A rare neurological condition has been identified as a potential risk of the Pfizer-BioNTech COVID-19 vaccine, the US Food and Drug Administration (FDA) said in a statement Wednesday.

The condition, known as Multisystem Inflammatory Syndrome in Children (MIS-C), is a rare but serious condition that affects the heart, lungs, kidneys, brain, skin, eyes and other organs. It is believed to be triggered by an infection with the novel coronavirus.

The FDA said it was aware of the potential for this rare neurological condition to occur in people who have received the Pfizer-BioNTech vaccine, and that it was an “important potential risk”.

The agency said it was working with the Centers for Disease Control and Prevention (CDC) and other public health partners to further investigate the potential risk.

The FDA said it was important for healthcare providers to be aware of the potential for MIS-C in people who have received the Pfizer-BioNTech vaccine and to report any cases to the Vaccine Adverse Event Reporting System (VAERS).

The agency also urged healthcare providers to remain vigilant for signs and symptoms of MIS-C in people who have received the Pfizer-BioNTech vaccine and to report any cases to VAERS.

The FDA said it was continuing to evaluate the safety and effectiveness of the Pfizer-BioNTech vaccine and that it was committed to ensuring the safety of all vaccines.