All Jack Reacher wanted was a ride to Virginia. All he did was stick out his thumb. But he soon discovers he has hitched more than a ride. He has tied himself to a massive conspiracy, in which nothing is what it seems, and nobody is telling the truth.
Older adults are at higher risk of developing serious complications from flu. In December 2009, the high-dose trivalent influenza vaccine (IIV3-HD) was licensed for adults 65 years and older. Using the Vaccine Adverse Event Reporting System, researchers analyzed the 12,320 reports submitted after IIV3-HD vaccination from 2011-2019. Of the total, there were 61 reports of GBS and 13 of anaphylaxis. Nearly 6% of all reports were classified as serious (723). The most commonly reported serious events were fever (30.2%), weakness (28.9%), and shortness of breath (24.9%). There were 55 reports of death following IIV3-HD, and cause of deaths reported were typical for those in this age group with no evidence to suggest the vaccine caused the deaths. There were reports of 13 pregnant women and 59 children who inadvertently received IIV3-HD. Overall, this review of IIV3-HD did not reveal any new safety concerns among individual adults 65 years and older.
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Anaphylaxis is a rare, serious hypersensitivity reaction, which can happen within minutes and is characterized by multisystem involvement. Although anaphylaxis may occur after any vaccine, the risk following flu vaccines is important to understand due to the large number of persons vaccinated annually. This review looks at two recent CDC studies that confirm its rarity. In a 25-year review of data from the Vaccine Adverse Event Reporting System, reports in children most commonly followed childhood vaccinations, and in adults most often followed influenza vaccine. In a Vaccine Safety Datalink study, the estimated incidence of anaphylaxis was 1.3 per million vaccine doses administered for all vaccines and 1.6 per million doses for IIV3 (trivalent) influenza vaccine. Despite its rarity, the rapid onset and potentially lethal nature of anaphylaxis requires that all personnel and facilities providing vaccinations have procedures in place to treat it.
Women are encouraged to get immunizations when they are pregnant; but in certain areas of the world, there are no programs to implement vaccine recommendations. Maternal immunization is a promising strategy to reduce infectious disease-related illness and death in pregnant women and their infants. Pre-requisites for introducing immunization during pregnancy include: (1) political commitment and adequate financial resources, (2) healthcare workers to deliver vaccines, (3) combining immunization programs with prenatal care and maternal/child health services, and (4) access to prenatal care for pregnant women in low and middle-income countries where births occur in healthcare facilities. A system to advance a vaccine program from product licensure to successful country-level implementation needs to include evidence of anticipated vaccine program impact, developing supportive policies, and translating policies into local action.
9-valent human papillomavirus vaccine (9vHPV) was approved by FDA in December 2014. 9vHPV is not recommended during pregnancy but some women of childbearing age may be inadvertently exposed. This study assessed reports to Vaccine Adverse Event Reporting System (VAERS) of pregnant women vaccinated with 9vHPV in the United States between December 2014-December 2017. Disproportionate reporting of adverse events (AEs) was assessed using proportional reporting ratios. A total of 82 pregnancy reports were identified. Sixty reports (73.2%) did not describe an AE. The most frequently reported AEs were miscarriage and injection site reactions (both n=3; 3.7%). Of note, miscarriage may occur in up to one-third of pregnancies; the observed reports in this study were not unusual or unexpected. No disproportional reporting for any AE was found. Overall, no unexpected AEs were observed among these pregnancy reports.
A recent GlaxoSmithKline post-marketing study found a possible association between the administration of the first dose of the rotavirus vaccine Rotarix and lower respiratory tract infections (LRTI) in infants 0-6 days after vaccination. Using Vaccine Adverse Event Reporting System data, this study examined reports of LRTIs in infants 6-15 weeks old who received one of two rotavirus vaccines, Rotarix or RotaTeq, in addition to either the 7-valent (PCV7) or 13-valent (PCV13) pneumococcal conjugate vaccine. Reports of LRTIs occurring in the 0-29 day window following the first dose of the rotavirus vaccination were analyzed between January 2008 and December 2016. Researchers found LRTI rates were not different in those infants from rates of LRTIs in infants receiving other recommended childhood vaccines.
Inactivated Vero cell culture-derived vaccine (JE-VC; IXIARO) was licensed by Food and Drug Administration in 2009 and has a generally favorable safety profile. In this review of adverse events (AEs) following JE-VC reported to Vaccine Adverse Event Reporting System during May 1, 2012 through April 30, 2016, researchers found reporting rates of AEs were similar to those of the previous analysis (2009-2012). Although reporting rates of AEs in children could not be calculated, there were low numbers of reported events in this age group. Safety surveillance for this relatively new vaccine continues to be important to monitor AE reporting rates and identify possible rare serious events.
