A press conference to provide a COVID-19 update was attended by the Minister of Health, Janez Poklukar, and the head of the vaccination advisory group, Bojana Beović.
Minister of Health Janez Poklukar confirmed that a case of a suspected serious adverse event in the period following a vaccination against COVID-19 in a young woman occurred at the Ljubljana University Medical Centre (UKC). The incident had a tragic outcome, and the Minister expressed his condolences to the families and asked the entire public to show deference and respect.
As he explained, he was not familiar with the details of the case and could therefore not comment thereon. He assured that all the necessary prescribed procedures were in place to clarify all the circumstances. The National Institute of Public Health has been informed by the UKC Ljubljana of this event and the Ministry of Health has received the decision of the special vaccination advisory group at the National Institute of Public Health, which reads as follows: “In view of the notification of a serious adverse event following vaccination with Janssen, the members of the advisory group propose that vaccination with this vaccine be suspended until the situation is clarified.”
In line with the advisory group’s proposal, the Ministry of Health has called on the National Institute of Public Health to suspend vaccination with the Janssen vaccine and to inform vaccination centres and other vaccination providers of this decision.
The Minister stressed that he trusted the profession and followed its recommendations, and therefore supported the decision of the expert group that decided to temporarily withdraw this vaccine from vaccination centres.
To date, only one case has been recorded in Slovenia where a link between vaccination and death has been confirmed, Minister Poklukar said. At the same time, 2.1 million doses have been administered in Slovenia, and nearly one million people have been received two vaccine doses. These people experienced expected side effects after vaccination, thus protecting themselves against a disease that has taken the lives of 4,861 Slovenian residents, 100 in September alone, he pointed out. He added that thus far 120,000 people in Slovenia have received the Janssen vaccine, and he believes that the benefits of vaccination outweigh any risks.
The head of the vaccination advisory group, Bojana Beović, expressed her sympathy for the girl’s family and loved ones. She confirmed that, as soon as the advisory group learned that the unfortunate incident might be connected to vaccination, they decided to suspend vaccination with the Janssen vaccine until the details of the case have been established, after which they would reach a decision on the continued use of the vaccine.
Dr Beović explained that, although the vaccine was registered without any age group restrictions, there were a few rare contraindications. Countries around the world advise against vaccination in certain age groups, but practices vary. In certain countries, it is still possible to get the shot, but the vaccinated person must be familiar with the potential adverse reactions. In Slovenia, a vaccinated person receives a text which clearly lists the adverse effects, advising people to seek medical attention should they emerge, said Beović.
In the spring, the Medical Chamber of Slovenia circulated a notification among all doctors specifying how to act in such situations. Beović emphasised that such incidents were extremely rare, and it was particularly unfortunate that it happened in Slovenia. According to US statistics, where the Janssen vaccine is the only viral vector vaccine being used, complications have developed in 28 cases out of a little over eight million people vaccinated with this vaccine. Beović believes that when something like this happens to a specific person, such statistics are irrelevant, and the reaction should be based on a case-by-case examination and the decision reached according to the situation at hand.