Showing 99 of 119 results

Omar Salman, Katherine Topf, Rebecca Chandler, Laura Conklin MD1
This report describes global progress toward meeting World Health Organization (WHO) indicators on minimal country capacity for vaccine safety surveillance and coordina- tion of AEFI reporting...
TechNet-21
The consolidated answers to the questions asked during and after Session #08 of the 'COVID-19 Vaccination: Building Global Capacity' webinar series for Health workers. The session was entitled '08:...
Anna Taddio, C Meghan McMurtry, Lucie M Bucci, Noni MacDonald, Anthony N T Ilersich, Angela Alfieri-Maiolo, Christene deVlaming-Kot, Leslie Alderman
Background Students experience fear, pain, and fainting during vaccinations at school. While evidence-based interventions exist, no Knowledge Translation (KT) interventions have been developed to...
Carolina Danovaro
Reducing pain during vaccination is becoming increasingly relevant as more vaccines become available and two or more vaccines may need to be administered simultaneously. While in some countries, up...
Suragh TA, Lamprianou S, MacDonald NE, Loharikar AR, Balakrishnana MR, Benes O, Hyde TB, McNeil MM
Background: Adverse events following immunization (AEFI) arising from anxiety have rarely been reported as a cluster(s) in the setting of a mass vaccination program. Reports of clusters of anxiety...
Madhava Ram Balakrishnan, C. Meghan McMurtry, Noni E. MacDonald, Michael S. Gold, Ulrich Heininger, Lisa Menning, Oleg Benes, Robert Pless, Patrick L.F. Zuber
The Council for the International Organizations of Medical Sciences (CIOMS) and WHO working group on pharmacovigilance defines five cause specific AEFI which includes an immunization anxiety-related...
World Health Organization (WHO)
Monitoring of adverse events following immunization (AEFI) is an essential strategy for ensuring the safety of vaccines. This new manual provides guidance on setting-up AEFI surveillance systems...
World Health Organization (WHO)
The second edition of the manual was developed by the WHO with support from the Global Advisory Committee for Vaccine Safety (GACVS) based on the findings of a scientific study conducted in April...
Hibbs BF et al.
BACKGROUND: Vaccines should be stored and handled according to manufacturer specifications. Inadequate cold chain management can affect potency; but, limited data exist on adverse events (AE)...
ChristineGuillard-Maure et al.
Timely and effective evaluation of vaccine safety signals for newly developed vaccines introduced in low and middle- income countries (LMICs) is essential. The study tested the development of a...
PamelaBravo-Alcántara et al.
New vaccines designed to prevent diseases endemic in low and middle-income countries are being introduced without prior utilization in countries with robust vaccine pharmacovigilance systems. Our aim...
Tiffany A. Suragh, Oleg Benes, Madhava R. Balakrishnan, Noni E. MacDonald, Anagha Loharikar, Smaragda Lamprianou, Terri B .Hyde, Michael M. McNeil
Background: Clusters of anxiety-related adverse events following immunization (AEFI) have been observed in several countries and have disrupted country immunization programs. We conducted a...
Prasad S. Kulkarni et al.
Rotavirus is the most common cause of moderate-to-severe infant diarrhoea in developing countries, resulting in enormous morbidity, mortality, and economic burden. A bovine-human reassortant...
Joseline Guetsop Zafack et al.
For vaccines to be fully effective and induce long-term protective immunity, individuals should receive all recommended doses. Vaccine recipients who experienced an adverse event following...
U. Heininger et al.
In 2013, the Council for International Organizations of Medical Sciences (CIOMS) created a Working Group on Vaccine Safety (WG) to address unmet needs in the area of vaccine pharmacovigilance....
Wendi Wu et al.
Introduction: Two types of Japanese encephalitis (JE) vaccines, inactivated JE vaccine (JE-I) and live-attenuated JE vaccine (JE-L), are available and used in China. In particular, one JE-L, produced...
Francesco Nicolia & Victor Appay
Despite the fundamental role of vaccines in the decline of infant mortality, parents may decide to decline vaccination for their own children. Many factors may influence this decision, such as the...
John O. Otshudiema et al.
