AstraZeneca should not be given to people who have less than 60 years old, while you can continue to use Johnson & Johnson.
This is foreseen by the circular signed by the Director of Prevention of the Ministry of Health Giovanni Rezza, the text of which is available in full format below.
And it does so on the basis of the indications of the Scientific Technical Committee (also included in the infographic below). The government measure will change the plans of the vaccination campaign: at least 900,000 under-60s have had the first dose of AstraZeneca, and will now have the second dose of another vaccine.
–
The words about AstraZeneca
CTS experts report that AstraZeneca’s vaccine is currently approved by both Ema (the European Medicines Agency) and Aifa (the Italian Medicines Agency) for individuals over 18 years of age. , and that already at the time of the meeting of the Committee that preparation preferentially recommended for subjects aged 60 or over. In light of an epidemiologically improved situation, and of some adverse winds, chronologically and probably also etiologically (i.e. causally) linked to the administration of the AstraZeneca vaccine, the experts explain that a re-evaluation of the benefit-risk ratio for the age groups at risk of severe forms of Covid. And therefore, the experts suggest to strengthen the recommendation for the use of the first dose of the Vaxzevria vaccine in subjects over 60 years of age, in which the benefit deriving from vaccination outweighs the potential risks associated with the development of phenomena. [di trombosi rare] associated with vaccination. In light of these indications – therefore prescribes the Ministry of Health – the Vaxzevria vaccine is administered only to people aged 60 or over.
–
What about the second dose?
Experts also address the topic of the second dose for those who have had the first of AstraZeneca, and are in an age range for which this would not happen, from today (ie for those under 60). What to do? The CTS reports that all the registration studies for the various vaccines were conducted using two doses of the same vaccine, there are no studies on the so-called heterologous vaccination that include a large number of subjects, nor are there any randomized studies on this, but – on the basis of the available evidence – vaccination with a second dose different from the first does not appear to be inadvisable either on the safety front or on that of immunogenicity. For this reason – and despite the fact that thromboembolic phenomena are less frequently observed after administration of the second dose (according to estimates from the United Kingdom they are equal to 1.3 cases per million, a value which corresponds to less than 1/10 of the rare phenomena observed after first dose) – the CTS recommendation to continue administration with the Vaxzevria vaccine, in the second dose, only for subjects over sixty years of age, using those with mRNA in subjects less than 60 years of age, whose administration should take place 8 to 12 weeks after the first dose of Vaxzevria was given.
–
The decision on Johnson & Johnson
While taking into account the similarities between the Vaxzevria vaccine and the Janssen vaccine, as regards both the platforms and the type of thromboembolic events reported in the literature, the current state of knowledge (which suggests a risk associated with adenovirus), the a number of just over a million doses currently administered in the country and the rarity, even in Europe, of the reports of VITT available today, they do not allow to draw conclusive evaluations with respect to the benefit / risk ratio of the Janssen vaccine, characterized by the advantage of single administration, a peculiarity that can be of particular benefit in certain categories of the population. The Janssen vaccine comes recommended, also in light of what is defined by the AIFA CTS, for subjects over 60 years of age. If specific situations arise in which the advantageous conditions of the single administration are evident and in the absence of other options, the Janssen vaccine should preferably be used, subject to the opinion of the territorially competent Ethics Committee. Any evidence, in the national and international context, of thromboembolic phenomena after the Janssen vaccine must be subject to careful and constant monitoring through the pharmacosurveillance and vaccine-surveillance procedures, in such a way as to offer, in the short future, the possibility of formulating more opinion on this vaccine upon the acquisition of further evidence regarding the possible incidence of VITT phenomena and the evolution of the epidemiological situation.
–
–
June 12, 2021 (change June 12, 2021 | 10:37)
© REPRODUCTION RESERVED
–
