HAMBURG, June 11 - BioNTech
The plaintiff claims she suffered upper-body pain, swollen extremities, fatigue and sleeping disorder due to the vaccine.Tobias Ulbrich, a lawyer at Rogert & Ulbrich, told Reuters he aimed to challenge in court the assessment made by European Union regulators and German vaccine assessment bodies that the BioNTech shot has a positive risk-benefit profile.
"The positive benefit-risk profile of Comirnaty remains positive and the safety profile has been well characterised," the biotech firm said, referring to the vaccine's brand name. In a media briefing last week, the EMA reaffirmed the benefit of all COVID shots it approved, including BioNTech's, saying in the first year of the pandemic alone, vaccines were estimated to have helped save almost 20 million lives globally.
Almost 768 million vaccine doses have been administered in the European Economic Area , which includes the 27 EU member states plus Iceland, Liechtenstein and Norway.The EMA also monitors adverse events or illness after vaccination, and checks for frequencies that surpass normal rates in the non-vaccinated population.It is not clear who would pay the legal costs or compensation if the plaintiff wins the case.