Why is stopping a #SARSCoV2 vaccine trial early such a bad idea?
A proper clinical trial is statistically powered to make a call at its completion
There's wobble, random chance, in events during a trial
The true beneficial effect has turned out less in some trials stopped early
The trials are reportedly powered to detect 50% efficacy w/ a lower 95% CI of 30%. That's not nearly as high as ideal
Stopping early:
— could even exaggerate that
— could impact other placebo-controlled trials
— could also miss relatively rare but important adverse safety events
The @pfizer CEO again today asserted they will know by the end of October whether their vaccine w/ @BioNTech_Group works @FaceTheNation cbsnews.com/news/covid-vac…
That can only be determined by stopping the trial early.
And they're not releasing their stopping rules.
It's all wrong
Breaking down the risks and benefit for lecanemab, the amyloid beta-directed antibody vs Alzheimer's drug approved @US_FDA last year. It doesn't look good.
My oped on the JN.1 variant and the 2nd biggest US wave of infections (after Omicron) since the pandemic began
@latimes @latimesopinion #LongCovid latimes.com/opinion/story/…
Recent @CDCgov #SARSCoV2 wastewater data for current wave (vs Omicron Jan 2022 and subsequent waves), graph by @luckytran
Sorry, @washingtonpost, but this is not "another Covid-19 uptick" as you put it in your Health Alert. You ignore the best metric for infections that we have at present—wastewater—focusing only on hospitalizations washingtonpost.com/health/2024/01…
3 New #LongCovid reports 1. Vaccination protection—1 dose 21%, 2 doses 59%, 3 doses 73% among ~590,000 people in Sweden (strong association) bmj.com/content/383/bm…
2. 3-year prospective follow up of a cohort of ~1350 participants, hospitalized in China
—Lung function restored back to baseline in most
—Higher risk of reinfection that people w/o Long Covid
—Half w/ persistent symptoms thelancet.com/journals/lanre…
3. At @RSNA annual meeting, brain MRI with microstructure imaging (DMI), participants with #LongCovid vs controls had microstructure changes associated with impaired cognition, sense of smell and fatigue eurekalert.org/news-releases/…
Big news #ESC2023 and @NEJM
In a placebo-controlled randomized trial of people with obesity + heart failure (with preserved ejection fraction). semaglutide (Wegovy) markedly improved symptoms, exercise time, reduced inflammatory markers (and weight loss) nejm.org/doi/full/10.10…
This also tells us something about the underlying mechanism of heart failure with preserved EF—metabolic dysfunction and attendant systemic inflammation—not previously acknowledged or confirmed
The accompanying editorial lays this finding out well. Prior studies of weight loss didn't help HFpEF
Two new papers @NatureMedicine and @JAMAInternalMed shed light on #LongCovid at 2-years. But there's no shortage of known unknowns.
Reviewed in a new Ground Truths (link in my profile, because that would be it X-suppressed)