 Welcome to Immunization Update 2009. We are coming to you live from the Centers for Disease Control and Prevention in Atlanta, Georgia. I'm Sharon Collins, and I will be your host for this program. There have been many developments in immunization in the past year, although no new vaccines have been licensed, new recommendations have been published for several existing vaccines. We have put together today's program to tell you about these changes and how they will affect your practice. As always on this program, we will begin with a discussion of influenza vaccines, including an update on the novel H1N1 virus that emerged in 2009 and the vaccine being developed to prevent it. Our second topic is the expanded recommendations for the use of pneumococcal polysaccharide vaccine among adults. Following our discussion of pneumococcal vaccine will be a presentation concerning the childhood immunization schedule and so-called alternative immunization schedules. We will then discuss the use of combination vaccines and several vaccine supply issues, including reinstatement of the Hib booster dose. Our vaccine briefs segment will include information about a new interval and age recommendation for inactivated polio vaccine, a new recommendation for selective re-vaccination with meningococcal conjugate vaccine, revised criteria for MMR immunity among healthcare personnel, vaccine administration errors, and an update on recent changes to vaccine information statements. We have two instructors for this part of today's program. Our first instructor is Dr. Ayobadeh Baisalo. Dr. Baisalo is a pediatrician and a medical officer in the National Center for Immunization and Respiratory Diseases at CDC. Our second instructor is Donna Weaver, a nurse educator in the National Center for Immunization and Respiratory Diseases at CDC. The goal of today's program is to provide you with information that will improve immunization practice in the United States. We have four objectives for this program. After completing the training, the participant will be able to list two recent immunization recommendations made by the advisory committee on immunization practices, describe two emerging immunization issues, locate resources relevant to current immunization practice, and for pharmacists, locate resources to assist with patient education in a pharmacy seed setting. Now our program will begin with a discussion of influenza vaccines right after this pause. Don't need to go to extremes to prevent the flu. You just need common sense. Cover your mouth and nose when you cough or sneeze. Avoid close contact. Keep your hands clean. Avoid touching your eyes, mouth, and nose. And if you're sick, stay home. Remember, with a little common sense, you can prevent getting or giving the flu. Please give others a shot. We will begin today's program with an update on influenza and influenza vaccine recommendations. The 2009-2010 influenza season is going to be a challenging one because we may be required to distribute not only seasonal vaccine, but also a vaccine for the novel H1N1 influenza virus. We will discuss H1N1 influenza and the vaccine for it later. The advisory committee on immunization practices revises its influenza vaccine recommendations annually. The 2009-2010 ACIP statement was published in Morbidity Immortality Weekly Report on July 24th, 2009. There are no new recommendations, but one recommendation from 2008 was revised. The revised recommendation is that beginning in the 2009-2010 influenza season, all children six months through 18 years of age should receive influenza vaccine annually. We will discuss this issue in more detail a little later. This year's statement will also re-emphasize the importance of annual vaccination of all children six months through 59 months of age and older children with conditions that place them at increased risk for complications from influenza. Children and adolescents at high risk for influenza complications should continue to be a focus of vaccination efforts as providers and programs transition to routinely vaccinating all children. Before we talk about these issues in more detail, we would like to briefly review information about the impact of influenza. 10 to 20% of the U.S. population may be infected with influenza virus every year with an even higher infection rate in children. Influenza is the most frequent cause of death from a vaccine-preventable disease in the United States. Approximately 36,000 influenza-associated pulmonary and circulatory deaths occur during each influenza season from 1990 through 1999. Influenza seasons in which H3N2 viruses predominate are associated with higher mortality. Person 65 years of age and older accounted for more than 90% of deaths attributed to pneumonia and influenza. Persons with underlying medical conditions account for most of the remaining 10% of deaths, but children can also die from influenza. In fact, more children die from influenza than from all other vaccine-preventable diseases combined. 89 influenza-related deaths were reported among children 18 years or younger during the 2008-2009 season. Of these, 22 were caused by the new novel H1N1 virus. In addition to fatalities, influenza and these complications are also responsible for an average of 226,000 hospitalizations per year. Although persons 65 years of age and older are at the highest risk of dying from influenza, other age groups are at nearly as high of a risk for influenza-associated hospitalization. Young children are at increased risk of influenza-related hospitalization, particularly children younger than one year of age, but rates of hospitalization are very high through two years of age in both healthy children and those with high-risk conditions. Rates of hospitalization in children younger than two years are similar to those of persons 65 and older with high-risk medical conditions. The increased risk of hospitalization for children extends at least through four and possibly five years of age. In addition, children two through four years of age are at increased risk for influenza-related clinic and emergency department visits. Healthy children five through 18 years of age are not at increased risk of complications of influenza. However, children typically have the highest attack rates during community outbreaks of influenza. They also serve as a major source of transmission of influenza within communities. This graphic shows influenza infection rates by age groups from two different multi-year community-based studies conducted during the 1960s and 1970s. A study conducted in Houston is shown in the yellow line and Tecumseh, Michigan is shown in the red line. In both studies, the highest influenza attack rates up to 40% occurred among children five through 14 years of age. Influenza has a substantial impact among school-aged children and their contacts. These impacts include school absenteeism, parental work loss, and medical care visits. Studies have documented five to seven influenza-related outpatient visits per 100 children annually, and these children frequently receive antibiotics. In addition to the direct benefits of influenza vaccination of school-aged children, there could be indirect health benefits if sufficient vaccination coverage among children can be achieved. Studies have demonstrated reductions in influenza like symptoms and medical visits among household contacts in communities where vaccination programs among school-aged children were established. It is for these reasons that the Advisory Committee on Immunization Practices expanded its recommendation for routine influenza vaccination to include children through 18 years of age. Donna? We will first discuss recommendations for seasonal influenza vaccine. We will talk about the vaccine for the novel H1N1 virus later in the program. The majority of seasonal influenza vaccine available in the United States is inactivated subunit vaccine. There are now five brands of inactivated influenza vaccine available, two of which have different age indications than the other three. A live attenuated influenza vaccine administered by nasal spray is also available again this year. We will discuss this vaccine in more detail in a few minutes. Both types of influenza vaccine, inactivated and live attenuated, contain the same three influenza viruses, two type A viruses and one type B. The viruses in both types of influenza vaccine are grown in hen's eggs and both vaccines contain residual egg protein. The inactivated influenza vaccination schedule is relatively simple. One intramuscular dose per year. But the dose is not the same for all age groups and some recipients need two doses. Here is the routine schedule for trivalent inactivated influenza vaccine, which we will abbreviate TIV. The minimum age is six months. No influenza vaccine is approved for children younger than six months. Children six through 35 months of age receive a dose of 0.25 milliliter, half the dose of an older child or adult. Recipients three years of age and older should receive a 0.5 milliliter dose. Children six months through eight years of age should receive either one or two doses depending on their prior influenza vaccination history. Children receiving influenza vaccine for the first time should receive two doses separated by four weeks. The first dose is an immunologic primer. Two doses are not necessary for persons nine years or older because by this age our immune systems have been primed by infection with wild type influenza virus. For persons nine years or older only one dose per season is recommended even if the first dose was given in August. We receive many questions about administration of a second dose of TIV in the same season particularly among high risk persons vaccinated in August or September. There are a few data to support the need for a second dose in a season. ACIP does not recommend administration of more than one dose of seasonal influenza vaccine per season for any group except children six months through eight years of age receiving influenza vaccine for the first time. This recommendation may be different for the novel H1N1 vaccine. Now, despite your best efforts some children six months through eight years of age who need two doses of influenza vaccine do not return for their second dose. In the past ACIP has recommended that in this situation the child receive one dose in subsequent years. Studies suggest timing of the two doses is important. Children younger than nine years of age who receive one dose of inactivated influenza vaccine in the spring and the second dose in the fall are less well protected than children who receive two doses in the fall. As a result of these studies ACIP and the American Academy of Pediatrics revised their recommendation for this situation in 2007. Children six months through eight years of age who did not receive the recommended second dose of influenza vaccine in the initial year that they received influenza vaccine should receive two doses during the next influenza season. This recommendation applies only to the influenza season that follows the first season that a child younger than nine years receives influenza vaccine. This recommendation applies to both inactivated and live attenuated influenza vaccine. Children six months through eight years of age who are being vaccinated two or more seasons after receiving an influenza vaccine for the first time should receive a single annual dose regardless of the number of doses administered previously. This recommendation has caused some confusion among clinicians vaccinating children. We want to be sure you are clear on it. So here are three examples. A child six months through eight years of age received her only dose of vaccine last year. This year she should get two doses separated by four weeks. A child was