ty, immunogenicity, and efficacy of RV-1 and RV-5 have each involved more than 65,000 infants in the United States and other countries. These are among the largest vaccine trials ever conducted, and were necessary to evaluate the vaccine for possible rare adverse events, particularly into deception. These large clinical trials demonstrated that both rotavirus vaccines are effective. The vaccines were found to be 74 to 87 percent effective in preventing any rotavirus diarrhea. The vaccines are 95 to 98 percent effective in preventing severe diarrhea. Protection appears to persist through the second rotavirus season post-vaccination. Both vaccines significantly reduce physician visits for diarrhea and reduce rotavirus-related hospitalization. Revised ACIP recommendations for the use of rotavirus vaccine were published in MMWR in February 2009. Because of similar estimates of efficacy and safety, neither ACIP nor the Academies of Pediatrics or Family Physicians stated preference for one vaccine over the other. Clinicians can use whichever vaccine they choose. ACIP recommends routine rotavirus immunization of all infants without a contraindication. The vaccine should be administered as a series of either two or three oral doses for RV-1 and RV-5 respectively, beginning at two months of age. The vaccination series for both vaccines may be started as early as six weeks of age. Subsequent doses in the series should be separated from the previous dose by one to two months. Rotavirus vaccines should be given at the same visit as other vaccines given at these ages. RV-1 is a very different vaccine than RV-5. RV-1 is a two-dose series. RV-5 is a three-dose series. The labeled maximum age for any dose of RV-1 is 24 weeks, while the labeled maximum age for any dose of RV-5 is 32 weeks. These differences could complicate decisions by clinicians who encounter children who received a brand of rotavirus vaccine other than the brand the clinician has in stock. There are currently no data on schedules that include both RV-1 and RV-5. The ACIP worked for more than a year to develop recommendations that would help guide the use of both rotavirus vaccines. ACIP's main objective was to develop a single set of rules that would apply to both rotavirus vaccines. For both rotavirus vaccines, ACIP recommends that the maximum age for the first dose is 15 weeks, zero days. This is an off-label recommendation for RV-5 since the approved maximum age for the first dose of that vaccine is 12 weeks. The minimum interval between doses of both rotavirus vaccines is four weeks. The maximum age for any dose of rotavirus vaccine is eight months, zero days. No rotavirus vaccine should be administered to infants older than eight months, zero days of age. This is an off-label recommendation for both vaccines because the labeled maximum age for RV-1 is 24 weeks and the labeled maximum age for RV-5 is 32 weeks. ACIP recommends that the rotavirus vaccine series should be completed with the same product whenever possible. However, vaccinations should not be deferred if the product used for a prior dose or doses is not available or is not known. In this situation, the provider should continue or complete the series with the product that is available to them. If any dose in the series was RV-5, Rotatech, or the vaccine brand used for any prior dose in the series is not known, a total of three doses of rotavirus vaccine should be administered. We've received questions about the maximum interval between doses of rotavirus vaccine. Some clinicians believe there is a maximum of 10 weeks between doses because of wording in the RV-5 product insert. However, ACIP did not define a maximum interval between doses. It is preferable to adhere to the recommended interval of eight weeks, but if the interval is prolonged, the child can still receive the vaccine as long as can be given on or before the child's eight-month birthday. It is not necessary to restart the series or add doses because of a prolonged interval between doses. The duration of immunity is not known for either rotavirus vaccine. Protection appears to last through at least two rotavirus seasons, although efficacy may be lower in the second season than in the first. There are at least five serotypes of rotavirus that may cause diarrheal disease in the United States. Also, infants may experience multiple episodes of rotavirus diarrhea. So infants documented to have had rotavirus gastroenteritis before receiving the full course of rotavirus vaccinations should still begin or complete the three-dose schedule. This is because the initial infection will provide only partial immunity. Breastfeeding does not significantly reduce the immunogenicity of rotavirus vaccine, so breastfeeding children should be vaccinated on schedule. Dana? Rotavirus is a live virus vaccine. However, because of the oral route of administration and the age at which it is given, the