In this illustration from November 27, 2021, syringes with needles are seen in front of a displayed Novavax logo. Portal/Dado Ruvic/Illustration/File Photo Acquire License Rights
Oct 15 (Portal) – European Union (EU) regulators have postponed a decision to grant approval for Novavax’s (NVAX.O) variant-tailored COVID-19 vaccine, the company said on Sunday.
The European Medicines Agency (EMA) has requested more information from Novavax about the shot, which targets the XBB variant, the company said.
“As part of the ongoing review process, the EMA’s Committee for Medicinal Products for Human Use (CHMP) has additional questions, which we are responding to promptly,” Novavax said in an emailed statement to Portal.
The Financial Times, which first reported the news, said the EMA had questions about the effectiveness of the latest version of the vaccine and wanted to ensure its properties were the same across different production sites.
Novavax said it was working closely with the EMA and looked forward to the regulator’s recommendations. The EMA did not immediately respond to Portal’ requests for comment.
EMA director Emer Cooke said in September that she was expected to decide on the use of the vaccine this month. According to the FT report, the authority is expected to give its approval within four weeks.
Novavax said 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 was approved by the U.S. Food and Drug Administration ( FDA) had received emergency use authorization for use in people 12 years of age and older.
Reporting by Rishabh Jaiswal in Bengaluru; Additional reporting by Jose Joseph; Edited by Muralikumar Anantharaman and Jan Harvey
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