September 28, 2021

EMA evaluating data on booster dose of COVID-19 vaccine Spikevax

The European Medicines Agency (EMA) 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 6 months after the second dose in people aged 12 years and older.

“EMA’s human medicines committee (CHMP) will carry out an accelerated assessment of data submitted by the company that markets Spikevax (Moderna), including results from an ongoing clinical trial,” the agency noted, adding that “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.”

According to the EMA, while this evaluation is ongoing, the agency and the European Centre for Disease Prevention and Control (ECDC) have highlighted their position regarding the need for additional and booster doses of COVID-19 vaccines in a separate communication, noting that “although EMA and ECDC do not consider the need for COVID-19 vaccine booster doses to be urgent in the general population, EMA is evaluating the present application to ensure evidence is available to support further doses as necessary.”

Nonetheless, the EMA said “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,” adding that “while [it] assesses relevant data, Member States may already consider preparatory plans for giving boosters and additional doses.”

SOURCE: European Medicines Agency