Bivalent mRNA Vaccine Under Review in Europe

The European Medicines Agency (EMA) recently announced it started a rolling review for a bivalent version of Moderna Inc.'s Spikevax vaccine adapted to protect against specific variants of the SARS-CoV-2 coronavirus.

Announced on June 17, 2022, the EMA confirmed this mRNA vaccine candidate would target two strains of SARS-CoV-2, in this case, the original strain and the newer Omicron variant of concern.

Currently, Omicron's BA.4 and BA.5 variants are dominating throughout Europe.

By starting this rolling review for Spikevax, EMA's human medicines committee (CHMP) will be able to review data from ongoing studies as they become available. 

The EMA review will continue until there is enough data for a formal application.

The composition of adapted COVID-19 vaccines will ultimately depend on the recommendations of public health authorities and the World Health Organization.

As of May 15, 2022, about 152 million doses of Spikevax had been given to people in the EU/EEA.

The EMA recently confirmed a total of 219,135 cases of suspected spontaneous side effects were reported from EU/EEA countries, with 1,059 of these reporting a fatal outcome.

Note: This EMA announcement was manually curated for mobile readership.