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EU regulators have delayed a decision to approve Novavax’s variant-tailored Covid-19 vaccine, a setback for the U.S.-listed biotechnology company as it struggles with a drop in demand for coronavirus shots.
The European Medicines Agency, which was due to approve the updated shot last Friday, instead requested more information. The regulator had also asked the drugmaker questions about its first Covid vaccination in 2021 before ultimately approving the shot.
“As part of the ongoing review process [the EMA] has further questions, which we will answer immediately,” Novavax told the Financial Times.
The company continued to work in “close partnership” with the regulator on the “shared goal” of bringing to market an updated protein-based Covid vaccination that is not based on mRNA technology, it added.
The EMA has questions about the effectiveness of the latest version of the vaccine and wants to ensure its properties are the same across different production sites, a person with knowledge of the talks said.
The EMA declined to comment.
Novavax, whose Covid shot is the only product it can market, warned in February that there was “significant doubt” about its future and recently unveiled detailed plans to cut costs by up to 50 percent and cut 2,000 employees of the company by a quarter.
Shares are down 98 percent from their 2021 highs to just over $7 on Friday, giving them a market value of $674 million.
The EMA is expected to give its approval within four weeks, one of the people said. The variant formulation of the vaccine was approved by the U.S. Food and Drug Administration earlier this month.
“It is the first time that they are changing the composition of their vaccine and this is the first that is not based on mRNA. Therefore, it is important to ensure that the vaccine works in the same way in terms of effectiveness,” the person added.
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Due to production problems, Novavax was late to market, although its Covid vaccine, made using more traditional technology, has proven safe and highly effective in trials.
Health authorities had also hoped it might help convince skeptics who preferred not to get an mRNA vaccine, although demand has since collapsed.
With the European market saturated with the vaccines from BioNTech/Pfizer and Moderna, it remains unclear what impact approval could have on the company’s revenue.
Novavax “intends to supply doses of our vaccine to European countries that have requested it under an advance purchase agreement following approval,” it said. “We value EMA’s continued partnership and look forward to their recommendation and the European Commission’s decision.”
“We have made tremendous progress in strengthening the company’s financial position,” it added.