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EU Holds Back Approval for Novavax’s Revised Covid-19 Vaccine


Setback for Novavax as EU Regulators Seek More Information

The European Medicines Agency (EMA) has decided to postpone the approval of Novavax’s variant-tailored Covid-19 vaccine, marking a setback for the US-listed biotech. This delay comes at a challenging time for Novavax as it grapples with a decline in demand for coronavirus vaccines.

Originally scheduled for approval last Friday, the EMA has requested additional information as part of the ongoing review process. Novavax, which faced questions from the regulator in 2021 regarding its initial Covid jab, is diligently addressing the new queries. The company emphasized its commitment to a close partnership with the EMA to achieve the shared goal of introducing an updated protein-based Covid vaccine that doesn’t rely on mRNA technology.

Responding to the situation, Novavax informed the Financial Times that they are working expeditiously to answer the additional questions posed by the EMA. The regulatory body is particularly interested in understanding the potency of the latest version of the vaccine and ensuring consistent characteristics across various production sites.

One source familiar with the discussions mentioned that the EMA is seeking clarity on the uniformity of the vaccine’s features, highlighting the meticulous evaluation process. However, the EMA has refrained from providing official comments on the matter.

Novavax, whose Covid vaccine is its sole marketed product, faced uncertainty about its future in February, expressing “substantial doubt.” In response, the biotech company recently unveiled plans to cut costs by up to 50% and reduce its workforce by 25%, a strategic move to navigate the challenges in the current landscape.

The delay in the approval process adds to the complexities faced by Novavax, which is striving to maintain its position in the evolving landscape of Covid-19 vaccinations. The outcome of ongoing discussions with the EMA will play a crucial role in shaping the future trajectory of Novavax and its efforts to contribute to global vaccination efforts.


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