vaccinated for the first time two years ago. She received one dose that year and one dose last year. This year and all subsequent years she will receive only one dose. And finally, a child was vaccinated for the first time two years ago. She received only one dose that year and no influenza vaccine last year. This year and all subsequent years she should receive one dose. When it comes to vaccination for the novel influenza virus such as the H1N1 strain, it is possible that most people will need two doses to be protected. And we'll talk about the novel H1N1 vaccine later in the program. Yabo. Thanks, Donna. Several different formulations of seasonal and activated vaccine are being produced for 2009, 2010. Some of this vaccine will be packaged in 10 dose vials. Whenever vaccine is packaged in a multi-dose vial, the vial must contain a preservative. For inactivated influenza vaccine packaged in multi-dose vials, the preservative is thimerosal. Although there is no evidence that thimerosal in vaccine is harmful, manufacturers have removed it from most vaccines by changing from multi-dose vials to single-dose vials or syringes. Preservative-free influenza vaccine in single-dose vials and syringes will be available again this year. For the 2009, 2010 influenza season, four manufacturers are expected to produce more than 100 million doses of seasonal inactivated influenza vaccine. Three manufacturers produce multiple presentations and three of the four have different age indications for their products. Sanofi Pasteur produces Fluzone, which is available in four presentations. The first is a multi-dose vial that contains thimerosal as a preservative. This formulation may be administered to anyone six months of age or older. Fluzone is also available in three thimerosal-free formulations. A single-dose syringe with a 0.25-milliliter pediatric dose for children six through 35 months of age and a single-dose syringe in vial with a 0.5-milliliter dose for persons 36 months and older. Fluviron is produced by Novartis. It is available in a multi-dose vial that contains thimerosal. It is approved for persons four years and older. Fluorix is produced by GlaxoSmithKline and is available only in a single-dose 0.5-milliliter syringe. Glaxo also produces Fluleval in a multi-dose vial. Both vaccines are approved for persons 18 years and older. The Fluleval multi-dose vial contains thimerosal as a preservative. Fluorix does not contain thimerosal as a preservative. Afloria is produced by CSL Biotherapies. It is the first Australian vaccine approved for use in the United States. Afloria is available in a single-dose 0.5-milliliter syringe and in a multi-dose vial. Both vaccines are approved only for persons 18 years and older. The multi-dose vial contains thimerosal as a preservative. The single-dose syringe presentation is preservative free. You should be careful to administer these vaccines only to persons in the age group for which they are approved. If you intend to administer inactivated influenza vaccine to children younger than four years of age, you must use Fluzone. None of the other inactivated vaccines are approved for children this age. And ACIP does not recommend use of these vaccines outside their approved age ranges. The second type of influenza vaccine available in the United States is live attenuated influenza vaccine, which we will refer to as LAIV. The vaccine is produced by Metamune and marketed as FluMist. It is administered as a nasal spray. LAIV is trivalent and contains the same virus strains included in inactivated influenza vaccine. It does not contain thimerosal, but does contain egg protein. Among healthy children, LAIV has been demonstrated to reduce culture-confirmed influenza, febrile illnesses, and acute otitis media requiring antibiotics. Among healthy adults, LAIV reduces febrile upper respiratory tract illnesses, lost workdays, healthcare provider visits, and antibiotic use. LAIV is approved for healthy persons two through 49 years of age who are not pregnant. This group includes many healthcare personnel and other persons in close contact with high-risk groups, such as household contacts. The vaccine is also an option for persons who want to reduce their risk of influenza. These persons now have the option of choosing either TIV or LAIV. LAIV should not be administered to anyone younger than two years, older than 49 years, or persons with an underlying medical condition that increases the person's risk of complications of influenza. TIV should be used for these groups. LAIV contains egg protein, so it should not be administered to a person with anaphylactic egg allergy. This table shows the vaccination schedule for LAIV based on age and prior influenza vaccination history. A dose of LAIV is 0.2 milliliters, regardless of age, divided equally between the nostrils. Children two through eight years of age who have received no previous influenza vaccine, either LAIV or inactivated influenza vaccine, should receive two doses of LAIV separated by at least four weeks. Children two through eight years of age previously vaccinated with either LAIV or inactivated influenza vaccine, should receive either one or two doses of LAIV depending on the number and timing of the prior dose or doses. As we discussed earlier, children two through eight years of age who received only one dose, either TIV or LAIV, in their first year of vaccination, should receive two doses the next year. Persons nine through 49 years of age should receive one dose of LAIV. In summary, inactivated influenza vaccine can be administered to persons six months of age and older. But because of licensure issues, not all brands of TIV can be administered to all age groups. You should only administer a brand licensed for the age group you're vaccinating. LAIV is approved for healthy, non-pregnant persons two through 49 years of age. It should not be administered to persons younger than two years, older than 49 years, pregnant women or persons with underlying medical conditions. These persons should receive only TIV. Dana? In any given year, the optimal time to vaccinate for influenza cannot be determined because influenza seasons vary in their timing and duration. In addition, more than one outbreak might occur in a community in a single year. In the United States, localized outbreaks that indicate the start of seasonal influenza activity can occur as early as October. However, in more than 80% of influenza seasons since 1976, peak influenza activity has not occurred until January or later. And in more than 60% of seasons, the peak was in February or later. In general, immunization providers should begin offering vaccine as soon as it becomes available. Even if vaccine becomes available in August. This will be particularly important in 2009 because vaccine for the novel H1N1 virus may become available late in the year and overlap with your seasonal influenza vaccination activities. To avoid missed opportunities for vaccination, providers should offer vaccine during routine healthcare visits or during hospitalizations whenever vaccine is available. ACIP recommends that providers continue to offer influenza vaccine in December, especially to healthcare personnel and those at high risk of complications. Providers should continue to vaccinate throughout influenza season, typically December through March, even after influenza activity has been documented in the community. Vaccine administered in December or later, even if influenza activity has already begun is likely to be beneficial in the majority of influenza seasons. The majority of adults have antibody protection against influenza virus infection within two weeks after vaccination. Planners are encouraged to develop the capacity and flexibility to schedule at least one vaccination clinic in December. CDC has developed guidelines for planning large scale immunization clinics. We will provide a link to these guidelines on our updates and resources webpage. Yebo. Thanks. Persons that increase risk for influenza complications or infection are a high priority for your inactivated influenza vaccination program. Some of these persons may also be candidates for live attenuated influenza vaccine. Age is an important risk factor for complications of influenza, in particular adults 65 years and older. However, ACIP recommends routine vaccination for persons 50 years and older, because persons 50 through 64 years of age have an increased prevalence of high risk conditions. As we discussed earlier, children six months through 18 years of age should be vaccinated. In addition to age, the medical conditions that increase the risk of influenza complications include pulmonary disease such as emphysema and asthma, cardiovascular disease, and metabolic disease such as diabetes. Other persons at increased risk of influenza related complications include those of renal dysfunction, such as chronic renal failure or nephropathy, hemoglobinopathy and immunosuppression, including HIV infection. Persons with conditions that compromise respiratory function or increase the risk of aspiration are at increased risk of complications of influenza. Examples of these conditions are spinal cord injury, stroke and seizure disorder. In addition to persons with chronic illness, other groups at increased risk of complications include residents of long-term care facilities and persons six months through 18 years of age receiving chronic aspirin therapy. Finally, pregnant women should be routinely vaccinated. ACIP recommends vaccination with inactivated influenza vaccine for all women who will be pregnant during influenza season, December through March. The American College of Obstetrics and Gynecology concurs with this recommendation. Vaccination can occur in any trimester of pregnancy. Pregnant women should receive only inactivated influenza vaccine. Live attenuated influenza vaccine is contraindicated during pregnancy. Pregnant women may receive inactivated influenza vaccine either with or without thimerosal as a preservative. Finally, influenza vaccine can be administered to persons who are not at increased risk of complications of influenza. Immunization providers should administer influenza vaccine to any person who wishes to reduce the likelihood of becoming ill with influenza or transmitting influenza to others should they become infected. Healthy, non-pregnant persons two through 49 years can choose to receive either type of influenza vaccine. So far we have emphasized vaccination of persons who are at increased risk of complications of influenza. It is also critical to vaccinate persons who are in close contact and can transmit influenza to those at increased risk of complications. This group includes household members of high-risk persons and healthcare personnel, including home care. Finally, you should vaccinate all employees of long-term care facilities and not just the nurses and doctors. Do not forget the nursing aides, housekeepers, physical therapists, dieticians, and anyone else who shares air with the patients. Healthcare personnel are a higher priority for early supplies of influenza vaccine. Healthcare personnel are often implicated in introducing influenza into healthcare settings and cause an outbreak among patients. Outbreaks among patients have been reported in a number of healthcare settings including ICUs, neonatal intensive care units, and nursing homes. Yet influenza vaccination levels among healthcare personnel are abysmally low. Vaccination of healthcare personnel is a high priority for reducing the impact of influenza in healthcare settings. We do not have time during this program to go into detail on this issue, but many resources are available to help increase influenza vaccination levels among healthcare personnel. In February of 2006, the ACIP published