© Reuters. FILE PHOTO: A BioNTech company logo seen in Marburg, Germany on February 2, 2023. REUTERS/Fabian Beamer
Written by Ludwig Berger and Patricia Weiss
HAMBURG (Reuters) – BioNTech will go to court on Monday to defend itself against a lawsuit from a German woman seeking damages for alleged side effects of a COVID-19 vaccine, the first of hundreds of potential cases in the country.
The woman, who is exercising her right under German privacy law not to be named, is suing the German vaccine maker for at least 150,000 euros ($161,500) in damages plus compensation for unspecified material damages, according to the Hamburg Regional Court that Considering the case and the law firm Rogert & Ulbrich representing it.
The plaintiff claims that she suffered from upper body pain, swelling of the extremities, fatigue and disturbed sleep due to the vaccine.
The first session is on Monday.
Tobias Ulbrich, a lawyer at Rogert & Olbrich, told Reuters he aims to challenge in court the assessment made by EU regulators and German vaccine evaluation bodies that the BioNTech shot has positive risk-benefit characteristics.
German drug law states that makers of medicines or vaccines are only liable to pay compensation for side effects if “medical science” shows that their products cause disproportionate harm compared to their benefits or if label information is wrong.
BioNTech, which holds marketing authorization in Germany for the imaging developed with it Pfizer (N:), I concluded after careful consideration that the case was without merit.
“The positive risk-benefit profile for Comirnaty remains positive, and the safety profile is well characterized,” the biotech said, referring to the vaccine’s brand name.
She indicated that about 1.5 billion people have received the vaccine worldwide, including more than 64 million in Germany.
The European Medicines Agency (EMA) says BioNTech’s Comirnaty, the most widely used in the Western world, is safe to use.
In a briefing last week, the EMA reaffirmed the usefulness of all COVID shots it has approved, including BioNTech, saying in the first year of the pandemic alone, the vaccines were estimated to have helped save nearly 20 million lives globally. the world.
She said there is a very small risk of developing myocarditis and pericarditis, two types of inflammation of the heart, after vaccination with Comirnaty, especially for young males.
Unexpected side effects are rare after a drug receives regulatory approval. The unprecedented speed with which COVID vaccines have been developed during the pandemic means that potentially uncommon side effects may not have been detected as easily as they were in longer conventional trials.
EMA said safety oversight was not compromised during the fast-track evaluation.
The EMA had recorded nearly 1.7 million spontaneous reports of suspected side effects by May, which translates to about 0.2 for every 100 doses taken.
Nearly 768 million vaccine doses have been administered in the European Economic Area (EEA), which includes 27 EU member states plus Iceland, Liechtenstein and Norway.
The most common temporary side effects are headache, fever, fatigue, and muscle aches.
EMA also monitors for adverse events or disease after vaccination, checking for frequencies above normal rates in the unvaccinated population.
legal liability
It is not clear who will pay legal costs or compensation if the plaintiff wins the case.
Sources said some EU bulk purchase agreements with vaccine makers, including BioNTech-Pfizer, contained full or partial waivers of liability for both legal costs and potential damages, which could force EU governments to foot some of the costs.
Like many countries, Germany also has a system of public sector financial support for people with permanent damage from vaccines, known as the No-Fault Compensation Scheme, but participation in the scheme does not preclude anyone seeking compensation separately.
The United States has granted manufacturers immunity from liability for COVID vaccines that receive regulatory approval.
Rogert & Ulbrich says it has filed about 250 cases for clients seeking compensation for alleged side effects of its COVID-19 vaccines.
Another law firm, Caesar-Preller, says it accounts for 100 cases, with both firms separately saying they cover almost all cases in Germany between them.
A few similar cases have been filed in Italy.
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