The European Medicines Agency (EMA) identified severe allergic reactions as potential side effects of the Novavax COVID-19 vaccine on Thursday.

The protein-based vaccine is the fifth one recommended in the EU for preventing COVID-19, and got a conditional marketing authorization on December, 2021, according to a statement from the EMA. 

The regulator also updated the vaccine's label to include the risk of unusual or decreased feeling in the skin as a side effect.

An emergency use authorization was issued on Wednesday for the vaccine by the U.S. Food and Drug Administration (FDA) in individuals aged 18 and older.

The FDA said common side effects with the vaccine include pain, swelling, redness and itching at injection site, fatigue, headache, joint pain, vomiting, fever and chills.

It warned against administering the shot to people with "a severe allergic reaction after a previous dose of this vaccine" or "to any ingredient of this vaccine."

The vaccine producer, Novavax Inc., said in a statement after the EMA updating its label that the reason why allergic reaction had not been listed on the initial label was because its "clinical development program reported no severe allergic reactions" and since severe allergic reaction "can occur with all vaccines," the company agreed to update the label.

About 216,000 doses of the vaccine had been administered in Europe as of June 26, according to statistics released by the EMA.

(With input from Reuters)