Paul-Ehrlich-Institut

COVID-19 Vac­cine As­traZeneca – Safe­ty As­sess­ment Re­sult: The Vac­cine is Safe and Ef­fec­tive in the Fight against COVID-19

The safety assessment by the Pharmacovigilance Risk Assessment Committee (PRAC) at the European Medicines Agency (EMA) confirms the positive benefit-risk ratio of COVID-19 Vaccine AstraZeneca. As a risk-mitigation warning, the SmPC includes the fact that in very rare cases, specific thromboses are found in the period up to 16 days after vaccination. Based on the positive safety assessment by the EMA, Germany will resume vaccination with the COVID-19 Vaccine AstraZeneca starting 19 March 2021. Those willing to be vaccinated will be informed about the above cases during vaccination education. Medical doctors can find information on the website of the Paul-Ehrlich-Institut.

Vaccine ampoule is held in hand (Source: Stanislav Sukhin/Shutterstock.com)

On 18 March 2021, the EMA’s PRAC, in which an expert from the Paul-Ehrlich-Institut and the national competent authorities of the EU member states work together, held an extraordinary meeting to evaluate the very rare events observed by some member countries in temporal association with vaccination with the COVID-19 Vaccine AstraZeneca, in particular blood clots, bleeding, and platelet deficiency. Findings: The benefits of the vaccine in combating SARS-CoV-2 pandemic and associated COVID-19 disease continue to outweigh the risk of adverse events. It was decided to include a warning about these very rare events in the technical and use information. The vaccine is not associated with an increase in the overall risk of blood clots (thromboembolic events) in vaccinated individuals. There is no evidence of a quality defect - that is, an association of specific batches or manufacturing at specific sites of the vaccine with the observed thromboembolic events.

A very rare form of thrombosis (primarily cerebral venous thrombosis) associated with platelet deficiency (thrombocytopenia) was observed in a very small number of vaccinated individuals predominantly under the age of 55 years following vaccination with COVID-19 Vaccine AstraZeneca. All cases occurred with persistent symptoms approximately four to 16 days after vaccination with the COVID-19 Vaccine AstraZeneca. Approximately one case per 100,000 vaccinations with COVID-19 Vaccine AstraZeneca has been reported to the Paul-Ehrlich-Institut to date. This very rare coagulation disorder occurred more frequently among those vaccinated than would be expected numerically based on the rarity of this clotting disorder without vaccination. There is currently no evidence that the occurrence of these clotting disorders was caused by the vaccine.

Vaccinated individuals have already been made aware of certain persistent or worsening symptoms in the period of approximately 14 days following vaccination after the temporary suspension of AstraZeneca vaccination in Germany on Monday, 15 March 2021, in the presence of which presentation to a medical doctor would be advisable. Vaccinated individuals should seek immediate medical attention if they develop symptoms such as shortness of breath, chest pain, arm or leg swelling after vaccination. In addition, anyone who has severe or persistent headaches that last longer than four days after vaccination or who has bruising beyond the vaccination site after a few days should see a doctor immediately.

Medical doctors should be alert for signs and symptoms of thromboembolism when patients present who have recently been vaccinated with COVID-19 Vaccine AstraZeneca.

The Paul-Ehrlich-Institut agrees with the PRAC and recommends the use of AstraZeneca's COVID-19 vaccine. On this basis, the German Federal Ministry of Health (BMG) has decided to continue vaccinations with the AstraZeneca COVID-19 vaccine.

Updated: 08.04.2021