On April 23, 2016, the Democratic Republic of the Congo (DRC) Ministry of Health reported an outbreak of yellow fever. As of May 24, 2016, among 41 confirmed yellow fever cases, 31 (75.6%) had...
Andrew T. Boyd, Diambi Dombaxe, Rosa Moreira, M.S. Oliveira, Eusebio Manuel, Carlos Navarro Colorado, Tatiana M. Lanzieri
The yellow fever outbreak declared in Angola in January 2016 soon became the largest recorded yellow fever outbreak in the country’s history. In response, the Angola Ministry of Health, supported...
Sheila Isanaka et al.
Background: Each year, rotavirus gastroenteritis is responsible for about 37% of deaths from diarrhea among children younger than 5 years of age worldwide, with a disproportionate effect in...
Nissen TN et al.
INTRODUCTION: BCG vaccination has been associated with beneficial non-specific effects on child health. Some immunological studies have reported heterologous effects of vaccines on antibody responses...
Vescovo P et al.
In a single-center study, 66 healthy volunteers aged between 18 and 50years were randomized to be immunized against rabies with three different injection routes: intradermal with DebioJect™ (IDJ),...
Linny Kimly Phuong et al.
Background: Kawasaki disease is a complex and potentially serious condition. It has been observed in temporal relation to immunisation. Methods: We conducted a systematic literature review using...
Tanya R. Myers et al.
Background: Limited data are available describing the post-licensure safety of meningococcal vaccines, including Menveo®. We reviewed reports of adverse events (AEs) to the Vaccine Adverse Event...
Inácio Mandomando et al.
The 9th African rotavirus symposium was held in Maputo, Mozambique from the 8th to 10th of December 2015, including a total of 101 delegates from 17 countries, 15 of which were African countries....
Sam F. Halabi et al.
Vaccines are extremely safe and harm is rare. Worldwide, more than 30 000 vaccine doses are delivered per second through routine immunization programs, which, in turn, prevent an estimated 2...
Bruce M. McClenathan et al.
An Adverse Event Following Immunization (AEFI) is an adverse reaction to a vaccination that goes above and beyond the usual side effects associated with vaccinations. One serious AEFI related to the...
Hung-Fu Tseng et al.
BACKGROUND: Meningococcal conjugate vaccination is recommended in the United States. This study evaluates the safety of quadrivalent meningococcal conjugate vaccine in a cohort aged 11 to 21 years....
Paul V. Effler, Alan Leeb, Stephanie A. Williams, Darren W. Westphal
INTRODUCTION On-going post-licensure surveillance of adverse events following immunisation (AEFI) is critical to detecting and responding to potentially serious adverse events in a timely manner....
World Health Organization (WHO)
This guide enables effective planning and implementation of proactive communication actions to promote understanding of the importance of vaccines in preventing illness and preventable deaths, and...
Abel Negussie, Wondewosen Kassahun, Sahilu Assegid, Ada K. Hagan
Background: The prevention of child mortality through immunization is one of the most cost-effective and widely applied public health interventions. In Ethiopia, the Expanded Program on Immunization...
World Health Organization (WHO), Bill & Melinda Gates Foundation
The Global Advisory Committee on Vaccine Safety (GACVS), an independent expert clinical and scientific advisory body, provides WHO with scientifically rigorous advice on vaccine safety issues...
World Health Organization (WHO)
A WHO guideline on how to conduct AEFI
Frank Shann
There is now clear evidence that the simplistic conventional model of immunization is invalid [1]. We can no longer assume that a vaccine acts independently of other vaccines, or that it influences...
Bias H et al.
PURPOSE: The use of the 2009 H1N1 vaccine has generated much debate concerning safety issues among the general population and physicians. It was questioned if this is a safe vaccine. Therefore, we...
Paul V Effler, Gregory Leeb, Candice Leeb, Alan Leeb, Ian J Peters, Annette K Regan
To assess the performance of SmartVax, a prototypic active monitoring system for adverse events following immunisation (AEFI) using short message service (SMS) text messages and clinical data...
Deron C. Burton et al.
There is a theoretical risk of adverse events following immunization with a preservative-free, 2-dose vial formulation of 10-valent-pneumococcal conjugate vaccine (PCV10). We set out to measure this...
