EU delays approval of Novavax's revised COVID vaccine
EU delays approval of Novavax's revised COVID vaccine
(Reuters) - European Union (EU) regulators have delayed a decision to give approval for Novavax's (NVAX.O) variant-tailored COVID-19 vaccine, the Financial Times said on Sunday.
The European Medicines Agency (EMA), which was due to approve the updated vaccine last Friday has requested more information from the company, the FT report added.
"As part of the ongoing review process, (the EMA) has additional questions, which we are answering expeditiously," Novavax told the Financial Times.
The EMA has questions on the potency of the vaccine's latest version, and it seeks to ensure its characteristics are going to be the same across different 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 on Friday that its updated COVID-19 vaccine was available at U.S. pharmacies such as CVS (CVS.N) and Rite Aid (RAD.N), a week after it received clearance from the U.S. Food and Drug Administration (FDA) for emergency use in individuals aged 12 years and older.
The updated shots target the XBB variant.
The EMA is expected to give its approval within four weeks, the FT report added further.
