EMA Assessing Variant-Adapted Spikevax, Probes Heart Inflammation With Nuvaxovid

A rolling review of an adapted version of Moderna’s COVID-19 vaccine Spikevax aimed at variants of SARS-CoV-2 has begun at the European Medicines Agency. The EMA has also given an update on its latest vaccine safety reviews, including reports of heavy menstrual bleeding with Spikevax and Comirnaty.

spikevax and comirnaty
Comirnaty and Spikevax are undergoing an EU safety review • Source: Shutterstock

The European Medicines Agency has begun a rolling review of a bivalent version of Moderna, Inc.’s COVID-19 vaccine, Spikevax, that targets the original strain of the virus as well as the Omicron variant of concern.

As with the variant-adapted version of Pfizer Inc./BioNTech SE’s Comirnaty, whose rolling review at the EMA began on...

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