(CercleFinance.com) – Novavax shares fell 26% yesterday on the Nasdaq, and are currently losing 4% in London, after the European Medicines Agency (EMA) announced yesterday an update to the label of the Covid vaccine to include the risk of severe allergic reactions.
‘This update is a commonly included disclaimer for commercially available vaccines, including COVID-19 vaccines. Novavax’s clinical development program has not reported any serious allergic reactions and therefore this risk was not listed on the original product label,’ Novavax defended yesterday.
The laboratory reports two cases of anaphylaxis (allergic reaction) which met a probable/certain case definition. “Given that anaphylaxis can occur with all vaccines and based on these cases, Novavax and the EMA have agreed to update the label accordingly,” continues Novavax.
As a reminder, Novavax had received an emergency use authorization for its Covid vaccine from the United States Food and Drug Administration (FDA) on July 13, in order to provide a primary series of two doses for the active immunization of the SARS-CoV-2 in people 18 years and older.
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