Safety of COVID-19 Vaccines, German transparent report

https://www.pei.de/EN/newsroom..../dossier/coronavirus

Reports received between 27 December 2020 (start of the vaccination campaign in Germany) and 31 March 2022.

A total of 172,062,925 COVID-19 vaccinations in Germany

296,233 reports of suspected adverse events

Overall reporting rate for all vaccines

1.7 reports per 1,000 doses of vaccine

(0.17%)

Reporting rate for serious adverse events

0.2 reports per 1,000 doses of vaccine

(0.02%)

(one per 5,000 doses of vaccine)




6.4. Definitions

Adverse events are noxious and unintended reactions to the medicinal product.

73.3% of vaccine doses Pfizer, (Comirnaty)

17.1% were Moderna (Spikevax)

7.4% were AstraZeneca AB (Vaxzevria)

2.1% were COVID-19 Janssen (now called Jcovden)

0.1% were Novavax (Nuvaxovid)

Reporting rate after booster vaccinations Pfizer (Comirnaty) or Moderna (Spikevax) was lower than after primary immunisation.

The Paul-Ehrlich-Institut will closely monitor and continue to investigate cases of,

myocarditis/pericarditis

thrombosis

immunologically mediated adverse events such as immune thrombocytopenia,

occurring after administration of the approved vaccines.

Full detailed report

https://www.pei.de/SharedDocs/Downloads/EN/newsroom-en/dossiers/safety-reports/safety-report-27-december-2020-31-march-2022.pdf?__blob=publicationFile&v=8


Germany, Paul-Ehrlich-Institut, authority responsible for monitoring the safety of vaccines and biomedicines.

Institute’s Division Pharmacovigilance collects and reviews reports on adverse drug effects,

takes the necessary steps if required.

Reporting suspected cases of adverse effects is a central pillar for being able to judge the safety of medicines.

New signals can be detected in a timely manner,

and the risk/benefit profile of vaccines can be continuously monitored.

Even reactions with a timely relation to a vaccine do not necessarily have a causal relation.

Safety Reports

Open communication of risks, including potential ones, is a prerequisite for a high acceptance rate for vaccines among the population.

The benefit of the COVID-19 vaccination for the health of individuals and the population as well as their effect in combating the pandemic essentially depends on,

Confidence in the vaccination is essential to get benefits of the vaccine

Paul-Ehrlich-Institut publishes continuously all suspected cases reported in Germany,

on adverse effects or vaccination complications,

in a temporal relationship with the COVID-19 vaccination.

Reporting Portal for Suspected Cases of Adverse Effects

Healthcare providers

Marketing authorisation holder

Persons vaccinated or relatives.