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Novavax has backtracked on its timeline and will apply for authorization for its vaccine in the UK, US and Europe in the third quarter of the year as the company struggles to quickly collect the data needed to send them.
“It’s just a long process,” Novleyx executive director Stanley Erck told the Financial Times. “Our orientation had been that we would be able to do the project before the second quarter and now I’m saying … we can’t do everything at the end of June, so unfortunately it will be put in the third quarter.”
His comments came when biotechnology reported first-quarter revenue of $ 447 million, exceeding analysts’ expectations of $ 234 million and exceeding the $ 3 million in sales it set aside in the same period. last year.
The United States and the United Kingdom do not rely on the Novavax spike to immunize their populations because orders from other authorized drug manufacturers have been complied with. But if allowed, the protein-based vaccine would increase the global supply of punctures and benefit developing countries, especially because the puncture can be easily stored in the refrigerator.
The Novavax dose vaccine has been shown to be 96% effective against the original coronavirus strain and 86% effective against the variant first detected in the UK.
“It’s the workload,” Erck said of the delay, adding that the company has gone from 150 to 900 cash over the past year. “I have to have 100 consultants working on it.”
Data from Novavax clinical trials in the UK are complete, but work is underway to collect manufacturing data to show that the pharmacist can make the same doses of vaccine safely and repeatedly. Its clinical trial in the United States is expected to end in the second quarter of the year.
The Maryland-based company posted a net loss of $ 223 million in the three months following March. Analysts had expected a net loss of $ 256 million.
Erck said biotechnology has struggled with the shortage of raw materials, including bags, filters and cell culture media. He said it was “painful” that a Novavax plant would not work for three weeks due to the shortage of materials, which has now been resolved. If all of its plants are operating at full capacity, Novavax should be able to dose 150 million each month, he added.
Novavax’s share price has soared nearly 4,000% since early 2020. Its shares rose 3% on Monday after closing 9%.
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