a document that specifically addresses the issue of influenza vaccination of healthcare personnel. It includes specific recommendations that can help improve influenza vaccination levels in your facility. CDC has an entire section of its influenza webpage dedicated to infection control and employee health vaccination issues. We will include a link to these resources on the updates and resources webpage. Donna? Contraindications and precautions differ between inactivated and live attenuated influenza vaccines. Those to TIV are the same as most other inactivated vaccines. A history of a severe allergic reaction to a vaccine component or following a prior dose of vaccine is the only contraindication. Both influenza vaccines contain egg protein, so persons with a severe egg allergy should not receive either vaccine. Moderate or severe acute illness is a precaution and vaccination should be deferred until the acute illness has improved. A history of Guillain-Barre syndrome within six weeks following a previous dose of influenza vaccine is considered to be a precaution for use of influenza vaccines. LAIV has more contraindications and precautions than the inactivated vaccine. It might help to think of LAIV as being contraindicated for most persons for whom inactivated influenza vaccine is indicated. TIV should be considered in most persons for whom LAIV is contraindicated. LAIV is contraindicated for children younger than two years and adults 50 years of age and older. Persons with an underlying medical condition that is an indication for inactivated influenza vaccine should not receive LAIV. This includes persons with immunosuppression from any cause. Children 18 years and younger receiving chronic aspirin therapy should not receive LAIV. Pregnant women should not receive LAIV, but should be routinely vaccinated with TIV. As with all vaccines, a severe allergic reaction to a vaccine component or following a prior dose is a contraindication for LAIV. The viruses in LAIV are grown in chicken eggs, so severe egg allergy would be a contraindication just like it is for TIV. Children younger than five years with wheezing or asthma should not receive LAIV. We will come back to this issue in a moment. As with TIV, a history of Guillain-Barre syndrome within six weeks following a previous dose of influenza vaccine is considered to be a precaution for use of influenza vaccines. Likewise, vaccination with LAIV should be deferred in persons with a moderate or severe acute illness. LAIV can be administered to persons with minor acute illnesses. Some studies have found an increased risk of wheezing among children who received LAIV. Not all studies have found an increased risk of wheezing. When it was found, the increased risk was primarily seen in children younger than four years. The risk, if any, of wheezing among children who receive LAIV and have a history of wheezing or asthma is not known because experience with the vaccine among such children is limited. Young children might not have a history of recurrent wheezing if their exposure to respiratory viruses has been limited because of their age. Some children might have a history of wheezing with respiratory illnesses, but have not had asthma diagnosed. Clinicians and immunization programs should avoid use of LAIV in children two through four years of age with asthma or a recent wheezing episode within the previous 12 months. The ACIP developed screening recommendations to assist persons who administer influenza vaccines in providing the appropriate vaccine for children two through four years of age. Healthcare providers should consult the medical record when available to identify children two through four years of age with asthma or recurrent wheezing that might indicate asthma. In addition to identify children who might be at greater risk for asthma and possibly at increased risk for wheezing after receiving LAIV, parents or caregivers of children two through four years should be asked. In the past 12 months, has a healthcare provider ever told you that your child had wheezing or asthma? Children whose parents or caregivers answer yes to this question or whose medical record notes asthma or a wheezing episode within the past 12 months should not receive LAIV. Inactivated influenza vaccine should be administered to children with asthma or possible reactive airways diseases. This issue as well as other information regarding use of LAIV among children two through four years of age is discussed in the current influenza ACIP statement. We will include a link to it on the updates and resources webpage. Yabba. Novel H1N1 influenza is a new influenza virus of swine origin that first caused illness in Mexico and the United States in March and April 2009. The first person infected with the novel H1N1 virus in the United States was confirmed by laboratory testing at CDC on April 15, 2009. It was quickly determined that the virus was spreading from person to person. On April 26th, the United States government declared a public health emergency and has been actively and aggressively implementing the nation's pandemic response plan. By June 19th, infection with the novel H1N1 virus had been reported by all 50 states in the United States, the District of Columbia, Puerto Rico and the U.S. Virgin Islands. On June 11th, 2009, the World Health Organization indicated that a global pandemic caused by the novel H1N1 virus was in progress by raising the worldwide pandemic alert level to phase six. This is the first time an influenza pandemic was declared since their appearance in 1968 of Hong Kong influenza. This action by WHO was a reflection of the spread of the novel H1N1 virus, not the severity of illness caused by the virus. At the time, more than 70 countries had reported cases of novel H1N1 virus infection and there were ongoing community level outbreaks of novel H1N1 in multiple parts of the world. Since the WHO declaration of a pandemic, the novel H1N1 virus continues to spread with the number of countries reporting cases of novel H1N1 nearly doubling. The southern hemisphere's regular influenza season has begun and countries there are reporting that the novel H1N1 virus is spreading and causing illness along with regular seasonal influenza viruses. In the United States, significant illness caused by the novel H1N1 virus has continued into the summer with localized and in some cases, intense outbreaks occurring. The United States continues to report the largest number of novel H1N1 cases of any country worldwide. CDC anticipates that transmission of novel H1N virus will continue during the summer and into the fall and winter. The novel H1N1 virus in conduction with regular seasonal influenza viruses poses the potential to cause significant illness with associated hospitalizations and deaths during the U.S. influenza season. Vaccines are a very important part of a response to novel H1N1 influenza. The U.S. government is aggressively taking early steps in the process to manufacture a novel H1N1 vaccine working closely with manufacturers. CDC isolated the new H1N1 virus, made a candidate vaccine virus strain that can be used to create vaccine and is working with other agencies and industry to begin scaling up for testing and production of a vaccine. It is likely that novel H1N1 vaccine will be available later in 2009. Distribution of the pandemic vaccine will probably overlap with distribution of seasonal influenza vaccine. Our producer recently had the opportunity to speak to Dr. Anne Schuchat, director of the National Center for Immunization and Respiratory Diseases, about planning and deployment of the pandemic vaccine. Dr. Schuchat, where are we now in the production of the new H1N vaccine? The virus was first identified at the end of April, and by the end of May, we had turned the test virus over to the manufacturer so that they could produce larger amounts of vaccine. Right now, we're at the point where the companies have developed pilot lots of vaccine that can be studied. Those trials are going to begin probably by the end of July. If things go well, if the studies go well, if the production goes well, if they're not, lots of surprises, we're expecting a voluntary vaccination program could be launched by the middle of October. Of course, with influenza vaccine, everybody is used to surprises, and we always have to be alert to the idea that things could change. So those are our working assumptions at this point. How will the H1N vaccine be distributed? The US government is buying the vaccine, and at this point, the plans that we have for distribution are that this will be a publicly directed program, but we'll have a mixed model of actual delivery of vaccine. Some vaccine might be given in the public settings like school clinics or community centers, and some vaccine might be given in private settings like doctor's offices or occupational clinics or in pharmacies. The public health departments will actually be directing how things will work in each state or big city, and so for clinicians, it's gonna be really important to stay in touch with the public health community in your area and know what are the options where you live. We remember well the safety issues that came up with the 1976 swine flu vaccine. What's the plan for monitoring the safety of the new H1N vaccine? Vaccine safety is always important, and when we have a program where we expect a lot more people to be immunized, it's important that we have systems ready to go. What we're expecting right now is to use the usual systems, but to increase their capacity and try to make them easier to work with. So we are expecting that the vaccine adverse event reporting system, VAERS, will be a centerpiece of our safety monitoring. This is really an important message for clinicians because you're the front line, so we're hoping that clinicians will actively report events that they see in people who have been immunized, whether or not they think that they're related, just events that follow immunization so that we can look into them in more detail. We'll also be using some of the more active or intensive systems like the Vaccine Safety Datalink or VSD, which looks at a full population in managed care settings and is able to look at denominators. So we're expecting that will be an important system in some parts of the country to do intensive monitoring and investigation of signals that we see in the VAERS system. We're also expecting to set up an intensive surveillance system for Guillain-Barre syndrome itself, working with health departments to identify those cases. If the vaccine supply is limited, what groups will be the highest priority for the vaccine that is available? Our advisory committee for immunization practices is going to be deliberating at the end of this month on two questions, really. One will be recommended population groups to get the vaccine based on the epidemiology of what we've been seeing with this 2009 H1N1 strain and also based on complications and severe consequences of the influenza. The second question they're gonna look at is the question of prioritizing or tiering in the circumstances where there's not enough vaccine, are there some people that should get vaccine first and others get it later? And there's a lot of discussion about that. At this point, groups that we know are more heavily affected or have had more complications include younger people. We've seen outbreaks in schools. They include pregnant women and other adults with underlying conditions. And we've also heard a lot of discussion about healthcare workers as being very important frontline responders who we wanna keep healthy and caring for their patients and not spreading the infection to other patients. So those are the groups that people have been talking about, but whether they'll be prioritization or tiering or not will be something that comes out of the advisory committee for immunization practices. It's interesting that before the pre-pandemic planning assumed that we would have a circumstance with limited supply and a lot of demand for vaccine. And so there was a lot of work that went into priority groups. At this point, if things go well, we may be in a circumstance where there's a pretty good supply of vaccine by October or so. And so if we really are in that kind of scenario, the issue of whether tiering is needed is a question because it may actually not even be needed. But these are the kinds of things that our ACIP committee will be talking about at the end of July. Dr. Shukit, thank you for stopping by today to talk about H1 vaccine with us. It's been my pleasure, thank you. As Dr. Shukit mentioned, the advisory committee on immunization practices held a special meeting yesterday, July 29th here in Atlanta to discuss the current situation with novel H1N1 virus and planning for the H1N1 vaccination program. The purpose of the meeting and ACIP's charge was to identify target groups for the novel H1N1 vaccine, which is also being referred to as pandemic vaccine. The discussion was in the context of an unknown number of doses of pandemic vaccine that will be available and when it will be available. The recommendations were also influenced by the observation that younger age groups appear to be at the highest risk of infection with the novel H1N1 virus. 