contraindications and precautions are different than for injected live vaccines. The only contraindication to the use of rotavirus vaccine is a severe allergic reaction to a vaccine component or following a prior dose. Latex rubber is contained in the RV-1 oral applicator, so infants with a severe allergy to latex should not receive RV-1. The RV-5 dosing tube is latex-free. Rotavirus vaccine has several precautions. In general, when a precaution is present, the vaccine will not be given. However, clinicians may consider use of the vaccine on a case-by-case basis. Clinicians should consider the potential risk and benefits of administering rotavirus vaccine to infants with known or suspected altered immunocompetence. Children who are immunocompromised because of congenital immunodeficiency or hematopoietic stem cell or solid organ transplantation sometimes experience severe, prolonged, and even fatal rotavirus gastroenteritis. However, no safety or efficacy data are available regarding administration of rotavirus vaccine to infants who are or are potentially immunocompromised due to either disease or drugs. Clinicians will need to use their judgment in this situation. There are no data on the use of rotavirus vaccine among infants who are HIV-exposed or infected. However, two considerations support vaccination of HIV-exposed or infected infants. First, the HIV diagnosis might not be established in infants born to HIV-infected mothers before the age of the first rotavirus vaccine dose. 3% or less of HIV-exposed infants in the United States will be determined to be HIV-infected. Second, vaccine strains of rotavirus are considerably attenuated, and exposure to an attenuated rotavirus is preferable to exposure to wild-type rotavirus. Usually, rotavirus vaccine should not be administered to infants with acute, moderate, or severe gastroenteritis or other acute illness until the condition improves. However, infants with mild acute gastroenteritis or other mild acute illness can be vaccinated, particularly if the delay in vaccination will delay the first dose of vaccine beyond 15 weeks, zero days of age. Finally, available data suggests that infants with a history of insusception might be at higher risk for a repeat episode than other infants. So until post-licensure data on the safety of rotavirus vaccine are available, the risk for and the benefits of vaccination should be considered when vaccinating infants with a previous episode of insusception. There are two situations which ACIP previously considered precautions for rotavirus vaccination that are now not considered to be precautions. The first is pre-existing chronic gastrointestinal conditions. No data are available on the safety and efficacy of rotavirus vaccine for infants with pre-existing chronic gastrointestinal conditions such as congenital malabsorption syndromes, hersprungs disease, or short-gut syndrome. However, ACIP considers the benefits of vaccination to outweigh the theoretic risk. The second condition no longer considered to be a precaution to rotavirus vaccination is recent receipt of an antibody-containing blood product. The 2006 rotavirus ACIP statement suggested a six-week deferral of vaccination after receipt of an antibody-containing blood product. No data are available on the immune response to rotavirus vaccine in infants who have recently received a blood product. In theory, infants who have recently received an antibody-containing blood product might have a reduced immunologic response to a dose of oral rotavirus vaccine. However, two or three doses of vaccine are administered in the full rotavirus vaccine series and no increased risk for adverse events is expected. ACIP now recommends that rotavirus vaccine may be administered at any time before, concurrent with, or after administration of any blood product. Available data suggests that preterm infants are at increased risk for hospitalization from rotavirus during the first one to two years of life. In clinical trials, rotavirus vaccine appeared to be generally well tolerated in preterm infants, although a relatively small number of preterm infants have been evaluated. ACIP considers the benefits of rotavirus vaccination of preterm infants—that is, infants born at less than 37 weeks gestation—to outweigh the risk of adverse events. ACIP supports vaccination of a preterm infant according to the same schedule and precautions as a full-term infant provided the following conditions are met. The infant's chronological age is at least six weeks. The infant is clinically stable and the vaccine is administered at the time of discharge or after discharge from the neonatal intensive care unit or nursery. Although the lower level of maternal antibody to rotavirus is in very preterm infants theoretically could increase the risk for adverse reactions from rotavirus vaccine, ACIP believes the benefits of vaccinating the infant when