Severe allergic reactions are a new potential side effect of Novavax’s COVID-19 vaccine, the European Medicines Agency reported Thursday.
An updated safety assessment of the drug reported anaphylaxis, which can cause breathing difficulties and death, and “unusual or decreased feeling in the skin.” The product information will be updated in Europe to include information about the reactions, according to the report.
The news comes a day after the U.S. Food and Drug Administration authorized the vaccine for emergency use in adults aged 18 years and older. The vaccine, which goes by the brand name Nuvaxovid among others, received conditional authorization in Europe in December of 2021.
The frequency of the adverse reactions is unknown, with “a few cases” reported of anaphylaxis, the EMA noted. Anaphylaxis can cause breathing difficulties and death. In addition, there have been rare reports of paraesthesia, (unusual feelings in the skin such as a tingling or a crawling sensation) and hypoaesthesia, or decreased
feeling or sensitivity.
“It is generally difficult to robustly estimate side effect frequencies from spontaneously reported cases of suspected side effects,” the EMA stated.
Monitoring vaccine recipients
Allergic responses are also recognized as potential side effects for the other COVID-19 vaccines approved for use in the United States. A reaction will usually occur soon after the vaccine is given. U.S. vaccine recipients are therefore advised to wait 15 minutes at their vaccination location after receiving COVID-19 vaccines to be monitored for potential reactions. The EU’s drug agency advises the same vaccination safety protocol.
“Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic reaction,” it stated. In addition, a second dose of the Novavax vaccine should be avoided for those who experienced anaphylaxis after the first dose, it said.
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