📍Don’t let Trump FDA move goalpost! @ASlavitt
Not only do need a minimum 50% efficacy vaccine, but epidemiologists say we must ensure its not too low!
Meaning what? ➡️ Not only does average have to hit >=50%, but the 95% confidence interval’s lower range must also EXCLUDE 30%.
Not only do need a minimum 50% efficacy vaccine, but epidemiologists say we must ensure its not too low!
Meaning what? ➡️ Not only does average have to hit >=50%, but the 95% confidence interval’s lower range must also EXCLUDE 30%.
2) Here is what experts say:
“successful vaccines should show an estimated risk reduction of at least one-half, with sufficient precision to conclude that the true vaccine efficacy is greater than 30%. This means that the 95% CI for trial result should exclude efficacy <30%.”
“successful vaccines should show an estimated risk reduction of at least one-half, with sufficient precision to conclude that the true vaccine efficacy is greater than 30%. This means that the 95% CI for trial result should exclude efficacy <30%.”
3) “Deployment of a weakly effective vaccine could actually worsen the COVID-19 pandemic if authorities wrongly assume it causes a substantial reduction in risk, or if vaccinated individuals wrongly believe they are immune, hence reducing compliance with, other control measures.”
4) “Deployment of a marginally effective vaccine could also interfere with evaluation of other vaccines, as subsequent vaccines would then have to be compared with it rather than with a placebo.” ➡️ this is bad, cuz then we are stuck with a bad control that makes trials messy.
5) “For a vaccine superior to the weakly effective vaccine, the increased sample size required could delay recognition of its efficacy.”
6) “More importantly, if the weak vaccine is compared against an even weaker vaccine, the statistical criteria used to analyse non-inferiority trials could well endorse the even weaker vaccine as being non-inferior (so-called bio-creep).”
7) “The criteria used to define a successful vaccine in the initial clinical trials of vaccination versus placebo should therefore be strict enough to protect against risk of a weakly effective vaccine being deployed, especially since there are already many candidate vaccines“
8) “Hence, the initial trials comparing COVID-19 vaccines versus placebo should seek reliable evidence not only of some efficacy but of worthwhile efficacy.”
BOTTOM LINE: We need to make the first trial right, and test it fully, or else we shoot ourselves in the foot later on.
BOTTOM LINE: We need to make the first trial right, and test it fully, or else we shoot ourselves in the foot later on.
9) “In comparison with individual trials for each of the many different vaccines, a global multivaccine trial with a shared control group could provide more rapid and reliable results. Additionally, its use of established clinical trial infrastructure could save time and effort”
10) “accelerating the needed discovery of several safe and effective vaccines. High enrolment rates facilitated by flexible trial design and hundreds of study sites in high-incidence locations could yield results on short-term efficacy for each vaccine within just a few months”
11) Lancet editorial source: thelancet.com/journals/lance…
12) ...gosh... it’s almost as if we should pool resources to do multiple vaccine trials together... and join some global vaccine consortium to fight pandemic together.
Oh wait, never mind. Thanks Trump. google.com/amp/s/thehill.…
Oh wait, never mind. Thanks Trump. google.com/amp/s/thehill.…
