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EU regulators have delayed a decision to approve Novavax’s variant-tailored Covid-19 vaccine, dealing a blow to the US-listed biotech company as it faces a decline in demand for coronavirus jabs.
The European Medicines Agency, originally scheduled to approve the updated vaccine last Friday, has instead requested additional information. In 2021, the regulator also raised concerns about Novavax’s first Covid jab before eventually granting approval.
Novavax told the Financial Times, “As part of the ongoing review process, [the EMA] has additional questions, which we are answering expeditiously.”
The company emphasized its continued collaboration with the regulator to develop an updated protein-based Covid vaccine that does not rely on mRNA technology.
According to an insider, the EMA has raised questions about the potency of the latest version of the vaccine and wants to ensure consistency across production sites.
The EMA has declined to comment on the matter.
Novavax, whose Covid vaccine is its sole product, expressed doubt about its future in February. The company recently announced plans to cut costs by up to 50% and reduce its workforce by 25%.
Novavax’s shares have plummeted 98% from their 2021 peak, reaching just over $7 on Friday and giving the company a market value of $674mn.
Insiders suggest that the EMA is likely to grant its approval within four weeks. The US Food and Drug Administration has already approved the variant formulation of the vaccine earlier this month.
An insider added, “This is the first time they are changing the composition of their vaccine, and it’s important to ensure that the vaccine remains potent.”
Novavax faced challenges with production, causing it to enter the market later than its competitors. However, its Covid vaccine, which uses a more traditional technology, has proven to be safe and highly effective in trials.
Initially, health authorities hoped Novavax’s vaccine could convince skeptics who preferred not to receive mRNA vaccines, but demand has declined significantly.
Considering the saturation of the European market with BioNTech/Pfizer and Moderna shots, the impact of Novavax’s approval on its revenues remains uncertain.
Novavax stated, “We intend to supply doses of our vaccine to European countries that have requested it through advanced purchase agreements post-authorization. We value EMA’s continued partnership and look forward to their recommendation and the European Commission’s decision.”
The company also added, “We have made tremendous progress in strengthening the financial position of the company.”
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