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Novavax has further delayed the submission of data for its Covid-19 vaccine to the US regulator as the biotechnology company continues to struggle with collating consistent manufacturing information.
Its shares were down more than 10 per cent in after-market trading following the announcement.
Stanley Erck, chief executive of Novavax, told the Financial Times: “It’s getting all the manufacturing, all the analytics, potency and purity assays in line and qualified and valid. It’s a time-consuming process.”
He said Novavax would submit data for emergency use approval of its two-dose vaccine to the Food and Drug Administration in the fourth quarter of the year, a further push back from a previous delay from the second to third quarter. He said submissions to the European and UK medicines regulators would be made in the third quarter.
Erck said Novavax would apply for UK approval in September and to other regulators including in Europe and Canada “within weeks of that”.
“We have a traditional way of doing a potency assay that takes x amount of time that can be used in the [UK’s Medicines and Healthcare products Regulatory Agency] filings and there’s a second generation version of that we’re working on with the FDA that’s not validated yet,” said Erck.
Assays are tests carried out to determine the quality and effect of a drug. The company must show regulators that its manufacturing processes are consistent across all facilities.
On Thursday, the Maryland-based company said it had sent data to agencies in India, Indonesia and the Philippines, marking the drugmaker’s first regulatory submission.
Erck’s comments came as Novavax reported a $352m loss in the second quarter, deeper than the $18m loss it made in the first quarter of the year and below analysts’ expectations.
The company’s protein-based Covid vaccine is 90 per cent effective at preventing against severe disease.
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