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EMA Plans Anaphylaxis Label on Novavax COVID-19 Vaccine

The European agency says there have been “a few cases of anaphylaxis.” The label will also include warnings for paraesthesia and hypoaesthesia.


The European Medicines Agency (EMA) announced yesterday it was going to place a warning label on the Novavax (Nuvaxovid) COVID-19 vaccine for anaphylaxis, paraesthesia (tingling, pricking, chilling, burning, numbness of the skin) and hypoaesthesia (decreased feeling or sensitivity, especially in the skin).

“A few cases of anaphylaxis have been reported spontaneously with use of Nuvaxovid. Generally, cases reported spontaneously by a patient or healthcare professional concern suspected side effects, i.e. medical events that have been observed after vaccination, but which are not necessarily related to or caused by the vaccine,” the EMA wrote in its COVID-19 Vaccines Safety Update.

EMA did not say how many the few cases consisted of, and in the same report, the agency wrote that a total of 1094 cases of suspected side effects spontaneously reported from EU/EEA countries overall and none of these reported a fatal outcome.

According to the EMA, about 216,000 doses of Novavax vaccines had been administered in adults in the European Union from authorization to June 26, 2022.

EMA oversees the evaluation and supervision of medicinal products in the European Union.

It is important to note, other vaccines were discussed in the EMA report, and had warning labels added including tinnitus, paraesthesia and hypoaesthesia warnings for the AstraZeneca COVID-19 vaccine, and extensive swelling of the vaccinated limb for the Moderna COVID-19 vaccine.

Interested parties can go here to learn more about the warning label specifics for the vaccines.

FDA EUA
In the United States, the Food and Drug Administration (FDA) granted Novavax an Emergency Use Authorization (EUA) for its COVID-19 vaccine on Wednesday. The vaccine is indicated as a two-dose primary series for active immunization to prevent the virus in individuals 18 years of age and over.

The Novavax vaccine is seen as an alternative to the mRNA vaccines and do not have the same refrigeration requirements.