It was December 2020 when the first doses of vaccines against the virus that has been infecting the world for a year and a half, arrived in Italy. Between doubts and perplexities, almost 50 million doses have been administered to date. Let’s see what the data published by the Italian Medicines Agency (AIFA) say.

Reporting adverse events from Covid vaccines

It is the Italian Authority’s concern to publish monthly a report on the data of the reports of suspected adverse reactions given by the four vaccines available in Italy for Covid-19: AstraZeneca, Pfizer, Moderna and Johnson & Johnson. In this sixth report, the data refer to the time range from 27 December 2020 to 26 June 2021, during which 76,206 reports were submittedout of a total of 49,512,799 doses administered, with a reporting rate of 154 for every 100,000 doses administered.

The 88.1% of the reports reported non-serious events such as fever, fatigue, headache, chills, nausea, muscle aches or simply pain at the injection site; the remaining 11.9% reported severe reactions, more frequently identified as symptoms of severe flu, resulting in complete resolution or improvement in most cases.

About l’80% of adverse events occurred on the same day or the day after administration, more rarely beyond the following 48 hours. The most serious events commonly occur after the second dose of the mRNA vaccines or after the first dose of the AstraZeneca vaccine.

Age, sex and type of reporting subjects

The age group that counts the most reports is that from 20 to 29 years, then decreasing the following, resulting in an average age of 49 years.
However, for all groups, most of the reports occurred after the second dose.

As for the sex of the subjects, it is women who have the highest number of reports, or 73% against 26% of men, although the percentages of doses administered are respectively 54% and 46%.

About 77% of the reporter is a health worker of which 40% are doctors, 20% pharmacists and 16% other health professionals. The remaining 23% of the total is given by patients / citizens.

The 97% of these reports is are spontaneous.

Vaccine ranking by reactions

The vaccine with the most reports is the Comirnaty Pfizer, with69%, but it is also the most administered, in fact, it boasts 70% of administrations.
Following Vaxzevria Astrazeneca with 24,7% of reactions and only 17%of administrations.
In third position Spikevax Moderna with 5,2% of reports for a total 9,6% of administrations.
Finally, we find Janssen Johnson & Johnson with1,1% of reports and e 2,5%of inoculated doses.

Serious events: reporting rate, type and timing

The reporting rate for serious events is 18 for every 100,000 doses administered, regardless of the type of vaccine, the dose administered (first or second) and the possible causal role of the vaccination.
In detail, the reporting rate is:

  • Comirnaty Pfizer14 for every 100,000 doses administered
  • Spikevax Moderna14 for every 100,000 doses administered
  • Vaxzevria Astrazeneca37 for every 100,000 doses administered
  • Janssen Johnson & Johnson: 12 for every 100,000 doses administered

According to the data, the onset of a serious adverse event occurred in 60% of cases within 48 hoursin 18% within the first week and in 19% in the following weeks. For 3% of cases, unfortunately, there is not enough data to establish the timing.

The reporting of serious events, which as mentioned above represent l’11,9% of the total reports, refer to:

  • 7,0% other relevant clinical condition, or they alerted the subject and/or reporter without determining a specific intervention in a hospital setting
  • 3,2% hospitalization
  • 0,6% life-threatening
  • 0,6% death
  • 0,5% disability
  • 0,1% congenital anomalies

The 60% of serious events resulted in the “complete resolution” or “improvement” of the event, while 24% were not yet cured at the time of reporting.

Vaccine/severe event correlation rate

The causal link according to the WHO algorithm was included in 69% of reports of serious adverse events. It emerged that 46% % of these are correlatable, 33% are indeterminate, 19% are unrelated and 2% are unclassifiable.

Fatal events: age and gender of the affected subjects

The total number of fatal case reports in this sixth report is 423, with a reporting rate of 0.85 per 100,000 doses administered.

The average age is 77 and involved 51,5% women and 48% men; 0.5% of cases do not report the patient’s sex.

Of these cases, 244 occurred after the first dose, while 127 after the second. In 52 reports it was not specified.

The deaths occurred over a period of time ranging from two hours up to a maximum of 78 days. In most cases, the correlation is due to pathologies already present before vaccination, to cases of clinical frailty and polytherapy.

Vaccine/death correlation rate

The causality assessment with the WHO algorithm was used for 63,4% of the reports with a fatal outcome and it was found that: 59,6% of these are unrelated33,6% are indeterminate4,2% are unclassifiable for lack of data and 2,6% can be correlated.
This last figure refers to 7 cases: 4 were already known in the previous months, would therefore be newTwo of these refer to a possible lack of vaccine efficacy, as two patients with immunosuppression who, respectively 45 and 35 days after the vaccination course, tested positive for Coronavirus and were affected by complications of interstitial pneumonia which led to death. The last case, on the other hand, refers to a fragile condition in the patient who immediately after the first dose of the vaccine suffered from fever and vomiting which led to decompensation in the clinical condition until death after two days.

Vaccine ranking for deaths

  • Comirnaty Pfizer262, for arate of 0,75 per 100,000 doses administered
  • Spikevax Moderna75, for a rate of 1,58 per 100,000 doses administered
  • Vaxzevria Astrazeneca72, for arate of 0,84 per 100,000 doses administered
  • Janssen Johnson & Johnson14, for a rate of 1,15 per 100,000 doses administered

For further information visit the AIFA website