Novavax Again Delays Filing for Vaccine Approval
US biotech Novavax has again delayed filing for approval of its protein-based Covid-19 vaccine at least until July this year, citing issues related to an assay needed to show that its manufacturing process is consistent across different sites. CEO Stanley Erck said the company now aims to submit data to regulators in the UK, US and EU in the third quarter of 2021 rather than in the second quarter as previously planned. The vaccine is currently in a rolling review with the European Medicines Agency (EMA).
Management has also pushed back its forecast to reach full production run of 150 million doses per month until the fourth quarter. Its earlier target was the third quarter. Due to frequently cited problems in sourcing 2,000-liter plastic bags used to grow cells for vaccine production, for the present Novavax has also halved its expected output, which it initially put at 70-80 million doses per month.
CureVac slams US export restrictions
Novavax is not the only vaccine manufacturer citing problems with procuring materials. In an interview with German magazine Der Spiegel, CureVac CEO Franz-Werner Haas lashed out at US export restrictions. “Due to the Defense Production Act, we are not getting certain goods out of the USA," he told the magazine, adding that “at times we live from hand-to-mouth.”
Items in short supply, Haas said, include special plastic containers as well as the nucleotides it needs to produce messenger RNA, the vaccine's active ingredient. The biotech aims to produce up to 300 million doses of the vaccine called CVnCoV in 2021 and up to 1 billion in 2022. Its biggest customer is the EU, which has ordered 405 million doses. Curevac hopes to apply to European authorities for conditional marketing authorization before the end of the second quarter.
Author: Dede Williams, Freelance Journalist
