The European Medicines Agency's (EMA) Emergency Task Force (ETF) has proposed modifying the composition of COVID-19 vaccines so that they focus on the new XFG variant of SARS-CoV-2 in the upcoming 2026/2027 immunization campaign.
The recommendation comes after the increase in XFG circulation worldwide since last June. This variant, integrated into the JN.1 family of Omicron subvariants, reached a maximum of 74 percent of genetically sequenced infections globally in October and continues to be predominant within the JN.1 subvariants, although its presence is not homogeneous across all geographical areas.
According to the EMA, in Europe, the circulation of other variants such as NB.1.81, linked to JN.1, and BA.3.2, which is genetically different from the JN.1 family and is gaining ground in certain countries, is also detected simultaneously.
To prepare its opinion, the ETF has consulted with the World Health Organization (WHO), various international partners, and the marketing authorization holders for COVID-19 vaccines. Furthermore, it has analyzed a broad set of evidence, including the evolution of the virus, the performance of vaccines incorporating the JN.1/KP.2 and LP.8.1 strains, as well as preclinical animal studies on the effect of candidate vaccines adapted to the XFG, LP.8.1, and BA.3.2.2 strains.
Based on this data, the expert group concludes that targeting vaccination towards XFG would offer the most adequate protection against COVID-19 caused by the Omicron JN.1 subvariants, as well as against BA.3.2. At the same time, it points out that vaccines targeting the LP.8.1 strain could be considered for the 2026 vaccination campaigns.
"This recommendation could be updated if the epidemiological situation changes substantially, given the increasing circulation of BA.3.2 and its potential for evolution and immune evasion," it has pointed out.
The EMA expects all marketing authorization holders, who must contact the agency to review possible updates to said authorizations, to adjust the formulation of their vaccines in accordance with this recommendation.
Likewise, it has encouraged companies developing new Covid-19 vaccines targeting strains other than XFG to contact the EMA to study strategies to facilitate the modification of the composition of their preparations.
Finally, it has stressed that it will be the national authorities of the European Union (EU) who will make the final decisions on the vaccination campaigns of 2026 and 2027, depending on the specific epidemiological situation of each Member State.