age-eligible clinically stable and no longer in the hospital outweigh the theoretic risk. Andrew? Vaccine strains of rotavirus are shed in the feces of vaccinated infants. So if an infant were to be vaccinated with rotavirus vaccine while still needing care in the hospital, a theoretic risk exists for vaccine virus being transmitted to infants in the same unit who are acutely ill and to preterm infants who are not age-eligible for vaccine. ACIP considers that in unusual circumstances the risk from shedding outweighs the benefit of vaccinating an infant who will remain in the hospital. Although rotavirus is shed in the feces of vaccinated infants, transmission of vaccine virus has not been documented. Infants living in households with persons who have or are suspected of having an immunodeficiency disorder or impaired immune status can be vaccinated. ACIP believes that the indirect protection of the immunocompromised household member provided by vaccinating the infant in the household and preventing wild-type rotavirus disease outweighs the small risk for transmitting vaccine virus to the immunocompromised household member. Infants living in households with pregnant women should be vaccinated according to the same schedule as infants in households without pregnant women. Because the majority of women of childbearing age have pre-existing immunity to rotavirus, the risk for infection by the attenuated vaccine virus is considered to be very low. Although transmission of vaccine virus has not been documented, it is prudent for all members of the household to employ measures such as good handwashing after contact with the feces of the vaccinated infant, such as after changing a diaper. The first rotavirus vaccine, RhodaShield, was removed from the market less than a year after it was licensed because of an association with inter-susception, which we will refer to as IS. The reason RhodaShield seemed to infrequently lead to this adverse reaction is not known. Consequently, the safety of the two current rotavirus vaccines has been studied very carefully. The phase three clinical trials of both vaccines were very large, primarily to be able to study the occurrence of IS in both vaccine and placebo recipients. This table shows the number of cases of IS diagnosed in both vaccine and placebo recipients during the clinical trials of both vaccines. The RV1 trial included more than 63,000 infants of which half received vaccine and half received the placebo. In the 30 days following either vaccine dose, there were seven cases of IS among the vaccine recipients and seven cases diagnosed among the placebo recipients. The RV5 clinical trial included more than 69,000 infants of which half received vaccine and half received a placebo. In the 42 days after vaccination, six cases of IS were diagnosed among the vaccinated infants and five cases were diagnosed among the placebo recipients. There are two important messages from these data. The first message is that there is a background incidence of intersusception in infants as evidenced by its occurrence in infants who received the placebo. The second is that while intersusception is to be expected in recipients of rotavirus vaccine, the risk is no higher than among children who are not vaccinated. Parents of children who receive rotavirus vaccine should understand this. CDC and the Food and Drug Administration have been monitoring the safety of rotavirus vaccine very closely, primarily using reports to the vaccine adverse event reporting system or VAERS. There have been reports of recently vaccinated children who have subsequently developed IS. This is to be expected since IS happens with or without rotavirus vaccine. However, the number of reports of IS among recent rotavirus vaccine recipients is not higher than would have been expected by chance alone. That is, the reports to date represent background cases of IS. The risk does not appear to be increased because of rotavirus vaccine. Careful monitoring of VAERS reports will continue. A variety of other adverse reactions were reported during the seven or eight days after rotavirus vaccination in the clinical trials, including vomiting in 15 to 18 percent, diarrhea in 9 to 24 percent, irritability in 13 to 62 percent, and fever in 40 to 43 percent. However, the rate of these symptoms in vaccinated children was similar to the rate in unvaccinated children. No serious adverse reactions attributable to rotavirus vaccine have been reported. Healthcare personnel have had concerns about exposure to the vaccine virus during administration of rotavirus vaccine or contact with vaccinated infants. Hand hygiene using soap and water or alcohol-based hand cleaners should already be standard practice wherever vaccines are being administered. This practice should minimize the risk of transmission of rotavirus vaccine virus during administration. Consequently, there are no restrictions on