BioNTech is facing a lawsuit in Germany filed by a woman who claims she suffered bodily harm as a result of taking its COVID-19 vaccine. The case is the first of hundreds, and possibly thousands, of similar lawsuits expected to be filed in the country. The plaintiff, whose name has not been disclosed under German privacy law, is seeking €150,000 ($161,500) in damages, as well as compensation for material damage. She alleges that she experienced multiple side-effects, including pain, swelling, and fatigue, after receiving the vaccine.
The case, which BioNTech will defend in court on Monday, raises questions over the liability of vaccine makers for side-effects. German pharmaceutical law only requires compensation for side-effects if a drug or vaccine causes disproportionate harm relative to its benefits. Tobias Ulbrich, the plaintiff's lawyer, argues that EU regulators and German vaccine assessors have ignored evidence of the vaccine's potential risks, as well as possible linkages to long-term consequences.
BioNTech, which developed the vaccine with Pfizer and has authorised its use in Germany, insists that the case is without merit. The company maintains that the vaccine's “benefit-risk profile” remains positive, and it has been extensively tested and characterised for safety. Globally, almost 1.5 billion people have received the vaccine, 64 million of whom are in Germany. The vaccine is also the most commonly administered in the western world.
The European Medicines Agency (EMA) has reaffirmed the safety of BioNTech's vaccine, along with the other vaccines it has approved. The EMA says that vaccines have helped save almost 20 million lives since the pandemic began. However, the agency has reported that vaccination with BioNTech's vaccine has a very small risk of myocarditis and pericarditis, in particular among young men. Nonetheless, the EMA maintains that safety monitoring was not compromised during the fast-track assessment.
It is uncertain who would be liable for costs or compensation if the plaintiff wins her case. The bulk purchase agreements between the EU and vaccine makers may hold them fully or partially liable. Some EU governments may also bear some of the costs, based on such agreements. Germany also has a no-fault compensation programme for those who suffer permanent harm from vaccines, but participating in the programme does not prevent individuals from seeking damages independently.
Law firms such as Caesar-Preller and Rogert & Ulbrich have filed close to 350 similar cases in Germany on behalf of clients seeking damages for alleged vaccine side-effects. Italy has seen a handful of similar cases filed. Unexpected side-effects after regulatory approval are rare. However, potential uncommon side-effects of COVID vaccines may also not have been detected as easily due to the expedited development of the vaccines during the pandemic.