50% of reported cases to date have been among persons five through 24 years of age. The first recommendation concerned the initial target groups, assuming a limited number of doses would be available. Initial efforts should focus on vaccination of as many as possible in the initial target groups. These groups are pregnant women, household and caregiver contacts of children younger than six months of age, healthcare and emergency medical services personnel, children from six months through 24 years of age, and persons 25 through 64 years who have high risk medical conditions. ACIP is assuming that for optimum protection, the pandemic vaccine will require two doses. The second recommendation was that although two doses could be necessary, vaccine should not be kept in reserve for later administration of the second dose. That is vaccine should be administered on a first come first served basis within the target groups and vaccine should not be saved just for second doses. The third recommendation concerned vaccination when supply is adequate. When vaccine availability is sufficient at the local level to routinely vaccinate initial target populations, vaccination against pandemic influenza is recommended for healthy adults, 25 through 64 years of age. And finally, ACIP considered vaccination of persons 65 years of age and older. ACIP voted to recommend that vaccination should be offered to persons 65 years and older once vaccination programs are capable of meeting demand for vaccination of younger age groups. The recommendation to offer vaccine to persons 65 years of age or older might need to be reassessed as new epidemiologic, immunologic or clinical trials data warrant or in the context of global need for pandemic vaccine. ACIP reiterated that seasonal influenza vaccination should begin as soon as it is available for all groups currently recommended for seasonal vaccination. Slidesets, minutes and provisional recommendations of the meeting will be posted on the ACIP webpage soon. In addition, CDC has developed guidance for state and local public health departments to assist them in planning for a novel H1N1 influenza vaccination campaign. We will include a link to this guidance as well as other information about the novel H1N1 virus and vaccine on our updates and resources webpage. Sharon? Donna, Yabo, because we've had so many questions about this issue, I'd like to stop right now and address some of those concerns we've already received some questions. Donna, let me start with you. For pandemic influenza vaccination, why are pregnant women among the initial target groups? Well, we know that pregnant women are at high risk for influenza anyway. They're at higher risk, not so much for infection, but if they are infected for complications and hospitalization. And what we've seen so far with this H1N1 virus is that they have higher attack rates. So that's why they're high on the target list. Okay, thanks, Donna. Yabo, why are people 65 years and older, not in the pandemic influenza vaccine initial target group? That's a good question, Sharon. Unlike in previous years with seasonal influenza vaccine where older individuals 65 and older were targeted for vaccine, this year, the priority has been shifted to the younger age group because what we're finding is that with this novel H1N1 influenza virus, the younger population are the ones who are getting sicker and ending up in the hospital more often than the older age group. There's also been some early data through the CDC which has shown that older individuals may have some protective antibodies against the H1N1 virus. That's interesting. I'm sure a lot of senior citizens are paying close attention. Donna, here's one for you. Can pandemic influenza and seasonal influenza vaccine be given at the same time? Well, we're assuming yes. I mean, really answering questions like this before we have all the data from the clinical trials is a little iffy, but at this point, we are assuming that would be the case. Now, one thing that you're gonna have to be very, very careful about is, number one, don't try to mix this with seasonal influenza vaccine. They have to be given as separate injections. And then just follow the guidelines like you normally would in a vaccine site when you're giving more than one vaccine, you know, or you can give them in different arms. Well, we'll hear more detail after the clinical trials are completed. And on that note, Donna, a question for you, Yvonne. How do I find out more about vaccine clinic trials? Okay. There are basically two arms of clinical trials. One now will be run by the manufacturers of the vaccines. And a second arm that will be run through the NIH, through different research hospitals throughout the United States. So you can either go to the manufacturer websites to find out about their clinical trials. We will also have posted on our resources webpage information about the NIH-sponsored clinical trials. All right, great. And one more question. Donna, won't we need a separate VIS for pandemic influenza vaccine? Yes, Sharon, you're absolutely right. We will. And I'm sure that they're working on that now. But again, they're gonna need, you know, the data from the clinical trials for that information. But there will be one posted as soon as they possibly can do that. Okay, thanks, Donna. We will return in a moment to discuss new recommendations for pneumococcal polysaccharide vaccine. Your baby needs his first shot by the time he's two months old. I know, we've done that. Great for starters. But there's still more shots due before two years than booster shots before kindergarten. More shots like hepatitis B around 12, tetanus subtheria boosters every 10 years after that, and flu and pneumonia shots after age 65. The fact is shots aren't just for babies. Have you got your shots? I don't know, ask my mommy. Ask wherever you get care or call 1-800-657-3970. In 2008, ASAP added two new indications for pneumococcal polysaccharide vaccine for adults 19 years of age and older. Asthma and cigarette smoking. We would like to discuss the rationale behind these new indications. Many underlying medical conditions are known risk factors for invasive pneumococcal disease or IPD. These conditions include decreased immune function from disease or drugs, functional or anatomic isplania, chronic heart, pulmonary, liver or renal disease, cerebral spinal fluid leak, and receipt of a cochlear implant. Since the introduction of pneumococcal conjugate vaccine in 2000, rates of invasive pneumococcal disease among children have fallen significantly. However, vaccination of children has not eliminated the risk among adults. The disease burden in adults still remains high with about 36,000 cases and 4,500 deaths due to invasive pneumococcal disease in 2007. The most current year for which data are available. Pneumococcal polysaccharide vaccine, which we will abbreviate PPSV, has been available in the United States since 1977. The most recent ACIP statement for PPSV was published in 1997. ACIP has recommended PPSV for persons with chronic pulmonary diseases such as emphysema for many years, but routine vaccination has never been recommended for persons with asthma. This was because until recently, there were no data on increased risk of pneumococcal disease among persons with asthma. Additional data have become available on risk factors for IPD since the 1997 PPSV recommendations were published. Asthma has now been identified as an independent risk factor for IPD. A 2005 study published in the New England Journal of Medicine demonstrated that adults with asthma had at least double the risk of IPD compared with adults of similar age without asthma. Another reason for adding asthma to the list of PPSV indications was to harmonize the PPSV recommendations with those for influenza vaccine. Asthma has been an indication for seasonal influenza vaccination for years. Including asthma among the other chronic lung diseases that are already indications for PPSV will be more consistent with recommendations for other chronic lung diseases. In addition, studies have shown that most adults with asthma that develop invasive pneumococcal disease already have another condition for which PPSV is recommended. ACIP now recommends routine vaccination with pneumococcal polysaccharide vaccine for all adults 19 years of age and older with asthma regardless of severity. ACIP did not define the severity of asthma, so even adults with mild asthma are included. Available data do not support asthma as an indication for PPSV among persons younger than 19 years. Recent population-based studies have consistently reported that cigarette smokers accounted for approximately half of otherwise healthy adults with invasive pneumococcal disease. Data from the Active Bacterial Course Availance System have shown an increased prevalence of current and former smokers among cases of IPD during 2001 through 2003. In those 18 through 64 years old, 53% of the IPD cases are among current smokers. 