VIDEONEWS & sponsored

(in )

EMA * VACCINE JANSSEN: « POSSIBLE LINK TO VERY RARE CASES OF UNUSUAL BLOOD CLOTS WITH LOW BLOOD PLATELETS *** POSSIBILE COLLEGAMENTO A CASI MOLTO RARI DI COAGULI DI SANGUE INSOLITI CON PIASTRINE BASSE »

COVID-19 Vaccine Janssen: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets.

EMA confirms overall benefit-risk remains positive.

At its meeting of 20 April 2021, EMA’s safety committee (PRAC) concluded that a warning about unusual blood clots with low blood platelets should be added to the product information for COVID-19 Vaccine Janssen. PRAC also concluded that these events should be listed as very rare side effects of the vaccine.

In reaching its conclusion, the Committee took into consideration all currently available evidence including eight reports from the United States of serious cases of unusual blood clots associated with low levels of blood platelets, one of which had a fatal outcome. As of 13 April 2021, over 7 million people had received Janssen’s vaccine in the United States.

All cases occurred in people under 60 years of age within three weeks after vaccination, the majority in women. Based on the currently available evidence, specific risk factors have not been confirmed.

PRAC noted that the blood clots occurred mostly at unusual sites such as in veins in the brain (cerebral venous sinus thrombosis, CVST) and the abdomen (splanchnic vein thrombosis) and in arteries, together with low levels of blood platelets and sometimes bleeding. The cases reviewed were very similar to the cases that occurred with the COVID-19 vaccine developed by AstraZeneca, Vaxzevria.

Healthcare professionals and people who will receive the vaccine should be aware of the possibility of very rare cases of blood clots combined with low levels of blood platelets occurring within three weeks of vaccination.

COVID-19 is associated with a risk of hospitalisation and death. The reported combination of blood clots and low blood platelets is very rare, and the overall benefits of COVID-19 Vaccine Janssen in preventing COVID-19 outweigh the risks of side effects.

EMA’s scientific assessment underpins the safe and effective use of COVID-19 vaccines. Use of the vaccine during vaccination campaigns at national level will take into account the pandemic situation and vaccine availability in individual Member States.

One plausible explanation for the combination of blood clots and low blood platelets is an immune response, leading to a condition similar to one seen sometimes in patients treated with heparin called heparin induced thrombocytopenia, HIT.

PRAC emphasises the importance of prompt specialist medical treatment. By recognising the signs of bloods clots and low blood platelets and treating them early, healthcare professionals can help those affected in their recovery and avoid complications. Thrombosis in combination with thrombocytopenia requires specialised clinical management. Healthcare professionals should consult applicable guidance and/or consult specialists (e.g., haematologists, specialists in coagulation) to diagnose and treat this condition.

As for all vaccines, EMA will continue to monitor the vaccine’s safety and effectiveness and provide the public with the latest information.

A similar signal evaluation was recently finalised for another COVID-19 vaccine, Vaxzevria (previously COVID-19 Vaccine AstraZeneca).

Information for the public

Cases of unusual blood clots with low platelets have occurred in people who received Janssen’s COVID-19 vaccine in the United States.
The risk of having this side effect is very low, but people who will receive the vaccine should still be aware of symptoms so they can get prompt medical treatment to help recovery and avoid complications.
Individuals must seek urgent medical attention if they have any of the following symptoms in the three weeks after being vaccinated with COVID-19 Vaccine Janssen:
shortness of breath
chest pain
leg swelling
persistent abdominal (belly) pain
neurological symptoms, such as severe and persistent headaches or blurred vision
tiny blood spots under the skin beyond the site of the injection.
Speak to your healthcare professional or contact your relevant national health authorities if you have any questions about your vaccination.
Information for healthcare professionals

