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  1. #1
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    Important information on COVID-19

    Here at the DBR we are quite fortunate to have a community that contains more than a few experts on various topics. At times, those experts can provide invaluable information to the entire community.

    Toward that end, the DBR moderator community want to highlight a pair of recent posts from the Coronavirus Plaguewatch thread. We recognize the thread is long and not everyone is able to keep up with it, which is why these two posts are being pulled out to ensure they can be read by the entire community.

    It is possible that we will periodically add new, informative posts to this thread, but if you want to reply to any of these posts, we ask that you do so in the Coronavirus thread itself. Replies to this thread will be locked, though it will be stickied to the top of the Off-Topic forum.

    Thanks and prepare to be educated...

    -Jason "we are truly lucky to have experienced medical professionals answering our questions at a time like this" Evans
    I don't know what you are doing right now, but if you aren't listening to the DBR Podcast, you're doing it wrong.

  2. #2
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    This post came in response to a discussion about an article in The Atlantic that cast some doubts about how America would react to a vaccine. If you want to read the entire conversation, try dropping in on the Covid thread here.

    Quote Originally Posted by tbyers11 View Post
    Hi - I have a PhD in viral immunology and worked in the field for 20 years, the last 10 with a large company that makes vaccines and I currently work in R&D for flu vaccine development. There are a lot of questions on many posts in response to the Atlantic article. Since freshmanjs listed many of them here I'll give responses to the best of my knowledge here

    A vaccine is likely to limit serious disease rather than all disease. - Yes, the COVID-19 vaccine as with many vaccine is not likely to provide sterilizing immunity but will hopefully reduce death, hospitalizations and severe cases greatly. If the "death rate" could drop from say 1% to 0.1% and the hospitalization rate from 15% to 1.5% that would be great. SARS-CoV-2 is not going to disappear a few months after a vaccine is available but if we can manage it like the other respiratory viruses that circulate (flu, RSV, parainfluenza, common corona, rhino) would be the goal

    A lot of doses will be required and that is logistically complicated - It seems very likely that the first COVID vaccine approaches in the pipeline will require 2 doses with the second one occurring about 3-4 weeks after the first. And then subjects would likely have their peak Ab response about 2 weeks after the second dose. So vaccine Ab immunity will peak about 6 weeks after first dose. Anytime that a vaccine requires 2 dose it is logistically much more difficult but it is not a failing of these first COVID vaccine approaches it is common that vaccine to naive (unencountered) viruses require 2 doses

    The 2009 flu vaccine only ended up being used in 20% of the population because demand was low, as the disease had become much less prevalent - Not as much of the 2009 "swine" flu H1N1 vaccine was used as was produced is true, but it wasn't due to that strain of flu becoming less prevalent. The H1N1 pdm/A/California strain that appeared in 2009 was the exact H1N1 strain in the seasonal flu vaccine for 7 years (meaning it was most prevalent circulating strain). The swine flu vaccine process began in April (after it was discovered) in March and large amounts of doses were made by Oct/Nov which is impressive. However, that specific vaccine was not needed as much as was thought because pre-existing T cell immunity from previous (but different H1N1) seemed to lessen the severity of the disease in most people

    Flu mist is scary because it's alive. - FluMist is live but it attenuated through cold temperature adaptation. It only replicates at around 33C when the human body is 37C. So while there is risk with any live vaccine, FluMist was quite safe. I do have issue with the NYT article about how live, intranasal vaccines would be preferable for coronavirus. While it is a true statement that intranasal administration of a live vaccine would theoretically be preferred because it is more likely to induce IgA Abs (the type associated with mucosal response in the lungs), the reality is that has no one has effectively proved that in dozens of years in human flu vaccine research. FluMist did show better response in kids (we gave it to our son when he younger) it was largely thought that improvement was due to enhanced T cell responses to FluMist and not to IgA Abs. VaxArt (mentioned in the NYT article) has been trying an oral flu vaccine approach for awhile but AFAIK have not gotten to a phase 3 efficacy trial yet. IgG Abs induced by intramuscular administration seem likely to work well enough for COVID-19 (early results are promising but not yet definitive

    Other thoughts on timing and manufacturing supply chain: This is an issue not be given enough attention in the rightfully optimistic articles about Ph 1 success. Moderna is supposed to start their Phase 3 efficacy trial next week. If everything works perfectly it will take 3 months to know if the trial was successful. Not all 30,000 people can get the vaccine on Day 1. Normally it would take 2 months to enroll this many people. Assume they streamline it to 1 month. As I said above it will take about 6 weeks to reach peak Ab response with a 2 dose regimen. So in an efficacy trial that would be the bare minimum time to determine if the vaccine is better at preventing/reducing disease than the placebo. So that's 10 weeks. Need some time to compile the data and present to FDA. This would normally take months but even if it fast tracked that's 2 weeks and about 3 months total.