75% of these smokers already had another chronic condition that was included in the ACIP's recommendation for PPSV vaccine. In a multi-center, population-based case control study in 2000, the data suggests that cigarette smoking was the strongest independent risk factor for invasive pneumococcal disease among immunocompetent, non-elderly adults. The adjusted population attributable risk was 51% for cigarette smoking. The risk of IPD also increased from about two-fold to 5.5-fold as the daily number of cigarette smoked increased, suggesting a dose-response relationship. The time since quitting smoking also showed clear dose-response relations with the risk of pneumococcal disease. Approximately half of adults 65 years of age or younger who develop severe pneumococcal disease are smokers. Cigarette smoking is a particularly strong risk factor for severe pneumococcal disease. Many adults who smoke cigarettes and develop pneumococcal disease also have another condition for which PPSV is already recommended. Cigarette smoking is a risk behavior that is easy to identify among patients in clinical practice. Lastly, smoking cessation should be part of the therapeutic plan regardless of immunization. ACIP now recommends routine vaccination with pneumococcal polysaccharide vaccine for all adults 19 years of age and older who smoke cigarettes. ACIP did not define the minimum number of cigarettes per day, so even adults who smoke only a few cigarettes per day are included. As with asthma, available data do not support smoking as an indication for PPSV among persons younger than 19 years. In summary, there is still a considerable burden of pneumococcal disease among adults, in particular, those who have underlying medical conditions or other risk factors. Available data indicate that adults who have asthma or who smoke cigarettes are at significantly increased risk for invasive pneumococcal disease. Vaccinated individuals who have established and new high-risk conditions with PPSV, as well as continuing efforts to increase coverage are important strategies to prevent pneumococcal infections. Donna? The majority of persons eligible for PPSV will only need a single dose in their lifetime. A few persons at very high risk of pneumococcal infection should receive a second dose. We receive many questions about revaccination with pneumococcal polysaccharide vaccine. We have heard of clinicians who want to administer it every 10 years or every five years or even every year along with influenza vaccine. The basic problem is that multiple doses of polysaccharide vaccine do not provide a significant boost in antibody titer. In addition, there is little evidence that more than one dose protects any better than just one dose. Routine revaccination of immunocompetent persons is not recommended regardless of the person's age. Revaccination is recommended for persons at highest risk of serious pneumococcal infection and for those who are likely to have a rapid decline in pneumococcal antibody levels. I will define these groups a little further in a moment. Revaccination is a one-time event. Data for the safety and efficacy of more than two doses are not available, so only one revaccination dose should be given. This single revaccination dose should be given five years or longer after the first dose. This revaccination interval applies to persons of all ages. Persons who are candidates for revaccination are those at highest risk of severe disease. This includes persons with functional or anatomic esplenia and persons with immunosuppression from either disease or drugs. Disease immunosuppression occurs with HIV infection, leukemia, lymphoma, and other malignancies. Therapeutic immunosuppression occurs with cancer chemotherapy, post-transplantation immunosuppressive drugs, and high doses of corticosteroids. Additional candidates for revaccination include persons with chronic renal failure and persons who have conditions that result in a rapid decline in antibody levels, such as nephrodic syndrome. Persons vaccinated before age 65 years should also be revaccinated. This would include adults who received PPSV because of asthma or smoking. However, smokers who do not quit might not live to 65 years. So for them, this could be a moot point. Revaccination of healthy persons 65 years of age and older is not routinely recommended, but persons 65 years of age and older should be revaccinated if they received their first dose five or more years earlier and were younger than 65 years of age at the time of the first dose. Also, if a healthy person receives the first dose of pneumococcal polysaccharide vaccine at 65 years of age and then develops a condition that increases the risk for pneumococcal disease, immunosuppression, for instance, a second dose five years or more after the first dose would be appropriate. Person 65 years of age and older whose vaccination status is not known should be given one dose of vaccine. Sharon? Donna, thanks. Coming up next is a discussion of the childhood immunization schedule and the use of so-called alternative schedules. Each year, children in Idaho move further and further from the reality of contacting deadly disease. Each year, life-threatening illnesses are things of the past. And each year, percentage-wise, more parents are keeping their children and community protected all thanks to child immunizations. But if immunization rates decline, these diseases could return. Parents, keep your child's immunization schedule current. With your help, we can keep the risk of disease to a minimum. Childhood immunization schedules have been recommended for decades by national advisory committees, such as the Advisory Committee on Immunization Practices. For many years, the schedule was quite simple because not many vaccines were available. The schedule has become increasingly complicated during the last 25 years as more vaccines were added. The number of vaccine doses routinely recommended by 24 months of age has increased from eight in 1983 to 15 in 1994, 19 in 1999, and 22 doses to complete the primary series in 2004. In 2009, we routinely protect children 24 months and younger against 14 diseases. Completing this schedule could require as many as 27 doses of vaccine with as many as nine injections at a single visit. Of course, the number of injections at one visit can be significantly reduced with the use of combination vaccines and flexible timing of the doses. But even two or three injections at one visit can concern some parents. Concerned about the number of vaccines, and particularly the number of injections, has led to the proliferation of so-called alternative immunization schedules. An internet search in July 2009 for alternative immunization schedule returned more than 150,000 hits. Some of the schedules advocated avoidance of all vaccines or avoidance of certain vaccines or delayed initiation or completion of the schedule. But by far, the most references and the alternative schedule that came up first on the search was the schedule created by Robert Sears in his 2007 book titled The Vaccine Book, Making the Right Decision for Your Child. The basic approach Sears takes with his alternative immunization schedule is that no more than two vaccines are given at any visit. The reason he gives for the two vaccine limit per visit is to limit potential adverse reactions, although he provides no evidence that this schedule will do this, and to limit exposure to aluminum and other components of the vaccine, although there's no evidence that this is necessary. Sears seems to be very concerned about the aluminum content of vaccines. Unfortunately, he does not put aluminum exposure in vaccines into context, in particular the lack of evidence of harm from aluminum adjuvants, and the fact that an infant is exposed to thousands of times more aluminum from breast milk formula and other sources. Sears does not specifically advise against receiving any recommended childhood vaccine, and generally does not reduce the number of doses in the series. Consequently, for a child to keep up to date with his schedule requires many more visits than with the standard schedule. Here's the Sears schedule for the first 18 months of life. Notice that it requires 10 visits, including seven monthly visits between two and seven months of age. If no visits were missed, and that's a big if, the child would receive by 18 months of age four doses of DTAP, three doses of rotavirus, four doses of pneumococcal conjugate, four doses of Hib vaccine, two doses of influenza vaccine, and one dose of varicella vaccine. This is the same number of doses of these vaccines a child would receive on a standard schedule, but requires twice as many visits to accomplish. Unfortunately, the child would receive no hepatitis B vaccine, mumps vaccine only rather than MMR, and only one dose of polio vaccine. To complete the childhood series on the Sears schedule requires another five visits, a total of 15 visits, and will not be completed until the child is three and a half years old. Using the standard schedule, the same series could be completed in five or six visits by 18 months of age. In addition to extending the time a child is susceptible to some diseases, particularly measles, the Sears schedule has other serious problems. The most important is that he does not recommend starting the hepatitis B vaccine series until the child is 30 months of age. This is a very dangerous recommendation. Although Sears agrees that hepatitis B is a serious disease, he believes that hepatitis B virus infection is not an issue for infants and children because it is primarily a sexually transmitted disease in the United States. Nowhere in the book does he mention the fact that an estimated 24,000 women with chronic hepatitis B virus infection give birth every year in the United States, and that every infant born to a woman infected with hepatitis B virus is at risk of perinatal infection. He seems to put all his faith in serologic testing of the mother, but does not take into account the many mistakes that can and do lead to failure to provide post-exposure prophylaxis for the infant. These can include orders for the wrong serologic test, misinterpretation of the test results, laboratory errors, and other mistakes that result in the infant not being properly treated. This alternative schedule will inevitably result in perinatal transmission of hepatitis B virus. Perinatal transmission of hepatitis B virus is not acceptable. The hepatitis B birth dose is a critical safety net to prevent transmission of the virus to infants from unknowingly infected women or from exposure in the home after leaving the hospital. Any parent considering this alternative immunization schedule should be strongly recommended to include hepatitis B vaccine at birth and to complete the series by six months of age. In addition to the schedule and quite a few factual errors, there are many other problems with the book. For instance, he generally does not acknowledge that many reports to the vaccine adverse event reporting system represent coincidental medical events and that various reports cannot be used to determine the true incidents of vaccine adverse reactions. This could easily bias the reader against the vaccines because of an inordinate fear of adverse reactions. We believe that the standard childhood immunization schedule provides plenty of flexibility for parents without resorting to special alternative schedules like this one. But it is likely that parents will continue to buy this book and will continue to ask questions about it or request to follow it for their child. Only the most reliable parents in your practice should even be considered for the series schedule and you should have a very low threshold for abandoning it should the child fall behind. You need to be sure that parents understand the large number of visits required and the financial implications of this. You should insist on a hepatitis B birth dose and you should insist on MMR at 12 to 15 months of age. Finally, you should have the parent read this article. It was written by Dr. Paul Offit at the Children's Hospital of Philadelphia and published in Pediatrics in 2009. The article critically examines the book and many of the claims made by the author. We will post the article on the Updates and Resources webpage. Welcome back to the program. Joining us for this part of the program is Dr. Andrew Kroger. Dr. Andrew Kroger is a medical officer in the National Center for Immunization and Respiratory Diseases at CDC. He has been with NCIRD since 2003. Several new combination vaccines have been licensed by the Food and Drug Administration in the last two years. While combination vaccines make it possible to reduce the number of injections in the immunization series, they can also create difficulties for clinicians. Andrew will begin our discussion on this topic. Andrew. Thank you, Sharon. Clinicians and other healthcare providers make decisions about whether they want to use combination vaccines in their practices. They often make this decision in collaboration with the public health department. There