EMA has reviewed eight cases of thrombosis in combination with thrombocytopenia in people who received Janssen’s COVID-19 vaccine in the United States.
These very rare types of thrombosis (with thrombocytopenia) included venous thrombosis mostly in unusual sites such as cerebral venous sinus thrombosis and splanchnic vein thrombosis, as well as arterial thrombosis, and fatal outcome in one case. All cases occurred in people below 60 years of age, and most were in women, within three weeks of the person being vaccinated.
The cases reviewed were very similar to the cases that occurred with the COVID-19 vaccine developed by AstraZeneca, Vaxzevria.
As for the mechanism, it is thought that the vaccine may trigger an immune response leading to a heparin-induced-thrombocytopenia like disorder. At this time, the pathophysiological mechanism has not been established, and it is currently not possible to identify specific risk factors.
Healthcare professionals should be alert to the signs and symptoms of thromboembolism and thrombocytopenia so that they can promptly treat people affected in line with available guidelines.
Thrombosis in combination with thrombocytopenia requires specialised clinical management. Healthcare professionals should consult applicable guidance and/or consult specialists (e.g., haematologists, specialists in coagulation) to diagnose and treat this condition.
Healthcare professionals should tell people receiving the vaccine that they must seek medical attention if they develop:
symptoms of blood clots such as shortness of breath, chest pain, leg swelling, persistent abdominal pain
neurological symptoms such as severe and persistent headaches and blurred vision
petechiae beyond the site of vaccination after a few days.
The benefits of the vaccine continue to outweigh the risks for people who receive it. The vaccine is effective at preventing COVID-19 and reducing hospitalisations and deaths.
A direct healthcare professional communication (DHPC) will be sent to healthcare professionals involved in giving the vaccine in the EU. The DHPC will also be published on a dedicated page on the EMA website.

More about the vaccine

COVID-19 Vaccine Janssen is a vaccine for preventing coronavirus disease 2019 (COVID-19) in people aged 18 years and older. COVID-19 is caused by SARS-CoV-2 virus. COVID-19 Vaccine Janssen is made up of another virus (of the adenovirus family) that has been modified to contain the gene for making a protein from SARS-CoV-2. COVID-19 Vaccine Janssen does not contain the virus itself and cannot cause COVID-19.

The most common side effects with COVID-19 Vaccine Janssen are usually mild or moderate and improve within a few days after vaccination. More information is available on EMA’s website.

COVID-19 Vaccine Janssen was authorised in the EU on 11 March 2021; the rollout of the vaccine in the EU was temporarily delayed by the company.

More about the procedure

The review of thromboembolic events with COVID-19 Vaccine Janssen is being carried out in the context of a safety signal, under an accelerated timetable. A safety signal is information on a new or incompletely documented adverse event that is potentially caused by a medicine and that warrants further investigation. The presence of a safety signal does not necessarily mean that a medicine has caused the reported adverse event. The assessment of safety signals seeks to establish whether a causal relationship between the medicine and the adverse event is at least a reasonable possibility.

The review is being carried out by EMA’s Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines. Once the review is completed, PRAC will make further recommendations as necessary to minimise risks and protect patients’ health. EMA’s human medicine committee, CHMP, will then rapidly assess any necessary changes to the product information.

EMA’s scientific assessment underpins the safe and effective use of COVID-19 vaccines. EMA’s recommendations are the foundation upon which individual EU Member States will design and implement their own national vaccination campaigns. These may differ from country to country depending on their national needs and circumstances, such as infection rates, priority populations, vaccine availability and hospitalisation rates.

 

 

TRADUZIONE DA “GOOGLE TRANSLATION” (è possibile che il testo in lingua straniera non sia tradotto in maniera ottimale, si raccomanda di verificare l’esatto contenuto-traduzione)

*

Vaccino COVID-19 Janssen: l’EMA trova un possibile collegamento a casi molto rari di coaguli di sangue insoliti con piastrine basse.

L’EMA conferma che il rapporto rischio-beneficio complessivo rimane positivo.

Nella riunione del 20 aprile 2021, il comitato per la sicurezza (PRAC) dell’EMA ha concluso che alle informazioni sul prodotto per il vaccino COVID-19 Janssen dovrebbe essere aggiunto un avvertimento su coaguli di sangue insoliti con piastrine basse. Il PRAC ha anche concluso che questi eventi dovrebbero essere elencati come effetti collaterali molto rari del vaccino.

Nel giungere alla sua conclusione, il Comitato ha preso in considerazione tutte le prove attualmente disponibili, inclusi otto rapporti dagli Stati Uniti di casi gravi di coaguli di sangue insoliti associati a bassi livelli di piastrine, uno dei quali ha avuto esito fatale. Al 13 aprile 2021, oltre 7 milioni di persone avevano ricevuto il vaccino di Janssen negli Stati Uniti.

Tutti i casi si sono verificati in persone di età inferiore a 60 anni entro tre settimane dalla vaccinazione, la maggioranza nelle donne. Sulla base delle prove attualmente disponibili, i fattori di rischio specifici non sono stati confermati.

