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ru848789

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ru848789 last won the day on February 24

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About ru848789

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  1. Don't feel bad - my wife barely makes it through one sentence...
  2. I think I shared this months ago, but I've been asked a lot about when do the vaccines "kick in" with effectiveness and the answer is a bit murky, since none of the mRNA trials (Pfizer/Moderna) were looking at efficacy for the first shot, per se, although they did track some metrics. The did have the observation that immunity appears to start to kick in around 11-14 days after the first dose, depending on the data set, i.e., Pfizer saw a reduction in infections starting about 11 days after the first dose (first link), while in Israel (with the Pfizer vaccine), they've seen signfica
  3. More good news on Regeneron's cocktail of two monoclonal antibodies for treatment/prevention of COVID (first link). The ongoing trial with mild to moderately ill COVID outpatients (not serious enough to be in a hospital), which showed good results at an interim analysis, was stopped by the IDMB (independent data monitoring board), as their review showed unequivocally strong efficacy (i.e., driving down viral loads and not allowing progression to severe COVID vs. placebo) for the cocktail, meaning it would be unethical to continue with a placebo arm of the trial. They also said th
  4. Thanks! You've also seen my long posts, no? That was the short version, lol. I could write a small book on the regulatory review and approval process. Literally. Just the process part of a filing, i.e., not the clinical part but just the details of how the active ingredient is made and then how the final drug product (which contains the active ingredient in a tablet or capsule usually) is made, both in the lab and in manufacturing, is typically at least 1000 pages and the clinical part is usually in excess of 100,000 pages and can be up to 500,000 pages (including the raw clinical data re
  5. Thanks. Yeah Merck has been pretty good to me, although it's an extraordinarily competitive place, which wears on some - I guess I got used to it. The positive side of that competitive spirit was being part of a large, highly motivated team that truly wanted to make a difference in people's lives by getting the best new medicines to market. I was privileged to lead a bunch of these teams in the process development and scaleup/manfacturing area over my last 10-15 years there, as I had 3-4 groups of 5-7 scientists working on several projects in parallel - most fail (due to lack of efficacy us
  6. Don't take this the wrong way, but if you were aware of what FDA applications look like and what regulatory review entails, you wouldn't be asking these questions. Most applications for an EUA or an NDA (final approval) contain thousands of pages of information on the clinical trials and the manufacturing/processing/packaging steps employed, much of it very data-dense, and teams of regulatory personnel, who are esteemed scientists in their own right, need at least some time to review these documents, so they can assemble lists of questions - because these documents are not always clearly writ
  7. I know it may look slow, but some of you guys might need a little education in the regulatory review process. Normally, it takes 6-12 months to review applications for new vaccines, so it likely taking about 3 weeks from the application for an EUA (emergency use authorization) by J&J to approval of that EUA (probably on Friday) is an absolute miracle and shows the incredible efforts the FDA is going through to review and approve these new vaccines. FYI, it also took about 3 weeks from application to EUA approval for the Pfizer/Moderna vaccines. I've worked on about a dozen n
  8. Great news. It's a bit of a repeat, but since I posted this elsewhere I'll post it here, too... The FDA moved one step closer to granting an EUA (emergency use authorization) for the J&J single shot, refrigerated storage, adenovirus vector vaccine, which has been expected; the FDA review panel meets Friday and will almost certainly approve the EUA. We've talked a lot about the clinical trial results, but IMO, by far the most important result is that like the Pfizer/Moderna mRNA vaccines, there were very few severe infections and zero hospitalizations and deaths in the
  9. Preliminary data on the "California variant" indicate that it is likely somewhat more transmissible than the original strain and that it is somewhat more resistant to the neutralizing antibodies from vaccines and previous infections, although not as much as the South African variant, meaning it's not expected to "escape" vaccine protection. However, this is just one more reason why getting vaccines in arms as fast as possible is so important, since there are no mutations if there are no transmissions. https://www.latimes.com/science/story/2021-02-23/california-homegrown-coronavi
  10. Here's some interesting science. Derek Lowe posted a couple of blog entries, recently, about the challenges of scaling up mRNA manufacturing output. The 1st link, below, provides an excellent overview of all the major steps required to scaled up to make mRNA vaccine, while the 2nd link below dives deeply into the difficulties of making the key lipid nanoparticles. And the 3rd link below is to an article describing how the mRNA vaccines, encapsulated in the lipid nanoparticles, work inside the body to achieve the desired immune response. These lipid nanoparticles are pretty
  11. Yes, beyond 10 days after the first dose and day 10 was today for me...
  12. Got Pfizer dose one on 2/13 get dose 2 on 3/6. Feel like a huge weight is already off my shoulders, especially having reached day 10, which is when immunity really kicks in after the first dose (not full immunity but still pretty strong).
  13. Very good news on both Pfizer and Moderna promising to ramp up vaccine supplies to achieve 220MM doses by the end of March, which is a 20-40MM dose increase over what was expected by then. That's enough to fully vaccinate 110MM people, which is 40% of the 270MM eligible adults in the US. Throw in another 20MM J&J doses (for 20MM people fully vaccinated, since it's a single shot) by the end of March and that's enough to fully vaccinate 130MM people, which is enough to vaccinate almost 50% of eligible adults. Combined with recent announcements (2nd link) that we'll have 600MM doses of the
  14. As we reach the horrible tragic number of 500K US coronavirus deaths, it makes me sad and angry. Here's what I wrote on 3/1/20: "This virus is as or more transmissible than influenza and has a mortality rate roughly 10-20X that of influenza (~2% vs. about 0.1-0.2%). So if we largely ignored it like the flu, we'd potentially have 10-20X the ~12K-60K deaths/year we have from the flu, which would give a range of deaths of 120K to 1.2MM if we did nothing." I was simply reporting things from experts, but the key point is that most experts knew back then what this virus was capable of if
  15. There are no 6-month effects that are serious (anaphylaxis is only in 5 in 1MM), so far, and every other vaccine that's ever been on the market had all of its significant effects seen in the acute phase, i.e., within days, normally. There truly is no reason not to get the vaccine and huge reasons to get one. We're talking zero risk of death and near zero risk of any significant side effects vs. 0.1-5% chance of death if you get symptomatic COVID, depending on age/comorbidities. I cannot understand how anyone with any understanding of science and risk analysis wouldn't be jumping at getting
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