The European Medicines Agency (EMA) on Friday reconfirmed that its strain selection for Covid-19 vaccines for the fall season will differ slightly from the FDA’s selection, pending any further approvals.
In line with a World Health Organization recommendation in April, the EMA said it’s sticking with its task force’s recommendation that the latest Covid vaccines target the JN.1 family of Omicron. On July 3, the European Commission signed off on BioNTech and Pfizer’s Comirnaty targeting JN.1. EMA’s CHMP is still considering similar vaccines from Moderna, Novavax and Hipra that target JN.1.
While the EMA notes the FDA’s recommendation that Covid vaccines should target the KP.2 subvariant, the EMA said it “was made aware of one potential regulatory submission” for a vaccine targeting KP.2, and that vaccine may be available in the future but would still need a sign-off from the EMA.
As for why it’s sticking to its initial decision, the EMA said the task force “considered that available animal data on cross-neutralisation are not sufficiently clear to indicate a greater benefit of a vaccine targeting KP.2 over the JN.1 variant since the difference in immunogenicity between JN.1 and KP.2 vaccines remains uncertain at this stage and of minor relevance compared to the large differences in the immune response against currently circulating strains shown by JN.1 vaccines compared to XBB1.5 vaccines.”
KP.2 is a descendant of JN.1, with both variants differing by only three mutations in the spike protein, according to the EMA.
While acknowledging that exactly matching the strain in circulation next fall with the vaccine “is not possible,” the EMA said its strategy is to ensure that updated vaccines are available to protect against the dominant family of viruses.
Considering the available evidence, the EMA said “no change is currently warranted to the previously published ETF recommendation for Covid-19 vaccines update. Targeting JN.1 will facilitate timely vaccination campaigns in Europe after the summer to help reduce the burden of disease associated with Covid-19.”