Il PRAC ha osservato che i coaguli di sangue si sono verificati principalmente in siti insoliti come nelle vene del cervello (trombosi del seno venoso cerebrale, CVST) e dell’addome (trombosi della vena splancnica) e nelle arterie, insieme a bassi livelli di piastrine del sangue e talvolta sanguinamento. I casi esaminati erano molto simili ai casi verificatisi con il vaccino COVID-19 sviluppato da AstraZeneca, Vaxzevria.

Gli operatori sanitari e le persone che riceveranno il vaccino devono essere consapevoli della possibilità che si verifichino casi molto rari di coaguli di sangue associati a bassi livelli di piastrine nel sangue entro tre settimane dalla vaccinazione.

COVID-19 è associato a un rischio di ospedalizzazione e morte. La combinazione segnalata di coaguli di sangue e piastrine basse è molto rara ei benefici complessivi del vaccino COVID-19 Janssen nella prevenzione del COVID-19 superano i rischi degli effetti collaterali.

La valutazione scientifica dell’EMA è alla base dell’uso sicuro ed efficace dei vaccini COVID-19. L’uso del vaccino durante le campagne di vaccinazione a livello nazionale terrà conto della situazione pandemica e della disponibilità di vaccini nei singoli Stati membri.

Una spiegazione plausibile per la combinazione di coaguli di sangue e piastrine basse è una risposta immunitaria, che porta a una condizione simile a quella osservata a volte nei pazienti trattati con eparina chiamata trombocitopenia indotta da eparina, HIT.

Il PRAC sottolinea l’importanza di un trattamento medico specialistico tempestivo. Riconoscendo i segni di coaguli di sangue e piastrine basse e trattandoli precocemente, gli operatori sanitari possono aiutare le persone colpite nel loro recupero ed evitare complicazioni. La trombosi in combinazione con la trombocitopenia richiede una gestione clinica specializzata. Gli operatori sanitari devono consultare la guida applicabile e / o consultare specialisti (ad es. Ematologi, specialisti in coagulazione) per diagnosticare e trattare questa condizione.

Come per tutti i vaccini, l’EMA continuerà a monitorare la sicurezza e l’efficacia del vaccino e fornirà al pubblico le informazioni più recenti.

Una simile valutazione del segnale è stata recentemente finalizzata per un altro vaccino COVID-19, Vaxzevria (precedentemente COVID-19 Vaccine AstraZeneca).

Informazioni per il pubblico

Casi di insoliti coaguli di sangue con piastrine basse si sono verificati in persone che hanno ricevuto il vaccino COVID-19 di Janssen negli Stati Uniti.
Il rischio di avere questo effetto collaterale è molto basso, ma le persone che riceveranno il vaccino dovrebbero comunque essere consapevoli dei sintomi in modo da poter ottenere un trattamento medico tempestivo per aiutare il recupero ed evitare complicazioni.
Gli individui devono cercare cure mediche urgenti se hanno uno dei seguenti sintomi nelle tre settimane successive alla vaccinazione con il vaccino COVID-19 Janssen:

fiato corto
dolore al petto
gonfiore alle gambe
persistente dolore addominale (pancia)
sintomi neurologici, come mal di testa grave e persistente o visione offuscata
minuscole macchie di sangue sotto la pelle oltre il sito di iniezione.
Parla con il tuo medico o contatta le autorità sanitarie nazionali competenti in caso di domande sulla vaccinazione.
Informazioni per gli operatori sanitari

L’EMA ha esaminato otto casi di trombosi in combinazione con trombocitopenia in persone che hanno ricevuto il vaccino COVID-19 di Janssen negli Stati Uniti.
Questi tipi molto rari di trombosi (con trombocitopenia) includevano trombosi venosa principalmente in siti insoliti come la trombosi del seno venoso cerebrale e la trombosi della vena splancnica, nonché trombosi arteriosa e in un caso esito fatale. Tutti i casi si sono verificati in persone di età inferiore a 60 anni e la maggior parte erano donne, entro tre settimane dalla vaccinazione.
I casi esaminati erano molto simili ai casi verificatisi con il vaccino COVID-19 sviluppato da AstraZeneca, Vaxzevria.
Per quanto riguarda il meccanismo, si ritiene che il vaccino possa innescare una risposta immunitaria che porta a un disturbo simile alla trombocitopenia indotta da eparina. In questo momento, il meccanismo fisiopatologico h