Johnson & Johnson recommended over 60
The Minister of Health, Roberto Speranza, interpreted the indications of the Cts in a stringent manner and the Director General of Prevention of the Ministry of Health, Giovanni Rezza, signed the circular regulating the administration of AstraZeneca.
The same circular also speaks of the single-dose vaccine J&J, for which it was decided to leave the indications unchanged and, that is, to reserve it preferentially, at the level of recommendation, to people over 60 years of age. The circular reads: While taking into account the similarities between the Vaxzevria vaccine (AstraZeneca) and the Janssen vaccine (Johnson & Johnson), as regards both the platforms and the type of thromboembolic events reported in the literature, the current state of knowledge ( which make one lean towards a risk associated with adenovirus), the number of just over one million doses administered in the country to date and the rarity, even in Europe, of reports of VITT (thrombosis associated with thrombocytopenia, ed) currently available, 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 risk associated with viral vector vaccines (adenovirus)
It is mentioned that there have been cases of thrombosis associated with thrombocytopenia (VITT or vaccine-induced immune thrombotic thrombocytopenia) also for the Johnson & Johnson vaccine and it is recalled that the current knowledge on this adverse event suggests a risk associated with adenovirus, that the harmless virus used by the AstraZeneca and Janssen vaccines to bring DNA into human cells that contains the instructions necessary to produce the Spike protein, which stimulates the response of our immune system. It seems that somehow some parts of the Spike protein divide in the cell nucleus, creating mutant versions. The mutant proteins they would be expelled from the cells and, left free to circulate, would trigger – in rare cases – the phenomenon of blood clots. There are no cases of VITT in the Pfizer and Moderna vaccines.
The data in Italy, Europe and the USA
The decision to provide only a recommendation therefore stems from the fact that i numbers of rare thrombosis recurring after vaccination with Johnson & Johnson are even lower than the calculated incidence as probable of 1 case in 100 thousand (as per documents of the EMA, the European Medicines Agency). Real-world data is indeed lower for the Janssen vaccine.
In Italy, who administered approximately 1,143,620 doses of Johnson & Johnson, there were no cases of VITT thrombosis after the single-dose vaccine.
In Europe, according to data collected in an article published on 10 June on the New England Journal of Medicine, the European Medicines Agency have been reported 6 possible cases of cerebral venous sinus thrombosis (with or without splanchnic vein thrombosis) among others 7 million recipients of the Janssen vaccine.
A June 8 report fromAmerican College of Cardiology (ACC) found that cerebral venous thrombosis occurred in 3.6 per million people after the AstraZeneca vaccine and in 0.9 per million people after the Johnson & Johnson vaccine. In the US, the Morbidity and Mortality Weekly Report Surveillance System as of April 30, 2021, reports 17 cases of thrombosis in atypical sites associated with thrombocytopenia with the Johnson & Johnson vaccine on 7.98 million doses of this vaccine administered in North America. The CDC recommends monitoring for 3 weeks following vaccination for abnormal side effects, such as persistent severe headaches associated with blurred vision, chest and abdomen pain, breathing difficulties, swelling of the legs and a tendency to develop wounds or bleeding especially near the injection site. Additionally, the CDC advise women between the ages of 18 and 49 to opt for an mRNA vaccine if possible.
Thrombosis with Covid is much more frequent
Thrombosis with thrombocytopenic syndrome has long been added as an important risk identified in the risk management plan for the vaccine. According to ACC data, if a patient received the Johnson & Johnson vaccine, the presumed narrow risk window between 5 and 42 days after vaccination. The vast majority of cases involved young women under the age of 60 and protocols currently exist to intervene and treat the rare disorder. For comparison, we recall that the cerebral venous thrombosis rate is estimated at 207 per million in patients hospitalized due to Covid and 2.4 per million in the general population. The risk of death and serious outcomes from Covid, including thrombosis, far exceed the risk of VITT (in the USA estimated, as written above, at 3.6 per million people after AstraZeneca vaccine and in 0.9 per million people after Johnson & Johnson vaccine).
June 15, 2021 (change June 15, 2021 | 09:39)
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