The European Medicines Agency (EMA) has recommended a modification to the approved use of the COVID-19 mRNA vaccine Comirnaty (BioNTech Manufacturing GmbH), lowering the eligible age group for certain formulations.

At its April 2026 meeting, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion to update the indication for all Comirnaty 10 mg formulations, including the JN.1, KP.2, and LP.8.1 variants. Under the revised indication, these vaccines are now approved for active immunization against COVID-19 in individuals aged 6 months or older, replacing the previous lower age limit of 5 years. 

The update expands access to variant-adapted mRNA vaccines for younger pediatric populations, aligning with evolving vaccination strategies aimed at broader protection against circulating SARS-CoV-2 variants.

How the Vaccine Works 

Comirnaty contains messenger RNA (mRNA) molecules that provide instructions for producing spike proteins from specific SARS-CoV-2 variants. When administered, cells read the mRNA instructions and temporarily produce spike proteins, prompting the immune system to generate antibodies and activate T cells for protection against future SARS-CoV-2 exposure.

For children aged 6 months to 4 years who have not completed a primary vaccination series and have no history of COVID-19, the first two doses are administered 3 weeks apart, followed by a third dose at least 8 weeks after the second dose.

In contrast, children who have already completed a primary vaccination series or have previously had COVID-19 require only a single dose. Clinicians may administer injections in either the upper arm or the thigh muscles. While the CHMP has issued this recommendation, the vaccine should be used in accordance with the specific official recommendations issued by national public health bodies.

The EMA did not identify, in its announcement, specific trials supporting the revised indication. 

Safety Profile 

The most common side effects with Comirnaty include pain and swelling at the injection site, tiredness, headache, muscle and joint pain, chills, fever, and diarrhea. 

In children aged 6-23 months, the most common side effects also include irritability, sleepiness, loss of appetite, tenderness or redness at the injection site, and fever. 

Comirnaty is under additional monitoring, and its use should continue to follow official national and international vaccination recommendations.

Detailed guidance on dosing and administration will be provided in the updated Summary of Product Characteristics, to be published on the EMA website following the European Commission’s final decision.