The third Italian pharmacovigilance report on the vaccine against Covid-19

The third Italian pharmacovigilance report on the vaccine against Covid-19

It concerns the period between the end of December and the beginning of March and sees 46 thousand reports on 9 million doses. There is also a focus on thromboembolic events

(photo: PublicDomainPictures / Pixabay) In the first three months of the vaccination campaign against Covid-19, over 46 thousand reports were detected by the Italian Pharmacovigilance System out of a total of over 9 million doses administered (with a rate of 510 reports per 100 thousand doses). The vast majority of these (about 93%), reports the Italian Medicines Agency, concern non-serious events, which are completely resolved, such as pain at the injection site, fever, fatigue, and muscle aches. . Serious reports, on the other hand, are 7% (about 36 events out of 100 thousand doses), regardless of the type of vaccine or the first or second dose. Compared to the previous report, reporting rates are stable.

In the period between December 27, 2020 and March 26, 2021, the majority of reports (81%) concerned Pfizer's Comirnaty vaccine. This percentage is understandable, given that it was the most used at the time, with 68% of the doses administered. On the other hand, 17% of the reports relate to AstraZeneca's Vaxzevria, inoculated in 27% of cases, while 2% of the reports concern Moderna (5% of administrations).

(graphic: Italian Medicines Agency) The events reported occur mainly on the same day of vaccination or the next day (87% of cases).

For all vaccines the most reported adverse events are fever, headache, muscle / joint pain, injection site pain, chills and nausea, in line with the known information on vaccines so far used in Italy.

In the report there is also an in-depth analysis dedicated to thromboembolic events that occurred temporally after the administration of AstraZeneca's Vaxzevria vaccine. Very rare cases of thrombi associated with low levels of platelets in the blood have occurred within two weeks of vaccination. Out of a total of 62 cases entered in Eudravigilance in Italy, 7 cases (with 2 deaths) of intracranial venous sinus thrombosis (Csvt) were reported up to 22 March 2021 and 4 cases (with 2 deaths) of thrombosis of several blood vessels in atypical office out of the 24 inserted in the same period in the European surveillance network.

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Vaccines vaccine AstraZeneca-Oxford Coronavirus vaccine Modern vaccine Pfizer vaccine BioNTech globalData.fldTopic = "Vaccines, AstraZeneca-Oxford Vaccine, Coronavirus Vaccine, Modern Vaccine, Pfizer BioNTech Vaccine"

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