Is that a CVVHD-based device?
Yes. I know I am over simplifying it.
Is that a CVVHD-based device?
How long does an EUA take to process?
There are three processes to consider:
1. Pharma company internally reviews data, possibly leading to decision to file EUA.
2. They have to creat a data package to go with their submission. Normally this takes weeks/months, but in this case I'm sure a lot of it can be prepared in advance, just pending the data dump.
3. Then they submit to the FDA who have to review the data. I can't see this review taking less than a week or two. Even for a vaccine there is a lot of data. Has anyone seen an estimate for this?
4. FDA may have follow-up questions or require additional analysis to be conducted.
New research and COVID news:
- Army has found that the virus effects the myocardium and limits Activity Duty cardiovascular fitness. This appears to be a direct effect from the virus through ACE II receptors in the hard muscle. They are developing a return to duty plan for those that catch the virus. This could have a significant effect on athletes. Specialists think this could require a 6 month reduction in activity
How long does an EUA take to process?
Hi Chuck, here's a question:
Check out this article:
https://www.yahoo.com/news/measures...tists-want-to-keep-it-that-way-182216307.html
Specifically:
"The weekly average of positive lab results is now 0.2 percent, compared with 2.35 percent in 2019. The positive rate is usually between 1 and 2 percent. "
So, if it's normally 1-2% this time of year, and it's 0.2% now, that means the amount of flu circulating is about 1/5 to 1/10 normal. Flu and COVID-19 spread the same way: people breathe on each other and spread droplets when they talk, cough, sneeze, pick their noses... We are using masks and social distancing this year, and from the numbers above, this has contributed to a dramatic 5-10x reduction in the flu prevalence. Since flu and COVID-19 spread the same way, it's reasonable to conclude that at least to an approximation, the distancing measures we are taking are having a similar effect on COVID-19 spread as is being seen on influenza.
So Chuck, is it reasonable to conclude that the measured impact on influenza spread can be used as a strong proxy to extrapolate how much more COVID-19 spread there would be if we hadn't been doing lockdowns and social distancing and masks and such?. There may be subtle differences between effectiveness of masks and other distancing measures between flu and COVID-19, but in my view they should be in the same ballpark since the key in both cases is droplet containment. So, by this logic, if the US hadn't done what it did, we might be seeing 5x-10x as many infectious people circulating. I think it's actually more complicated than this, since flu and COVID-19 have different replication values (so, the impact may be stronger for COVID).
But ballparking it, does this seem to be a reasonable line of logic?
It's also interesting to note that Sweden did relatively little early on to blunt the virus, whereas it's neighbors with similar ways of life Finland and Norway did a lot, and over that period Sweden had 10x the cases and death rate per capita as those countries that took it more seriously.
Thoughts?
That's interesting. Are there any studies being done into whether ACE inhibitors or ARBs might be useful in reducing or preventing this damage?
Would health care providers qualify as “high risk groups” for EUA?
Would their immediate family also qualify?
It's important to prioritize the front line workers for sure. Once they are protected, it keeps their families safe and prevents spread from care giver to patients.Health care workers will be a priority prior to the high risk. Families likely will not.
I know this is harsh, but we are immunizing health care workers in the front line to protect them as they vaccinate and give care. We want to prevent absenteeism and protect the "force". Families are important, but they often do not contribute to that directly.
It's important to prioritize the front line workers for sure. Once they are protected, it keeps their families safe and prevents spread from care giver to patients.
Health care workers will be a priority prior to the high risk. Families likely will not.
I know this is harsh, but we are immunizing health care workers in the front line to protect them as they vaccinate and give care. We want to prevent absenteeism and protect the "force". Families are important, but they often do not contribute to that directly.
I am a provider but will probably not be eligible. I do Not spend 50% of my time in direct patient contact.
Update from research:
- New treatment near release - monoclonal Antibodies given to symptomatic non-admitted patient and resulted reduced admission and ER visits.
- Screening at entrances has been proven ineffective to prevent infections. Temperature checks appear to be useless At presenting infections. Data appears to show that universal masks are more effective than screening or vaccination.
- Glasses seem to be effective at reducing infections and the severity of infections. Seems to point to the eyes being a source or site of initial infection.
Is this treatment, you speak of, is it Regeneron's REGN-COV2 ?
Chuck, I'm relieved to hear FDA is considering specific science driven approaches to EUA approvals for vaccines. Do you have any comments on what is proposed here (but not yet ratified).
https://www.cnn.com/2020/09/22/health/coronavirus-vaccine-fda-authorization-rules/index.html
Update: You hear it here first, The vaccine will be available no later than the end of November. I reviewed data today. Announcement to come soon.
Still seems like a rush on the safety side.Hopefully this means efficacy was proven with one dose.
My personal concern isn't with effectiveness ("does it prevent COVID-19?") as that data is easy to collect and interpret, and a statistical measure of effectiveness could come quite early, well before the whole patient cohort gets all their shots. There are lots of reasons to believe the vaccine should be strongly effective.What's the downside to taking one of these vaccinations soon if it turns out in 6 months that it doesn't meet whatever levels are normally needed to accept a vaccine?
For instance, does it just mean that you may not actually be vaccinated but think that you are? If that's the worst thing then I'd definitely sign up and keep wearing masks and social distancing.
Or maybe it keeps you from taking the actual vaccine when it's proven to work a couple of months later, and now you have to remain unvaccinated for a longer period of time? That seems unlikely to me.
Surely the risk isn't that it would be directly unhealthy to you if it turns out not to work (as opposed to allowing you to still get infected). Also seems very unlikely.
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