Updated joint statement from ECDC and EMA on additional booster doses of COVID-19 vaccines

The updated recommendations come amid rising COVID-19 notification rates and hospital and intensive care unit (ICU) admission and occupancy rates in several countries, as evidenced by them ECDC Country Summary Report (Country summary report: week 26 2022 (europa.eu), and in the context of the emergence of the Omicron BA.4 and BA.5 lines. These data indicate that a new wave of COVID-19 is intensifying across the European Union/European Economic Area (EU/EEA).

This statement is based on the assessment of current epidemiological trends and available scientific evidence. As such, it is preliminary and subject to change as more data becomes available.

National Immunization Technical Advisory Groups (NITAGs) will ultimately make national decisions on the use of COVID-19 vaccines, taking into account the epidemiological situation in their country.

Considerations for additional booster doses of mRNA vaccines

Licensed COVID-19 vaccines continue to be highly effective in preventing COVID-19 hospitalizations, severe illness and death, even in the context of emerging SARS-CoV-2 variants and waning protection against the virus. natural and vaccine-induced immunity. Based on current evidence, public health authorities in EU/EEA countries should consider the following:

  • To improve the uptake of primary treatment and the first booster dose in eligible individuals, particularly for population groups at higher risk of serious outcomes and in countries where uptake of primary treatment and the first booster dose recall is lower. It is important that efforts to reach these groups continue over the summer months with currently available vaccines.
  • People over 60 and medically vulnerable populations remain most at risk of serious illness. Mathematical modeling suggests clear benefits of early deployment of the second booster to protect people over 60. Therefore, early deployment of the second booster should be considered not only for the population aged 80 and over, but also for adults aged 60-79 and medically vulnerable individuals, regardless of age, to prevent serious illnesses and preserve the capacity of the health system. . Countries should consider rapid deployment of second booster doses with currently available vaccines. These could be given at least four months after the previous one, with a focus on people who received a previous booster more than 6 months ago. This would be particularly relevant and impactful in countries where the BA.4/5 wave is starting or has not yet peaked.
  • Giving a second booster dose of currently available vaccines early to healthcare workers and people working in long-term care facilities is likely to provide only limited benefit due to limited and declining protection. rapid against infection and transmission. Healthcare workers and staff in long-term care facilities may receive a second booster dose for their own protection if they belong to a priority group based on age or medical vulnerability. Residents of long-term care facilities should receive all recommended booster doses according to these guidelines.
  • At present, there is no clear epidemiological evidence to support the administration of a second booster dose in immunocompetent individuals under the age of 60, unless they have medical vulnerabilities. ECDC and EMA will continue to closely monitor vaccine efficacy and epidemiological data and update their advice accordingly.
  • The EMA is working on the possible approval of suitable vaccines in September. However, given the current epidemiological situation and forecasts, it is important to use currently available vaccines now and not wait until suitable vaccines become available.
  • In anticipation of the next wave expected in the fall and winter seasons, countries should plan for the deployment of additional new booster doses to be given to population groups at risk of severe disease (e.g., people aged over 60 and medically vulnerable people) in early fall (provided sufficient time has elapsed since the administration of the previous booster dose), possibly combining vaccination campaigns against COVID-19 and the flu.
  • If suitable vaccines show increased neutralization against Omicron variants of concern, indicating possible higher protection against infection and transmission, vaccination of healthcare workers and people working in long-term care facilities should also be considered for fall/winter deployment to provide both direct and indirect protection.

In April 2022, the EMA and ECDC recommended that people over the age of 80 could receive a second booster dose of mRNA vaccines. The two agencies also noted at the time that if there was a significant resurgence in infections, people between the ages of 60 and 79 and medically vulnerable people of all ages should also be considered for a second booster dose. With a new wave currently unfolding in Europe, it is important that public health authorities now consider these groups for a second recall.

Currently, more than half of European Union/European Economic Area (EU/EEA) countries already recommend and deploy second booster doses of COVID-19 vaccines, primarily to older population groups. However, adoption is still low and uneven across countries, as shown by the ECDC Vaccine Tracking.

ECDC and EMA will continue to closely assess the efficacy of emerging vaccines and epidemiological data and monitor progress in the development of suitable vaccines. EU authorities will also continue to work closely with the World Health Organization (WHO) and international partners on policies regarding suitable vaccines.

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