ECDC and EMA update recommendations on additional booster doses of mRNA COVID-19 vaccines

The European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA) are updating recommendations on booster doses of mRNA COVID-19 vaccines.

Due to current wave of COVID-19 cases and the emergence of the Omicron lineages BA.4 and BA.5, the agencies are recommending the second booster doses of mRNA COVID-19 vaccines be considered for not only people over 80 years of age, but also for people between 60 and 79 years old and vulnerable persons of any age, who are at high risk of severe disease.

Second boosters for people above 60 years and vulnerable persons

According to current epidemiological trends, there are increasing numbers of reported COVID-19 cases, and rates of hospital and intensive care unit (ICU) admissions.

Since currently authorised vaccines continue to be highly effective in reducing COVID-19 hospitalisations, severe disease, and deaths in the context of emerging SARS-CoV-2 variants, ECDC and EMA recommend countries should consider a rapid deployment of second booster doses in early fall and winter periods, with currently available vaccines. It is important that efforts to reach vulnerable groups continue over the summer months with currently available vaccines. This would be particularly relevant and impactful in countries where the BA.4/5 wave is starting or has not yet peaked.

Second booster doses of mRNA COVID-19 vaccines could be administered at least four months after the previous one, with a focus on people who have received a previous booster more than 6 months ago.

Currently over half of the European Union/European Economic Area (EU/EEA) countries are already recommending and rolling out second booster doses of COVID-19 vaccines, mainly to older population groups. However, the uptake is still low and uneven across countries, as shown in the ECDC Vaccine Tracker. In anticipation of the next expected wave in the autumn and winter seasons, countries are advised to plan the rollout of further additional booster doses to be administered to population groups at risk of severe disease in early autumn, provided sufficient time has elapsed since the administration of the previous booster dose.

ECDC and EMA recommend possibly combining campaigns for vaccination against COVID-19 and influenza.

Since, currently there is no clear epidemiological evidence to support the administration of a second booster dose to immunocompetent individuals below 60 years of age, second booster dose is not recommended in this population, unless they have medical vulnerabilities.

Adapted vaccines

EMA is currently working towards possible approvals of adapted vaccines in September. According to ECDC and EMA, it is vital, with regards to current epidemiological situation, for the EU member states to protect the vulnerable populations with currently available vaccines.

Should the adapted vaccines show increased neutralisation against Omicron variants, indicating a possible higher protection against infection and transmission, the vaccination of healthcare workers and people working at long-term care facilities should also be considered for the autumn/winter rollout to provide both direct and indirect protection.

Other considerations for additional booster doses of mRNA vaccines

Considering the epidemiological situation in the Republic of Slovenia, the National Immunisation Technical Advisory Groups (NITAGs) will ultimately make national decision on who should receive the second booster dose of COVID-19 vaccines.

ECDC and EMA will continue to closely evaluate emerging vaccine effectiveness and epidemiological data and will monitor the progress of the development of adapted vaccines. Authorities in the EU will also continue working closely together with the World Health Organization (WHO) and international partners on policies concerning adapted vaccines.

Additional details about the latest advice on second booster doses is available in the ECDC/EMA joint statement.

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