Researchers Break From Normal Protocol In Rush To Create Vaccine As Pandemic Deaths Mount Ever Higher
Scientists aren't testing in animals first in a highly unusual step that some consider justified and others irresponsible.
Reuters:
As Pressure For Coronavirus Vaccine Mounts, Scientists Debate Risks Of Accelerated Testing
Drugmakers are working as quickly as possible to develop a vaccine to combat the rapidly spreading coronavirus that has infected more than 100,000 people worldwide. Behind the scenes, scientists and medical experts are concerned that rushing a vaccine could end up worsening the infection in some patients rather than preventing it. Studies have suggested that coronavirus vaccines carry the risk of what is known as vaccine enhancement, where instead of protecting against infection, the vaccine can actually make the disease worse when a vaccinated person is infected with the virus. (3/11)
Stat:
Coronavirus Vaccine Clinical Trial Starting Without Usual Animal Data
As they race to test an experimental coronavirus vaccine, researchers aren’t waiting to see how well it prevents infection in animals before trying it in people, breaking from the usual protocol. “I don’t think proving this in an animal model is on the critical path to getting this to a clinical trial,” said Tal Zaks, chief medical officer at Moderna, a Cambridge, Mass.-based biotech that has produced a Covid-19 vaccine candidate at record speed. He told STAT that scientists at the National Institutes of Health are “working on non-clinical research in parallel.” Meanwhile, the clinical trial started recruiting healthy participants in the first week of March. (Boodman, 3/11)
WBUR:
Test Kits, Antiviral Drugs And Vaccines: The Science You Need To Know About Coronavirus
What does it take to make an effective vaccine quickly? Why are testing kits so hard to find? What makes this coronavirus so virulent? We’ll dig deep into the science you need to know. (Chakrabarti and Kotsonis, 3/12)
In other pharmaceutical news —
NPR:
China's Drug Manufacturers Are Getting Back To Work
The coronavirus outbreak that originated in Wuhan, China, is causing businesses, health officials and patients to worry about potential shortages of prescription drugs. That's because the vast majority of active ingredients in medicines dispensed in the U.S. are made in factories overseas, many in China. NPR has exclusive reporting on how disruptions in China are affecting some drugmakers' ability to make key ingredients. On March 3, we emailed facilities registered with the U.S. Food and Drug Administration to ask what products they manufacture, how the outbreak was affecting their work and how they were coping. (Lupkins, 3/12)
