Rare cases of Guillain-Barré syndrome after COVID-19 vaccination, Germany, December 2020 to August 2021.

BackgroundGuillain-Barré syndrome (GBS) has been associated with vaccination against COVID-19.AimWe aimed to compare clinical characteristics and analyse excess GBS cases following administration of different COVID-19 and influenza vaccines in Germany versus the expected numbers estimated from pre-pandemic background incidence rates.MethodsWe analysed safety surveillance data reported to the German national competent authority between 27 December 2020 and 31 August 2021. GBS cases were validated according to Brighton Collaboration (BC) criteria. We conducted observed vs expected (OvE) analyses on cases fulfilling BC criteria levels 1 to 4 for all four European Medicines Agency-approved COVID-19 vaccines and for influenza vaccines.ResultsA total of 214 GBS cases after COVID-19 vaccination had been reported, of whom 156 were eligible for further analysis. Standardised morbidity ratio estimates 3-42 days after vaccination were 0.34 (95% confidence interval (CI): 0.25-0.44) for Comirnaty, 0.38 (95% CI: 0.15-0.79) for Spikevax, 3.10 (95% CI: 2.44-3.88) for Vaxzevria, 4.16 (95% CI: 2.64-6.24) for COVID-19 Vaccine Janssen and 0.60 (95% CI: 0.35-0.94) for influenza vaccines. Bilateral facial paresis was reported in 19.7% and 26.1% of the 156 GBS cases following vaccination with Vaxzevria and COVID-19 Vaccine Janssen, respectively, and only in 6% of cases exposed to Comirnaty.ConclusionThree and four times more GBS cases than expected were reported after vaccination with Vaxzevria and COVID-19 Vaccine Janssen, respectively, therefore GBS might be an adverse event of vector-based vaccines. Bifacial paresis was more common in cases with GBS following vaccination with vector-based than mRNA COVID-19 vaccines.

[Postvaccinal complications and management of suspected cases]. / Impfkomplikationen und der Umgang mit Verdachtsfällen.

In all developed countries there is the possibility to protect oneself from vaccine-preventable diseases. However, not all individuals make use of this option. It is precisely in highly developed countries where a trend to vaccination hesitancy is noticeable, i. e. reluctance to get oneself or one's children vaccinated. The reasons why this is so are many, but the most important reason is the fear of postvaccinal complications, especially of those that imply sequelae or those with fatal outcomes.Whereas there are some proven associations between vaccination and adverse drug reaction, for example febrile seizures after the measles-mumps-rubella (MMR) vaccination, other hypotheses can be refuted, for example autism after the MMR vaccination. On one hand, this article gives an overview of known postvaccinal complications with indication of a causal association with vaccination and on the other hand addresses hypotheses of potential adverse drug reactions that have been refuted by pharmacoepidemiological studies.Only the scientific debate of these hypotheses, which are repeatedly discussed, especially on social media, can contribute to corroborating or refuting a potential causal association. If evidence for a causal association grows, e. g. intussusception, the relevant authorities (e.g. Paul Ehrlich Institute, European Medicines Agency) will take risk-minimizing measures. If studies and meta-analyses do not reveal any evidence of a causal association, a targeted information strategy will be required in order to prevent myths from circulating, vaccination coverages from declining, and infectious diseases from spreading.

[The Working Group of Enforcement Officers (WGEO) : The European Network of Drug Regulatory Authorities to Combat Pharmaceutical Crime]. / Die Arbeitsgruppe der Vollzugsbeamten (WGEO) : Das europäische Netzwerk der Arzneimittelbehörden zur Bekämpfung der Arzneimittelkriminalität.

Ten years ago the Heads of Medicines Agencies (HMA) officially founded the Working Group of Enforcement Officers (WGEO), a European working group to reduce falsifications of human and veterinarian medicinal products in the legal and illegal supply chain. Police, customs and other international organisations are also represented in the WGEO. Partner organisations are for example the Directorate General for Health and Food Safety of the European Commission, the European Medicines Agency (EMA), the European Police Office (Europol), the International Criminal Police Organization (Interpol), the European Directorate for the Quality of Medicines and Healthcare (EDQM) and the World Health Organization (WHO). The main goal of the group is the protection of public health from harmful medicines for both humans and animals. The WGEO has created a network of its members and a rapid alert system to exchange confidential information on falsified or stolen medicinal products. There are face-to-face meetings twice a year including training using case studies.

[The Herceptin® case : A case of falsification of medicinal products to a greater extent]. / Der Herceptin®-Fall : Ein Fälschungsfall von Arzneimitteln größeren Ausmaßes.

Falsified medicines are a raising problem for the German drug market. The complex distribution channels across the European market facilitates the introduction of falsified and stolen medicines into the legal supply chain and may pose a risk for patients. The "Herceptin® case" from 2014 of falsified medicines of Italian origin demonstrates how complex distribution systems have been misused by criminal organizations in order to introduce stolen and thus falsified medicines via the parallel trade into the market, and which measures the authorities and the parallel-traders in the national and European network have taken to ensure patient safety. Falsified medicines will continue to be a problem in the future, so new monitoring systems have to be established and effectively used for prevention. The introduction of the EU-wide serialisation system in February 2019 is therefore intended to identify falsified drugs and to prevent the further trade as well as the expenditure to the patient. Furthermore, the maintenance and intensification of the cooperation between all EU authorities involved remains indispensable to close gateways in the distribution system for falsified medicines and to minimise the risk to the population.

Midterm Outcome after Mega-Prosthesis Implanted in Patients with Bony Defects in Cases of Revision Compared to Patients with Malignant Tumors.

Use of mega-prostheses is a common option for the treatment of patients with malignant tumors as well as in patients with large osseous defects at the time of revision surgery. No studies have compared the two groups to determine whether there is a relative difference in clinical outcomes. We performed a midterm-outcome-study to evaluate our results in these two patient populations. Deep infection was found more often in our revision group (29.5% vs. 9.1%), however no significant differences in WOMAC-results could be found between the two groups. Surgeons should recognize the high complication rate as well as the differences in results using mega-prostheses in these two distinct groups of patients.