COVID-19 vaccines: EMA reviewing cases of multisystem inflammatory syndrome
EMA’s safety committee (PRAC) is assessing whether there is a risk of multisystem inflammatory syndrome (MIS) with COVID-19 vaccines following a report of MIS with Comirnaty. The case occurred in a 17-year old male in Denmark who has since fully recovered. Some cases of MIS were also reported in the EEA following vaccination with other COVID-19 vaccines.[1] MIS is a serious inflammatory condition affecting many parts of the body and symptoms can include tiredness, persistent severe fever, diarrhoea, vomiting, stomach pain, headache, chest pain and difficulty breathing. MIS has previously been reported following COVID-19 disease. The Danish patient, however, had no history of COVID-19. MIS is rare and its incidence rate before the COVID-19 pandemic estimated from 5 European countries was around 2 to 6 cases per 100,000 per year in children and adolescents below 20 years of age and below 2 cases per 100,000 per year in adults aged 20 years or more. At this stage, there is no change to the current EU recommendations for the use of COVID-19 vaccines. The PRAC encourages all healthcare professionals to report any cases of MIS and other adverse events in people having these vaccines. The PRAC will now assess the available data on MIS to determine whether the condition can be caused by the vaccine and recommend whether any changes to the product information of the vaccines are needed. EMA and national authorities will provide further updates as necessary.
COVID-19 Vaccine Janssen and venous thromboembolism As part of the ongoing close safety monitoring of the COVID-19 vaccines, PRAC is reviewing data on cases of venous thromboembolism (blood clots in the veins) with COVID-19 Vaccine Janssen. This safety issue is distinct from the very rare side effect of thrombosis with thrombocytopenia syndrome (TTS) (i.e. blood clots with low blood platelets). Venous thromboembolism was included in the risk management plan for COVID-19 Vaccine Janssen as a safety issue to be investigated, based on a higher proportion of cases of venous thromboembolism observed within the vaccinated group versus the placebo group in the first clinical studies used to authorise this vaccine. PRAC will assess additional data from two large clinical trials of the vaccine, which are to be submitted shortly by the marketing authorisation holder of the vaccine, in order to further evaluate whether the condition is linked to the vaccine. New safety information for healthcare professionals As part of its advice on safety-related aspects to other EMA committees, the PRAC discussed a direct healthcare professional communication (DHPC) containing important safety information for Imbruvica. Imbruvica: new safety signal for use in combination with rituximab and ACE inhibitors This DHPC aims to inform healthcare professionals about a new safety signal of sudden or cardiac death with Imbruvica (ibrutinib) when used in combination with rituximab and angiotensin-converting enzyme (ACE) inhibitors. The signal was recognized following a review of the findings of a clinical trial. Imbruvica is a medicine for treating the blood cancers mantle cell lymphoma, chronic lymphocytic leukaemia (CLL) and Waldenström’s macroglobulinaemia (also known as lymphoplasmacytic lymphoma). An interim analysis of the clinical trial suggested that the risk of sudden or cardiac death in patients on an ACE inhibitor when entering the study was increased in patients randomised to ibrutinib and rituximab, compared to those randomised to fludarabine, cyclophosphamide and rituximab. While the PRAC is reviewing the signal, as a precautionary measure, for patients with CLL currently receiving ibrutinib plus rituximab together with an ACE inhibitor, the PRAC advises healthcare professionals to reconsider the treatment strategy. For patients with CLL on ACE-inhibitors who have not yet started treatment with ibrutinib plus rituximab, the treatment strategy should be reconsidered before commencing ibrutinib. The PRAC will communicate final conclusions and recommendations as soon as the evaluation has been completed. The DHPC for Imbruvica will be forwarded to EMA’s human medicines committee, the CHMP. Following the CHMP decision, the DHPC will be disseminated to healthcare professionals by the marketing authorisation holder, according to an agreed communication plan, and published on EMA’s website and in national registers in EU Member States. PRAC votes to extend mandate of vice-chair Martin Huber for another three years The PRAC has voted to prolong, for another three years, the mandate of Dr Martin Huber as vice-chair of the committee. Dr Huber’s new mandate will take effect from October 2021.
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Ongoing referrals
[1] As of 19 August, cases reported as MIS in children in the EEA from the EudraVigilance database were: Comirnaty: 5; Spikevax: 1; Vaxzevria: no case; COVID-19 Vaccine Janssen: 1. Some of the cases occurred in adults rather than in children. The numbers are likely to change and will be updated as necessary and as the evaluation progresses. |
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