desire to receive it.
However, when I discussed it with my mother, an interesting process began to occur. She did not know any information about the HPV vaccine and when I spoke to her about the fact that it prevents a sexually transmitted disease, I could see a shift in her gaze as she narrowed her eyes. I sensed that she was hesitant because of the social stigma that surrounded a female who would get a vaccine that was related to sexual contact.
All of these opinions are related to a negative stigma around sexual behaviors that are not true. And yet these are the thoughts I sensed were running through my mother’s head as she also considered what her own peers would think, as I am sure many others do.
Back then I perceived that the assumptions that are made about females that get an STD vaccine were:
a) She is promiscuous.
b) She is about to become promiscuous.
c) She wants to be promiscuous.
At the time, I even remember having a discussion with a teacher about the HPV vaccine and her speaking about how she refused to give her child the HPV vaccine because “they should not be giving 11-12 girls a vaccine to prevent a sexually transmitted disease”. Now I understand that the 11-12 year old visit is the optimal visit, as it eliminates the connection of the vaccine with future sexual contact by integrating it within the routine vaccine schedule, which includes meningitis vaccines and a Tdap booster. In addition, I’ve learned that by waiting to provide the vaccine at a later date, many children fall through the cracks because they do not receive routine health care in their teen years. Read more…
Since the human papillomavirus (HPV) is transmitted from one person to another through sexual activity, many parents question why the CDC recommends the vaccine be administered to boys and girls as young as 11 or 12 years of age. HPV vaccination is critical if we are to prevent the 27,000 cases of anal, mouth/throat, penile, cervical, vaginal, or vulvar cancers that are diagnosed each year in the U.S. However, since some parents have difficulty acknowledging that their teenage children may be engaging in activity that puts them at risk of HPV, they’re often reluctant to vaccinate at the recommended age.
If you’re a parent who is questioning whether your preteen child should get the HPV vaccine, it’s important to realize the benefits of vaccinating at an early age.
The vaccine works best prior to exposure to the HPV virus.
The fact is that almost all sexually active people will get HPV at some point in their lives. While most of these infections go undetected and may even clear up on their own, we know that one in four people in the U.S. are currently infected and that initial infection typically occurs in the teens or early 20s.
While most parents are hopeful that their teenagers will refrain from sexual activity until later in life, research tells us otherwise. The data suggests that 5% of 12-year-olds, 10% of 13-year-olds and 20% of 14-year-olds are sexually active. And the likelihood of sex continues to escalate with each school grade level with 32% of 9th grade students to 62% of 12th grade students. And since HPV can be transmitted through oral sex as well, it’s important to note that as many as 51% of 15-24 year-olds are having oral sex before they have their first sexual intercourse.
Since it’s entirely possible to get HPV the very first time that a person has sexual contact with another person, the question we must ask ourselves is why should we wait until a child is sexually active to offer vaccination? As we can see by the data, even a child as young as 12 years old can be at risk. Even if a child should abstain from sex until marriage, there is no guarantee that their partner did the same, and they can still contract HPV that may one day lead to cancer. However, if a child should complete the three dose series of HPV vaccination before they begin any type of sexual activity, then they’ll be better protected if they get exposed to the virus, at whatever age that may be.
The HPV vaccine produces a higher immune response in preteens than it does in older teens and young women.
This guest post was written by Denise Olson, a mother of four who connected with The Arizona Partnership for Immunization (TAPI) in her efforts to learn more about the HPV vaccination.
Like all good moms, I want my kids to grow up safe and healthy. I want to make decisions that will benefit them right now, but I also need to think about things that could help them in the future. I feel like it’s a big job and a lot is depending on me. That is why I wanted to learn more about the HPV vaccine before my children were old enough to get it. I wanted to make an informed choice, and I had all kinds of questions.
What is HPV, anyway? Could a vaccine actually protect my children from cancer? Are there side effects? What about the scary rumors I heard on the internet? Why is the vaccine given at age 11? Are my kids really at risk for HPV, or is this unnecessary medicine?
I wrote this article to share the answers I found to my questions, and to hopefully convince other parents to think about how they can protect their own children, not only now, but in the future.
What is HPV anyway?
HPV stands for human papilloma virus. HPV lives on soft mucous membranes and skin. Usually, it can be found on the genitals of an infected person, but it can also infect the anus, mouth and throat.
Some strains of HPV viruses cause genital warts, while others can cause tumors or cancers to grow. While there are many different types of HPV, there are several different HPV vaccines licensed by the Food and Drug Administration (FDA). The bivalent HPV vaccine (Cervarix) prevents the two HPV types, 16 and 18, which cause 70% of cervical cancers. There is also a quadrivalent HPV vaccine (Gardasil) which prevents against four HPV types: HPV 16 and 18, as well as HPV 6 and 11, which cause 90% of genital warts. The quadrivalent vaccine has also been shown to protect against cancers of the anus, vagina and vulva and is the only HPV vaccine licensed for use in males. And just last week, the FDA approved a new HPV vaccine (Gardasil 9) which will protect against nine different strains has the potential to prevent approximately 90 percent of cervical, vulvar, vaginal and anal cancers.
Can the HPV vaccine actually protect my child from cancer?
The primary cancer the HPV vaccine is designed to protect against is cervical cancer, the same cancer that is checked for when women go in for a pap smear. However, because the vaccine stops dangerous HPV viruses anywhere in the body, it may help protect against some cancers of the penis, throat, mouth, and anus. This is one reason it is recommended for boys as well as for girls. (The other reason is to protect future partners from cervical cancer.) Read more…