BioNTech, a German pharmaceutical company, is set to appear in court on Monday to defend itself against a lawsuit brought by an anonymous woman.
The woman, protected by German privacy laws, is seeking damages from the vaccine manufacturer due to alleged side effects she experienced after receiving the BioNTech COVID-19 vaccine.
This case is likely to be the first of many in Germany.
Represented by the law firm Rogert & Ulbrich, the plaintiff is claiming a minimum of €150,000 ($161,500) in compensation for physical harm and unspecified material damage.
She asserts that she suffered various symptoms such as upper-body pain, swollen extremities, fatigue, and sleeping disorders as a result of the vaccine.
Tobias Ulbrich, a lawyer from Rogert & Ulbrich, plans to challenge the assessments made by European Union regulators and German vaccine assessment bodies, which deemed the BioNTech vaccine to have a positive risk-benefit profile.
German pharmaceutical law stipulates that pharmaceutical companies are only liable for damages caused by side effects if medical evidence demonstrates that their products cause disproportionate harm relative to their benefits or if the label information is incorrect.
BioNTech, authorized to market the vaccine in Germany through its partnership with Pfizer, has responded by stating that the case lacks merit.
The company insists that the Comirnaty vaccine maintains a positive benefit-risk profile, with a well-characterized safety profile.
They highlight that over 1.5 billion individuals worldwide, including more than 64 million in Germany, have already received the vaccine.
The European Medicines Agency (EMA) supports the safety of BioNTech’s Comirnaty, which is widely used in the Western world. In a recent media briefing, the EMA reaffirmed the benefits of all approved COVID-19 vaccines, including BioNTech’s, emphasizing that these vaccines have potentially saved nearly 20 million lives globally during the first year of the pandemic.
Although there is a minimal risk of heart inflammation, particularly among young males, the EMA asserts that the benefits of vaccination outweigh the potential side effects.
It is worth noting that unexpected side effects following regulatory approval of a drug are uncommon.
The accelerated development of COVID-19 vaccines during the pandemic may have resulted in a less comprehensive detection of rare side effects compared to longer, traditional trials.
The EMA has diligently monitored vaccine safety and received approximately 1.7 million reports of suspected side effects by May, equivalent to 0.2 reports for every 100 administered doses. In the European Economic Area, which includes EU member states as well as Iceland, Liechtenstein, and Norway, around 768 million vaccine doses have been administered.
Common temporary side effects include headache, fever, fatigue, and muscle pain.
It remains uncertain who would bear the legal costs or compensation if the plaintiff succeeds in her case.
Sources suggest that certain bulk purchase agreements between the EU and vaccine manufacturers, including BioNTech-Pfizer, contain waivers of liability for legal costs and potential compensation, potentially shifting some of the financial burden to EU governments.
Germany, like many other countries, has a no-fault compensation program for individuals who suffer permanent harm from vaccines, which provides financial support.
However, participating in this program does not prevent someone from seeking additional damages separately. In the United States, manufacturers of COVID-19 vaccines that receive regulatory approval are granted immunity from liability.
Rogert & Ulbrich and Caesar-Preller, two law firms, are representing numerous clients who have filed cases seeking compensation for alleged vaccine side effects.
Rogert & Ulbrich has filed approximately 250 cases, while Caesar-Preller is representing 100 cases. Together, these firms cover the majority of such cases in Germany. A small number of similar cases have also been reported in Italy.