Eval­u­a­tion Pro­cess for Boost­er Vac­ci­na­tion with the COVID-19 Vac­cine Spike­vax has Start­ed

The CHMP will conduct an accelerated assessment of the data submitted by Moderna. In an ongoing clinical trial, over 300 adults with healthy immune systems received a booster dose approximately six months after receiving two consecutive doses of the basic immunisation vaccine.
Booster doses are given to people who have completed their basic immunisation to maintain or restore vaccine protection after it has worn off.

After reviewing the data, the CHMP will make a recommendation on whether the variation to the marketing authorisation should be granted by the European Commission. The outcome of this assessment is expected in the coming weeks. If authorised by the European Commission, the booster vaccination will be included in the Spikevax product information.

In a separate procedure, the CHMP is also currently assessing data from the literature on the use of an additional, third dose of the mRNA vaccine Spikevax in severely immunocompromised individuals who may require an additional vaccine dose as part of their basic immunisation to achieve adequate protection.
The EMA office will also provide information on the outcome of these CHMP assessments in due course.

Background

The EMA and the European Centre for Disease Prevention and Control (ECDC) have stated their current position on the need for supplementary and booster doses of COVID-19 vaccine in a separate communication. Although the EMA and ECDC do not consider the need for booster doses of COVID-19 vaccine in the general population to be urgent, the CHMP at the EMA is reviewing the current application to ensure that there is evidence to support additional doses in the event of a severe decline in vaccine effectiveness.

Advice on how to vaccinate is provided by the National Immunisation Technical Advisory Groups (NITAGs), among others. While the CHMP is assessing relevant data, the Member States may already be considering preparatory plans for the administration of booster vaccines and additional doses. In Germany, the Standing Committee on Vaccination (Ständige Impfkommission, STIKO) has already recommended an additional vaccine dose for people with immunodeficiency.

Spikevax is a vaccine for the prevention of COVID-19. It is currently authorised for use in people aged 12 years and older. It contains messenger RNA (mRNA) with the genetic information to form the spike protein, a surface protein of SARS-CoV-2.