EU health agencies recommend vaccines targeting Omicron subgroup for autumn

On Tuesday (6 June), EU health agencies recommended updating COVID-19 vaccines to target XBB strains, a subgroup of Omicron, with hopes to advance protection from infection and mild-symptomatic disease. 

Last autumn, the European Medicines Agency (EMA) recommended an adapted bivalent Pfizer/BioNTech vaccine.

However, ahead of the season this year, the health agency has instead recommended monovalent vaccines, meaning those that include only one XBB strain, according to a joint European Centre for Disease Prevention and Control (ECDC) and EMA statement.

“Last year we were concerned about what the virus was doing,” said Marco Cavaleri, the EMA’s head of health threats and vaccines strategy. When asked for the reason for recommending monovalent vaccines, he said: “We wanted to keep it broad, to have a vaccine that could allow maintaining really broad immunity.”

According to him, what has been observed was that individuals that have been repeatedly vaccinated with the ancestral [original] strain and then maybe naturally exposed to the new Omicron sub-variants have good immunity against the “old viruses that have been circulating in the past”.

“But this immunity is not very good what looks like is coming up next,” he warned.

That is the explanation behind why EMA wants to see vaccines directed against these new sub-variants that are dominant. Currently, that is the XBB family. According to ECDC/EMA statement, such monovalent vaccines could be used for revaccination and as primary vaccinations in younger children below five years of age.

The inclusion of a strain belonging to the XBB family of Omicron subvariants is adequate to ensure cross-reactivity against current dominant and emerging strains, and XBB.1.5 is considered a reasonable choice to increase the breadth of immunity also against XBB descendent lineages. Vaccine compositions containing other XBB strains such as XBB.1.16 could be considered based on adequate justification.

Cavaleri said that thanks to this approach, “we can increase the chances of having good protection not only from severe disease but also from infection and the mild-symptomatic disease.”

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Following global approach

The preference for monovalent vaccines follows the global approach. Less than a month ago, on 18 May, the WHO’s Technical Advisory Group for COVID-19 Vaccine Composition advised using newer COVID variants in future formulations of COVID-19 vaccines such as XBB.1 descendant lineages.  

“Global alignment on vaccine composition is extremely important for a worldwide cohesive response to COVID-19,” said Cavaleri. 

Similar to last year, the ECDC and EMA advise that future vaccination campaigns ahead of the next cold season should prioritise people who are more at risk of having severe disease. These include people aged 60 years and above, people with weakened immune systems and underlying conditions and those who are pregnant.

The currently authorised COVID-19 vaccines in the EU/EEA continue to provide protection against hospitalisation, severe disease and death due to COVID-19. The available eight vaccines include bivalent Wuhan and Omicron BA.1, bivalent Wuhan and Omicron BA.4/5, monovalent Wuhan, monovalent Beta (B.1.351), and bivalent Beta (B.1.351) and Alpha (B.1.1.7).

All the companies for which vaccines are approved are in discussions with EMA regarding updating COVID-19 vaccines to target XBB strains, but, according to Cavaleri, “it’s not a mystery that particularly the messenger RNA vaccines are eager to look into adopting their vaccines for the next vaccination campaigns”.

While there was news coming from Novavax on looking at how to update their vaccines, regarding other companies the situation “is still a bit unclear”, Cavaleri said.

For the future there are aims to provide a recommendation on vaccine composition ahead of autumn earlier, “for example, in April or May at the latest” Cavaleri said, adding that it is important to take into account mutations of the virus.

[Edited by Nathalie Weatherald]

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