immunosuppressed or pregnant healthcare personnel administering the vaccine. We have heard reports of some doses of rotavirus vaccine being administered using the nipple from a bottle. We strongly discourage this. Rotavirus vaccine should be administered using a device supplied by the manufacturer to ensure that the full dose is administered. Despite your best efforts, sometimes infants spit up or regurgitate oral vaccine. There are almost no data on the safety or efficacy of giving more than one dose, even partial doses, close together. ACIP recommends that you do not repeat the dose if the infant spits out or regurgitates the vaccine. You should administer any remaining doses on schedule. Doses of rotavirus vaccine should be separated by at least four weeks. Providers now have a choice of two different rotavirus vaccines in the United States. We hope that wide use of these safe and effective vaccines will help reduce the huge burden of rotavirus disease in the United States. Donna? We get fair amount of questions about rotavirus. And Yabba, I think you talked about this, but it gets asked so often. I think we need to clarify. If a child has had rotavirus disease, do they still need to be vaccinated? Yes, they do, Donna. We still recommend rotavirus vaccine administration to these children because data did not support how long they'll be protected. Only the first two seasons right now and the efficacy seems to decrease even in the second season. So we still recommend that they get the rotavirus vaccine. Okay. Andrew, why did ACIP change that recommendation about antibody containing product and rotavirus vaccine? Yes, excellent question. There's no recommendation to wait an interval between administration of an antibody containing blood product and rotavirus vaccine. Rotavirus vaccine, of course, is a live vaccine. Several reasons play into this. First of all, there'll be two or three additional doses, as we mentioned, that will be provided. So we think that there will be an adequate immune response to this vaccine. The vaccine is administered orally. And when you give an antibody containing blood product, the antibody response that we're typically concerned about after administration of an antibody containing blood product is peripheral. So there's that idea that perhaps this is less critical with a live vaccine that is given orally. Also, there's no adverse reactions that are expected to occur following administration of such a product after rotavirus vaccine. Practically, there's a maximum age to begin with. So there's no reason to put it to put a maximum spacing would set up a situation where it's an issue of perhaps a slightly reduced immune response versus no response at all because you can't give the vaccine dose beyond a certain age. So that practical consideration actually plays in as well. So multiple reasons for this. Okay. Good. Thanks. Okay. A couple of questions about varicella. That birth in the U.S. before 1980 can be accepted as evidence of immunity to varicella. But does that apply to healthcare personnel? No, Donna. It actually does not. That criteria for using birth before 1980 is a presumptive criteria. And it does not mean absolutely that everyone born before 1980 will be immune to chickenpox. And we hold healthcare workers to a higher level. So there's a higher threshold there. So in this case, we do not use that criteria as evidence of immunity. Other criteria would still apply such as using positive serological testing or provider documented verification of disease. Okay. Good. Thanks. Here's another one of those. Why, you know, with varicella vaccine, okay, it's two doses for everyone now. But the intervals are different depending on what age you're giving it to. If it's for the little ones, 12 months or 12 years, you need three months between the doses. And if it's 13 or older, it's only four weeks. Why is that? Varicella vaccine intervals are very complicated. The reason is is that when manufacturers were looking at two doses of vaccine to be given in children between 12 months and 12 years of age, what was studied was an interval of three months. So we don't have any data on the use of varicella vaccine in that particular age group at an interval narrow than three months of age. Whereas we did have it for those persons 12 years of age and older. So that being said, if this does happen and a second dose of varicella vaccine is given to someone between 12 months and 12 years of age, at a four week interval, you can still count the dose. You don't have to invalidate the dose and try to worry about when that next dose is going to be given. You can validate the dose. But we don't recommend that you do it. We recommend that you use a three month minimum interval for varicella vaccine between 12 months and 12 years of age. And then older than that is a 28 day four week interval. Okay. Yeah, well here's a storage and handling