BioNTech faces first German lawsuit over COVID vaccine side effects

The unnamed woman is suing the German vaccine manufacturer, seeking at least 150,000 euros in compensation for bodily harm as well as unspecified material damages, according to the regional court in Hamburg and the law firm Rogert & Ulbrich, which represents the plaintiff.

The plaintiff said she suffered from pain in half her body, swelling in her extremities, fatigue and sleep disturbances as a result of the vaccine. The first hearing is scheduled for today.

German pharmaceutical law stipulates that drug or vaccine manufacturers are only liable for damages for side effects if " medical science" shows that their products cause disproportionate harm compared to their benefits or if the information on the label is false.

BioNTech, which has marketing authorization in Germany for the vaccine, said it had concluded after careful consideration that the case was unfounded. The company noted that around 1.5 billion people have been vaccinated worldwide , including more than 64 million in Germany.

The European Medicines Agency (EMA) says BioNTech Comirnaty, the COVID-19 vaccine most widely used in the West, is safe to use.

In a media briefing last week, the EMA reaffirmed the benefits of all the COVID vaccines it has approved, including BioNTech's, saying that in the first year of the pandemic alone, vaccines had helped save nearly 20 million lives globally.

Scientists say there is a very low risk of myocarditis and pericarditis after vaccination with the BioNTech Comirnaty vaccine.

Nearly 768 million doses of BioNTech's COVID vaccine have been administered in the European Economic Area (EEA), which includes 27 EU member states plus Iceland, Liechtenstein and Norway.

Of these, the EMA recorded nearly 1.7 million reports of suspected side effects in May, equivalent to about 0.2%. The most common temporary side effects were headache, fever, fatigue and muscle pain.

Like many countries, Germany also has a financial support program for people who suffer permanent harm from vaccines, called the no-fault compensation program, but participation in the program does not prevent them from suing the manufacturing companies.

Law firm Rogert & Ulbrich said it has filed about 250 cases of clients seeking damages for COVID-19 vaccine side effects. Another law firm, Caesar-Preller, said it is representing 100 cases, with the majority of the cases in Germany.

A handful of similar cases have been filed in Italy. The US has granted manufacturers immunity from liability for COVID vaccines.

Trung Kien (according to Reuters)