Pushpa Ranjan Wijesinghe et al.
To facilitate introduction of live attenuated SA 14-14-2 Japanese encephalitis vaccine (LJEV) into the National Immunization Programme of Sri Lanka, we evaluated the safety and immunogenicity of...
Margaret A. Maglione et al.
ACKGROUND: Concerns about vaccine safety have led some parents to decline recommended vaccination of their children, leading to the resurgence of diseases. Reassurance of vaccine safety remains...
Parrella A et al.
BACKGROUND: Healthcare provider spontaneous reporting of suspected adverse events following immunisation (AEFI) is central to monitoring post-licensure vaccine safety, but little is known about how...
Cassidy, Christine, MacDonald, Noni E, Steenbeek, Audrey, Ortiz, Justin R, Zuber, Patrick L F, Top, Karina A
Strengthening antenatal care as a platform for maternal immunization is a priority of the World Health Organization (WHO). Systematic surveillance for adverse events following immunization (AEFI) in...
Pierluigi Lopalco, Eleonora Agricola, Elisabetta Pandolfi, Angelo D’Ambrosio, Francesco Gesualdo, Alberto E. Tozzi
In order to successfully control and eliminate vaccine-preventable infectious diseases, an appropriate vaccine coverage has to be achieved and maintained. This task requires a high level of effort as...
A.M. Alguacil-Ramos, J.A. Lluch-Rodrigo, E. Pastor-Villalba, J. Diez-Domingo, A. Portero-Alonso, T.M. Garrigues-Pelufo, J. Muelas-Tirado
The surveillance of vaccine safety is an essential requirement in vaccination programmes. Computerized immunization registries such as the Vaccination Information System (SIV) of Valencian Community...
M Šubelj et al.
Adverse events following immunisation (AEFIs) with qHPV reported to the Slovenian AEFI Registry for the first four school years of the vaccination programme were analysed. We calculated annual...
S. Elizabeth Williams et al.
Many events occurring after vaccination have been attributed to vaccines, when in fact the association was often due to chance.1 However, as with any medical intervention, there are times when...
YouXin Wang et al.
It is critical to distinguish events that are temporarily associated with, but not caused by, vaccination from those caused by vaccination during mass immunization. The researchers performed a...
Cha SH et al.
This study evaluated the immunogenicity and safety of a combined measles-mumps-rubella-varicella (MMRV) vaccine compared to co-administration of measles-mumps-rubella and varicella (MMR+V) vaccines...
Stuart Gilmour et al.
The Japanese Ministry of Health, Labour, and Welfare (MHLW) partially suspended the human papillomavirus (HPV) vaccination programme in June, 2013. Although HPV vaccination has just been included in...
Adriana Parrella, Michael Gold, Helen Marshall, Annette Braunack-Mayer, Peter Baghurst
Parents commonly perceive and report that their child has experienced an AEFI. In this group of parents the subsequent expectation of an AEFI and vaccine safety concerns may be heightened. Further...
Alberto E. Tozzi, Edwin J. Asturias, Madhava Ram Balakrishnan, Neal A. Halsey, Barbara Law, Patrick L.F. Zuber
Serious illnesses or even deaths may rarely occur after childhood vaccinations. Public health programs are faced with great challenges to establish if the events presenting after the administration...
Robin P. Goin-Kochel et al.
A contentious theory espoused by some parents is that regressive-onset of autism spectrum disorder (ASD) is triggered by vaccines. If this were true, then vaccine receipt should be higher in children...
Sven Arne Silfverdal et al.
As 13-valent pneumococcal conjugate vaccine (PCV13) is introduced, children who began vaccination with 7-valent pneumococcal conjugate vaccine (PCV7) may complete their vaccination with PCV13. This...
Studies from low-income countries indicate that co-administration of inactivated diphtheria–tetanus–pertussis (DTP) vaccine and live attenuated measles vaccine (MV) is associated with increased...
Matthew F. Daley et al.
In this safety surveillance study of more than 200,000 DTaP–IPV vaccine recipients, there was no evidence of increased risk for any of the pre-specified adverse events monitored. Continued...
Md Z. Sadique et al.