    However, as the Atlantic article pointed out we have to manufacture 100 million doses, which is a huge undertaking. For my company it takes normally 5-6 months of highly entwined processes to make, fill vials, package, and distribute 100 million doses of flu vaccine. The filling, packaging, and distribution requires a lot of expertise but that expertise can be bought. The tricky part is upscaling your manufacturing processes from say thousands of research grade doses to millions of manufacture grade doses. This process can theoretically go quicker with mRNA but can be fraught with lots of pitfalls. Moderna has contracted with Lonza to do this but who knows. In addition to the technical and logistical difficulties, normally you don't start manufacturing a vaccine at risk (before FDA licensure). Not a sound financial strategy. Now Operation Warp Speed is likely to help provide $$$ to start these processes at risk but I'd say we have 1-2 months minimum from licensure to having say 10 million doses available.

    Deciding who gets these doses and how to distribute these doses should be underway by the federal government right now. But I have seen no efforts on this front. NIH/FDA have experience in the running trial and regulatory approval but not in distribution. That is generally left to the individual companies. That doesn't seem like a good idea for COVID.

    So in summary. I am more optimistic than the tone of the Atlantic article that we will have effective vaccines. I agree with Jesse Goodman (former FDA official quoted in the Atlantic article) that we are probably 5 months from say 10 million doses of a vaccine. This won't be wrapped up by Christmas. Not even close. However, I think that with the second wave of companies (that are a few months behind Moderna/Pfizer) we will have hundreds of millions of vaccine available by late spring early summer 2021. Enough to vaccine all in US that want it. If enough people get the vaccine, I think we could have a situation where COVID-19 is a bit more like a normal respiratory virus public health situation by fall 2021. However, sadly we won't really know if that is the case until we get through the 2021 flu season. So, in my opinion there is a likely path at the end of the tunnel I just don't think it is quite as close as some articles make it seem.
    I don't know what you are doing right now, but if you aren't listening to the DBR Podcast, you're doing it wrong.

  3. #3
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    And if you have not been reading all of RSVMan's posts in the COVID thread, you are missing out on some serious knowledge. Like tbeyers, RSV is a immunology professional.

    Quote Originally Posted by rsvman View Post
    I read through the article. I didn't think it was that bad, actually. The person they quoted about potential for misted live-virus vaccine is a friend of mine I used to work with at Vanderbilt many years ago. She is an influenza expert. Many of the trials that allowed FluMist to go to market were carried out at Vanderbilt by a team that included her, Bill Gruber, Peter Wright, and others.

    FluMist was never dangerous. At all. Period.

    When thinking about live attenuated vaccines, there are a few things of importance; perhaps the most crucial point was not mentioned in the article (Dr. Neuzil probably thought it was too complex for a lay article) and that is this: How stable is the attenuation?

    Once you put a live, replication competent vaccine virus into a human body, it replicates. Virus can make many, many copies of themselves. In some past vaccines, with multiple rounds of replication the attenuation would go away, yielding a wild-type virus. This was case, for example, with oral polio vaccine. Oral polio vaccine attenuation was actually highly unstable. It reverted to wild type virus with alarming frequency. It was also spread very easily in the community, which actually helped contribute to herd immunity (even "unvaccinated" people were getting vaccinated!). The good news was that even wild type polio infection was benign in the vast majority of people who contracted it. Thus, we were able to get away with using an unstable vaccine for many years, and achieving herd immunity by having the vaccine spread all over the community. Babies and children vaccinated with oral polio vaccine would shed it in their stools for weeks to months. Because of this, for many years we had small numbers of children getting what was known as "VAPP" (vaccine-associated paralytic poliomyelitis), generally between 3 and perhaps 10 or 11 kids per year in the U.S., averaging about 5 or 6 per year. I actually took care of one of these kids when I was at Vandy. This is the reason that we moved away from oral polio vaccine and now exclusively use the injectable vaccine (which is not live).

