The European Medicines Agency (EMA) announced on Tuesday that it has begun evaluating a Moderna Covid-19 vaccine targeting the Omicron BA.4 and BA.5 sublines, amid fears of a new wave on the continent.
If approved, the serum will become the second Covid vaccine suitable for these Omicron subvariants licensed in the EU.
The EMA said it had “initiated the assessment of an application for authorization of an adapted version of Spikevax”, targeting both the original Covid-19 strain and types BA.4 and 5.
The European regulator, however, did not specify when the approval of the booster dose could 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/BioNTech, target the original strain of the virus and the BA.1 variant of Omicron. A vaccine from Pfizer/BioNTech targets the original strain and the BA.4 and BA.5 subvariants of Omicron.
Omicron and its sub-variants have been dominant throughout 2022, quickly taking the place of previous variants. Today, it is essentially the Omicron BA.5 sub-variant that dominates in Europe and the United States.
Covid vaccines approved almost two years ago offered some protection against Omicron and its subvariants, which were less harmful but more contagious than the original strain, but more targeted and effective sera against the newer sublineages were very expected.
The UK, Canada and the US have also approved serums targeting Omicron.
The European regulator warned last week that the Covid-19 pandemic was ‘still ongoing’ and urged countries to introduce vaccine booster programs ahead of winter when a spike in cases is expected.
European health authorities also recommended at the beginning of the month that the elderly and people at risk of a severe form of Covid-19 be on the front line for the administration of vaccines adapted to the Omicron variant.
/ATS