EU regulators delay approval of Novavax’s revised Covid-19 vaccine

European Union (EU) regulators have delayed a decision to give approval for Novavax’s variant-tailored COVID-19 vaccine, the company said on Sunday.

 

The European Medicines Agency (EMA) has requested more information from Novavax on the shot, which targets the XBB variant, the company said.

 

“As part of the ongoing review process, EMA’s human medicines committee (CHMP) has additional questions which we are answering expeditiously,” Novavax said in an emailed statement to Reuters.

 

The Financial Times, which first reported the news, said the EMA had questions on the potency of the vaccine’s latest version, and that it is seeking to ensure its characteristics will be the same across different production sites.

 

Novavax said it was working closely with the EMA and is looking forward to the recommendations from the regulator. The EMA did not immediately respond to Reuters’ requests for comment.

 

EMA director Emer Cooke said in September that it expected to decide on the use of the vaccine this month. The agency is expected to give its approval within four weeks, according to the FT report.

 

Novavax said on Friday its updated COVID-19 vaccine was available at US pharmacies such as CVS and Rite Aid , 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.