by Ludwig Burger and Patricia Weiss
HAMBURG (Reuters) – BioNTech will appear in court on Monday to defend against a lawsuit brought by a German woman seeking damages for alleged side effects of the COVID-19 vaccine developed by the group.
This lawsuit is the first in a series of hundreds of potential lawsuits in the country.
The woman, who is exercising her right to confidentiality, is suing the German vaccine manufacturer and is seeking at least 150,000 euros in damages for bodily injury as well as compensation for unspecified material damage, according to the Hamburg regional court which is hearing the case and the law firm Rogert & Ulbrich, which represents it.
The complainant claims to have suffered from upper body pain, swelling of extremities, fatigue and trouble sleeping as a result of the vaccine.
BioNTech, which holds marketing authorization in Germany for the vaccine developed with Pfizer, concluded after careful review that the case was unfounded.
“The benefit-risk profile of Comirnaty (the brand name of the vaccine, editor’s note) remains positive and the safety profile has been well characterised,” the biotech company said, adding that around 1.5 billion people had received the vaccine worldwide, including more than 64 million in Germany.
The European Medicines Agency (EMA) considers BioNTech’s Comirnaty, the most widely used COVID-19 vaccine in Western countries, to be safe even though it poses a very low risk of myocarditis and pericarditis, two types heart inflammation, mainly in young men.
The EMA assures that the monitoring of the safety of the vaccines against COVID-19 has not been compromised during their accelerated evaluation, after a phase of development whose speed has been unprecedented.
By May, the authority had recorded nearly 1.7 million spontaneous reports of suspected side effects, or about 0.2 per 100 doses administered.
Nearly 768 million doses of vaccine have been administered in the European Economic Area (EEA), which includes the 27 member states of the European Union (EU) plus Iceland, Liechtenstein and Norway.
(Reporting by Ludwig Burger and Patricia Weiss; additional reporting by Emilio Parodi in Milan and Natalie Grover and Sam Tobin in London, Dina Kartit, editing by Blandine Hénault)
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