Call for Full FDA approval of covid vaccines
The stakes could not be higher.
In print, @nytopinion
nytimes.com/2021/07/01/opi… Image
The @US_FDA is unhappy about this essay. That's good. Maybe they will do something.
Perhaps @DrWoodcockFDA will even make a public statement?
According to @KFF survey, 1 in 3 Americans would be more likely
vaccinated if FDA gave full approval.
Not expected until "at least September"
There's simply no excuse for this delay.
It's called a pandemic. We need this done now
nytimes.com/2021/07/06/us/… @shearm @noahweiland Image

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More from @EricTopol

2 Jul
The @US_FDA's overdue full approval of mRNA vaccines is holding us back from getting millions of more people protected, at a time of urgent need, with the Delta variant on the rise. My guest essay @nytopinion nytimes.com/2021/07/01/opi… w/ thanks for editing @jopearl
I start off w/ the paradox of FDA's accelerated approval of the Alzheimer's drug despite a 10-0 vote against it by their Advisory Committee, 2 clinical trials that did not show clinical benefit, and for any person w/Alzheimer's even though the trials were for early disease, MCI
Then a brief review of the exceptionally large, completed clinical trials and real world evidence for these vaccines—the 1st ever new vaccines to get Emergency Use Authorization (EUA)—now given to hundreds of millions of people /3
Read 9 tweets
30 Jun
This likely represents the Delta variant inflection point for the US, as cases start to increase in several states (log plot to show trend). Let's hope the rise is limited and without much in the way of hospitalizations and deaths.
A lot more people vaccinated would sure help
Mississippi, the least vaccinated state, starts to show an increase in cases. Had dropped to 3.5/100,000 and now back up to 6/100K. Delta is now approaching dominance there; sequencing is limited.
Sequencing data from Mississippi. There's plenty of Delta (B.1.617.2) there now, but confidence intervals are wide
outbreak.info
Read 4 tweets
26 Jun
The US is now over 30% Delta variant for new cases. So how could the 7-day average still be heading down, now at 3.2/100,000? Here compared w/UK trajectory, >93% Delta
There's no question that of the new cases in the US, many are Delta, but sequencing is minimal. The 30%+ is based on a limited sample (wide 95% CI) compared with the UK. Look at the numbers at bottom of US, UK graphs outbreak.info
The 30% Delta is very unevenly distributed. Missouri is >60% and is the hotspot of the US for new cases. Neighboring states Arkansas and Oklahoma are also heating up and have high Delta frequency.
Read 4 tweets
23 Jun
While the Delta variant case frequency for US infections is ~20% overall by @CDCgov, there's marked heterogeneity among states
ft.com/content/730e35… by @nikasgari and @jburnmurdoch (@FT estimates Delta prevalence much higher 37-42%)
The 3 states--Missouri, Utah, Arkansas--with highest Delta variant prevalence are all increasing in cases, leading the country (still relatively low cases/capita rates), going in the opposite direction as most of the country /2
There are other states with some increase in cases where Delta is out-competing Alpha /3
Read 4 tweets
19 Jun
Genome editing with #CRISPR is the most important life science breakthrough of our time. It's a B.C. and A.C. We interviewed @WalterIsaacson about his new book, THE CODE BREAKER, which is a masterpiece medscape.com/viewarticle/95…
w/ transcript /1
We started the conversation reading 2 key passages that convey the significance of #CRISPR /2
And this one /3
Read 11 tweets
18 Jun
The Delta variant: updates from the new @PHE_Uk report
assets.publishing.service.gov.uk/government/upl…
1st dose vaccine (either AZ or Pfizer) quite protective vs hospitalization
Fully vaxxed vs unvaxxed:
Infections 7.7% vs 67%
Hospitalizations 8% vs 48%
Delta's secondary attack rate is coming down some in the latest dataset. Its enhanced transmission over alpha appears to be more in the 40-60% range

Reinfections by sequencing data: 311/1260 were Delta
This 71-page report is rich. And that 60% of infections are getting sequenced (91% are Delta) is quite impressive.
It makes the output from CDC and the genomic surveillance in the US particularly weak
Read 6 tweets

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