    On the other hand, we have been using live measles, mumps, rubella, and varicella vaccines for long periods of time without any real problems.

    Back to FluMist. There is a lingering belief that the vaccine could be spread to others, but there have been no reliable case reports of this. The original studies looking at the potential for spread were done in daycare centers, to maximize the chances that spread would occur. They gave half the toddlers in the daycare the vaccine. They did nasal samples for vaccine virus every day in every kid, looking to see how long it was shed and whether it would spread. The official report of the research says that there was one child who did not receive vaccine who developed infection with the vaccine virus, but in truth it was probably a labeling error. Kid A, who got the vaccine, tested, on consecutive days, positive, positive, positive, negative, positive, positive. Kid B, who did not receive vaccine, tested, on consecutive days, negative, negative, negative, positive, negative negative. So on that one day, the vaccinated child suddenly stopped shedding for one day, but started up again the next? And the unvaccinated kid, supposedly infected with the vaccine virus, shed it for only one day and then cleared it? And that day just happened to coincide with the day the vaccinated kid cleared it transiently? Yeah, right. The samples were labelled incorrectly (in my opinion). So, bottom line, even toddlers in a daycare couldn't figure out how to share it with others. And, the attenuation was incredibly stable.

    The reason FluMist fell out of favor was not because it was dangerous but because there was a problem that led to inefficient protection from H1N1 for one season. The problem was solved by the company by the next year, but by then the horse was out of the barn.

    It is not at all clear to me that a live attenuated vaccine misted up the nose would be superior to other forms of vaccines for SARS-CoV-2, although the argument could be made that allowing a replication-competent vaccine virus to replicate generally produces a broader response, usually including some T-cell responses to internal proteins, which could be helpful as most viral mutations take place in the outer proteins.

    What was I talking about? Oh yeah, live attenuated viral vaccines. So, the next concern is will the vaccine produce immunity without making the recipient ill? That's a fine line to walk; attenuate the virus too much and it will be tolerated fine but not produce significant immunity. Attenuate it not enough and it will make people sick.

    Finally, will it be spread to others? The general public would see spread as bad, and it probably mostly is, because if we had a live virus vaccine we would not give it to people who are severely immune suppressed. If it spread around readily we could not control who would get "vaccinated," and that could lead to disastrous consequences.

    Sorry if this was too long. Talk about walking a fine line...if I gloss over stuff too much it won't have any meaning but if I go too deeply into it, nobody will want to read it and/or it will be really difficult to understand. I hope this was on that line, providing information that is understandable and helpful without being overly technical and ridiculously boring.
    I don't know what you are doing right now, but if you aren't listening to the DBR Podcast, you're doing it wrong.

  4. #4
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    Feb 2007
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    A rundown of cardiomyopathy in covid patients:

    Quote Originally Posted by johnb View Post
    A NYT review from yesterday:

    Here’s a sampling. Different rates are based partly on how they measure cardiomyopathy.

    Medical journals:


    Here’s an article on Eduardo Rodriguez, the top pitcher for the Red Sox, who’s out indefinitely because of post-covid cardiomyopathy:

    People who rebound from covid-induced myocarditis may feel fine when walking around afterward, but it seems that an unknown percentage will have lingering disability. If they happen to play an aerobic sport, they’re finished as athletes.

  5. #5
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    Ozzie is one of the most respected posters on these boards. Been around forever and always a "paragon of optimism."

    This post from him about his family's loss due to Covid is a must read.

    Damn this disease... damn it to hell!

