BioNTech will appear before judges on Monday to defend itself in a lawsuit filed by a woman in Germany seeking damages for alleged side effects from her COVID-19 vaccine, the first of potentially hundreds of cases this year in the country, Reuters reported.

The woman, who exercised her right under German privacy law not to have her name published, is suing the German vaccine maker and is seeking at least 150,000 euros for personal injuries, as well as damages for unspecified property damage, according to the Hamburg Regional Court. . hearing the case and the law firm Rogert & Ulbrich representing it.

The plaintiff claims that because of the vaccine, her upper body hurts, her limbs swell, fatigue and sleep disturbances occur.

The first meeting will be held on Monday. Tobias Ulbrich, a lawyer at Rogert & Ulbrich, told Reuters he intends to challenge in court the assessment by European Union regulators and German vaccine review authorities that the BioNTech vaccine has a positive risk-benefit profile.

German pharmaceutical law states that drug or vaccine manufacturers are only liable for damages for side effects if “medical science” proves that their products cause harm disproportionate to their benefits, or if the information on the label is incorrect.

What BioNTech and EMA say about vaccine side effects

BioNTech, which has permission to sell a vaccine it developed with Pfizer in Germany, said it had concluded after a thorough review that the case had no merit.

“The positive benefit-risk profile of Comirnaty remains positive and the safety profile was well presented,” the biotech firm said, referring to the vaccine’s brand name.

About 1.5 billion people worldwide have received the vaccine, including more than 64 million in Germany, it said. The European Medicines Agency (EMA) says BioNTech’s Comirnaty vaccine, which is most commonly used in the Western world, is safe to use.

At a press conference last week, the EMA confirmed the benefits of all the COVID vaccines it has approved, including BioNTech, saying that in the first year of the pandemic alone, the vaccines are estimated to have helped save nearly 20 million lives worldwide.

The EMA said there is a very small risk of myocarditis and pericarditis, two types of inflammation of the heart, after vaccination with Comirnaty, especially in young men.

Unexpected side effects are rare after a drug has received regulatory approval. The unprecedented speed with which COVID vaccines were developed during the pandemic meant that any unusual side effects may not have been detected as quickly as they might have been in longer, traditional trials.

The EMA reported that safety monitoring was not breached during the rapid assessment. By May, the EMA had recorded almost 1.7 million reports of suspected side effects, which is about 0.2 for every 100 doses administered.

Almost 768 million doses of the vaccine were administered in the European Economic Area (EEA), which includes the 27 EU member states as well as Iceland, Liechtenstein and Norway.

The most common temporary side effects are headache, fever, fatigue, and muscle aches. The EMA also monitors adverse events or conditions that occur after vaccination and checks for rates that exceed normal rates in the unvaccinated population.

Hundreds more lawsuits are being prepared

It is unclear who will pay legal costs or damages if the plaintiff wins the lawsuit. The sources said some of the EU’s joint purchasing agreements with vaccine makers, including BioNTech-Pfizer, contained full or partial disclaimers of both legal costs and potential damages, which could force EU governments to bear some of the costs.

Like many other countries, Germany also has a system of public financial support for people injured by vaccines, known as the no-fault compensation program, but participation in this program does not prevent someone from claiming compensation separately.

The United States has given manufacturers immunity from liability for regulatory-approved COVID vaccines.

Rogert & Ulbrich says it has filed about 250 lawsuits for clients seeking compensation for alleged side effects of COVID-19 vaccines. Another law firm, Caesar-Preller, says it represents 100 cases, with both firms separately saying they cover almost all cases in Germany. Several similar cases were initiated in Italy.