Doctor’s potential liability for prescribing or administering COVID vaccine

The CJEU, in a case known as Frajese v. Commission (Case C-586/23 P), decided on January 30, 2025, addressed issues related to the marketing authorizations of COVID-19 vaccines (specifically Spikevax by Moderna and Comirnaty by Pfizer/BioNTech). The Court confirmed that these vaccines required a medical prescription for administration, as stipulated in the annexes to the European Commission's decisions. It also clarified that the granting of a marketing authorization does not impose an obligation on doctors to prescribe or administer these vaccines. This means doctors retained professional discretion to decide whether to recommend or administer them based on their clinical judgment and the individual patient's circumstances.

The ruling emphasizes that a doctor’s potential liability arises not from the marketing authorization itself, but from the specific act of prescribing or administering the vaccine in a given case. In other words, if adverse effects occur, responsibility would depend on whether the doctor’s decision-making adhered to medical standards and ethics—such as properly assessing risks versus benefits for the patient—rather than being a blanket assignment of "sole responsibility" for all consequences of the injections.

The claim that "doctors will be solely responsible for the consequences of COVID injections because they were free to refuse" exaggerates the scope of the ruling. The CJEU did not explicitly state that doctors are "solely responsible" for all outcomes, nor did it absolve other parties (e.g., manufacturers, regulators, or policymakers) of potential liability. Instead, it reaffirmed the doctor’s role as a gatekeeper in the prescription process, preserving their freedom to refuse if they deemed it inappropriate, while tying liability to their individual actions rather than the broader vaccine authorization framework.

This nuance is critical: the ruling does not shift all responsibility onto doctors universally, nor does it suggest they bear exclusive blame for adverse effects. It simply clarifies that their professional autonomy comes with corresponding accountability for their decisions, consistent with existing medical practice norms across the EU. Misinterpretations suggesting a sweeping legal burden on doctors alone likely stem from sensationalized reporting or incomplete readings of the judgment.

For a definitive understanding, the full text of the CJEU’s decision in Case C-586/23 P would be needed, but based on reputable summaries, the Court’s focus was on procedural and regulatory clarity—not on assigning sole liability to doctors as a blanket rule.