The European Medicines Agency (EMA) Monday announced that it has started evaluating an application for the use of a booster dose of Spikevax, Moderna's COVID-19 vaccine, to be given at least six months after the second dose in people aged 12 years and older. Booster doses are given to vaccinated people to restore protection after it has waned, it said in a press release. EMA's human medicines committee will carry out an accelerated assessment of data submitted by the company that markets Moderna, including results from an ongoing clinical trial. EMA, which is based in Amsterdam, said it would communicate the outcome of the assessment in due course. Although EMA and the European Centre for Disease Prevention and Control do not consider the need for COVID-19 vaccine booster doses to be urgent in the general population, EMA said it is evaluating the present application to ensure evidence is available to support further doses as necessary. EMA's human medicines committee (CHMP) will carry out an accelerated assessment of data submitted by the company. Based on this review, the CHMP will recommend whether updates to the product information are appropriate. Advice on how vaccinations should be given remains the prerogative of the national immunization technical advisory groups guiding the vaccination campaigns in each EU Member State. While EMA assesses relevant data, member states may already consider preparatory plans for giving boosters and additional doses. Spikevax is a vaccine for preventing COVID-19. It is currently authorized for use in people aged 12 and older. It contains a molecule called messenger RNA (mRNA) with instructions for producing a protein, known as the spike protein, naturally present in SARS-CoV-2, the virus that causes COVID-19. The vaccine works by preparing the body to defend itself against SARS-CoV-2. — Agencies
