Vaccine: BioNTech’s first trial on alleged side effects begins

In the first of hundreds of trials it may encounter in Germany, BioNTech will be called on Monday to respond to a woman’s claim that she suffered severe side effects from an mRNA vaccine against Covid-19.

The plaintiff, whose details were not disclosed under privacy laws, claims the German company’s vaccine caused her torso pain, swelling in her extremities, fatigue and sleep disturbances.

The woman is demanding compensation of at least 150,000 euros for the alleged damage to her health, in addition to an unspecified amount as compensation for material damage.

Her lawyer is Tobias Ulbrich of Rugert & Olbrich, who told Reuters he will challenge the assessment by European and German regulators that the BioNTech vaccine has positive risk-benefit characteristics.

German law states that manufacturers of medicines or vaccines must pay compensation for side effects only if “medical science” shows that their products cause harm disproportionate to benefit, or if the information in the product leaflet is incorrect.

It’s hard to dispute the vaccine’s positive picture, however, given that the European Medicines Agency reiterated last week that vaccines are safe and noted that in the pandemic’s first year alone, vaccines saved nearly 20 million lives worldwide.

However, the EMA acknowledged that there was a very small risk of myocarditis and pericarditis from the Pfizer/BioNTch vaccine, especially for young adults.

BioNTech’s answer

For its part, BioNTech announced that it had carefully reviewed the plaintiff’s claims and found them to be unfounded.

“The profile of the positive benefits and risks of the vaccine remains positive and the safety profile has been sufficiently distinguished,” the company said, noting that the vaccine was administered to about 1.5 billion people worldwide, including 64 million in Germany.

By May, the EMA had received nearly 1.7 million reports of possible side effects, a number that corresponds to about 0.2 reports per 100 doses of the vaccine.

But many of these reports are likely to be serendipitous after vaccination, which is statistically expected given the large number of vaccinations.

To assess whether symptoms are indeed caused by the vaccine, the EMA checks whether their frequency is greater among the vaccinated than in the unvaccinated population.

Who pays?

It remains unclear who will pay the damages and legal costs if BioNtech is found guilty, Reuters comments.

Contracts signed by the EU largely exempt drug companies from legal liability, meaning that member states will bear part of the costs.

Germany and many other countries have also set up special funds to compensate citizens who suffer permanent vaccine damage, but compensation from the fund does not automatically preclude the possibility of a separate lawsuit.

The situation is even more pronounced in the United States, where pharmaceutical companies have been completely absolved of liability.

In Germany, most of the plaintiffs are represented by two law firms: Rogert & Ulbrich, which said it has about 250 clients seeking damages, and Caesar-Preller, which represents 100 other cases.

A few similar lawsuits have been filed in Italy.