EMA evaluating booster doses of COVID-19 vaccines

Evaluation of data on booster doses of Comirnaty and Spikevax are now underway at the European Medicines Agency (EMA), according to a recent press release.

Comirnaty, the name for Biotech – Pfizer mRNA vaccine, is authorised for use in people aged 12 and older. EMA’s Committee on Human Medicines (CHMP started evaluating an application for the use of a booster dose of Comirnaty to be given 6 months after the second dose in people aged 16 years and older as a way to boost protection after it has waned.

Spikevax (formerly COVID-19 Vaccine Moderna) is also to be given after six months of the second dose in people aged 12 years and older.

CHMP plans to carry out an accelerated assessment of data submitted by the two companies, including data from ongoing clinical trials. Depending on the strength of evidence, CHMP will recommend whether updates to the product information are required.

Both EMA and the European Centre for Disease Prevention and Control (ECDC) have already made clear what their positions are on booster doses, which was that booster doses were not necessarily critical in fully vaccinated people, unless they were immunocompromised.

EMA has already reviewed evidence on vaccine effectiveness and duration of protection, and verified the highly protective effects of all authorised vaccines against COVID-19-related hospitalisation, severe disease and death.

However, with around 30% of all adults in the EU yet to be inoculated, EMA believes the urgency should be to vaccinate all those eligible individuals who still have to complete vaccination courses.

National immunisation technical advisory groups of individual member states still retain prerogative on how vaccinations are to be given remains. EMA’s role is simply to assess relevant data, and member States are free to consider contingency plans for booster doses and additional doses.

Comirnaty and Spikevax received conditional marketing authorisation across the EU, respectively on 21 December 2020 and 6 January 2021.