EMA evaluate booster dose of COVID-19 vaccine Spikevax

The European Medicines Agency (EMA) is evaluating an application for the use of a booster dose of Spikevax in people aged 12 years and older.

COVID-19 vaccine Moderna

The European Medicines Agency (EMA) has started evaluating an application for the use of a booster dose of Spikevax (formerly COVID-19 Vaccine Moderna) to be given at least six months after the second dose in people aged 12 years and older. 

The EMA’s Committee for Medicinal Products for Human Use (CHMP) will carry out an accelerated assessment of data submitted by the company that markets Spikevax (Moderna), including results from an ongoing clinical trial. Based on this review, the CHMP will recommend whether updates to the product information are appropriate. EMA will communicate the outcome of the assessment in due course. 

The EMA and the European Centre for Disease Prevention and Control (ECDC) have already released a statement regarding their position on booster doses of COVID-19 vaccines, stating that booster doses are not considered urgent in fully vaccinated people, although they also asserted that a booster dose should already be considered for immunocompromised individuals as part of their primary vaccination.

The EMA also stated that evidence on vaccine effectiveness and duration of protection shows that all vaccines authorised in the EU/EEA are currently highly protective against COVID-19-related hospitalisation, severe disease and death, while about one out of three adults in the EU/EEA over 18 years is still currently not fully vaccinated. In this situation, the priority now should be to vaccinate all those eligible individuals who have not yet completed their recommended vaccination course. However, EMA is evaluating the present application to ensure evidence is available to support further doses as necessary.  

Advice on how vaccinations should be given remains the prerogative of the national immunisation technical advisory groups guiding the vaccination campaigns in each EU Member State. EMA stated that while it assesses relevant data, Member States may already consider preparatory plans for giving boosters and additional doses. 

COVID-19 Vaccine Moderna received a conditional marketing authorisation valid throughout the EU on 6 January 2021. The name of the vaccine was changed to Spikevax on 22 June 2021.