Novavax has pushed back its timeline and will apply for authorisation of its vaccine in the UK, US and Europe in the third quarter of the year as the company struggles to quickly collate the data required for submission.
“It’s just a long process,” Stanley Erck, chief executive of Novavax, told the Financial Times. “Our guidance had been that we’d get the project done by the second quarter and I’m now saying … we can’t get it all done by the end of June so it’s going to slip into the third quarter unfortunately.”
His comments came as the biotech reported first-quarter revenues of $447m, surpassing analysts’ expectations of $234m and surging beyond the $3m worth of sales that it booked in the same period last year.
The US and UK are not reliant on the Novavax jab for immunising their populations because orders from other authorised drugmakers have been met. But if authorised, the protein-based vaccine would boost the global supply of jabs and benefit developing countries, especially because the jab can be easily stored in a refrigerator.
Novavax’s two-dose vaccine has proved 96 per cent efficacy against the original strain of coronavirus and 86 per cent efficacy against the variant first detected in the UK.
“It’s the volume of work,” Erck said about the delay, adding that the company has gone from a staff of 150 to 900 over the past year. “I must have 100 consultants that are working on it.”
Novavax’s UK clinical trial data are complete but it is working on collecting manufacturing data that would show the drugmaker can safely and repeatedly make the same vaccine doses. Its US clinical trial is expected to finish in the second quarter of the year.
The Maryland-based company made a net loss of $223m in the three months to March. Analysts had expected a net loss of $256m.
Erck said the biotech has struggled with a shortage of raw materials including bags, filters and cell culture media. He said it was “painful” that one Novavax plant did not operate for three weeks because of a shortage of materials, which has now been resolved. If all its plants are operating at full capacity, Novavax should be able to make 150m doses every month, he added.
Novavax’s share price has rocketed nearly 4,000 per cent since the start of 2020. Its shares rose 3 per cent in after-market trading on Monday after closing 9 per cent lower.