Moderna's Omicron BA.4-5 targeting booster gets EMA panel nod for use in ages 12, above
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A committee of the European Medicines Agency (EMA) on Wednesday said it recommended the expanded use of Moderna's (NASDAQ:MRNA) adapted Spikevax COVID vaccine, targeting the Omicron subvariants BA.4 and BA.5, for people aged 12 years and above who have already received a primary vaccination course.
The adapted bivalent vaccine targets the original strain of the coronavirus and the Omicron subvariants BA.4 and BA.5.
This is the second adapted Spikevax vaccine that EMA has recommended for approval, after an adapted Spikevax vaccine targeting Omicron BA.1 and the original strain was authorized in September, the Committee for Medicinal Products for Human Use (CHMP) noted.
The CHMP added that apart from containing mRNA matching different, but closely related, Omicron subvariants, the two adapted vaccines have the same composition.
A study found that a booster dose of Spikevax bivalent Original/Omicron BA.1 induced a stronger immune response versus the original strain and the Omicron subvariant BA.1, compared to a booster dose of the original Spikevax shot.
The European Commission, which generally follows the opinion of the CHMP, will issue final decisions on the vaccine.
Separately, the CHMP had also recommended the approval of original COVID vaccines from Moderna and Pfizer/BioNTech for use in infants.