This is why Covid vaccines are safe. Aifa report
Aifa has monitored the effects of vaccines on people and in its report shows that the numbers leave no room for doubts about the benefits derived from them. All the details
Serious adverse reactions to the vaccine are very rare. This was stated by the Italian Medicines Agency (Aifa) in the Annual Report on the safety of anti Covid vaccines which takes into consideration the period 27 December 2020 – 26 December 2021.
The Report was prepared by AIFA with the contribution of all the Regional Pharmacovigilance Centers, the Ministry of Health and the Higher Institute of Health (Iss).
HOW MANY REPORTS OF ADVERSE EVENTS WERE
As of December 26, 2021, a total of 117,920 reports of suspected adverse events following the anti-Covid vaccination were entered in the National Pharmacovigilance Network out of a total of 108,530,987 vaccine doses, with a reporting rate of 109 reports per 100,000 doses administered, regardless of the vaccine and dose.
Most of the reports (about 73%) occurred on the same day as vaccination or the day after, and only more rarely did the event occur beyond the following 48 hours.
The reporting rate of adverse reactions is higher in the age groups between 20 and 60 years, and then decreases in the more advanced age groups and in the very young.
HOW MANY CASES OF SERIOUS ADVERSE EVENTS HAVE BEEN
83.7% (98.717) of the reports entered, according to the report, refer to non-serious events and 16.2% (19,055) to serious adverse events.
The serious adverse events with a fatal outcome after the anti Covid vaccination are defined by Aifa as "rare" because, as explained by Pasquale Marchione of the Agency's Signal Management Office, "there are 456 events after the first dose, 267 after the second and 35 after the third, with a mean age of 79 years, but at the moment only 22 events are related to vaccination (0.2 cases per million doses). These are 2 systemic events, 10 thrombosis and 10 vaccination failures in fragile patients for which patients became infected and died from Covid ".
WHICH VACCINE HAS THE MOST REPORTED
The largest number of reports concerned Comirnaty (68%) of BioNTech / Pfizer, but it was also the most used. Then follow Vaxzevria (19.8%) of AstraZeneca , Spikevax (10.8%) of Moderna and Johnson & Johnson of Janssen (1.4%).
WHAT WERE THE ADVERSE EVENTS
For all vaccines, the most reported adverse events were fever, fatigue, headache, muscle / joint pain, injection site pain, chills and nausea.
The reported events, the report clarifies, are mostly not serious and have already been resolved at the time of reporting.
Up to 64% of undesirable effects were detected in the placebo group (which therefore were not actually vaccinated) of the clinical studies and are attributable to the so-called nocebo effect.
MYOCARDITES AND PERICARDITES
No deaths were reported from either myocarditis or pericarditis. It was observed, however, that both diseases "affect adolescents and young adults in the healthy population with a certain frequency," said Marchionne.
"There is a greater risk of myocarditis in the 14 days after vaccination in males – he explained – but it is a very rare high event, equal to 2 cases for a million doses administered, and in a percentage of cases there is the problem resolution. The pericarditis have a similar trend ".
FOCUS CHILDREN
The reporting rates of adverse events from Covid vaccination in the 5‐11 age group are preliminary and no particular safety concerns are currently emerging.
The most frequently reported adverse events are fever, headache, fatigue and vomiting. 69% of responses in the pediatric population resolved completely or were improving at the time of reporting.
In Italy, the data made available by the ISS show a total of over 263,000 cases of infection in children aged 6-11 years since the beginning of the pandemic (data updated as of 1 December 2021): 1,453 were hospitalized ( hospitalization rate 6 / 1,000), of which 36 in intensive care (1 / 7,000) and 9 died.
PREGNANCY AND BREASTFEEDING
The vaccination against Covid, writes Aifa, “is indicated both in pregnancy and lactation and no particular safety problems emerge from the pharmacovigilance data and ad hoc studies in this population. There is also no evidence to suggest that anti-Covid-19 vaccines can negatively affect fertility in both sexes ". Indeed, "the need to vaccinate this population has become evident in light of the risks associated with the onset of Covid for the mother or fetus".
FEWER ADVERSE EVENTS FOR THE THIRD DOSE
The reporting rate after the third dose is 21.7 reports per 100,000 administrations, therefore, lower than that observed for primary cycle doses.
WHAT IS SAYING ABOUT HETEROLOGICAL VACCINATION
Most of the reports following heterologous vaccination relate to the administration of an mRNA vaccine after the first administration of an adenoviral vector vaccine. However, they are mostly not serious and have the same characteristics as the rest of the reports.
This is a machine translation from Italian language of a post published on Start Magazine at the URL https://www.startmag.it/sanita/ecco-perche-i-vaccini-anti-covid-sono-sicuri-report-aifa/ on Wed, 09 Feb 2022 13:55:24 +0000.