COVID-19 vaccines are considered promising agents in the control of the pandemic. Although their safety was assessed in randomised clinical trials, severe adverse events (AEs) have been reported after large-scale administration. This study aims to evaluate thromboembolic AEs reported
after vaccination in a real-world context and how they led to the interruption of vaccination campaigns. We also review the benefits and risks of the vaccines approved in the European Union and provide recommendations. A review of the literature was performed using Medline/PubMed electronic
database as well as institutional and pharmacovigilance official reports. Our findings show that vaccine-induced prothrombotic immune thrombocytopenia has been suggested as a very rare AE associated with viral vector vaccines. Unusual thrombotic events combined with moderate-to-severe thrombocytopenia
were reported mainly in women under 60 years of age. As safety signals emerged, Vaxzevria and Janssen´s COVID-19 vaccine campaigns have been paused while investigations proceed. On the other hand, the number of deep vein thrombosis and pulmonary embolism reports have not increased. Post-marketing
surveillance indicated that mRNA vaccines are safe and should continue to be used. The thrombotic events report rate is not increased in people over 60 years. As they are at greater risk for COVID-19 complications and death, no vaccine restrictions are recommended in this group. Risk factors
for vaccine-induced prothrombotic immune thrombocytopenia should be established so that evidence-based decisions can be made. Systematic monitoring of COVID-19 vaccine safety is essential to ensure that the benefits of vaccination outweigh the risks.
The need for the safety monitoring of the COVID-19 vaccine is unprecedented. It is an ongoing process starting from different phases of clinical trials and continued to post-marketing to tackle the emergency used authorized COVID-19 vaccines across the world. Rapid detection, exchange, prioritization, and assessment of safety signals based on available real-world data, surveillance of Adverse events following immunization (AEFI), and adverse event of special interest (AESI) by studying the observed/expected cases. Enhanced collaboration, and availability of resources, tools, and methods will add to the lessons learned from previous experiences.
As the coronavirus disease 2019 (COVID-19) pandemic is ongoing and new variants of severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) are emerging, there is an urgent need for COVID-19 vaccines to control disease outbreaks by herd immunity. Surveillance of rare safety issues related to these vaccines is progressing, since more granular data emerge with regard to adverse events of COVID-19 vaccines during post-marketing surveillance. Interestingly, four cases of anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) presenting with pauci-immune crescentic glomerulonephritis (GN) after COVID-19 mRNA vaccination have already been reported. We here expand our current knowledge of this rare but important association and report a case of AAV presenting with massive rhabdomyolysis and pauci-immune crescentic GN after Pfizer-BioNTech COVID-19 mRNA vaccination. As huge vaccination programs are ongoing worldwide, post-marketing surveillance systems must continue to assess vaccine safety important for the detection of any events associated with COVID-19 vaccination. This is especially relevant in complex diseases where diagnosis is often challenging, as in our patient with AAV presenting with massive rhabdomyolysis and pauci-immune crescentic GN.
In order to meet the multifarious needs for drug information and to cope with the post-marketing surveillance of drugs adequately, an on-line drug information network, which is composed of two data bases, clinical case record data base and literature data base, has been developed. Primary considerations in designing these systems were input of clean data, accurate input, insuring that no ADRs are overlooked, accumulation of the latest data, saving manpower required for processing, and processing large quantities of data. This system is also designed to input and to output in Japanese character.
Adverse events after Japanese encephalitis vaccination: review of post-marketing surveillance data from Japan and the United States
