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EMA calls for review of Moderna jab

The European Medicines Agency (EMA) has asked for an in-depth review of all data linked to heart inflammation disorders following inoculation with Moderna’s Covid jab, after several countries suspended or advised against its use.

In a safety update published on Thursday, the EMA revealed that its Risk Assessment Committee is evaluating “further data on the risk of myocarditis and pericarditis following vaccination with Spikevax.”

Incidences of the two inflammatory disorders have previously been analyzed after reports of the conditions cropped up across Europe. The first review ended in July 2021, resulting in the drug regulator recommending that both conditions be added to the side-effects list of Moderna’s jab.

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The latest notice, however, stated that “the committee has now asked the company that markets Spikevax to perform an in-depth review of all published data on the association of myocarditis and pericarditis with the vaccine.” 

Clinical trial findings, as well as “other data available in the public domain,” have been requested by the regulator. 

The EMA said that it will continue to monitor the safety and efficacy of the jab and “communicate further when new information becomes available.” 

The EMA update comes just a day after Germany’s vaccine advisory committee recommended that under-30s receive Pfizer-BioNTech’s Comirnaty, citing current reports which suggest heart muscle and pericardial inflammation in young people is more commonly observed after inoculation with Moderna’s Spikevax.

France’s public health body had previously issued similar guidance, saying the risk of myocarditis is around five times less with Pfizer’s jab.

October saw Nordic nations impose restrictions on Spikevax to varying levels. Iceland announced a total suspension of the jab, while Sweden froze its use for all under 30s. Finland, on the other hand, halted its rollout for men born in 1991 and later. 

More than 61.6 million shots of Spikevax have been injected into arms across the EU and EEA as of the end of October.

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source: RT




Împotriva articolelor redacției noastre, persoanele nemulțumite pot formula Contestație în termen de 10 zile de la publicarea articolului, la judecătoria Orășenească nr. 1 München Bayern Deutschland, in conformitate cu Legea federală Germană. Considerăm că nu se pot formula acțiuni la instanțele din România deoarece nici o persoană care activează în trustul nostru nu poate fi extrasă de sub jurisdicția federală germană. Considerăm că redacția noastră nu răspunde în fața autorităților din România ci doar celor federale sau civile germane. deoarece legea română nu are efecte de extraneitate asupra redacției chiar dacă subiectul știrilor face obiectul unor evenimente sau persoane din România și sunt scrise în limba română. Limba română nu este izvor de extraneitate a legii.

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Marius Leontiuc
absolvent WEB DESIGN Academia Britanică de Comunicare Iasi - absolvent COMUNICARE IN AFACERI Academia Britanica de Afaceri si Comunicare -absolvent JURNALISM EDITORIAL - London School University - 2019 inscris la echivalare diploma la Universitatea Politehnica Timisoara - absolvent studii de Drept Universitatea Europeană Drăgan, cursuri in Drept la Universitatea de Vest Timisoara, absolvent studii de proiectare, pastor coordonator in Biserica Protestanta Evanghelica, Android Developer pe Google Play și plugin developer la Oxwall, creator de teme Wordpress și Oxwall, operator Wordpress, Drupal, Oxwall, Osclass, Moodle, tehnologii HTML și PHP
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