Article mid August...Stanley Erck, chief executive of Novavax,...

Article mid August...

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 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”. Novavax’s Covid jab was touted as an important addition to meet the global clamour for vaccines, but the company has not yet received approval from any medicines regulator.

The company’s protein-based Covid vaccine is 90 per cent effective at preventing severe disease. “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 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, working with the Serum Institute of India, said it had sent data to agencies in India, Indonesia and the Philippines, marking the drugmaker’s first regulatory submission. “We’re in the best place we’ve been globally,” said Erck. “Now that we have our first [data] package done, the others I think are going to be pretty straightforward.”