The demand for vaccination against infectious diseases involves a choice between vaccinating and not vaccinating, in which there is a trade-off between the benefits and costs of each option. The aim...
Mônica P. L. Cunha et al.
Despite good safety records, vaccines given to young children can cause adverse events. We investigated the reported adverse events following immunization (AEFI) of vaccines given to children of less...
Muchekeza M et al.
The outpatient surveillance system in Kwekwe district reported 86 AEFI cases in 2009. No surveillance forms were completed for these cases. This study was therefore conducted to identify reasons for...
Thoon KC et al.
Hospital-based active surveillance can enhance signal detection and follow-up investigations of AEFI. Subsequently, public health bodies are better equipped to maintain public confidence in...
Saarela O & Hanley JA.
Pooling of controls under nested-case control settings can produce substantial efficiency gains compared to standard time-matched analysis using the Mantel-Haenszel method or conditional logistic...
Yael Levy et al.
The population at risk of adverse events after smallpox vaccination has increased in recent years. This has important implications for preparedness strategies against bioterrorism with the variola...
Sean T. O’Leary et al.
Measles–mumps–rubella–varicella (MMRV) vaccine is associated with increased febrile seizure risk compared with measles–mumps–rubella and varicella vaccine given separately (MMR + V) in...
Glen R. Abedi et al.
During a 2009–2010 mumps outbreak in a New York State village, a third dose of measles, mumps, and rubella (MMR) vaccine was administered to children in three schools as a control measure....
Pina Bozzo et al.
Exposure to either live or inactive vaccines during pregnancy has not been associated with an increased risk of adverse pregnancy outcomes, and no child to date has been born with CRS or varicella...
Zheteyeva Y A et al.
The report concludes that during a time when Tdap was not routinely recommended in pregnancy, review of reports to VAERS in pregnant women after Tdap did not identify any concerning patterns in...
Betsch, Cornelia & Sachse, Katharina
Information about risks is often contradictory, especially in the health domain. A vast amount of bizarre information on vaccine-adverse events (VAE) can be found on the Internet; most are posted by...
Gidengil C et al.
New combination vaccines reduce the number of injections needed for immunization. However, possible drawbacks include higher prices, extra doses of vaccine antigens and increased minor adverse...
P. McHale et al.
Uptake rates for the combined measles, mumps and rubella (MMR) vaccine have been below the required 95% in the UK since a retracted and discredited article linking the MMR vaccine with autism and...
Joseph S. Zickafoose et al.
The study sought to determine whether hospital discharges for intussusception in children younger than 1 year have changed since the reintroduction of rotavirus vaccine in the United States.
Brigitte Keller-Stanislawski
Vaccine-preventable infectious diseases are responsible for significant maternal, neonatal, and young infant morbidity and mortality. While there is emerging scientific evidence, as well as...
Stephanie O. Klopfer et al.
In randomized clinical studies, over 11,800 children, 12 months to 6 years of age, were administered ProQuad®, a combination measles, mumps, rubella, and varicella vaccine (MMRV). This paper...
Noni E. MacDonald et al.
Poorly managed AEFI undermine immunization programs. Improved surveillance in SEAR countries means more AEFIs but management varies. SEAR brought countries together to share AEFI experiences, and...
Lakshmi Sukumaran et al.
Limited data exist on the safety of the measles, mumps, and rubella (MMR) vaccine in adults. The researchers reviewed reports of adverse events (AEs) to the Vaccine Adverse Event Reporting System...
Hussam Ammar et al.
The author\'s report that to the best of their knowledge, this is the first case of Guillain-Barre syndrome to be reported in the English literature after administration of tetanus toxoid, reduced...
Pedro L. Moro et al.
Vaccines are among the safest medical products in use today. Hundreds of millions of vaccinations are administered in the United States each year. Serious adverse reactions are uncommon. However,...
Emily S Jentes et al.
The changing epidemiology of yellow fever and continued reports of rare but serious adverse events associated with yellow fever vaccine have drawn attention to the need to revisit criteria for the...
R.M. Carlsson et al.
Prior study children from a DTaP efficacy trial were recruited at ages 5 and 15 years to randomized booster trials addressing immunogenicity and reactogenicity; 475 preschool children received mixed...
