Europe Confirms COVID-19 Vaccine Side Effects

The European Medicines Agency (EMA) reported updated safety data today for each of the COVID-19 vaccines Authorized for use in the European Union (EU) and European Economic Area (EEA).

Nearly 563 million COVID-19 vaccine doses have been given to people in the EU and EEA as of the end of September 2021.

• Comirnaty (Pfizer - BioNTech): 420 million doses administered; 361,767 suspected side effect cases reported. Main outcomes from the latest safety assessment: Erythema multiforme (red spots/patches on the skin) and unusual or decreased feeling in the skin will be added to the product information as side effects of Comirnaty.

• Vaxzevria (AstraZeneca AB): 68.7 million doses administered; 199,999 suspected side effect cases reported. In addition, primary outcomes from the latest safety assessment: Immune thrombocytopenia (an autoimmune condition with low blood platelet levels) will be added to the product information as a side effect of Vaxzevria and warning advice about thrombocytopenic disorders.

• Spikevax (Moderna Biotech Spain, S.L.): 59.8 million doses administered; 80,486 suspected side effect cases reported. In addition, the main outcome from the latest safety assessment, Erythema multiforme (red spots/patches on the skin), will be added to the product information as a side effect of Spikevax.

• Janssen (Janssen-Cilag International NV): 14.3 million doses administered; 23,455 suspected side effect cases reported. In addition, primary outcomes from the latest safety assessment Venous thromboembolism (VTE, blood clotting in the veins) and immune thrombocytopenia (ITP, an autoimmune condition with low blood platelet levels) will be added to the product information as side effects of COVID-19 Vaccine Janssen, together with warnings and advice. And transverse myelitis (inflammation in parts of the spinal cord) was recommended by PRAC to be added to the product information as a side effect of COVID-19 Vaccine Janssen.

The safety of COVID-19 vaccines is continuously monitored and evaluated. Reported suspected side effects, i.e., medical events that have been observed after vaccination but which are not necessarily related to or caused by the vaccine. 

The vast majority of known side effects of COVID-19 vaccines are mild and short-lived, and serious safety problems are extremely rare, says the EMA.

Based in The Netherlands, the EMA monitors the safety of COVID-19 vaccines authorized in the EU extremely carefully. This enables the detection of any rare side effects that may emerge once many millions of people are vaccinated.

The EMA is a decentralized agency of the EU responsible for the scientific evaluation, supervision, and safety monitoring of medicines in the EU. An independent Management Board governs it.