Europe confirms side effects of COVID-19 vaccine – Precision vaccinations

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(Precision vaccinations)

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

Almost 563 million doses of the COVID-19 vaccine had been given to people in the EU and EEA by the end of September 2021.

  • Comirnaty (Pfizer – BioNTech): 420 million doses administered; 361,767 suspected cases of side effects reported. Main results of the last safety assessment: Erythema multiforme (red spots / patches on the skin) and unusual or decreased sensation 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 cases of suspected side effects reported. In addition, the main results of the latest safety assessment: immune thrombocytopenia (an autoimmune disease with low levels of blood platelets) will be added to the product information as a side effect of Vaxzevria and updates. guard regarding thrombocytopenic disorders.

  • Spikevax (Moderna Biotech Spain, SL): 59.8 million doses administered; 80,486 cases of suspected side effects reported. In addition, the main outcome of 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 cases of side effects reported. In addition, the main findings of the latest safety assessment Venous thromboembolism (VTE, blood clotting in the veins) and immune thrombocytopenia (ITP, an autoimmune disease with low blood platelet count) will be added to the product information as side effects of COVID-19. Janssen vaccine, with warnings and advice. And transverse myelitis (inflammation in parts of the spinal cord) has been recommended by the PRAC to be added to the product information as a side effect of the COVID-19 Janssen vaccine.

The safety of COVID-19 vaccines is continuously monitored and evaluated. Suspected side effects reported, that is, medical events that were seen after vaccination but not necessarily related or caused by the vaccine.

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

Based in the Netherlands, the EMA is monitoring the safety of COVID-19 vaccines authorized in the EU very carefully. This helps detect any rare side effects that might occur after several million people are vaccinated.

EMA is a decentralized EU agency responsible for the scientific evaluation, supervision and control of the safety of medicines in the EU. An independent board of directors governs it.


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