BioNTech, the German vaccine maker behind the widely used COVID-19 vaccine, is scheduled to appear in court on Monday as it defends Germany’s first lawsuit over alleged side effects of its vaccine.
The plaintiffs, who remain anonymous under German privacy law, are seeking damages of at least 150,000 euros ($161,500) for personal injury and unspecified material damages. The woman claimed to have experienced upper body pain, swelling in her extremities, fatigue and sleep disturbances after being vaccinated. Reuters report.
In its response, BioNTech maintained that the case was unfounded, emphasizing the positive benefit-risk profile and favorable safety profile of its vaccine Comirnaty.
“Comirnaty’s positive benefit-risk profile remains positive and the safety profile is well characterized,” BioNTech said.
The lawsuit challenges the risk-benefit assessment of BioNTech’s vaccine, with plaintiffs’ attorney Tobias Ulbrich aiming to challenge the conclusions reached by EU regulators and Germany’s vaccine assessment agency.
According to German pharmaceutical law, the manufacturer is liable for damage caused by side effects if the harm is medically proven to be disproportionate to the benefit or if the label information is incorrect.
In another development, biotech company Promosome has filed a lawsuit against Moderna, Pfizer and BioNTech in California federal court alleging patent infringement related to messenger RNA (mRNA) technology used in COVID-19 vaccines. Promosome seeks a cut of royalties from vaccine sales.
Last year, Pfizer reportedly earned $37.8 billion from its COVID-19 vaccine Comirnaty, while Moderna earned $18.4 billion from its vaccine Spikevax.
The legal action adds to ongoing litigation facing Pfizer and Moderna, as Alnylam Pharmaceuticals Inc. sued them last month, claiming infringement of its intellectual property in lipid nanoparticle (LNP) technology, a drug delivery mechanism. An integral part of the mRNA COVID-19 vaccine.
The lawsuits underscore the legal challenges vaccine makers face as they address claims related to side effects and intellectual property infringement in the context of global vaccination efforts against COVID-19.
Published by Medicaldaily.com