Cases with fatal outcome after Covid-19 vaccination. Aifa report

11 June 20213 years ago babelfish

In Italy, as of May 26, 2021, 328 reports with a “death” outcome have been entered with a reporting rate of 1 / 100,000 doses administered, regardless of causality. The numbers and comparisons between Astrazeneca, Pfizer, Moderna and Janssen vaccines taken from the most updated Aifa report

Extract from the COVID-19 Vaccine Surveillance Report by Aifa :

Cases with fatal outcome after Covid-19 vaccination

(With the collaboration of the Regional Centers of Pharmacovigilance of the Lombardy and Tuscany regions)

In Italy, as of May 26, 2021, 328 reports with a “death” outcome have been entered with a reporting rate of 1 / 100,000 doses administered, regardless of causality.

Based on the type of vaccine, 213 deaths were reported after Comirnaty, 58 after Covid-19 Vaccino Moderna, 53 after Vaxzevria and 4 after Covid-19 Vaccino Janssen (table 4). 53.4% of cases concern women, 46% men while 0.6% (2 cards) do not report this data; the mean age is 78.6 years (range 26-104 years).

The time between administration and death varies from two hours up to a maximum of 55 days.

In 211 cases death is recorded after the first dose, in 98 after the second (where specified in the report form).

No deaths following anaphylactic shock or major allergic reactions have been reported, while the correlation with cardiovascular causes (eg hypovolemic and cardiogenic shock) is frequent in patients with pathologies of this apparatus.

The different reporting rate of events with a fatal outcome is largely dependent on the different target population of the individual vaccines and on the different exposure. Rates are decreasing for the three vaccines already in use from the previous analysis, as is the overall rate. The cases accompanied by detailed and complete information report alternative causes to the vaccine, in particular complications of existing or previous pathologies, in subjects with clinical frailties and polytherapy, which make the evaluation of the cause of death and the causal relationship complex.

At the time of writing, 68.6% of the forms (225 out of 328) have a causality assessment with the algorithm used in the vaccine surveillance (WHO Algorithm), according to which 57.8% of cases is not correlable, 36.9% undetermined and 3.6% unclassifiable due to lack of information necessary for the application of the algorithm. In four cases (1.8% of the total), causality is correlated. Three cases have already been described in previous reports. The fourth case refers to a 58-year-old man (suffering from hypercholesterolemia and previously undergoing thyroidectomy), who died 17 days after the first dose of the vaccine, due to thrombosis of the splanchnic veins with thrombocytopenia, splenomegaly, haemoperitoneum and consequent splanchnic ischemia. The case was interpreted as suspected atypical site thrombosis associated with thrombocytopenia in a patient vaccinated with Vaxzevria and evaluated as correlable, pending further information from the autopsy examination.

Here is briefly an update of the international databases:

– the "Weekly Summary of Yellow Card reporting" of the United Kingdom Regulatory Agency (MHRA – Medicines and Healthcare products Regulatory Agency), updated on 19/05/2021, reports a total of 1,213 reports with a fatal outcome out of a total of approximately 59 million administered doses of the Comirnaty, Vaxzevria and Moderna vaccines, with a reporting rate of approximately 2 cases per 100,000 doses administered;

– the Vaccine Adverse Event Reporting System (VAERS) in the United States reports as of May 24, 2021 4,863 death reports among people who have received at least one dose of vaccine out of a total of over 285 million doses of Covid-19 vaccines (rate of reporting 1.7 / 100,000 doses administered);

– the latest periodic report from Swissmedic dated 21/05/2021, prepared in collaboration with the regional pharmacovigilance centers, reports 84 reports with fatal outcome out of a total of 2269 notifications of suspected adverse reactions and 3.7 million doses of vaccines Comirnaty and Covid-19 Modern Vaccine (currently used in Switzerland), with a rate of 2.3 reports per 100,000 doses administered.

Even in these reports, despite the temporal association with vaccination, the cases with a fatal outcome mainly involved frail people with significant comorbidities and there are no indications confirming a causal link with the vaccine, since the causes of death reported (infections, cardiovascular / pulmonary events) occur in relation to the pathologies reported in the medical history and regardless of vaccination. From the evaluation of the literature and from the communications of other regulatory agencies, situations do not emerge that are particularly different from those observed in Italy.

This is a machine translation from Italian language of a post published on Start Magazine at the URL https://www.startmag.it/sanita/casi-con-esito-fatale-dopo-vaccinazione-covid-19-report-aifa/ on Fri, 11 Jun 2021 09:04:29 +0000.