are advantages and disadvantages to using a combination vaccine. Generally, the advantages outweigh the disadvantages. We need to share with you new CDC recommendations that affect the use of combination vaccines. A combination vaccine is defined as a product whose components can be equally divided into independently available routine vaccines. Although MMR and DTAP vaccines are technically combination vaccines, they do not meet this definition because not all components are independently available for routine use. There are seven vaccines that meet this definition. You need to be aware of new recommendations for three of these vaccines, Proquod, Kinrix, and Pentacell. The complexity of these recommendations has led ACIP to provide new guidance to providers about how to approach combination vaccines generally. Proquod is combined measles, mumps, rubella, varicella vaccine, or MMRV. The measles, mumps, and rubella components of MMRV are identical to MMR. MMRV has seven to eight times as much varicella vaccine virus as monovalent varicella vaccine. MMRV is approved only for children 12 months through 12 years of age and should not be administered to anyone 13 years of age or older. The ACIP originally stated a general preference for this combination product rather than use of separate MMR and varicella vaccines. At its February 2008 meeting, new information was presented to ACIP regarding an increased risk for febrile seizures among children 12 through 23 months of age after administration of the first dose of combination MMRV vaccine. At the time, ACIP thought best to remove the general preference recommendation for this specific combination vaccine. Follow-up analyses using data from the Vaccine Safety Datalink have confirmed a two-fold increased risk of febrile seizures in children who receive the combination MMRV product when compared to the MMR and varicella vaccine separately. The increased risk of febrile seizures was observed for the first dose only of these respective vaccines. The increased risk of febrile seizures is most likely related to the higher incidence of fever following MMRV and to the age of the child. This finding reinforces the guidance given by ACIP in February 2008. At its June 2009 meeting, ACIP voted to recommend that for the first dose of measles, mumps, rubella, and varicella vaccines given at 12 through 47 months of age, either MMRV vaccine or separate MMR and varicella vaccines can be used. The potential benefits and risks of both vaccination options should be discussed with the parents or caregivers. This is an exception to the general rule for combination vaccines because the general rule states a particular preference for combination products. For children older than 47 months of age, providers are encouraged to follow the general recommendations for combination vaccines for either dose one or dose two of MMR, varicella, or MMRV. We will return to a discussion of the general preference for combination vaccines in a moment, but first we need to discuss new recommendations for two other combination vaccines that were licensed last year. Kinricks is produced by GlaxoSmithKline and was licensed by the Food and Drug Administration on June 24, 2008. It contains DTAP and inactivated poliovirus vaccine, or IPV. The individual components are identical to those contained in GSK's DTAP vaccine, Infinrix, and the IPV component of GSK's combination, DTAP-HEP-B IPV vaccine, Pedirix. Kinricks is approved for the fifth dose in the DTAP series and the fourth dose in the IPV series in children four through six years of age, whose prior DTAP vaccine doses were Infinrix and or Pedirix for the first three doses and Infinrix for the fourth dose. Data are limited on the safety and immunogenicity of interchanging currently used DTAP vaccines from different manufacturers. The ACIP recommends that, whenever feasible, the same manufacturer's DTAP vaccine should be used for all doses of the series. However, vaccination should not be deferred if the specific DTAP brand previously administered is not available or not known. So Kinricks may be used for the fifth dose of the DTAP series for a child who received a different brand of DTAP for the earlier doses. Kinricks is approved by the Food and Drug Administration only for the fifth dose of the DTAP series and as the fourth dose of the IPV series. Off-label use of Kinricks for earlier doses in the DTAP and IPV series is not recommended. In fact, use of Kinricks for any dose except the fifth dose of DTAP and fourth dose of IPV should be considered a vaccine administration error. We will discuss vaccine administration in more detail later in the program. However, if Kinricks is inadvertently administered as an earlier dose in the series, that is, for DTAP doses one through four or IPV doses one, two, or three, the dose may be counted as valid and does not need to be repeated if the minimum age and minimum interval since the prior dose are met. In October, 2008, CDC published a notice to readers regarding Kinricks in Morbidity and Mortality Weekly Report. We will include a link to the publication on the Updates and Resources webpage. Donna? Another combination vaccine that generates a lot of questions is Pentacell. Pentacell contains DTAP, IPV, and Hib vaccines and is produced by Santa Fe Pasteur. The package contains Santa Fe's lyophilized Hib, that is reconstituted with a liquid DTAP IPV solution. The DTAP component is identical to Santa Fe's Daptacell DTAP vaccine. The vaccine was licensed by the FDA on June 20th, 2008. Pentacell is licensed by FDA for doses one through four of the DTAP series among children six weeks through four years of age. Pentacell should not be used for the fifth dose of the DTAP series or for children five years or older. The schedule for Pentacell is four doses which are typically administered at ages two, four, six, and 15 through 18 months. Each of the first three doses should be separated by a minimum of four weeks. The fourth dose may be administered as early as 12 months of age if at least six months have elapsed since the third dose of DTAP. As we discussed earlier for Kenricks, the ACIP recommends that whenever feasible, the same manufacturer's DTAP vaccine should be used for all doses of the series. However, vaccination should not be deferred if the specific DTAP vaccine brand previously administered is not available or not known. So Pentacell may be used for any of the first four doses of the DTAP series for a child who received a different brand of DTAP for the other doses. The decision to choose a combination vaccine versus separate components is complex and providers must weigh the advantages against the disadvantages of combination vaccines. Some of the advantages of combination vaccines include a reduced number of injections, improved vaccination timeliness and coverage, and reduced shipping and storage cost. Disadvantages of combination vaccines include the potential for increased adverse events and extra doses of antigen. The final decision on the use of combination vaccines requires a careful provider assessment taking into account patient preference and the known potential for adverse events. As we described earlier for MMRV vaccine, some combination products do have a higher risk for adverse events. A provider assessment must also carefully weigh certain considerations that include the number of injections, vaccine availability, likelihood of improved coverage, likelihood of patient return, and storage and cost considerations. Providers must ultimately choose whether or not to use a combination vaccine. We hope you understand the complexity of the anatomic, immunologic, safety, and programmatic concerns that can affect this decision. You should discuss these issues with your patients and listen to their concerns. A strong relationship with your local and state public health department can also be a valuable asset in navigating these issues because they are often directly involved with the programmatic issues of vaccine availability. Sharon? Donna, a quick question. Pentacell is unique because the ACT-HIB component is reconstituted with liquid DTAP IPV solution rather than a more typical diluent, such as saline or sterile water. Sometimes providers make a mistake and administer the DTAP IPV solution without using it to reconstitute the HIB vaccine. Can DTAP IPV vaccine be counted as a valid dose when this happens? We get that question a lot and it's unfortunate that this vaccine administration error happens quite often. The DTAP IPV component of Pentacell is not approved by the FDA for separate administration. But there is no reason to believe that the DTAP IPV component given without the HIB would be less effective. So we advise that the dose be counted as valid. Now a more serious problem in this situation is that when the DTAP IPV component is given alone, there will be no diluent for the HIB component. ACT-HIB cannot be reconstituted with any diluent except the DTAP IPV solution that comes in the Pentacell box or a specific ACT-HIB diluent. You cannot use MMR or varicella diluent or any other liquid to reconstitute it. So if you make a mistake and have ACT-HIB without diluent, you must contact Santa Fe Pasteur and ask them to send you the ACT-HIB diluent. Okay, thanks Donna. We will be back in just a moment to update you on the vaccine supply. Romper Room, to have fun and stay healthy, you need your doctor's help. Here's my friend, Dr. John Witte. How can girls and boys stay healthy? Boys and girls, all children of Romper Room size must be immunized to stay healthy. A little hurt from an immunization can keep you from getting many big hurts or sicknesses. To stay healthy, immunize at Romper Room size. Talk to your parents and your doctor. Immunize at Romper Room size. In this segment of the program, we wanna update you on the status of the supply of certain vaccines and discuss re-institution of the HIB booster dose. First, let's talk about the supply of hepatitis A vaccine. VACTA is Merck's hepatitis A vaccine. The adult formulation of VACTA is not currently being distributed and this product will not be available in 2009. Merck will provide an update on 2010 availability when information becomes available. The supplies of the adult formulation of Havrex, GlaxoSmithKline's hepatitis A vaccine, and their adult hepatitis A, hepatitis B combination vaccine, TwinRx, are currently adequate to meet demand. There are also supply issues related to hepatitis B vaccine. Since February, there have been intermittent pediatric hepatitis B vaccine supply constraints in the United States with some local areas experiencing delays in shipments. Merck expects the supply of their pediatric formulation of hepatitis B vaccine, RecombaVax HB, to be limited during the remainder of 2009 and does not expect to return to a full supply until 2010. GlaxoSmithKline will provide additional NJRxB beginning in September 2009 in order to assure a sufficient supply. The summer months of July and August are anticipated to have the tightest supply, but CDC has determined that available pediatric monovalent supply will remain sufficient to support routine immunization during that time period if providers continue to order vaccine judiciously. Regarding the supply of other formulations of hepatitis B vaccine, Merck's adult and dialysis formulations of their hepatitis B vaccine, RecombaVax HB, will not be available in 2009. Merck expects to return to full supply sometime in 2010. Supplies of GlaxoSmithKline's adult formulation of NJRxB and the hepatitis A, hepatitis B combination vaccine, TwinRx, are sufficient to meet demand for routine adult usage as well as CDC's ongoing high risk adult hepatitis B initiative. Finally, an update on monovalent measles, mumps, and rubella vaccine and the combination