Coronavirus newest: Novavax delays vaccine approval plans to 3rd quarter

Coronavirus latest: Novavax delays vaccine approval plans to third quarter

Novavax has pushed again its timeline and can apply for authorisation of its vaccine within the UK, US and Europe within the third quarter of the yr as the corporate struggles to rapidly collate the information required for submission.

“It’s only a lengthy course of,” Stanley Erck, chief govt of Novavax, informed the Monetary Instances. “Our steering had been that we’d get the venture executed by the second quarter and I’m now saying … we will’t get all of it executed by the top of June so it’s going to slide into the third quarter sadly.”

His feedback got here because the biotech reported first-quarter revenues of $447m, surpassing analysts’ expectations of $234m and surging past the $3m price of gross sales that it booked in the identical interval final yr.

The US and UK are usually not reliant on the Novavax jab for immunising their populations as a result of orders from different authorised drugmakers have been met. But when authorised, the protein-based vaccine would increase the worldwide provide of jabs and profit growing international locations, particularly as a result of the jab will be simply saved in a fridge.

Novavax’s two-dose vaccine has proved 96 per cent efficacy towards the unique pressure of coronavirus and 86 per cent efficacy towards the variant first detected within the UK.

“It’s the amount of labor,” Erck stated in regards to the delay, including that the corporate has gone from a employees of 150 to 900 over the previous yr. “I should have 100 consultants which might be engaged on it.”

Novavax’s UK scientific trial information are full however it’s engaged on amassing manufacturing information that might present the drugmaker can safely and repeatedly make the identical vaccine doses. Its US scientific trial is anticipated to complete within the second quarter of the yr.

The Maryland-based firm made a internet lack of $223m within the three months to March. Analysts had anticipated a internet lack of $256m.

Erck stated the biotech has struggled with a scarcity of uncooked supplies together with luggage, filters and cell tradition media. He stated it was “painful” that one Novavax plant didn’t function for 3 weeks due to a scarcity of supplies, which has now been resolved. If all its crops are working at full capability, Novavax ought to be capable to make 150m doses each month, he added.

Novavax’s share worth has rocketed almost four,000 per cent because the begin of 2020. Its shares rose three per cent in after-market buying and selling on Monday after closing 9 per cent decrease.

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