The German biotechnology company BioNTech will go to court on Monday to defend itself against a lawsuit from a woman who alleges that its COVID vaccine caused her to suffer damaging side-effects.
The trial at a Hamburg regional court is the first to deal with such allegations regarding a COVID vaccine. Several hundred damages lawsuits have been filed or are in preparation nationwide, according to figures from lawyers' offices.
BioNTech says more than 64 million people in Germany and some 1.5 billion across the world received its Comirnaty vaccine, the most commonly used in the Western world, during the coronavirus pandemic.
The European Medicines Agency (EMA) has approved it as safe.
Under German pharmaceutical law, makers of drugs or vaccines are liable for damages only if it is scientifically shown that their products cause harm that is disproportionate to their benefits or if the label information is wrong.
The court has said no decision in the case is likely on Monday.
What is the plaintiff claiming?
The woman, who is not being publicly named under German privacy laws, alleges that the vaccine caused her to suffer upper-body pain, swollen extremities, fatigue and sleeping disorder.
She is suing BioNTech for at least €150,000 ($161,500) in damages for bodily harm as well as compensation for unspecified material damage, according to the court.
A lawyer representing her, Tobias Ulbrich, told Reuters news agency that he would challenge assessments made by EU and German health regulators that the Comirnaty jab had a positive risk-benefit profile.
What have BioNTech and the EMA said?
BioNTech said it has given the case careful consideration and concluded that it was without merit.
"The positive benefit-risk profile of Comirnaty remains positive and the safety profile has been well-characterized," it said.
The EMA reaffirmed last week the benefit of all COVID shots it approved, including Comirnaty. It said vaccines were estimated to have helped save almost 20 million lives across the world in the first year of the coronavirus pandemic alone.
It conceded that there was a very small risk, mostly to young males, of two types of heart inflammation — myocarditis and pericarditis — following vaccination with the Comirnaty shot.
The EMA says it registered almost 1.7 million spontaneous reports of suspected side-effects by May, which amounts to about 0.2 for every 100 administered doses. Many vaccinations against illnesses produce adverse side-effects, but these are normally temporary and limited to headache, fever, fatigue or muscle pain.
The EMA monitors adverse events or illnesses after vaccination, also watching whether they are more frequent in the vaccinated than the non-vaccinated population.
