UncleEbenezer wrote:Mike4 wrote:funduffer wrote:
I signed up by agreeing to consider taking part in CV19 research last autumn. Then I was contacted when the trial started.
I was unblinded due to ethics. It is unethical to deny a participant a vaccine when one is offered, for the sake of the trial. I think all trials in progress will face this hurdle.
An interesting related point is the vaccination programme rolls out, the pool of unvaccinated people on whom to conduct trials of newer vaccines gets ever smaller.
More to the point, it's becoming rapidly skewed towards the young. For future vaccines it'll be gone altogether.
Arguably they should've kept funduffer blind while they administered the regular rollout vaccine. They're telling us it's fine to be vaccinated if you've had the virus, so presumably it should be equally fine to have more than one vaccine (provided they're not too bunched up). And provided the subject is still blind in the trial, it shouldn't compromise the trial, because it's a life event completely independent of that trial.
I was unblinded for the following reasons:
1. It is unethical to deny someone who may have had a placebo to have to reject a vaccine opportunity.
2. It was stated after I was unblinded that I should not have a second vaccine of a different type, as there was no medical evidence that having a second vaccine on top of the first was safe.
I remain on the trial unblinded, but mainly I suppose because I have to give a blood sample every 3 months until the end of the trial to monitor the decay rate of anti-bodies. Also, it is possible I may still contract Covid-19 in some form, or enough to be infectious and infect my wife, who is also on the trial, but as yet unblinded.
As to how the Novavax trial uses data from people who are unblinded, I am not sure. However, the trial has gathered enough data to apply for emergency authorisation from the MHRA, so it may be a moot point. I expect to see it approved in this way for use in the next few weeks, just like Pfizer and Astra vaccines are. Novavax are talking about manufacture from the Fujifilm Biotech plant on Teesside with UK distribution starting in April, so they must be confident they have enough data for this.
I agree it will be harder to conduct further trials in the UK, where vaccinations are happening so quickly. The Novavax trial hit the sweet spot. It was fully enrolled by November, ran through the huge January peak of cases, catching new variant cases into the trial. In parallel, the S African trial included cases with that variant. I think this is why the trial reached their interim data target so quickly, allowing them to apply for emergency authorisation.
FD
FD