    Quote Originally Posted by OZZIE4DUKE View Post
    I stopped reading the thread back on November 1st. My mom was transported to the hospital with shortness of breath and being flushed on Friday night, Oct. 30. On Saturday she tested positive for Covid-19 and viral pneumonia. On Sunday they gave her the convalescent plasma with antibodies and steroids to help her lungs. She was on oxygen, varying from 2 L/min through a nose tube to 8 L/min with a full mask. On that Tuesday, she got the 5 day course of Remdesivir. A week or two later she had a bladder infection and they started antibiotics. Then they discovered she had MRSA, not sure where because they couldn't/wouldn't do a T.E.E. (Trans Esophageal Echocardiogram) to see if there was vegetative matter on the back of a heart valve, so they started her on more powerful antibiotics. After 6 weeks, she finally tested negative twice for Covid, but she still had the MRSA. They did the T.E.E. and found two heart valves were damaged, but because of her age (90) they didn't do any surgery because "she'd likely die on the table".

    When I spoke to her on the phone almost daily she always sounded out of breath to varying degrees, but said she had just eaten and she said she felt "fine".

    Last week they started talking about moving her to a SNF (Skilled Nursing Facility) so she could continue the steroids and antibiotics, but then her heart rate raced and her potassium level dropped. They got that back under control, but her speaking became very muffled. Apparently last week she stopped eating and drinking and the nurse said her tongue was so dry it was sticking to the roof of her mouth. More talk of the SNF "in a few days" and discussions about hospice to keep her comfortable.

    This morning at 1:30 a.m., waking from a deep sleep, I heard my cell phone vibrating and I ignored it. How dare those spammers call that late/early. But then it rang again I answered it and it was my brother. I had slept through the first two calls, from the hospital (they left a voicemail after the second call and then called my brother). He told me the hospital called and that Mom had passed about 30 minutes ago. I had to call the nurses' station to tell them about our per-arrangements. I asked what happened and the nurse said her pulse had dropped to ~30, they gave her atropine and then her heart just stopped. She had a DNR so that was it.

    My mother was a relatively healthy 90 year old, living in an assisted living facility (ALF) at care level "0" on a scale of 0 to 5, she took care of all her daily needs without assistance. She didn't have any heart problems and certainly didn't have MRSA. I assume the official cause of death will be Covid related symptoms, like the Louisiana congressman who just died, even though she didn't "have" Covid at the time. She is one of the 300,000+ and counting that have died from this virus.

    Wear a mask, wash your hands, social distance and for God-sake, get the vaccine as soon as you can.

    To all you anti-vaccers and Covid statistic deniers, go to Hell. It is real.
    I don't know what you are doing right now, but if you aren't listening to the DBR Podcast, you're doing it wrong.

  6. #6
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    Must read this morning -- not for its depth but for its simplicity -- is the NYTimes Morning Briefing.

    Right now, public discussion of the vaccines is full of warnings about their limitations: They’re not 100 percent effective. Even vaccinated people may be able to spread the virus. And people shouldn’t change their behavior once they get their shots.

    These warnings have a basis in truth, just as it’s true that masks are imperfect. But the sum total of the warnings is misleading, as I heard from multiple doctors and epidemiologists last week.

    Here’s my best attempt at summarizing what we know:

    • The Moderna and Pfizer vaccines — the only two approved in the U.S. — are among the best vaccines ever created, with effectiveness rates of about 95 percent after two doses. That’s on par with the vaccines for chickenpox and measles. And a vaccine doesn’t even need to be so effective to reduce cases sharply and crush a pandemic.
    • If anything, the 95 percent number understates the effectiveness, because it counts anyone who came down with a mild case of Covid-19 as a failure. But turning Covid into a typical flu — as the vaccines evidently did for most of the remaining 5 percent — is actually a success. Of the 32,000 people who received the Moderna or Pfizer vaccine in a research trial, do you want to guess how many contracted a severe Covid case? One.
    • Although no rigorous study has yet analyzed whether vaccinated people can spread the virus, it would be surprising if they did. “If there is an example of a vaccine in widespread clinical use that has this selective effect — prevents disease but not infection — I can’t think of one!” Dr. Paul Sax of Harvard has written in The New England Journal of Medicine. (And, no, exclamation points are not common in medical journals.) On Twitter, Dr. Monica Gandhi of the University of California, San Francisco, argued: “Please be assured that YOU ARE SAFE after vaccine from what matters — disease and spreading.”
    • The risks for vaccinated people are still not zero, because almost nothing in the real world is zero risk. A tiny percentage of people may have allergic reactions. And I’ll be eager to see what the studies on post-vaccination spread eventually show. But the evidence so far suggests that the vaccines are akin to a cure.
    I don't know what you are doing right now, but if you aren't listening to the DBR Podcast, you're doing it wrong.