question. I noticed in the package inserts for varicella and MMRB when it was available that if someone inadvertently put it in the refrigerator that you could use it as long as you used it within 72 hours and don't put it back in the in the freezer though. Is that okay too for Zoster vaccine? No, actually Donna, it's not. Zoster Vax must be kept in the freezer at all times and used within 30 minutes of being removed from the freezer. If it's not used within 30 minutes, it must be discarded. Okay, good. So the best thing to do is just put them all all varicella containing vaccines in the freezer like exactly and keep them there. The other thing that we're hearing is that sometimes shock givers are changing the needle between reconstituting Zoster vaccine and administering it. Is that necessary? No, it is not. And I think that goes back to we used to hear about this a lot from providers and I think it stems primarily from concerns about needle being bent or some issue with the needle. Is it necessary to making it necessary to change that needle? Nowadays the needles that are made are much stronger so this really should be less of an issue and therefore we do not, it is not necessary to change the needle between reconstitution and administration. To do so would introduce risks of needle stick injury perhaps if you're manipulating so much or contamination if you're removing the needle. These things can happen so unless the needle action is bent and you should change it for that reason of course there's no general recommendation for the need to change the needle between these various steps. Okay well thank you very much Andrew, Yabo, thank you also very much. This brings us to the close of this session of epidemiology and prevention of vaccine preventable diseases. We would like to remind you of resources that you can use to get more information in order to contact us. Here's the companion book for this program. The Public Health Foundation is the sole source for a printed copy. The book costs $35 plus shipping and handling and is a useful resource for any office that administers vaccine to persons of any age. You can contact the Public Health Foundation through their toll-free number at<PHONE_NUMBER>. You can also order materials online from their website at bookstore.ph.org. If your patients or their parents have 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. If you or your staff have questions you should direct them to us at the National Center for Immunization and Respiratory Diseases by email. Our email address is nipinfo at cdc.gov. Throughout this program we've mentioned additional immunization resources available to you on the updates and resources web page. The address is www.cdc.gov front slash vaccines. Click on education and training, then the self-study link. Choose this program from the list to find all the materials we've discussed during this program. We want you to have the most current immunization information at your fingertips. An easy way to do this is to have the information available on your computer. We've compiled all the current ACIP statements, vaccine information statements, the course text and much more on a CD called Immunization Works. The CD is a great way to have all your current immunization information together in one place. Immunization Works is distributed free of charge by the CDC. The updates and resources web page has a link to order it. Continuing education credit is available for viewing this program. Details and instructions can be found in the continuing education chapter of the DVD or on the updates and resources web page. Thank you for joining us for this session of Epidemiology and Prevention of Vaccine Preventable Diseases. Please join us for other programs in this series when we discuss specific vaccine preventable diseases and the vaccines to prevent them. Until then, goodbye.


I got to say, I really enjoyed the interconnectedness of the sessions and as well the honesty that came across each such point. Although it was nerve-wracking, I loved every moment. I really did. I really enjoyed every bit of it. Back in January, he was let go and I wanted to be very intentional about the next step that I wanted to make in my career. I love this. You know, it was incredibly engaging to be on both sides of the fence. It was incredibly enriching. I got a lot of takeaways from this. I really have areas that I'm going to keep improving on.


The study presents an advanced CNN algorithm that accurately detects autism spectrum disorder and pediatric cohorts using resting-state fMRI data from the abiodi repository. The model achieved high diagnostic metrics and demonstrated hierarchical feature extraction capabilities, providing a deep learning framework for computer-assisted ASD screening via fMRI with transformative implications for early diagnosis and intervention. This article was authored by Min Feng and Jun Kaesu.