Investigators from the University of Oxford began testing a potential vaccine in 1100 volunteer patients, while the vaccine undergoes early mass manufacturing in hopes early results show benefit.
The ChAdOx1 nCoV-19 is comprised of genetic material used to make Spike glycoproteins, a surface protein from SARS-CoV-2 that plays an essential role in the virus’ binding to ACE2 inhibitors and eventual infection of the person.
A week later, Pfizer and BioNTech announced first dosing for a phase 1/2 clinical trial assessing mRNA vaccine candidate in global patients stratified by age groups.
The investigators are hoping to simultaneously evaluate the 4 different mRNA candidates while sharing data with regulatory authorities in real-time—streamlining the process from identifying a safe and viable vaccine, and it reaching the public market.
Another mRNA candidate, mRNA-1273 from Moderna, will be assessed as 2 different doses in 600 participants versus placebo—with hope and expectation of federal support that it will reach phase 3 trial analysis in the Fall.
What is there to make of all these differing candidates? What’s the value of different trial designs? What is a realistic timeline for results?
Answers to these questions are highly dependent on what is learned from clinical results, but a lot could be learned from previous prophylaxis development.
In an interview with Contagion, William Schaffner, MD, professor of Preventive Medicine and Medicine at the Vanderbilt University Medical Center, discussed the finer details of these vaccine candidates and their trial makeup—and gave perspective as to what people should expect in the coming months.
Namely, is it reasonable to begin manufacturing a vaccine for a pandemic disease before it’s known whether it works?
“It’s a little like a horse race,” he said. “The horses haven’t gone around the track yet, but you put your money down.”
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