The European Medical Agency (EMA) has commenced evaluating data on a booster dose of Pfizer-BioNTech’s Covid-19 vaccine Comirnaty.

The booster dose is intended for people aged 16 years and above, administered six months after receiving the two-dose primary regimen, to restore protection.

EMA’s human medicines committee (CHMP) is expected to undertake an accelerated assessment of data submitted by Pfizer and BioNTech.

The assessment includes results from an ongoing clinical trial of the booster dose in nearly 300 adults with healthy immune systems, after six months from the second dose.

CHMP will announce the outcome of its assessment in few weeks, except if any supplementary information is required.

Comirnaty is a messenger RNA (mRNA)-based vaccine candidate, designed to produce spike protein of SARS-CoV-2, the virus that causes Covid-19.

Previously known as Pfizer-BioNTech Covid-19 vaccine, Comirnaty is currently authorised in the US for use in individuals aged 12 and older.

Also, it was recently approved to prevent Covid-19 in people aged 16 years and above as the first Covid-19 vaccine to receive full regulatory approval by the FDA.

Recently, European Centre for Disease Prevention and Control (ECDC) has issued a report which noted that there is no urgent need for a booster dose for fully vaccinated individuals.

Also, the report stated that additional doses should be allocated for people with severely weakened immune systems as part of their primary vaccination.

The regulator said that together with ECDC, it does not consider the need for Covid-19 vaccine booster doses to be urgent in the general population.

People with severely weak immune systems who do not achieve adequate protection from the primary vaccination may need an additional dose.

Earlier this month, Moderna has filed an application with the EMA, seeking conditional marketing approval for a booster shot of its mRNA vaccine SpikeVax, at a 50μg dose.

EMA stated that it is evaluating data on the use of an additional, third dose of an mRNA vaccine, including Comirnaty and SpikeVax, in severely immunocompromised people.