11-6-2023 (HAMBURG) BioNTech, the German pharmaceutical company that co-developed the Covid-19 vaccine with Pfizer, is set to defend itself in court against a lawsuit from a German woman claiming damages for alleged side effects caused by the vaccine. This case is expected to be the first of potentially hundreds of similar lawsuits in the country.
The woman, whose identity remains undisclosed due to German privacy laws, is seeking at least €150,000 (S$217,000) in damages for bodily harm, as well as compensation for unspecified material damage. The regional court in Hamburg is presiding over the case, with the law firm Rogert & Ulbrich representing the plaintiff.
According to her claims, the woman experienced upper body pain, swollen extremities, fatigue, and sleeping disorders as a result of the vaccine.
Tobias Ulbrich, a lawyer at Rogert & Ulbrich, stated his intention to challenge the assessment made by European Union regulators and German vaccine-assessment bodies that the BioNTech vaccine has a favorable risk-benefit profile.
Under German pharmaceutical law, manufacturers of drugs or vaccines are liable to pay damages for side effects only if “medical science” proves that their products cause disproportionate harm compared to their benefits or if the label information is incorrect.
BioNTech, which holds the marketing authorization for the vaccine in Germany, developed in collaboration with Pfizer, has responded by stating that the case lacks merit after careful consideration.
The biotech firm emphasized that the positive benefit-risk profile of their vaccine, known as Comirnaty, remains intact, with a well-characterized safety profile. They highlighted that over 1.5 billion people worldwide, including more than 64 million in Germany, have received the vaccine.
The European Medicines Agency (EMA) has affirmed 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 reaffirmed the benefit of all approved Covid-19 vaccines, including BioNTech’s, stating that vaccines have estimatedly saved almost 20 million lives globally in the first year of the pandemic.
The EMA has acknowledged a very small risk of myocarditis and pericarditis, two types of heart inflammation, following vaccination with Comirnaty, particularly among young males.
Unforeseen side effects after regulatory approval of a drug are rare. The accelerated development of Covid-19 vaccines during the pandemic means that potential uncommon side effects may not have been detected as readily as in traditional, longer trials. The EMA has emphasized that safety monitoring was not compromised during the fast-track assessment.
As of May, the EMA had registered nearly 1.7 million spontaneous reports of suspected side effects, equivalent to about 0.2 reports per 100 administered doses. In the European Economic Area, comprising the 27 EU member states, Iceland, Liechtenstein, and Norway, nearly 768 million vaccine doses have been administered.
The most common temporary side effects reported are headache, fever, fatigue, and muscle pain. The EMA also closely monitors adverse events or illnesses following vaccination and examines frequencies that exceed normal rates in the non-vaccinated population.
It remains unclear who would bear the legal costs and compensation if the plaintiff wins the case. Some of the European Union’s bulk purchase agreements with vaccine manufacturers, including BioNTech-Pfizer, reportedly include waivers for full or partial liability for legal costs and potential compensation, potentially placing some of the financial burden on EU governments.
Germany, like many other countries, has a public-sector financial support scheme, known as a no-fault compensation program, for individuals who experience permanent harm from vaccines. However, participation in this program does not prevent individuals from seeking separate damages.
In the United States, manufacturers of Covid-19 vaccines that have received regulatory approval are granted immunity from liability.
Rogert & Ulbrich has filed approximately 250 cases on behalf of clients seeking damages for alleged side effects of Covid-19 vaccines, while another law firm, Caesar-Preller, is representing 100 cases. These firms claim to cover almost all the cases in Germany between them. A few similar cases have also been filed in Italy.
