Abstract:Vaccine licensure requires a very high safety standard and vaccines routinely used are very safe. Vaccine safety monitoring prelicensure and postlicensure enables continual assessment to ensure the benefits outweigh the risks and, when safety problems arise, they are quickly identified, characterised and further problems prevented when possible. We review five vaccine safety case studies: (1) dengue vaccine and enhanced dengue disease, (2) pandemic influenza vaccine and narcolepsy, (3) rotavirus vaccine and in… Show more
“…Dengvaxia ® , one of the most advanced developments in vaccines against dengue, raised serious safety concerns when data showed an increased risk of hospitalization in naïve vaccinees when they were exposed to natural infection [ 80 ]. Takeda vaccine TAK-003 is still in phase III trials and has been shown to be safe and to induce protection against dengue-related hospitalization with efficacies around 75–80% independent of serostatus of vaccinated individuals [ 9 ].…”
Section: Safety Issues With Dengue Vaccinesmentioning
Dengue is one of the most prevalent mosquito-borne diseases in the world, affecting an estimated 390 million people each year, according to models. For the last two decades, efforts to develop safe and effective vaccines to prevent dengue virus (DENV) infections have faced several challenges, mostly related to the complexity of conducting long-term studies to evaluate vaccine efficacy and safety to rule out the risk of vaccine-induced DHS/DSS, particularly in children. At least seven DENV vaccines have undergone different phases of clinical trials; however, only three of them (Dengvaxia
®
, TV003, and TAK-003) have showed promising results, and are addressed in detail in this review in terms of their molecular design, efficacy, and immunogenicity. Safety-related challenges during DENV vaccine development are also discussed.
“…Dengvaxia ® , one of the most advanced developments in vaccines against dengue, raised serious safety concerns when data showed an increased risk of hospitalization in naïve vaccinees when they were exposed to natural infection [ 80 ]. Takeda vaccine TAK-003 is still in phase III trials and has been shown to be safe and to induce protection against dengue-related hospitalization with efficacies around 75–80% independent of serostatus of vaccinated individuals [ 9 ].…”
Section: Safety Issues With Dengue Vaccinesmentioning
Dengue is one of the most prevalent mosquito-borne diseases in the world, affecting an estimated 390 million people each year, according to models. For the last two decades, efforts to develop safe and effective vaccines to prevent dengue virus (DENV) infections have faced several challenges, mostly related to the complexity of conducting long-term studies to evaluate vaccine efficacy and safety to rule out the risk of vaccine-induced DHS/DSS, particularly in children. At least seven DENV vaccines have undergone different phases of clinical trials; however, only three of them (Dengvaxia
®
, TV003, and TAK-003) have showed promising results, and are addressed in detail in this review in terms of their molecular design, efficacy, and immunogenicity. Safety-related challenges during DENV vaccine development are also discussed.
“…Nach Impfung gegen humane Papillomviren Humane Papillomviren kam es in Dänemark und Japan zu Verdachtsfallmeldungen eines komplexen regionalen Schmerzsyndroms („complex regional pain syndrome“ [CRPS]) und posturalen Tachykardiesyndroms (POTS). Groß angelegte Studien ergaben jedoch keinen Anhalt für einen statistischen Zusammenhang [ 29 , 30 ].…”
“…Vor allem nach der ersten Gabe der Rotavirusimpfung Rotavirusimpfung tritt bei Kindern aus Ländern mit hohem und mittlerem Einkommen geringfügig häufiger eine Darminvagination auf [ 30 ]. Das Gesamtrisiko für eine Invagination bis zum Ende des ersten Lebensjahrs zeigte sich in einer Studie des PEI jedoch nicht erhöht gegenüber ungeimpften Kindern [ 31 ].…”
“…In der Phase-III-Studie zur chimären tetravalenten Denguevakzine Denguevakzine traten bei seronegativen Personen im Rahmen einer antikörperabhängigen Verstärkungsreaktion Antikörperabhängige Verstärkungsreaktion („antibody-dependent enhancement“ [ADE]) gehäuft Durchbruchsinfektionen mit schwerem Krankheitsverlauf auf. Die Anwendung des Impfstoffs ist deshalb streng auf Personen im Alter von 9 bis 45 Jahren beschränkt, die in Endemiegebieten leben und in der Vergangenheit bereits gesichert mit Dengueviren infiziert waren [ 30 ].…”
“…4 The detection of potential AEFIs that have arisen during routine or mass vaccination campaigns led to the development of passive and active vaccine surveillance systems that were leveraged and enhanced for AEFI monitoring of COVID-19 vaccines. 4,5 While these surveillance systems have shown COVID-19 vaccines to be safe, they have also led to the identification of rare AEFIs that were not identified in prelicensure clinical trials, such as thrombosis with thrombocytopenia syndrome following adenoviral vector COVID-19 vaccines, and myocarditis following COVID-19 mRNA vaccines. 6,7 This narrative review focuses on events of myocarditis and pericarditis that occurred after COVID-19 mRNA vaccines, given the extensive use of this platform worldwide and the significant impact of this AEFI on COVID-19 vaccine campaigns and vaccine acceptance, especially in the highest risk groups.…”
Vaccines have had a tremendous impact on reducing the burden of infectious diseases; however, they have the potential to cause adverse events following immunization (AEFIs). Prelicensure clinical trials are limited in their ability to detect rare AEFIs that may occur in less than one per thousand individuals. While postmarketing surveillance systems have shown COVID‐19 mRNA vaccines to be safe, they led to the identification of rare cases of myocarditis and pericarditis after COVID‐19 vaccination that were not initially detected in clinical trials. In this narrative review, we highlight concepts of vaccine pharmacovigilance during mass vaccination campaigns and compare the approaches used in the context of myocarditis and pericarditis following COVID‐19 vaccination to historical examples. We describe mechanisms of passive and active surveillance, their strengths and limitations, and how they interacted to identify and characterize the safety signal of myocarditis and pericarditis after COVID‐19 mRNA vaccination. Articles were synthesized from a PubMed search using relevant keywords for articles published on vaccine surveillance systems and myocarditis and pericarditis after COVID‐19 vaccination, as well as the authors' collections of relevant publications and grey literature reports. The global experience around the identification and monitoring of myocarditis and pericarditis after COVID‐19 mRNA vaccination has provided important lessons for vaccine safety surveillance and highlighted its importance in maintaining public trust in mass vaccination programmes in a pandemic context.
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