MMRV vaccine ProQuad. Merck is not currently distributing monovalent measles, mumps, and rubella vaccines. Merck plans to resume production of these monovalent vaccines in the future based on available resources and capacity. Merck does not anticipate the monovalents will be available for at least two years. MMRV ProQuad will not be available during 2009. Merck expects MMRV to return to the US market with full availability in the first half of 2010. Additional information about vaccine shortages is available on our vaccine supply webpage. We will include a link on the updates and resources webpage. Ghana. In December, 2007, Merck initiated a voluntary recall of 10 lots of their Hib vaccine, PeedVaxHib, and two lots of Comvax, their Hib hepatitis B vaccine combination and the company temporarily suspended production of these vaccines. To conserve the limited supply of Hib containing vaccines, CDC recommended that vaccination providers temporarily defer the routine Hib vaccine booster dose. Production of Merck Hib vaccine products, PeedVaxHib, and Comvax remain suspended. A limited supply of PeedVaxHib will be available in the fourth quarter of 2009. Full availability of PeedVaxHib is expected in the first quarter of 2010. The return of Comvax will be dependent upon the supply situation for both Hib and hepatitis B vaccine components. However, Santa Fe Pasteur's Hib containing vaccines, Monovalent Hib vaccine, ActHib, and DTAP-IPV Hib vaccine Pentacel have been available during the shortage. Beginning in July, 2009, Santa Fe increased the number of doses of these two products. This will provide sufficient supply to reinstate the Hib vaccine booster dose. CDC now recommends reinstatement of the booster dose of Hib vaccine for children aged 12 through 15 months who have completed the primary three-dose series. Infants should continue to receive the primary Hib vaccine series at ages two, four, and six months. Children 12 through 15 months of age should receive the booster dose on schedule. Now, older children for whom the booster dose was deferred should receive their Hib booster dose at the next routinely scheduled visit or medical encounter. Although supply is sufficient to reinstate the booster dose and begin catch-up vaccination, the supply is not yet sufficient to support a mass notification process to contact all children with deferred Hib booster doses. Sufficient vaccine will be available to administer the primary series at ages two, four, and six months and a booster dose on time to children aged 12 through 15 months. As part of delivering the booster dose to those children for whom it was deferred at the next routinely scheduled appointment or medical encounter, practices should discuss with parents the reasons for the change in recommendation. Practices should also consider reviewing electronic or paper medical records or immunization information system records to identify children in need of a booster dose before physician encounters, evaluating children's vaccination status during their scheduled visit and sharing immunization schedules with parents. During the Hib shortage, children may have received various permutations of available combination vaccines such as the DTAP-IPV Hib Combination Pentacel and the DTAP-IPV-HEP-B Combination Pediatrics and monovalent vaccines such as ACTIB, hepatitis B, and IPV. As a result, a mismatch might exist between patient vaccination needs and the available stock of different vaccine formulations in local provider offices. This situation presents a challenge for providers to administer vaccines to ensure appropriate coverage while minimizing extra doses of unneeded vaccine. Children who need the Hib booster and who already have received four doses of DTAP should receive monovalent Hib vaccine, ACTIB, as their Hib booster dose. However, if DTAP-IPV Hib Pentacel is the only Hib-containing vaccine available, it can be used to complete the series of Hib vaccination even if the child already has received all the necessary doses of DTAP and IPV. Providers with questions about their supplies of monovalent Hib vaccine or the DTAP-IPV Hib Combination purchased with non-public funds should contact Sanofi Pasteur's Customer Service Department. Sanofi Pasteur will work directly with physicians to increase allotments of Hib-containing vaccines on the basis of previous purchasing patterns or practice birth cohort and estimates of additional vaccine doses needed. For public vaccine supplies, including vaccines for children program vaccine, providers should contact their state or local immunization program to obtain vaccine. Sharon. Thanks, Donna. We will return in a moment for our vaccine briefs segment. Some New York City kids are not getting into school this September because that's the law. The law says if your kids don't have their shots for dangerous diseases like mumps, measles, and polio, they aren't getting into school. The law also says they must go to school so you have no choice. Get your kids their shots called 349-2664 to get free shots now. Remember, no shots, no school. It's the law. Our first vaccine brief concerns a change in a recommended minimum interval and age for inactivated polio vaccine or IPV. The recommended IPV schedule in the United States consists of four doses administered at ages two months, four months, six through 18 months, and four through six years. Although this is the routine schedule, the minimum interval between doses has been four weeks. So it is possible to receive IPV at six, 10, 14, and 18 weeks, which meets the minimum age and interval criteria and be considered series complete for polio vaccine. Since 2002, three different combination vaccines containing IPV have been licensed for routine use in the United States. Pediatrics, which also contains DTAP and hepatitis B vaccines and is licensed for the first three doses of the DTAP and IPV series. Kinricks, which contains DTAP and is licensed for only the fifth dose in the DTAP series and the fourth dose in the IPV series. And Pentacell, which also contains DTAP and Hib vaccines and is licensed for the first four doses of the series for all four components at two, four, six, and 15 through 18 months. The availability of Pentacell raised the question of whether four doses of IPV administered before the second birthday would provide adequate long-term protection against polio. And if it did not, whether a fifth dose of IPV should be recommended later in childhood. It is known that age and dose intervals affect the response to IPV. For instance, a schedule of two, four, and six months induces higher seroconversion rates than schedules of two, three, and four months or six, 10, and 14 weeks. It is also known that maternal antibody level at the time of the first dose is inversely related to seroconversion rates. That is, the lower the maternal antibody level, the higher the seroconversion rate. Finally, it has been shown that longer intervals between doses provide an optimal booster response and that an interval of at least six months between the next to last and last dose provides the best immunologic effect. ACIP formed a polio vaccine work group that considered these issues. This work group also examined all data that was available concerning the duration of polio immunity following various IPV schedules. Based on information currently available, the polio work group recommended changes to the IPV schedule. ACIP approved these changes at their June 2009 meeting. There is no change in the recommended IPV schedule of four doses at ages two months, four months, six through 18 months, and four through six years. What has changed is the recommended minimum interval between the third and fourth doses. This interval should now be six months rather than four weeks. In addition, the minimum age for the final IPV dose is now four years rather than 18 weeks. The most immediate impact of this new recommendation will be for children who receive four doses of IPV before the fourth birthday. This could occur, for instance, when Pentacel is used for the first four doses of the series. When four doses of IPV are administered before the fourth birthday, an additional dose of age-appropriate IPV vaccine should be given on or after the fourth birthday. This will result in a five-dose IPV vaccine series, which is considered acceptable by ACIP. The minimum interval from dose four to dose five should be at least six months to provide an optimum booster response. ACIP also recommends that in the first six months of life, the minimum age and minimum intervals are recommended only if the person is at risk for imminent exposure to circulating polio virus, such as travel to a polioendemic region or during an outbreak. This is due to the fact that shorter intervals and earlier start dates lead to lower serial conversion rates. The Vaccines for Children resolution has already been updated to reflect these new recommendations. The new age and interval recommendations will also be included in the 2010 Childhood Immunization Schedule that will be published in January 2010. A notice to readers is being prepared for publication in the Morbidity and Mortality Weekly Report later this year. At the June 2009 ACIP meeting, updates were made to recommendations for meningococcal revaccination of high-risk persons. There are two meningococcal vaccines. Meningococcal polysaccharide vaccine, MPSV or Minimune, is approved for use in persons two years of age and older and is administered as a subcutaneous injection. Meningococcal conjugate vaccine, MCV or Minatra, is approved for use in persons two through 55 years of age and is administered as an intramuscular injection. Both vaccines are approved for prevention of invasive meningococcal disease caused by Nyceria meningitis, serogroups A, C, Y, and W135. A single dose of meningococcal conjugate vaccine is recommended for all adolescents, preferably at 11 or 12 years of age and also for unvaccinated college freshmen living in a dormitory. Meningococcal vaccination is also recommended for certain high-risk groups, including persons with persistent complement component deficiency, functional or anatomic asplenia, and persons with HIV infection, microbiologists who are routinely exposed to isolates of Nyceria meningitis, US military recruits, and persons who travel to and US citizens who reside in countries in which Nyceria meningitis is hyperendemic or epidemic. MCV is the preferred vaccine for persons two through 55 years of age in these risk groups. MPSV should be used for persons 56 years and older or if the person has a precaution to MCV, such as a history of Guillain-Barre syndrome. Revaccination with MCV has been recommended for persons who received a meningococcal polysaccharide vaccine and remain at increased risk of meningococcal disease. What is new is that ACIP now recommends revaccination of certain persons who previously received meningococcal conjugate vaccine. Children through age 18 years who received their first dose of MCV or MPSV at ages two through six years and remain at increased risk for meningococcal disease should receive an additional dose of MCV three years after their first dose. And persons through age 55 years who received a dose of MCV or MPSV after age six years and remain at increased risk for meningococcal disease should receive an additional dose of MCV five years after their previous dose. If the person is 56 years or older at the time of revaccination, MPSV should be used. Note that this recommendation does not apply to children who previously received MCV and who will be freshmen living in a dormitory. ACIP is still considering when or if this group should be revaccinated. High risk persons who should be revaccinated include persons with persistent compliment component deficiency, persons with anatomic or