The European Medicines Agency (EMA) is still monitoring the very rare blood clots with low levels of platelets, which have occurred after a vaccination with Vaxzevria (previously COVID-19 Vaccine AstraZeneca). After a meeting of the EU health ministers, the EU Commissioner of Health and Food Safety has also requested the EMA office to put the data on these rare events in the context of date from vaccination and disease epidemiology (including infection rates, hospitalisations, morbidity, and mortality) in order to to evaluate them accordingly (Article 5(3) of Regulation 726/2004).
The review in compliance with the Article 5(3) procedure by the Committee for Medicinal Products for Human Use (CHMP) at the EMA permits putting the risks related to Vaxzevria in the context of the benefit for public health. The CHMP will also check whether the recommendation to vaccinate persons who received Vaxzevria as the first vaccination should be vaccinated again with Vaxzevria, as contained in the SPC, should be updated. In Germany, the Standing Vaccination Commission (Ständige Impfkommission, STIKO) currently recommends that the second vaccination for those persons under 60 years of age who have received their first COVID-19 vaccination with Vaxzevria should receive their second vaccination with an mRNA vaccine (heterologous vaccination regimen).
So far, in the on-going procedure, the Pharmacovigilance Risk Assessment Committee (PRAC) and the CHMP at the EMA have concluded that the overall benefit of Vaxzevria continues to outweigh the risks for the vaccinated persons. The review by the CHMP is intended to support the on-going national vaccination campaigns in their decision on the optimum use of the vaccine. The decision to initiate an Article 5(3) procedure was made by the European Commission.
As with all vaccines, the Paul-Ehrlich-Institut and the EMA will continue to monitor the efficacy and safety of Vaxzevria and inform the public on new findings in a timely manner.
Updated: 15.04.2021
