Europe Confirms Over 900,000 COVID-19 Vaccine Side Effects

The European Medicine Agency (EMA) today confirmed latest information on the safety of four authorized COVID-19 vaccines is in the monthly, real-world safety update.

The EMA's Pharmacovigilance Risk Assessment Committee (PRAC) safety monitoring plan for COVID-19 vaccines requires EMA to monitor suspected side effects reported by individuals and healthcare professionals in the EU.

The PRAC reported that on January 20, 2022, more than 735 million vaccines had been given to people in the European Union (EU) and European Economic Area (EEA) as of early January 2022.

And there have been over 900,000 side effects reported during the COVID-19 pandemic.

The EMA reported the following data today:

• Comirnaty - 545,000,000 doses given to people in the EU/EEA, with 522,530 side effects reported (.0009),
• SpikeVax - 103,000,000 doses given to people in the EU/EEA, with 124,410 side effects reported (.001),
• Vaxzevria - 69,000,000 doses given to people in the EU/EEA, with 231,363 side effects reported (.003)
• Janssen (J&J) - 18,700,000 doses given to people in the EU/EEA, with 35,027 side effects reported (.0018).

The EMA says suspected side effects are medical events observed after COVID-19 vaccination but are not necessarily related to or caused by the vaccine.

An EU database called EudraVigilance holds these vaccine side effects reports. In addition, the European suspected adverse drug reactions database provides public access to these data in several ways while taking account of EU data protection law.

As of January 20, 2022, the EMA has authorized five COVID-19 vaccines, including Maryland-based Novavax's Nuvaxovid.

Furthermore, the EMA is reviewing Sputnik V, Sinovac, Vidprevtyn, and Valneva's VLA2001 vaccine candidate.

The mission of the EMA is to foster scientific excellence in the evaluation and supervision of medicines for the benefit of public and animal health in the EU.