Covid-19 roundup: Hydroxychloroquine fails again; Novavax lines up Warp Speed manufacturing partner
Hydroxychloroquine has failed in another major trial.
In a new study in the New England Journal of Medicine, 667 early-stage hospitalized patients were randomized to receive either standard of care, the anti-malaria drug, or the anti-malaria drug plus azithromycin. After 15 days, the patients in the different trial arms showed no difference in clinical improvement. Those in the hydroxychloroquine arm did, however, have more adverse events: namely a prolonged QT interval and an elevated number of liver enzymes.
The trial, conducted in Brazil, is just the latest in an expanding body of evidence suggesting the drug that captured much of the world’s attention and was promoted often by President Trump has little to no effect on Covid-19. Previous studies showed it worked neither as post-exposure prophylaxis nor in hospitalized patients. Leading research institutions and companies, including the NIH, Novartis and WHO, have halted studies on the drug.
Still, there is a small but vocal handful of public health researchers who continue to argue for the drug’s use in very early-stage patients. And some of the drug’s top non-medical proponents, including Trump and his allies, continue to push for the drug’s use by touting observational studies that are widely regarded as less informative than the randomized controlled studies that have come up negative.
Novavax gets Fujifilm to scale vaccine
Asked on a recent media call why Novavax needed $1.6 billion in Operation Warp Speed to support its Covid-19 vaccine, when AstraZeneca had just received less money for more doses and J&J and Moderna had received even less, a senior administration official pointed to manufacturing. A small biotech with no approved products, Novavax had virtually no manufacturing base and had much further to go in scaling up its product.
Today, Novavax gave the first glimpse of how it will spend that cash. The Maryland-based biotech announced a deal with Fujifilm Diosynth Biotechnologies to manufacture the drug substance for its Covid-19 vaccine, called NVX-CoV2373 at the Japanese drugmaker’s facility in Morrisville, North Carolina.
Production of the protein subunit vaccine has already begun, the companies said. Financial terms were not disclosed.
Novavax said they expect to read out Phase I/II results in the first week of August and then begin a 30,000-person Phase III in the fall. Fujifilm will make the doses for that trial, but it’s unclear if they will also have a hand in the rest of Novavax’s production, including the 100 million doses Novavax has promised to the US Government under OWS.
“We are grateful to partner with the team at FUJIFILM Diosynth Biotechnologies to ensure the large-scale manufacture of our COVID-19 vaccine candidate,” CEO Stanley Erck said in a statement.
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