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European Medicines Agency expected to approve Johnson and Johnson vaccine this week

Today’s press conference on the current situation with regard to COVID-19 was held by Mateja Logar, head of the advisory group at the Ministry of Health, and professor at the Faculty of Pharmacy of the University of Ljubljana Borut Štrukelj.

A total of 1,681 PCR tests were performed on Sunday, with 210 new cases confirmed, for a positivity rate of 12.5%. A total of 7,256 rapid antigen tests were also performed. A total of 2,785 PCR tests and 6,752 rapid tests were performed on Saturday. 382 new infections were confirmed via PCR testing. There are 527 Covid patients in hospital today, which is 17 more than on Sunday and 29 more than on Saturday, when the number of patients in hospital fell below 500 for the first time since 24 October. There are 91 patients in intensive care, two more than on Saturday. Six patients died yesterday, all in hospital. The seven-day rolling average of confirmed cases stands at 762 today, down from 766 yesterday. There are currently 10,737 active cases in the country. The 14-day incidence rate at the national level stands at 510. For comparison, this figure in Slovenia’s worst region, the Coastal-Karst region, stands at 836 cases.

The advisory group will not propose any major easing of preventive measures to the ministry and the Government this week, said Logar. The advisory group decided in favour of the proposal that children from the sixth school year onward should continuously wear masks, as this measure significantly reduces the spread of the virus among individuals in enclosed spaces. A case of the Brazilian variant of the virus was recorded in the Maribor area, which the person likely brought into the country from abroad. Two of the individual’s family members are also infected. There are no doses in Slovenia from the batch of AstraZeneca vaccine used to vaccinate the nurse in Austria. The cause of death, coagulation, is not included among the side effects listed by the manufacturer when applying to the European Medicines Agency (EMA). In Slovenia, five deaths have been recorded as potential side effects of the vaccine; in two cases it was established that the vaccine was not the cause, and three procedures are still underway.

According to Štrukelj, a positive opinion is expected from the EMA regarding the American vaccine from Johnson&Johnson, or its European manufacturer Janssen, on Thursday, 11 March. The first deliveries of the vaccine could be distributed to individual countries within as little as one month after its approval. It is a viral vector vaccine, similar to the AstraZeneca vaccine. The clinical trials included 44,000 people, with 72% effectiveness achieved in the USA, 66% in South America and 57% in South Africa. The degree of effectiveness achieved is also a result of the influence of the individual variants in the areas where the vaccine was tested. The EMA is currently evaluating two other vaccines, one from the German manufacturer CureVac, and since Thursday, 4 March also a vaccine from the Russian Gamaleya research institute. The Novavax vaccine is also currently being evaluated. More than 80 million people have been vaccinated with the AstraZeneca vaccine to date, but very few serious side effects have been recorded. It is unlikely that the problem lies in the batch of vaccine in question, as the manufacturers have established numerous protocols through which they assure quality in the manufacture of vaccines.