The regulatory bodies of the European Union (EU) They have delayed the decision to approve the vaccine COVID-19 of Novavaxas reported on Sunday by the Financial Times.
The European Medicines Agency (EMA), which was due to approve the updated vaccine last Friday, has requested more information from the company, according to the report.
“As part of the ongoing review process, (the EMA) has additional questions, which we are responding to quickly.”Novavax told the FT.
The EMA has questions about the potency of the latest version of the vaccine and wants to ensure that its characteristics will be the same across production sites, the FT report said, citing a person with knowledge of the matter.
Novavax and the EMA did not immediately respond to Reuters requests for comment.
Novavax said Friday that its updated COVID-19 vaccine was available at U.S. pharmacies such as CVS and Rite Aid, a week after receiving authorization from the U.S. Food and Drug Administration (FDA) for emergency use in people 12 years or older.
The updated vaccines are aimed at the XBB variant.
The EMA is expected to give its approval within four weeks, the FT report added.
Source: Reuters
Source: Gestion
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