Su Golder et al.
There is considerable debate as to the relative merits of using randomised controlled trial (RCT) data as opposed to observational data in systematic reviews of adverse effects. This meta-analysis of...
Okaïs C et al.
Vaccines can cause adverse reactions (AR), i.e. adverse events following immunization (AEFIs) due to the vaccine, such as local reactions or fever. In addition, live attenuated vaccines which...
Crawford NW et al.
Syncope and syncopal seizures occurred after 4vHPV vaccination in Victoria at rates similar to those seen internationally. Clinical review allowed clarification of the diagnosis and management,...
Ercan TE et al.
The aim of our study was to evaluate the effect of the seven-valent pneumococcal conjugate vaccine which has recently been included in the national immunization schedule on the nasopharyngeal...
Giuseppe Traversa et al.
The signal of an association between vaccination in the second year of life with a hexavalent vaccine and sudden unexpected deaths (SUD) in the two days following vaccination was reported in Germany...
Ama K. Edwin
Cervical cancer remains an important public health problem in developing countries where over 80% of the global burden occurs annually but screening has been ineffective. In a polygamous country like...
Centers for Disease Control and Prevention (CDC)
Since the 1988 World Health Assembly resolution to eradicate poliomyelitis (polio), transmission of wild poliovirus (WPV) has been interrupted in all countries except Afghanistan, Nigeria, and...
Dierig A et al.
The study concludes that immunisation policies regarding BCG vaccine exist in the majority of European countries. Indications for BCG immunisation varied considerably, likely reflecting national TB...
Diamond MR & O\'Brien-Malone A
Multidose vials (MDVs) for injectable therapeutic agents, including vaccines, pose a risk of infection to injected patients as a result of contamination of the vials. The Australian Government...
Ministry of Health and Family Welfare, Government of India
This updated edition offers guidelines to healthcare providers and programme managers for building an efficient AEFI surveillance system.
Shannon Stokley et al.
Since mid-2006, a licensed human papillomavirus (HPV) vaccine has been available and recommended by the Advisory Committee on Immunization Practices (ACIP) for routine vaccination of adolescent girls...
Jim P Buttery & Carl D Kirkwood
Suspected and unexpected clinical features of pathogens might only become apparent during clinical trials to test vaccines or after implementation of vaccination programmes. For example, the role of...
David RL & Kirk MD
To determine the effect of rotavirus vaccination on rotavirus hospitalisations in children under 5 years of age at The Canberra Hospital, Australian Capital Territory. Methods: Rotavirus...
George E. Armah et al.
Oral rhesus/rhesus-human reassortant rotavirus tetravalent (RRV-TV) vaccine was licensed in 1998 but withdrawn in 1999 due to a rare association with intussusception, which occurred...
I Mattheij et al.
The Indian government suspended research in April 2010 on the feasibility and safety of human papillomavirus (HPV) vaccine in two Indian states (Andhra Pradesh and Gujarat) amid public concerns about...
Even though we have already covered 99% of the path to eradicate poliomyelitis from the world, this disease is still causing paralysis in children. Its eradication means not only the end of wild...
Pedro L. Moro et al.
To evaluate and summarize reports to the Vaccine Adverse Event Reporting System (VAERS) in pregnant women who received HPV4 vaccine and assess for potentially concerning adverse events among...
José-Luis Díaz-Ortega et al.
Highlights •Both aerosolized vaccines, MMR-SII and MMR II yielded immune responses to the three viruses. •Successful response to Attenuvax component, related to Schwarz measles...
Nakalembe M, Mirembe F, Banura C
Currently, there is limited data on the immunogenicity and efficacy of human papillomavirus vaccines in Low and Middle income countries (LMIC). The review aims to summarize the current status from...
Giuseppe Traversa et al.
The signal of an association between vaccination in the second year of life with a hexavalent vaccine and sudden unexpected deaths (SUD) in the two days following vaccination was reported in Germany...
Mrozek-Budzyn D et al.
Despite the common use of Thimerosal as a preservative in childhood vaccines since the 1930s, there are not many studies on ethylmercury toxicokinetics and toxicodynamics in infants. The knowledge of...