EMA Recommends Update to COVID-19 Vaccines for 2025-26 Campaign

After consulting with the World Health Organization, marketing authorization holders, and international partners and examining worldwide and animal study data, the European Medicines Agency (EMA) announced on May 16, 2025, that its Emergency Task Force (ETF) would be recommending that COVID-19 vaccines be updated for the 2025-2026 vaccination campaign (1).

The recommendation is based on ETF’s desire to target LP.8.1, a variant of the SARS-CoV-2 virus that caused COVID-19, which is the most prevalent variant circulating worldwide as of the first third of 2025 (1). It has passed the previously dominant JN.1 variant, for which previous vaccine formulas were updated, and is different from the JN.1 family.

New variant becomes dominant

In a guidance document detailing the recommendation, EMA said LP.8.1 and XEC—the latter being another variant that had become dominant as 2024 turned to 2025—were both part of the BA.2.86 family of Omicron variants, antigenically different from the XBB variant that circulated in 2023 and others that circulated previously (2).

“A large body of evidence is now available to anticipate that, even if COVID-19 vaccines remain effective at preventing severe disease and death caused by new emerging variants, protection tends to decrease as the virus evolves into more antigenically distant variants,” the document said (2). “Studies have shown that matching the content of vaccines to the circulating viruses improves protection against the disease.”

Vaccines for other variants still approved

Novavax’s recombinant protein-based, non-messenger RNA (mRNA), marketed as Nuvaxovid, has gained full market approvals in the European Union and other countries and areas around the world as a COVID-19 treatment, and yet has only been available to date under emergency use authorization in the United States. On May 19, 2025, FDA approved the Biologics License Application for this vaccine in adults aged 65 and older, and individuals aged 12-64 who have at least one underlying condition putting them at high risk for severe outcomes (3).

However, the Novavax vaccine is formulated to target the JN.1 variant. While JN.1 sublineages are still emerging, EMA said, LP.8.1 has been shown to exhibit strong humoral immune evasion and holds potential to have the greatest growth advantage and increased transmissibility compared with other variants (2).

Despite that, the ETF said that vaccines targeting the JN.1 or KP.2 strains could still be considered for vaccination campaigns beginning later in 2025, until treatments specifically targeting LP.8.1 become available (1,2).

In the United States, the 2024-2025 COVID-19 vaccination campaign was launched with FDA’s announcement on Aug. 22, 2024 that it had granted an emergency use authorization for updated versions of the mRNA vaccines manufactured by Moderna and Pfizer, both of which targeted the KP.2 strain, another Omicron descendant (4). Following FDA’s approval, those vaccines were available to the general public within days.

EMA said in its May 16, 2025, release that marketing authorization holders contact the agency immediately to discuss updates, as should companies still developing new vaccines which may be targeting other strains (1).

References

1. EMA. ETF Recommends Updating COVID-19 Vaccines to Target New LP.8.1 Variant. Press Release. May 16, 2025.
2. EMA, EMA/166854/2025, EMA Recommendation to Update the Antigenic Composition of Authorised COVID-19 Vaccines for 2025-2026 (May 17, 2025).
3. Novavax. US FDA Approves BLA for Novavax's COVID-19 Vaccine. Press Release. May 19, 2025.
4. FDA. FDA Approves and Authorizes Updated mRNA COVID-19 Vaccines to Better Protect Against Currently Circulating Variants. Press Release. Aug. 22, 2024.