By Ludwig Burger and Patricia Weiss
HAMBURG (Reuters) -BioNTech will go to court on Monday 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 (N:PFE), 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's Comirnaty, 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.
It has said there is a very small risk of myocarditis and pericarditis, two types of heart inflammation, following vaccination with Comirnaty, mainly for young males.
Unexpected side-effects after a drug has regulatory approval are rare. The unprecedented speed at which COVID vaccines were developed during the pandemic meant that potential uncommon side-effects may not have been detected as readily as they might have been in traditionally longer trials.
EMA has said that safety monitoring had not been compromised during the fast-track assessment.
The EMA had registered almost 1.7 million spontaneous reports of suspected side-effects by May, which translates into about 0.2 for every 100 administered doses.
Almost 768 million vaccine doses have been administered in the European Economic Area (EEA), which includes the 27 EU member states plus Iceland, Liechtenstein and Norway.
The most common temporary side-effects are headache, fever, fatigue and muscle pain.
The EMA also monitors adverse events or illness after vaccination, and checks for frequencies that surpass normal rates in the non-vaccinated population.
LIABILITY
It is not clear who would pay the legal costs or compensation if the plaintiff wins the case.
Sources have said some of the EU's bulk purchase agreements with vaccine makers, including BioNTech-Pfizer, contained full or partial liability waivers for both legal costs and potential compensation, which could force EU governments to bear some of the costs.
Like many countries, Germany also has a public sector financial support scheme for people who suffer permanent harm from vaccines, known as a no-fault compensation programme, but participation in the programme does not block someone seeking damages separately.
The United States has granted manufacturers immunity from liability for COVID vaccines that receive regulatory approval.
Rogert & Ulbrich says it has filed about 250 cases for clients seeking damages for alleged side-effects of COVID-19 vaccines.
Another law firm, Caesar-Preller, says it is representing 100 cases, with both firms saying separately they cover almost all cases in Germany between them.
A handful of similar cases have been filed in Italy.
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