From: PDX (and now) London, UK
ORIGINAL: Cap Mandrake
Of all the different pharma companies researching a vaccine, who has the best chance of finding an effective one? There are several trying now
Can it be done by early next year?
A new question has arisen along these lines. Generally, you first do relatively large scale safety trials. Then you do a placebo controlled efficacy study which would take many, many months.
Some are now advocating a COVID CHALLENGE test of a vaccine. You sign up a couple of hundred volunteers and then you give them the vaccine..wait two weeks or so and then you DELIBERATELY expose them to the virus in a method highly likely to effect transmission under normal circumstances (for example, intranasal instillation of the the virus). Given that 95% of those who become ill after exposure to a sick person become ill by 11.5 days, you could have meaningful results in 3 weeks. Now, this is obviously ethically fraught because of the severe risk but 7,000 of your fellow human have SIGNED UP to do exactly that if needed.
This group is already in the human testing phase. A bit of a head start. I'd seen this is the UK press last week but this NY Times piece seems to be the latest news on it.
Most other teams have had to start with small clinical trials of a few hundred participants to demonstrate safety. But scientists at the university’s Jenner Institute had a head start on a vaccine, having proved in previous trials that similar inoculations — including one last year against an earlier coronavirus — were harmless to humans.
That has enabled them to leap ahead and schedule tests of their new coronavirus vaccine involving more than 6,000 people by the end of next month, hoping to show not only that it is safe, but also that it works.
The Oxford scientists now say that with an emergency approval from regulators, the first few million doses of their vaccine could be available by September — at least several months ahead of any of the other announced efforts — if it proves to be effective.
Scientists at the National Institutes of Health’s Rocky Mountain Laboratory in Montana last month inoculated six rhesus macaque monkeys with single doses of the Oxford vaccine. The animals were then exposed to heavy quantities of the virus that is causing the pandemic — exposure that had consistently sickened other monkeys in the lab. But more than 28 days later all six were healthy, said Vincent Munster, the researcher who conducted the test.
If social distancing measures or other factors continue to slow the rate of new infections in Britain, he said, the trial might not be able to show that the vaccine makes a difference: Participants who received a placebo might not be infected any more frequently than those who have been given the vaccine. The scientists would have to try again elsewhere, a dilemma that every other vaccine effort will face as well.
Donors are currently spending tens of millions of dollars to start the manufacturing process at facilities in Britain and the Netherlands even before the vaccine is proven to work, said Sandy Douglas, 37, a doctor at Oxford overseeing vaccine production.
“There is no alternative,” he said.
But the team has not yet reached an agreement with a North American manufacturer, in part because the major pharmaceutical companies there typically demand exclusive worldwide rights before investing in a potential medicine.
The scientists would declare victory if as many as a dozen participants who are given a placebo become sick with Covid-19 compared with only one or two who receive the inoculation. “Then we have a party and tell the world,” Professor Hill said. Everyone who had received only the placebo would also be vaccinated immediately.
"Success is the ability to go from one failure to another with no loss of enthusiasm." - Winston Churchill