EMA calls for review of Moderna jab

The European Medicines Agency (EMA) has requested an in-depth review of all data linked to myocardial infarction after inoculation with Modernas Covid jab, after several countries discontinued or advised against its use.

In a sense of security update published on Thursday, the EMA revealed that its risk assessment committee is evaluating “additional data on the risk of myocarditis and pericarditis after vaccination with Spikevax.”

The incidence of the two inflammatory diseases has previously been analyzed after reports of the condition appeared across Europe. The first review was completed in July 2021, which resulted in the drug regulator recommending that both conditions be added to the list of adverse reactions for Moderna’s jab.

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

Findings from clinical trials, as well as “other data available in the public domain,” have been requested by the regulator.

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

The EMA update comes just one day after Germany’s Advisory Vaccination Committee recommended that people under the age of 30 receive Pfizer-BioNTech’s Comirnaty, citing current reports suggesting that myocardial infarction and pericarditis are more common in adolescents after inoculation with Modern Spikevax.

The French public health body had previously issued similar guidelines, saying that the risk of myocarditis is about five times less with Pfizer’s stick.

In October, the Nordic countries introduced restrictions for Spikevax to various levels. Iceland announced a total shutdown of the jab, while Sweden froze the use for everyone under the age of 30. Finland, on the other hand, stopped its expansion for men born in 1991 and later.

More than 61.6 million injections of Spikevax have been injected into weapons throughout the EU and EEA by the end of October.


Source: sn.dk





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