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Those shots - while still useful in reducing the severity of COVID infections - have provided only limited (and relatively short-lived) protection against infection with these newer variants (see MMWR: Estimates of Bivalent mRNA Vaccine Durability in Preventing COVID-19–Associated Hospitalization and Critical Illness).
Last month the WHO Recommended Switching To A Monovalent XBB based COVID Vaccine this fall, and similar plans have been announced here in the United States (strain/strains yet to be decided).
Today the ECDC-EMA has published a news release and a joint statement on their plans for a fall COVID vaccination campaign, and recommended changes to the vaccine. I'll have a bit more after the break.
ECDC-EMA statement on updating COVID-19 vaccines composition for new SARS-CoV-2 virus variants
News
7 Jun 2023
ECDC and EMA have issued a joint statement on adapted COVID-19 vaccines and considerations for their use during the upcoming autumn 2023 vaccination campaigns.
Currently authorised vaccines continue to be effective at preventing hospitalisation, severe disease and death due to COVID-19. However, protection against the virus declines over time as new SARS-CoV-2 variants emerge.
In line with the outcome of recent meetings of international regulators and the World Health Organization, EMA’s Emergency Task Force recommends updating vaccines to target XBB strains (a subgroup of Omicron), which have become dominant in Europe and other parts of the world.
EMA and ECDC also note that monovalent vaccines (vaccines targeting only one strain such as XBB.1.5) are a reasonable choice to provide protection against current dominant and emerging strains.
Proposed revision of product information
Marketing authorisation holders in the EU should discuss the revision of the product information for vaccines with EMA’s human medicines committee (CHMP), to reflect the proposed simplified approach, as follows:
- For individuals above 5 years of age, when vaccination is recommended according to national guidelines, a single dose of the newly adapted vaccine is indicated.
- For children below 5 years of age, without history of vaccination or prior SARS-CoV-2 infection, a primary series composed of 2 or 3 doses depending on the specific newly adapted vaccine to be administered is indicated. Use in paediatric population is expected to follow national guidelines.
People with weakened immune systems may need additional doses in line with national recommendations.
For revaccinations, a minimum interval of 3 months should be adhered to, however a 4-month interval between doses may be considered in the light of evidence showing a high level of protection against severe disease 4 months after vaccination.
Final decisions on the wording of the product information will be taken by the CHMP following assessment of the relevant data.
Recommended groups to be targeted by vaccination campaigns in 2023
The ECDC and EMA advise that the future vaccination campaigns ahead of the next cold season should prioritize 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 putting them at higher risk of severe COVID-19 irrespective of age and those who are pregnant. Vaccination of healthcare workers should also be considered because of their likely increased exposure to new waves of SARS-CoV-2 and their key role in the functioning of healthcare systems.
Factors to be considered in autumn vaccination campaigns
Timely vaccination ahead of a potential autumn and winter 2023 surge of COVID-19 cases is essential for protecting people from severe COVID-19 and health systems from being overwhelmed.
National authorities in the EU make final decisions on the roll-out of vaccines, including revaccinations, and on type of vaccines recommended, considering factors such as the epidemiological situation, the impact of COVID-19 in different population groups and the emergence of new variants.
ECDC and EMA will continue to closely evaluate emerging vaccines’ effectiveness and epidemiological data and will update their recommendations accordingly.
Download
ECDC-EMA statement on updating COVID-19 vaccines composition for new SARS-CoV-2 virus variants - EN - [PDF-210.38 KB]
As we've seen here in the United States, uptake of the updated (2022) booster in Europe (see chart below) has been extremely disappointing, with only about 15% of the population embracing the new jab.
The relatively short history of COVID has been that the status quo doesn't last very long.
Dominant variants usually reign for only a few months before they are replaced with something new, and while a year ago recombinant variants were rare, today everything is a recombinant, and we are seeing recombinants of recombinants.
While we have hopefully seen the last hurrah from our COVID pandemic, its continued retreat is far from assured.
The SARS-CoV-2 virus increasingly circulates in non-human hosts (see Eurosurveillance: Cryptic SARS-CoV-2 Lineage Identified on Two Mink Farms In Poland), and there is also at least some recombination potential with other coronaviruses (see Nature: CoV Recombination Potential & The Need For the Development of Pan-CoV Vaccines).
As much as we'd all like to move on from COVID, SARS-COV-2 is now firmly entrenched in multiple species around the world, and - like influenza - it has the potential to produce new pandemic strains in the years to come.
