At the beginning of October, the Chief Pharmaceutical Inspector and the Chief Sanitary Inspector announced the suspension of the trade of hepatitis B vaccine, manufactured under the trade name Euvax B, at the request of the President of the Office for Registration of Medicinal Products, Medical Devices and Biocides (“ORMP”). The suspension applies only to one product batch, UFA 22507, and is in force until the end of the explanatory proceedings.

Preventive action versus actual risk

The suspension was justified by the death of a young patient who had received a dose of the vaccine from this batch a few hours before he died. The authorities emphasize that there is currently no basis for assuming any cause-and-effect relationship between the patient’s receipt of the vaccine and his death. It will be possible to classify the incident as an adverse event following immunization (AEFI) only if such a relationship is established.

Considering the recent skepticism towards vaccinations in society, including the attitude towards these included in the calendar of mandatory vaccinations, it should be emphasized that the suspension of trade of a product does not mean that it is dangerous or that there are justified suspicions of such kind. The mere temporal coincidence of the occurrence of a notified event does not yet prove its connection with the administration of a drug or vaccine.

How do EU safety procedures protect patients?

The immediate and automatic suspension of trade of a specific product batch proves that the procedures adopted at the EU level to guarantee the safety of trade of medical products, i.e., the so-called pharmacovigilance, have been adequately implemented. The system includes, among other things, the analysis of events occurring within four weeks of administering a protective vaccine. Such preventive decisions trigger a control mechanism that starts the procedure immediately after receiving appropriate information to explain the potential causes of the reported event and the possible connection with the product administered. No other report has been received concerning any of the remaining 86,852 doses of this batch of vaccine administered yet.

Nevertheless, the reported incident is sufficient to implement procedures that guarantee the safety of this medical product’s trade. According to the current announcements, it has been determined that the deceased patient suffered from chronic obstructive pulmonary disease and had experienced cardiorespiratory failure. Therefore, a crucial element of the proceedings before the ORMP will be the determination of whether the death was caused by the patient’s health condition existing before the administration of the vaccine and, if so, whether the administered product affected the activation of worsening of the medical problems he had. The procedure results shall determine whether the batch will be released for circulation or whether it will become necessary to take a closer look at the product’s safety or possibly the accuracy of its information forms.

Our law firm’s lawyers have extensive experience advising medical product manufacturers in proceedings concerning liability for dangerous products and their representation, among other things, in disputes with patients.