functional asplenia, persons with HIV infection and frequent travelers to or persons living in areas with high rates of meningococcal disease. That is the African meningitis belt. Again, the group recommended for revaccination does not include previously vaccinated children who will be freshmen living in a dormitory. The recommendations for revaccination of children are included in the revised vaccines for children resolution. We have included a link to the resolution on the updates and resources webpage. A notice to readers will be published in morbidity and mortality weekly report later this year. CDC continues to be very concerned about what appears to be a growing number of vaccine administration errors. We understand that clinics are busy and the number of vaccines and recommendations are increasing. By pointing out some of the common errors we are hearing about, systems can be examined, failures in the system identified and preventive strategies developed. We continue to hear about errors associated with giving the wrong vaccine or using the wrong diluent. We still hear of children older than six years and adults inadvertently receiving DTAP instead of TDAP and unfortunately, some children younger than seven years are needing revaccination because they received TDAP instead of DTAP. More alarming still are reports of children receiving Zoster vaccine instead of Varicella vaccine. We encourage clinics to clearly label vaccine storage containers in the refrigerator and freezer, not only with the vaccine name, but also the age indications to help prevent these errors with look-alike and sound-alike vaccines. Another common error that is not going away is using the wrong diluent when vaccines are reconstituted. Ensure your staff only reconstitute vaccines with the diluent supplied by the manufacturer for that vaccine. A related error concerns the Pentacell diluent, which is a solution of DTAP and IPV. This diluent should only be used to reconstitute ACT-HIB to create the combination vaccine Pentacell. The DTAP and IPV solution should not be used without the ACT-HIB. We are also hearing about vaccine being used for the wrong age or dose indication, especially with the new combination vaccine, Kinricks. Kinricks is only approved for use in children four through six years of age for the fifth dose of DTAP and the fourth dose of IPV. Kinricks should not be used for any child younger than four years, nor for any other doses in the DTAP or IPV series, even if the child is behind and does not require as many DTAP or IPV doses. Unfortunately, we also receive emails on a daily basis about administration of expired vaccine. Vaccines administered beyond the expiration date, even one day past their expiration date are not valid and should be repeated. Before administration of any vaccine, check the name of the vaccine and the expiration date on the label at least three times. The last error that I want to discuss today is administering vaccine into the wrong anatomic site. We have received several reports of instances where patients, especially adolescents and young adults, are requesting that their vaccines be given in the buttock and their requests are being honored. Please remember that the buttock is not an acceptable site for vaccine administration. The deltoid or anterolateral thigh should be used for intramuscular vaccine injection and the fatty part of the thigh or triceps area of the arm should be used for subcutaneous vaccine injection. Suggestions to help prevent administration errors will be included on the updates and resources webpage. Our next vaccine brief concerns revised recommendations for evidence of measles, mumps and rubella immunity for healthcare personnel voted on by the ACIP at their June 2009 meeting. Here are the revised recommendations for evidence of measles, mumps and rubella immunity for healthcare personnel. Healthcare personnel are considered immune if they have one or more of the following. Appropriate vaccination against measles, mumps and rubella which would be administration on or after the first birthday of two doses of measles and mumps vaccine separated by at least 28 days and at least one dose of rubella vaccine or laboratory evidence of immunity or laboratory confirmation of disease. ACIP voted to remove physician diagnosed disease as evidence of measles and mumps immunity for healthcare personnel. In light of recent measles and mumps outbreaks with several instances of virus transmission by healthcare personnel, ACIP expressed serious concern about reliance on presumptive evidence of immunity based on birth before 1957. In line with efforts to eradicate these vaccine preventable diseases, ACIP recommended the following for healthcare personnel born before 1957. Institutions with unvaccinated personnel born before 1957 who lack laboratory evidence of measles, mumps and or rubella immunity or laboratory confirmation of disease should consider recommending two doses of MMR vaccine for measles and mumps and one dose of MMR vaccine for rubella, respectively. And for unvaccinated personnel born before 1957 who lack laboratory evidence of immunity or laboratory confirmation of disease, healthcare facilities should recommend two doses of MMR during an outbreak of measles or mumps and one dose of MMR during an outbreak of rubella. These new recommendations have not yet been published. We expect them to be posted on the ACIP provisional recommendation webpage very soon. They will also be included in a revision of the ACIP healthcare personnel immunization recommendations, which is planned for 2010. Risk and benefit communication between the person administering the vaccine and the person receiving the vaccine is essential. The cornerstone of immunization patient education is the vaccine information statement or VIS. Every healthcare provider, public or private, who administers a vaccine covered by the National Childhood Vaccine Injury Act is required by law to provide a copy of the most current VIS prior to each dose of vaccine. That is not only the first dose of the series, but every dose. CDC also encourages healthcare providers to use all available VISs, whether the National Childhood Vaccine Injury Act covers the vaccine or not. This is just good practice. Healthcare providers should also encourage the patient or their legal representative to take the VIS home. This is important because the VIS contains information that may be needed later, including the recommended schedule for that vaccine and information about how to identify and report adverse reactions. The federal government does not require written informed consent for vaccinations, and VISs are not intended to be informed consent documents. But some states or organizations do require signed consent. So check with your agency or state immunization program to determine if there are any specific informed consent requirements that apply to you. Healthcare providers are also required by federal law to document every VIS that is distributed. You must note in each patient's permanent medical record or in a permanent office log or file the date the VIS is provided and the VIS addition date. The addition date is always located in either the left or right hand bottom corner of the second page of the document and sometimes on the front page as well. VIS is changed periodically, so it's a good idea to check CDC's VIS web page occasionally to ensure that your office has the most current version of each VIS. This page will always contain the latest versions. If you want to be notified when there is a change in a VIS, you can sign up to receive email updates from our VIS web page. Two new VISs have been posted since last year's immunization update. The first is an updated pneumococcal polysaccharide VIS, which notes new indications for this vaccine, for smokers, and for adults with asthma. The second, created by popular demand, is a combined TD-TDAP VIS. And you can look for a plethora of VIS updates in the near future. These will probably include anthrax to incorporate the new schedule and to update the adverse event information. MMR and varicella will be updated to update information about MMRV and febrile seizures and HPV, meningococcal, and TD-TDAP will be updated to include warning about syncope. Other updated VISs will likely include Japanese encephalitis for the new vaccine, zoster to remove a precaution for people with tuberculosis, and of course, the annual influenza update, and if necessary, a VIS for novel H1N1. Finally, I'd like to mention two policies that we have implemented in response to concerns that many parents are throwing VISs away as soon as they leave the office, thus wasting resources. First, and this has been in effect for a while now, providers can give parents or patients a permanent copy of a VIS, for example, a laminated copy, to read in the office before the vaccination, instead of giving each person their own individual paper copy, which might get thrown away. The only caveat is that you should still offer each patient their own copy to take home with them. They can decline, but legally, you must still offer it to them. And second, persons with a wireless device, such as an iPhone, a BlackBerry, or a Palm Pre, may now download VISs onto these devices in lieu of taking home a paper copy. A new link on our VIS webpage contains downloadable PDF files and simple instructions. You can learn more about your responsibilities as a provider at the Q&A link on the VIS webpage. Vaccine information statements are available in English from CDC and state immunization programs, and in 36 languages on the Immunization Action Coalition's website. You will also find audio versions of the VISs on CDC's VIS webpage. The VIS PDF files are now Section 508 compliant, which means they can be read by screen reader devices, so separate text files for the visually impaired are no longer needed and consequently are no longer available. We will have a link to all the vaccine information statements and supplementary information on the Updates and Resources website for this program. This brings us to the close of this edition of Immunization Update, and we hope the information we have provided will make your immunization practice a little easier. Continuing Education Credit is available for this program only through the CDC, ATSDR, Training and Continuing Education Online System at www.2a.cdc.gov. slash tceonline. You must have a verification code to apply for credit. The same verification code is used for both times and formats of the program. The verification code is DW459F. That is D as in Delta, W as in Whiskey, 459F as in Foxtrot. Please write down this verification code and enter it, and the course number when prompted in the online training and education system. Now throughout this program, we have mentioned several immunization resources. You will find links to these and much more on our Updates and Resources website. Click on the Education and Training section, then the Broadcasts and Webcasts link. Choose Immunization Update from the list to find all the materials we have discussed on the program today. If your patients or their parents have immunization-related questions, you can find the link in the video description. For more information, please visit www.cdc.gov. For more information on immunization-related questions, you can refer them to the CDC Info Contact Center. You can reach the Contact Center toll-free at 800-CDC-INFO. The CDC Info Contact Center is staffed 24 hours a day, seven days a week. You and your staff can use the Internet to email questions, comments, or requests for immunization and respiratory diseases. Our email address is nipinfo at cdc.gov. Thank you very much for joining us today. It has been our pleasure to bring this program to you. Enjoy the rest of your day.