CHMP Performs Accelerated Assessment of Booster Dose of Spikevax

The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) is going to perform an accelerated assessment of data submitted by Moderna regarding the use of a booster dose of Spikevax (the company’s COVID-19 vaccine).

According to a Sep. 27, 2021 press release, Moderna has applied to the regulatory authority for the use of a booster dose of Spikevax to be given at least six months after the second dose of the vaccine in people 12 years old and older. Based on its review of available data, CHMP will recommend whether or not updates to the product information are appropriate.

In a separate communication, EMA and the European Centre for Disease Prevention and Control (ECDC) have specified that the need for additional and booster doses of COVID-19 vaccines is not urgent for the general population. However, Moderna’s application is being considered to ensure evidence is available to support further doses as necessary.