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EU regulators have delayed a decision to approve Novavax’s variant-tailored Covid-19 vaccine, in a setback for the US-listed biotech which is battling a slump in demand for coronavirus jabs.
The European Medicines Agency, which was due to approve the updated jab last Friday, instead requested more information. The regulator had also raised questions to the drugmaker in 2021 for its first Covid jab before eventually approving the shot.
“As part of the ongoing review process, [the EMA] has additional questions, which we are answering expeditiously,” Novavax told the Financial Times.
The company continued to work in “close partnership” with the regulator on the “shared goal” of bringing an updated protein-based Covid jab not based on the mRNA technology, it added.
The EMA has questions on the potency of the latest version of the jab and seeks to ensure its characteristics are the same across different production sites, said one person with knowledge of the talks.
The EMA declined to comment.
Novavax, whose Covid jab is the only product it can market, warned in February that there was “substantial doubt” about its future and recently detailed plans to slash costs by up to 50 per cent and reduce the company’s 2,000-strong workforce by a quarter.
Shares have declined 98 per cent from their 2021 highs to a little over $7 on Friday, giving it a market value of $674mn.
The EMA is expected to give its approval within four weeks, one of the people said. The jab’s variant formulation was approved by the US Food and Drug Administration earlier this month.
“It is the first time they change the composition of their jab and this is the first non-mRNA one, so it’s important to ensure the vaccine acts in the same way when it comes to potency,” the person added.
Beset with production issues, Novavax was late to market, although its Covid vaccine, made with a more traditional technology, has been shown to be safe and highly effective in trials.
Health authorities had also hoped it could help sway sceptics who preferred not to receive an mRNA vaccine, though demand has since collapsed.
Because the European market is saturated with the BioNTech/Pfizer and Moderna shots, it remains unclear what impact on its revenues an approval might have.
Novavax “intends to supply doses of our vaccine to European countries that have requested it through advanced purchase agreement post-authorisation”, it said. “We value EMA’s continued partnership and look forward to their recommendation and the European Commission decision.”
“We have made tremendous progress in strengthening the financial position of the company,” it added.
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