  7. #7
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    The NYTimes sent out a newsletter this morning talking about vaccines. There is a portion of it that EVERYONE NEEDS TO READ AND UNDERSTAND!!

    Note: this excerpt is longer than we usually allow on DBR, but because it came in a newsletter there is no link to direct you to read. What's more, with the NYTimes making Coronavirus coverage free, I am sure they would not object to me posting this:

    We don’t need to eliminate it for life to return to normal. We instead need to downgrade it from a deadly pandemic to a normal virus. Once that happens, adults can go back to work, and children back to school. Grandparents can nuzzle their grandchildren, and you can meet your friends at a restaurant.

    As Dr. Ashish Jha, the dean of the Brown University School of Public Health, told me this weekend: “I don’t actually care about infections. I care about hospitalizations and deaths and long-term complications.”

    By those measures, all five of the vaccines — from Pfizer, Moderna, AstraZeneca, Novavax and Johnson & Johnson — look extremely good. Of the roughly 75,000 people who have received one of the five in a research trial, not a single person has died from Covid, and only a few people appear to have been hospitalized. None have remained hospitalized 28 days after receiving a shot.

    To put that in perspective, it helps to think about what Covid has done so far to a representative group of 75,000 American adults: It has killed roughly 150 of them and sent several hundred more to the hospital. The vaccines reduce those numbers to zero and nearly zero, based on the research trials.

    Zero isn’t even the most relevant benchmark. A typical U.S. flu season kills between five and 15 out of every 75,000 adults and hospitalizes more than 100 of them.

    I assume you would agree that any vaccine that transforms Covid into something much milder than a typical flu deserves to be called effective. But that is not the scientific definition. When you read that the Johnson & Johnson vaccine was 66 percent effective or that the Novavax vaccine was 89 percent effective, those numbers are referring to the prevention of all illness. They count mild symptoms as a failure.

    “In terms of the severe outcomes, which is what we really care about, the news is fantastic,” Dr. Aaron Richterman, an infectious-disease specialist at the University of Pennsylvania, said.

    What about the highly contagious new virus variants that have emerged in Britain, Brazil and South Africa? The South African variant does appear to make the vaccines less effective at eliminating infections.

    Fortunately, there is no evidence yet that it increases deaths among vaccinated people. Two of the five vaccines — from Johnson & Johnson and Novavax — have reported some results from South Africa, and none of the people there who received a vaccine died of Covid. “People are still not getting serious illness. They’re still not dying,” Dr. Rebecca Wurtz of the University of Minnesota School of Public Health told me.

    The most likely reason, epidemiologists say, is that the vaccines still provide considerable protection against the variant, albeit not quite as much as against the original version. Some protection appears to be enough to turn this coronavirus into a fairly normal disease in the vast majority of cases.
    I hear people debating, "if you are offered the JnJ vaccine, would you take it or wait for Moderna/Pfizer?" Heck, have been among those talking about that debate. But, I have become more educated in recent days and I now think that there should be no hesitation to take any of these vaccines the moment you can. Let me put this in simple terms... taking the JnJ vaccine makes Covid much less harmful than a normal flu. It basically turns Covid into a mild common cold. Waiting for a more potent vaccine is just plain foolish and is harmful to society because you are allowing yourself to be a vector for virus spread for no good reason. There are enough idiots who are vaccine deniers who will refuse this. The last think we need is people who would get a vaccine waiting for a better vaccine when a perfectly good one is available.

    -Jason "I swear, it is like some people want to keep us locked indoors and double-masking for as long as possible" Evans
    I don't know what you are doing right now, but if you aren't listening to the DBR Podcast, you're doing it wrong.

  8. #8
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    Nice summary of vax hesitancy:
    Quote Originally Posted by rsvman View Post
    I have heard it all from the vaccine hesitant. You have named several.

