BioNTech faces first German lawsuit over alleged COVID vaccine side effects

Berlin [Germany], June 12: BioNTech (22UAy.DE) will go to court to defend itself against a lawsuit from a German woman who is seeking damages for alleged side effects of its COVID-19 vaccine, the first of potentially hundreds of cases in the country.
The woman, exercising her right under German privacy law for her name not to be made public, is suing the German vaccine maker for at least 150,000 euro ($161,500) in damages for bodily harm as well as compensation for unspecified material damage, according to the regional court in Hamburg which is hearing the case and law firm Rogert&Ulbrich, which is representing her.
The plaintiff claims she suffered upper-body pain, swollen extremities, fatigue and sleeping disorder due to the vaccine.
The first hearing is on Monday.
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.
German pharmaceutical law states that makers of drugs or vaccines are only liable to pay damages for side-effects if "medical science" shows that their products cause disproportionate harm relative to their benefits or if the label information is wrong.
BioNTech, which holds the marketing authorisation in Germany for the shot it developed with Pfizer , said it concluded after careful consideration that the case was without merit.
"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.
It noted about 1.5 billion people had received the shot across the world, including more than 64 million in Germany.
The European Medicines Agency (EMA) says that BioNTech'sComirnaty, the most commonly used in the Western world, is safe to use.
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.
Source: Fijian Broadcasting Corporation