EU delays approval of Novavax’s revised COVID vaccine – FT

Novavax’s variant-tailored COVID-19 vaccine faces a slight delay in receiving approval from European Union (EU) regulators, according to a report by the Financial Times. The European Medicines Agency (EMA), which was scheduled to grant approval for the updated vaccine last Friday, has requested additional information from Novavax. The company has assured that it is responding promptly to the EMA’s queries.

The EMA’s questions primarily revolve around the potency of the latest version of the vaccine and ensuring consistency across different production sites. By seeking clarification on these aspects, the EMA aims to guarantee that the vaccine’s characteristics remain unchanged regardless of where it is manufactured. Novavax and the EMA have yet to comment on the matter.

Despite the delay in EU approval, Novavax recently announced that its updated COVID-19 vaccine is now available at various U.S. pharmacies, including CVS and Rite Aid. The U.S. Food and Drug Administration (FDA) granted emergency use authorization for the vaccine in individuals aged 12 years and older. The updated shots specifically target the XBB variant, which is a significant step in combating the evolving nature of the virus.

While the EMA’s decision is now expected within the next four weeks, Novavax remains committed to providing a safe and effective vaccine to combat the ongoing pandemic. The company’s swift response to the EMA’s queries demonstrates its dedication to meeting regulatory requirements and ensuring the highest standards of quality.

Novavax’s COVID-19 vaccine has shown promising results in clinical trials, with high efficacy rates against the original strain of the virus. The company’s commitment to tailoring the vaccine to address emerging variants showcases its proactive approach in staying ahead of the ever-changing landscape of the pandemic.

As the world continues to battle the COVID-19 crisis, the importance of effective vaccines cannot be overstated. Novavax’s dedication to developing a variant-tailored vaccine, coupled with its availability in U.S. pharmacies, highlights the company’s contribution to global vaccination efforts. With the imminent approval from the EMA, Novavax’s vaccine could soon play a crucial role in Europe’s fight against the pandemic, offering hope for a safer and healthier future.