Hepatitis B is a serious disease that affects the liver. The virus is highly infectious and can be transmitted in the absence of visible blood. As part of the recommended immunization schedule for infants and children, Hepatitis B vaccine should be given to children in three doses between birth and 18 months of age. In January 2018, the Advisory Committee on Immunization Practices (ACIP) published new recommendations for the vaccine. These include: 1) administration of the universal hepatitis B vaccination within 24 hours of birth of medically stable infants, 2) testing pregnant women for Hepatitis B, 3) post-vaccination serologic testing for infants whose mother has an unknown hepatitis B status, and 4) the removal of lenient language for delaying the birth dose until after hospital discharge. Vaccine safety information was updated to include data from the pre- and post-licensure studies and report information from the Vaccine Adverse Events Report System from 2005 to 2015.
Haber P, Moro PL, McNeil MM, Lewis P, Woo EJ, Hughes H, et al. Post-licensure surveillance of trivalent live attenuated influenza vaccine in children aged 2-18 years, Vaccine Adverse Event Reporting System (VAERS), United States, July 2005-June 2012. J Ped Infect Dis. Epub 2014 May 7.
Muhammad RD, Haber P, Broder KR, Leroy Z, Ball R, Braun MM, et al. Adverse events following trivalent inactivated influenza vaccination in children: Analysis of the Vaccine Adverse Event Reporting System. Pediatr Infect Dis J. 2010 Oct 29. [Epub ahead of print]
McMahon AW, Iskander J, Haber P, Chang S, Woo EJ, Braun MM, etc. Adverse events after inactivated influenza vaccination among children less than 2 years of age: Analysis of reports from the vaccine adverse event reporting system, 1990-2003. Pediatrics. 2005;115(2):453-60.
Jackson LA, Peterson D, Nelson JC, Marcy SM, Naleway AL, Nordin JD, Donahue JG, Hambidge SJ, Balsbaugh C, Baxter R, Marsh T, Madziwa L, Weintraub E. Vaccination site and risk of local reactions in children 1 through 6 years of age. Pediatrics. 2013 Feb; 131(2): 283-9. Epub 2013 Jan 14.
Huang WT, Gargiullo PM, Broder KR, Weintraub ES, Iskander JK, Klein NP, Baggs JM; Vaccine Safety Datalink Team. Lack of association between acellular pertussis vaccine and seizures in early childhood. Pediatrics. 2010 Aug; 126(2): 263-9. Epub 2010 Jul 19.
Pediatric urologist Gregory Tasian, MD, MSc, MSCE, is dedicated to a practice of compassionate care for children and adolescents. He strives to make sure families know all the available treatment options for their child. And he supports shared decision-making with families when considering alternative treatments.
In the Division of Urology, Dr. Tasian focuses his clinical efforts on the surgical and medical management of children with kidney stones. He holds the Cheers for CHOP Chair in Clinical Epidemiology of Pediatric Urological Disease and became interested in pediatric kidney stone disease during his residency. As he explains, the condition was once uncommon.
His group also analyzes ultrasound of the kidney to discover novel biomarkers of chronic kidney disease progression for children with congenital urologic disease. He collaborates with imaging experts at the University of Pennsylvania to use machine learning to develop automated methods to predict the risk of chronic kidney disease early in life when kidney function is still preserved.
Dr. Tasian's research focuses on two areas: epidemiology and clinical trials in nephrolithiasis (kidney stone disease) among children and adults, and applying machine learning to improve understanding of the pathophysiology, prediction of outcomes and identification of therapeutics in children and adults with benign urologic disease.
As PI of the CHOP/Penn Clinical Center for the NIDDK-supported Urinary Stone Disease Research Network (USDRN), Dr. Tasian co-leads the Prevention of Urinary Stones with Hydration (PUSH) randomized controlled trial, which is examining the effect of behavioral economic approaches to maintain high fluid intake to decrease stone recurrence, and is the first and largest clinical trial in kidney stone disease to include adolescents and adults. Dr. Tasian is also the Director of the Pediatric KIDney Stone (PKIDS) Care Improvement Network. PKIDS is a community of investigators, patients, caregivers, clinicians, industry partners, and payers who generate and apply knowledge that improves outcomes for children with kidney stones at 26 health systems in North America. Dr. Tasian also directs a large microbiome research program that published the first evidence that antibiotics increase risk of kidney stones, particularly for children. His group also discovered that dysbiosis of the gut microbiome is associated with early-onset calcium kidney stones. These studies identified a network of bacteria involved in butyrate production and oxalate degradation that is less abundant in kidney stone formers. 2ff7e9595c
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