The European Medicines Agency (EMA) announced on Tuesday that it has begun evaluating Moderna’s Covid-19 vaccine targeting the Omicron BA.4 and BA.5 sublines, as the continent fears a new wave.
If approved, the serum would become the second Covid vaccine suitable for this Omicron subtype to be licensed in the EU.
The EMA said it had “initiated a utility assessment to approve an adapted version of Spikevax” targeting both the original Covid-19 strain and BA.4 and 5.
However, the European regulator did not specify when the approval of the booster dose would take place.
The EMA has approved three “bivalent” vaccines, all of which use messenger RNA technology.
Two vaccines, one from Moderna and the other from Pfizer/BioEntech, target the original strain of the virus and the BA.1 variant of Omicron. A vaccine from Pfizer/BioNTech targets the original strain and Omicron’s BA.4 and BA.5 subtypes.
Omicron and its variants will dominate throughout 2022, quickly replacing earlier variants. Today, it is mainly the Omicron BA.5 sub variant that dominates Europe and the US.
Covid vaccines approved nearly two years ago offered some protection against Omicron and its subtypes, which were less harmful but more infectious than the original strain, but more targeted and effective sera against the new subtypes were highly anticipated.
The UK, Canada and the US have approved serums targeting Omicron.
The European regulator warned last week that the Covid-19 pandemic is “still ongoing” and urged countries to introduce vaccine booster programs before winter, when cases are expected to rise.
European health authorities recommended earlier this month that the elderly and those at risk of a severe form of Covid-19 should be at the forefront of administering vaccines adapted to the omicron variant.
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