By Isabelle Wilson-
German biotechnology company BioNTech is facing hundreds of lawsuits seeking compensation of up to €1M over the alleged long-term side effects of its COVID-19 vaccine, the Financial Times reported.
The lawsuits relate to Comirnaty, the blockbuster COVID-19 vaccine developed by BioNTech (BNTX) and Pfizer (PFE).
The first hearing scheduled for Monday involves a German medical worker who is seeking €150K (~$161.7K) in damages for symptoms including heart arrhythmia and brain fog that she claims were caused after getting vaccinated.
In 2022, Comirnaty accounted for 58% of total COVID vaccine sales. Comirnaty generated $3.1B worldwide revenue during Q1, down ~77% Y/Y as contracted deliveries and demand in international markets fell.
BioNTech, a leading biotechnology company, has played a pivotal role in the development and distribution of COVID-19 vaccines.
Lawsuits against BioNTech could lead to a decline in public trust in the company and its vaccines. Maintaining public confidence is crucial in combatting the COVID-19 pandemic and achieving widespread vaccination.
The potential for the law suits and its eventual outcome to set legal precedents in the field of vaccine liability remain high, and observers believe court decisions or settlements could influence future lawsuits against other vaccine manufacturers and developers.
”Precedents that hold companies accountable for adverse events, even if they occur rarely, may impact the broader pharmaceutical industry, one attorney told the Eye Of Media.Com on the condition of anonymity Striking a balance between holding companies accountable and maintaining a supportive environment for vaccine research and development is crucial to ensure the availability of safe and effective vaccines.
“Comirnaty’s benefit-risk assessment remains positive and the safety profile is well-characterized,” a BioNTech (BNTX) spokesperson told Seeking Alpha, adding that more than 1.5B people worldwide and over 64M people in Germany received the vaccine.
“The cases assessed by BioNTech (BNTX) so far concern events that are either known adverse drug reactions or health impairments for which no vaccine-associated connection has been established. We assessed the health impairments described by the plaintiff and concluded that the lawsuit is without merit,” they added.
However, the hearing was postponed after the plaintiff’s lawyer requested that the judge assigned be recused for bias and the case be heard by different judges, Reuters reported.
The trial at a Hamburg regional court is the first to deal with such allegations regarding a COVID vaccine in Germany. Several hundred damages lawsuits have been filed or are in preparation nationwide, according to figures from lawyers’ offices.
BioNTech says more than 64 million people in Germany and some 1.5 billion across the world received its Comirnaty vaccine, which it developed along with US pharmaceutical giant Pfizer. It has been the most commonly used jab in the Western world during the coronavirus pandemic.
German Law
Under German pharmaceutical law, makers of drugs or vaccines are liable for damages only if it is scientifically shown that their products cause harm that is disproportionate to their benefits or if the label information is wrong.
The court has said no decision in the case is likely on Monday.
The woman, who is not being publicly named under German privacy laws, alleges that the vaccine caused her to suffer upper-body pain, swollen extremities, fatigue and sleeping disorder.
She is suing BioNTech for at least €150,000 ($161,500) in damages for bodily harm as well as compensation for unspecified material damage, according to the court.
BioNTech said it has given the case careful consideration and concluded that it was without merit.
“The positive benefit-risk profile of Comirnaty remains positive and the safety profile has been well-characterized,” it said.
The EMA reaffirmed last week the benefit of all COVID shots it approved, including Comirnaty. It said vaccines were estimated to have helped save almost 20 million lives across the world in the first year of the coronavirus pandemic alone.
It conceded that there was a very small risk, mostly to young males, of two types of heart inflammation — myocarditis and pericarditis — following vaccination with the Comirnaty shot.
The EMA monitors adverse events or illnesses after vaccination, also watching whether they are more frequent in the vaccinated than the non-vaccinated population.
The EMA says it registered almost 1.7 million spontaneous reports of suspected side effects by May, which amounts to about 0.2 for every 100 administered doses. Many vaccinations against illnesses produce adverse side effects, but these are normally temporary and limited to headache, fever, fatigue, or muscle pain.ffetcs