Covid-19, Ema green light for the Johnson & Johnson vaccine: "Rare events, more benefits than risks"
Ministry of Health: "J&J safe, preferential use for over 60"
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April 21, 2021 AstraZeneca's "same conditions of use as VAXZEVRIA vaccine" are recommended for JANSSEN vaccine. Therefore, the JANSSEN vaccine, "which is approved for use from 18 years of age, should preferentially be given to people over the age of 60". This is what is read in the circular of the ministry of health 'Update of vaccines available against SARS-CoV-2 / COVID-19', sent to organizations and regions and signed by the director general of prevention of the ministry Gianni Rezza.
Also attached to the circular of the ministry is the note of the Technical Scientific Commission (Cts) of the Italian Medicines Agency, which met on 20 April after the pronouncement of the European Medicines Agency EMA on the J&J vaccine. A "combination of thrombosis and thrombocytopenia, in some cases accompanied by bleeding - notes the CTS - has been observed very rarely following vaccination with the COVID-19 Janssen vaccine. A causal relationship with the vaccine is considered plausible. Based on the data. currently available, the association with the above thrombotic events was found in subjects under the age of 60 and predominantly in women. " The Ema, it is emphasized in the note,updated the vaccine safety information contained in the Summary of Product Characteristics and Package Leaflet to account for thromboembolism events in unusual locations (including rare cases of sinus venous thrombosis, splanchnic and arterial thrombosis) associated with thrombocytopenia .
An Important Information Note has also been prepared for healthcare professionals. "On the basis of the current incidence estimates that indicate the extreme rarity of the events described above - the CTS opinion reads - the benefit / risk balance of the J anssen vaccine is confirmed overall positive, as the vaccine is certainly effective in reducing the risk of serious illness, hospitalization and death related to COVID-19 ". Furthermore, "taking into account the similarities between the two vaccines (Janssen and Vaxzevria), both as regards the platforms used (adenoviral vector in both cases) and the type of events (in particular with regard to the clinical picture and age of onset),it is believed that at the moment for the Janssen vaccine the same conditions of use of the Vaxzevria vaccine must be provided ". Aifa in collaboration with the EMA, it is noted," will continue the careful evaluation of any safety signal also in order to make any further recommendations ".