Yesterday the FDA Advisory committee recommended that the 15 million Americans who have had J&J vaccines, more than 2 months out, get a 2nd shot.
There are some significant issues with this that could have been prevented /1
By May 1, there were over 8 million people 5.5 months out
By June 1, the number rose to nearly 11 million people 4.5 months out
Yet data have consistently been showing attrition of protection vs infections for this vaccine, this week in 620,000 US Veterans /2
This is the only Covid vaccine that was positioned as "one and done." J&J is the largest healthcare company in the world, yet research to back that up was undone until recently.
Single dose: 70% protection vs symptomatic infection
2-dose: 94% protection /3 fda.gov/media/153129/d…
To start with, the 1-shot 70% efficacy vs. symptomatic infections was considerably lower than the mRNA vaccines (95%), the primary endpoint of all Covid vaccine trials, and a proxy for protection vs hospitalizations and deaths
2-shots brought it to parity in the US at 94% /4
A grand total of 17 people were studied for impact on spike protein binding antibody levels (not even neutralization Abs) at 6 months /5
Parenthetically, the antibody level increase from the 2nd J&J shot at 2 months were small relative to a booster with an mRNA vaccine (50-70 fold, 1 month)/6
How could this happen? 15 million Americans potentially left vulnerable and still no formal approval for a 2nd shot 1. J&J did insufficient and late in coming research to backup their "one and done" assertion 2. The poor US tracking of data obscured detection of this issue
/7
We've known about the lapses in antibody levels and reduced protection vs hospitalization for some time, but left these people (who typically had no choice and were told all vaccines were equivalent) susceptible over a prolonged period
The connection between #SARSCoV2 and neurodegeneration
@TheLancetNeuro
Quotes below: 1. SARS-CoV-2 infection should be considered as a risk factor for Alzheimer’s disease, even though the distinction between causation versus disease acceleration is not clear.thelancet.com/journals/laneu…
2. Inflammation in patients with COVID-19, and controlled experiments show prolonged neuro-inflammation after mild SARS-CoV-2 infection
in macaques.
3. A direct correlation has been reported
between prior SARS-CoV-2 infection and increased risk
of Alzheimer’s disease (figure).
4. So far, the estimated lifetime cumulative risk of dementia due to hospitalisation for any viral infection is 1·48 (95% CI 1·15–1·91).
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