What Janssen says (with Ema and Aifa) about thrombosis cases
The note from the Janssen house on the correlation between its Covid-19 vaccine and possible cases of thrombosis. It is not possible to identify, at least currently, whether there are specific risk factors.
Janssen as Astrazeneca.
There is a "plausible" link between the Johnson & Johnson Covid-19 vaccine and the rare cases of thrombosis. To say this is the same pharmaceutical company Janssen, in an information note agreed with the European and Italian regulatory activities, or with Ema and Aifa.
WHAT THE NOTE SAYS
“A combination of thrombosis and thrombocytopenia, in some cases accompanied by bleeding, has been observed very rarely following vaccination with Covid-19 Vaccine Janssen. A causal role of the vaccine is considered plausible ”, reads the information note signed by Janssen-Cilag International NV in agreement with the European Medicines Agency and Aifa.
THE CASES OF THROMBOSIS
In the same note, the company recalls that the cases "of venous thrombosis in unusual sites such as the cerebral venous sinus, the splanchnic vein, as well as arterial thrombosis in conjunction with thrombocytopenia, even with a fatal outcome", "occurred within the first three weeks following vaccination and mainly in women under the age of 60 ”.
NO SPECIFIC RISK FACTORS
It is not possible to identify, at least currently, whether there are specific risk factors.
“In many of the cases with concomitant thrombosis and thrombocytopenia, tests for anti-platelet factor (PF) -4 antibodies were positive or strongly positive. An extensive analysis for other potential mechanisms that could cause thrombosis and / or thrombocytopenia was performed for a minority of these cases; however, no other alterations were found that could be taken into account to explain the observed events, ”the note reads.
RECOMMENDATIONS TO HEALTHCARE PROFESSIONALS
Hence the recommendations to healthcare professionals, who must pay attention to the signs and symptoms of thromboembolism and / or thrombocytopenia.
WHAT VACCINATES SHOULD BEWARE OF
Those who have received the vaccine are required to “see a doctor immediately if they develop symptoms such as shortness of breath, chest pain, leg swelling, or persistent abdominal pain after vaccination. In addition, anyone who experiences neurological symptoms including severe or persistent headache or blurred vision after vaccination, or anyone who experiences bruising (petechiae) in a site other than that of the vaccination after a few days, should immediately consult a doctor ".
THE EMA SURVEY
On 9 April, the Prac, the safety committee of the European Medicines Agency (EMA), had launched a review to evaluate thromboembolic events and establish a possible connection.
THE VACCINE
The vaccine consists of an adenovirus, which has been modified to contain the gene for the production of the spike protein characteristic of Sars-CoV-2. Administration is carried out as a single dose.
EFFECTIVENESS
During the phase 3 trial showed the vaccine, says Ema to nnunciando the use approval , "a 67% reduction in the number of cases of symptomatic Covid-19 after two weeks, in people who have received the vaccine COvid -19 Janssen (116 Covid cases out of 19,630 people), compared to people who were given placebo (348 cases out of 19,691) ".
This is a machine translation from Italian language of a post published on Start Magazine at the URL https://www.startmag.it/sanita/che-cosa-dice-janssen-con-ema-ed-aifa-sui-casi-di-trombosi/ on Wed, 28 Apr 2021 04:37:38 +0000.