Expert commission confirms link between Janssen vaccine and death of 20-year-old woman
Minister of Health, Janez Poklukar, the head of the regional unit of the Maribor National Institute of Public Health, Zoran Simonovič, professor Borut Štrukelj from the Faculty of Pharmacy, Ljubljana and Maja Bratuša held a press briefing on the current situation regarding Covid-19 disease.
Maja Bratuša made a brief statement introducing the latest data, which indicates that the epidemiological situation is gradually improving throughout the country. 6,287 PCR tests were performed yesterday, with 2,482 confirmed new infections. The total share of positive cases was 39.5%. An exceptionally large number of rapid antigen tests, i.e. a total of 92,718, were carried out yesterday. According to the latest data, there are slightly more than 37,000 currently active cases.
75% of people over age 50 and approx. 65% of people over 18 are fully vaccinated against Covid-19 infection. So far, 290,137 people have been vaccinated with the supplemental dose, 4,731 of which were vaccinated yesterday.
Currently, 848 patients require ordinary hospital beds, 280 require intensive care beds. A total of 1,128 Covid-19 infected persons are going through medical treatment. 115 Covid patients were released from hospitals, 16 people died.
In continuation, the head of the regional unit of the Maribor National Institute of Public Health, Zoran Simonovič, and the coordinator of commission, appointed to examine the death of a woman following her vaccination with the Janssen vaccine, presented the results of the case.
Simonovič presented the composition of the five-member commission, namely, three doctors (neurologist, infectologist and vascular specialist), a pharmacologist and Zoran Simonovič, a representative of the epidemiological profession. The commission reviewed the medical records of a 20-year-old patient who developed thrombosis with thrombocytopenia syndrome following vaccination. The documentation included a treatment procedure as of the admission to the Clinical Department of Neurology in Ljubljana and a health record obtained from the patient’s personal doctor.
The commission confirmed thrombosis with thrombocytopenia or vaccine-induced immune thrombotic thrombocytopenia. All criteria were met for the fulfilment of the diagnosis. Upon examining the medical records before the vaccination, the commission established that no conditions had been identified in the patient that could indicate problems after vaccine administration. “The commission unanimously assessed that there was a direct link between the vaccination with Janssen Johnson & Johnson and the tragic complication, i.e. the onset of the syndrome”, said Simonovič.
He added that fatal complication had occurred despite proper treatment at the Clinical Department of Neurology, and expressed condolences to the relatives and friends of the deceased and deep regret for what happened on behalf of all members of the commission.
Borut Štrukelj took the floor, expressing his sincere condolences to the parents, relatives and friends for the death of young Katja, who was vaccinated on 16 September 2021 with one dose of Janssen vaccine from Johnson & Johnson, serial number XE393. Janssen is a single-dose vaccine used in many countries in Europe, Canada and the United States. In the development of Janssen, clinical studies involved 27,000 participants, making it one of the largest clinical studies in vaccines. Janssen and AstraZeneca are both vector DNA vaccines, and as has been said many times, vaccination with Covid-19 vector vaccines may result in extremely rare thrombosis, i.e. blood clots in the body or brain, with thrombocytopenia syndrome – a condition where there are not enough platelets in certain parts of the body. In the Janssen summary of product characteristics, the frequency is estimated to be less than 1 in 10,000, however, the incidence of this rare side effect varies slightly from country to country.
In the U.S., where no other vector vaccine than Janssen is used, as AstraZeneca has not been licensed for registration in the U.S., 28 cases per 8.7 million doses of the vaccine or approx. 1 in 300,000 have been recorded so far. Most cases were in the group of women between 30 and 37 years of age. If we further narrow down this group, the rate of the adverse event is 1.2 per 100,000 in this age group. Until 30 October, 16.3 million Janssen doses have been administered in Europe. Reports have identified six deaths that have been caused in relation to the Janssen vaccine.
In continuation, the Minister of Health, Janez Poklukar, said that the Ministry of Health is familiar with the content of the commission’s report, and is to inform the vaccine advisory group of the conclusions.
Moreover, he said that he is to propose to the vaccine advisory group to stop vaccinating with Janssen in Slovenia, or to enable vaccination with Janssen only at the explicit request of an individual, who must confirm this with signature. “This means that the currently valid provisional vaccination protocol with Janssen will become permanent”, said Minister Poklukar.
The Minister of Health, Janez Poklukar, said that he regretted young Katja’s death and expressed his sincere condolences to her family and friends.