EMA evaluates data on Comirnaty® COVID-19 vaccine booster dose

EMA begins evaluating the application for a booster dose of Comirnaty® in adults to be given six months after the second dose.

Pfizer/BioNTech, now Comirnaty, vaccine

The European Medicines Agency (EMA) has started evaluating an application for the use of a booster dose of Comirnaty® to be given six months after the second dose in fully vaccinated people aged 16 years and older to restore protection against COVID-19 after it has waned.

EMA’s Committee for Medicinal Products for Human Use (CHMP) will carry out an accelerated assessment of data submitted by the company that markets Comirnaty, including results from an ongoing clinical trial in which around 300 adults with healthy immune systems received a booster dose approximately six months after the second dose. The committee will subsequently recommend whether updates to the product information are appropriate. The outcome of this evaluation is expected within the next few weeks, unless supplementary information is needed, and will be communicated by agency.

EMA is also separately assessing data from the literature on the use of an additional, third dose of an mRNA vaccine (Comirnaty or SpikeVax) in severely immunocompromised people. According to the regulator, people with severely weakened immune systems who do not achieve an adequate level of protection from their standard primary vaccination may need an ‘additional’ dose as part of their primary vaccination.

EMA will communicate on the outcome of these evaluations in due course. While these evaluations are ongoing, EMA and the European Centre for Disease Prevention and Control (ECDC) have highlighted their current position regarding the need for additional and booster doses of COVID-19 vaccines: both organisations do not consider the need for COVID-19 vaccine booster doses to be urgent in the general population. However, EMA is evaluating the present application to ensure evidence is available to support further doses as necessary. 

The EMA stated that advice on how vaccinations should be given remains the prerogative of the national immunisation technical advisory groups (NITAGs) guiding the vaccination campaigns in each EU Member State. While EMA assesses relevant data, Member States may already consider preparatory plans for administering boosters and additional doses.