AstraZeneca and rare thrombosis cases, what do we know

Spotlights on the AstraZeneca vaccine, especially for administration to young people and women and for second doses. The vaccine, recommended in Italy for people over 60, in the numerous open days organized in different cities was also administered to people under the age of 60 and returned to the spotlight after two cases of thrombosis. Camilla, 18, died yesterday in Genoa. His parents agreed to donate the organs. Another young woman, 34, is hospitalized. AIFA – From the fifth Pharmacovigilance Report on Covid-19 vaccines, published by the Italian drug agency Aifa, it emerges that the reporting rate of intracranial and atypical venous thrombosis in subjects vaccinated with the AstraZeneca anti-Covid Vaxzevria vaccine “is in line with what has been observed at the European level “. This is “1 case in every 100,000 first doses administered” and “no cases after the second dose”. These rare adverse events were reported “predominantly in people under the age of 60”, is confirmed in the report, which contains data on reports of suspected adverse reactions registered in the National Pharmacovigilance Network between December 27, 2020 and May 26, 2021 for the 4 vaccines in use in the current vaccination campaign. Between 27 December 2020 and 26 May 2021, 66,258 adverse reaction reports were received for the 4 vaccines in use out of a total of 32,429,611 doses administered (reporting rate of 204 every 100 thousand doses), of which about 90% refer to non-serious events such as pain at the injection site, fever, asthenia / fatigue, muscle aches, according to what emerges from the Report. mostly on the same day as vaccination or the day after (83% of cases). Serious reports correspond to 10.4% of the total, with a rate of 21 serious events per 100 thousand doses administered, regardless of the type of vaccine, the dose (first or second) and the possible causal role of vaccination. Most of the reports are related to the Comirnaty vaccine (71.8%), so far the most used in the vaccination campaign (68.7% of the doses administered) and only to a lesser extent to the Vaxzevria * vaccine by AstraZeneca (24% of the reports and 20.8% of administered doses), Moderna vaccine (3.9% of reports and 9% of administered doses) and Janssen-J&J group vaccine (0.3% of reports and 1.5% of administered doses) . For all vaccines – it is specified in the Aifa report – the most reported adverse events are fever, fatigue, headache, muscle / joint pain, pain at the injection site, chills and nausea. The most frequently reported vaccination-related serious adverse events are a flu-like syndrome with severe symptoms, more frequent after the second dose of mRna vaccines and after the first dose of Vaxzevria. CTS – “In these hours there is an ongoing discussion in the CTS” on vaccinations with AstraZeneca, underlined yesterday the Minister of Health Roberto Speranza, responding in the Senate to the question on the creation of open days for the administration of the AstraZeneca vaccine dedicated to Young people. “Italy has gone from a high to a medium level of circulation of the virus in recent weeks and is now at a low level – he specified – These assessments will certainly be considered in the next CTS opinion”. “The EMA Pharmacovigilance Risk Committee revealed a first signal relating to thromboembolic events following the AstraZeneca vaccine in March 2021, however, concluding that the benefits of the vaccine remained overall greater than the risks – recalled Speranza – and that the venous thrombotic events in breasts unusual associated with low platelet levels should be listed among very rare adverse events. On April 7, 2021, the Ministry of Health, through a circular in force today, endorsing the opinion expressed by the CTS of the AIFA, recommended the ” preferential use of the AstraZeneca vaccine in people over 60 years of age based on current evidence and taking into account the low risk of adverse reactions of the thromboembolic type in the face of the high mortality from Covid in the advanced groups – he recalled – Subsequently to the end April the EMA concluded a further evaluation by analyzing the risks and benefits of the vaccine in divers and age groups and in different epidemiological scenarios, the outcome showed that the benefits of vaccination increase with increasing age and the level of circulation of the virus. The AIFA – he concluded – then reiterated that the benefit-risk profile is progressively more favorable with increasing age. “The Technical-Scientific Committee will take into account these evaluations.