The first German lawsuit over alleged side effects of Pfizer-BioNTech’s experimental COVID vaccine will go to court on Monday. The case will test whether German law allows damages if vaccine makers can be proven to have caused harm disproportionate to the benefits of their products. It is the first of potentially hundreds of cases that could emerge in Germany.
The woman, exercising her right under German privacy laws 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 news agency Anadolu. She argues the COVID-19 vaccine has left her with upper-body pain, swollen extremities, fatigue, and sleep disorder. The lawsuit is brought by the law firm Rogert & Ulbrich, which says it has filed about 250 cases for clients seeking compensation for the alleged side effects of the vaccines.
When Pfizer-BioNTech’s mRNA COVID-19 vaccine hit the market in 2021, it was met with relief and pride in Germany, where it was developed. But the enthusiasm was not universal, with some people refusing to get vaccinated and others feeling coerced into it by governments that ramped up vaccination rates. The experimental mRNA vaccines were found to be effective and safe in a wide range of patients, and the market for them has been booming. The manufacturers are making record profits, but many claimants have suffered severe side effects that they say were caused by the vaccine.
In the latest lawsuit, Moderna claims Pfizer and BioNTech copied two critical elements of its mRNA technology in developing their Comirnaty shot. Those include a “chemical modification” that ensures the vaccine can be delivered into cells without damaging them and coding for full-length spike protein in the lipid nanoparticles that deliver the mRNA and protect it from degradation, Moderna said in a statement.
Both Pfizer-BioNTech and its partner in the vaccine, US biotechnology company Genevant, have denied any infringement. They also cited assessments by EU and German health regulators, including the European Medicines Agency (EMA), that the mRNA vaccine is safe and has a favorable risk-benefit profile.
The EMA has reaffirmed that assessment and it will be up to the courts to determine if there is a link between the alleged harm and the vaccine. But if the woman’s case goes ahead, it could set a dangerous precedent for European vaccine makers. Sources have suggested some of the EU’s bulk purchase agreements with vaccine manufacturers, including BioNTech-Pfizer, contained liability waivers for legal costs and compensation, meaning that governments would need to bear the burden of any awards. Germany has a no-fault compensation program for vaccine harm, but that does not prevent individuals from seeking damages separately. It is unclear if the same will be confirmed in other countries.