    1) It's not even a vaccine! This one, for some reason, is incredibly popular. I can't even remotely understand the logic behind the argument, but it goes something like this, "a vaccine, by definition, PREVENTS INFECTION. This does not prevent infection. Therefore, it is not a vaccine." So many holes, it's hard to know where to start, but I'd start by saying that most vaccines do not prevent infection. They are designed to prevent DISEASE. Also, if the anti-vaxxers hate vaccines so much, wouldn't it HELP their cause to call this one a vaccine? Then they could just say, "I don't like any vaccines, so I'm not taking this one." Seems to me like they are shooting themselves in the foot with this argument.

    2) It hasn't been approved by the FDA! This one makes a little bit more sense, although a lot of the anti-vaxx crowd has no problem using or even being proponents of other things that are also not approved by the FDA, like, for example, hydroxychloroquine for Covid, lol. A lot of these people take echinacea, and St. John's wort, and even homeopathic remedies that are not even close to having FDA approval, so I'm not sure why FDA approval is so important in this particular case. Seems to me like they are using this argument just because it sounds like a reasonable argument. It's not. If we were not in the middle of a global pandemic, the FDA would have taken its time to review the studies and would have given full approval eventually. We just needed the vaccine to get out sooner, so they gave it an EUA, instead.

    3) It's experimental, and I won't be a guinea pig! Technically, it's not really experimental now. The experiments were done already. Telling these people this fact does nothing to persuade them.

    4) They made it WAY too fast! The argument here is that rapidity equals slip-shod, which isn't true in this case. The vaccines were in phase 1 experiments back in February of 2020 when most people were barely aware that there was a new virus afoot, well before conference basketball tournaments were canceled. Also, a lot of the time savings were in not having to wait for full FDA approval, and, most importantly, pressing forward with massive production during the time the FDA was reviewing the trial data.

    5) It's a brand new technology! This is a variant of the "guinea pig" argument. While it is true that no prior vaccine was based on mRNA technology, this idea has been in development and preclinical studies for a couple of decades.

    6) It's genetic material, therefore it will alter your DNA! A lot of people are espousing this one, which just displays a basic misunderstanding of how mRNA functions and what RNases are. There is zero possibility of this happening, but if you meet someone who enjoys this theory, there is nothing you can say that will change their mind.

    7) The vaccine contains a microchip; the government/big business/big brother is just trying to track you! This one is particularly amusing, especially given that it is a favorite of people who pretty much spend their whole lives posting everything they do, everything they eat, and everywhere they go on social media. A subtext of this particular argument is that the entire pandemic is fictional, and/or deliberate ("plandemic") in order to get you to accept this chip. This chip, together with 5G, is going to be the end of society as we know it.

    8) The vaccine is dangerous; lots of people have died from getting it! This one is gaining momentum as reports are appearing about people who passed away in temporal proximity to getting the vaccine. The fact that an extremely small percentage of people who got the AstraZeneca vaccine has suffered blood clots is not helping, either. Most anti-vaxxers are not necessarily getting into the nitty-gritty about different types of vaccines. For example, even to consider the idea/possibility that blood clotting could be an extremely rare adverse reaction to the AstraZeneca vaccine but not the Johnson and Johnson, the Pfizer, or the Moderna vaccines is a bridge too far for these people.

    There are others, but those are the main ones. Some Christians, and Catholics in particular, object to the Johnson and Johnson vaccine because the company utilized a cell line that was derived from an aborted fetus decades ago.

    There are other arguments, but these are the ones I have heard most commonly.

  9. #9
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    On J&J clots:
    Quote Originally Posted by MChambers View Post
    Here's a good blog piece by an epidemiologist about the J&J pause, putting the blood clot issue into better perspective:
    Quote Originally Posted by JasonEvans View Post
    This chart should tell you all you need to know about this issue (pay careful attention to all the extra zeros in the decimal points in this image):

    Worth noting that the JnJ vaccine is far, far less prevalent than the AZ one (6 in 7 million versus 4 in 1 million).

    I'm not a health expert and would love to hear from others who know more than I do about this... but it sure feels like the decision to unnecessarily alarm the public about the JnJ vaccine and halt distribution of it is mindbogglingly stupid.

  10. #10
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    Feb 2007
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    On the J&J blood clots:
    Quote Originally Posted by tbyers11 View Post
    here is a pretty good "cliffs notes" version from an epidemiologist who attended the ACIP meeting yesterday

    She is a really good follow on Facebook as Your Local Epidemiologist for vaccine info

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