EU delays approval of Novavax’s revised COVID vaccine

Novavax’s variant-tailored COVID-19 vaccine has hit a slight delay in its approval process by European Union (EU) regulators, the company announced on Sunday. The European Medicines Agency (EMA) has requested additional information from Novavax regarding the shot, which specifically targets the XBB variant. In response, Novavax assured that it is working diligently to address the EMA’s queries.

The Financial Times, which broke the news, reported that the EMA had concerns about the vaccine’s potency in its latest version and wanted to ensure consistency across different production sites. Novavax, however, remains optimistic and is collaborating closely with the EMA, eagerly awaiting the regulator’s recommendations. The EMA has yet to comment on the matter.

Back in September, EMA director Emer Cooke had stated that a decision on the vaccine’s use was expected this month. According to the Financial Times, the agency aims to grant approval within the next four weeks. Novavax, on the other hand, recently announced that its updated COVID-19 vaccine is already available at various U.S. pharmacies, including CVS and Rite Aid, following emergency use authorization from the U.S. Food and Drug Administration (FDA) for individuals aged 12 and older.

Novavax’s vaccine has been garnering attention for its potential to combat emerging variants of the virus. The company’s dedication to addressing the EMA’s concerns and its successful rollout in the United States demonstrate its commitment to global vaccination efforts. As the world continues to battle the ongoing pandemic, Novavax’s vaccine could play a crucial role in curbing the spread of COVID-19 and protecting vulnerable populations.

While the delay in the EU approval process may be disappointing, it is essential to ensure that all necessary information is provided to regulatory bodies. Novavax’s ongoing collaboration with the EMA reflects its commitment to meeting the highest standards of safety and efficacy. With the global fight against COVID-19 still ongoing, the potential approval of Novavax’s variant-tailored vaccine in the EU would be a significant step forward in the battle against the virus.