A lawsuit has been filed against BioNTech by a German woman who alleges that she experienced side effects from the COVID-19 vaccine. This case marks the first of what could potentially be numerous legal battles in Germany related to vaccine side effects.
The plaintiff, invoking her right to privacy under German law, has chosen to remain anonymous. She is seeking damages amounting to a minimum of €150,000 ($161,500) for bodily harm, as well as compensation for unspecified material damages. The case is being heard in the regional court in Hamburg, with the plaintiff being represented by the law firm Rogert & Ulbrich.
According to the plaintiff, she suffered from upper-body pain, swollen extremities, fatigue, and sleeping disorders as a result of receiving the vaccine.
The initial hearing for this case is scheduled for Monday.
Tobias Ulbrich, a lawyer from Rogert & Ulbrich, has stated that he intends to challenge the assessment made by European Union regulators and German vaccine assessment bodies, which concluded that the BioNTech vaccine has a positive risk-benefit profile.
Under German pharmaceutical law, drug or vaccine manufacturers are liable to pay damages for side effects only if medical science establishes that their products cause disproportionate harm relative to their benefits, or if the label information is incorrect.
BioNTech, the company authorized to market the vaccine in Germany, has stated that it believes the case to be without merit, after careful consideration. The biotech firm asserts that the Comirnaty vaccine continues to have a positive benefit-risk profile, and its safety profile has been extensively characterized. Notably, over 1.5 billion people worldwide, including more than 64 million in Germany, have received the vaccine.
The European Medicines Agency (EMA) has confirmed the safety of BioNTech’s Comirnaty, which is the most widely used COVID-19 vaccine in the Western world. During a recent media briefing, the EMA reiterated the benefits of all approved COVID vaccines, including BioNTech’s, stating that vaccines have estimated to have saved nearly 20 million lives globally in the first year of the pandemic alone.
The EMA has acknowledged a very small risk of myocarditis and pericarditis, two types of heart inflammation, following vaccination with Comirnaty, predominantly among young males.
Unforeseen side effects following regulatory approval of a drug are rare. The accelerated development of COVID vaccines during the pandemic may have resulted in potentially uncommon side effects not being readily detected compared to traditional, lengthier trials.
The EMA affirms that safety monitoring was not compromised during the expedited assessment process. By May, the EMA had received close to 1.7 million spontaneous reports of suspected side effects, which translates to approximately 0.2 reports per 100 administered doses.
Within the European Economic Area (EEA), which includes the 27 EU member states, as well as Iceland, Liechtenstein, and Norway, nearly 768 million vaccine doses have been administered. The most common temporary side effects reported include headache, fever, fatigue, and muscle pain.
The EMA also monitors adverse events and illnesses following vaccination, comparing frequencies against normal rates in the non-vaccinated population.
Regarding liability, it is unclear who would be responsible for covering the legal costs or compensation if the plaintiff wins the case. Sources suggest that some of the European Union’s bulk purchase agreements with vaccine manufacturers, including BioNTech-Pfizer, contain waivers for either full or partial liability regarding legal costs and potential compensation. This situation may result in EU governments bearing some of the associated costs.
Germany, like other countries, has a public sector financial support scheme known as a no-fault compensation program for individuals who suffer permanent harm from vaccines