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.
On Thursday the EMA released a safety update revealing that their Risk Assessment Committee was evaluating “further data on the risk of myocarditis and pericarditis following vaccination with Spikevax.”
Following reports that the diseases had been reported in Europe, the incidences of both inflammatory disorders were previously examined. 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.
However, the latest notice 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.”
Results from clinical trials as well as “other data available in the public domain,”A request was made by regulators.
The EMA indicated that they will monitor and continue to assess the safety and efficacy. “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.
Spikevax was restricted in different ways by the Nordic countries during October. Iceland suspended the jab completely, while Sweden stopped its use in all cases for those under thirty. Finland, however, stopped the rollout for those born between 1991 and 2002.
As of the October 31st, more than 61.6million shots of Spikevax had been administered to arms in the EU and EEA.
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