Coronavirus

The U.K. Approves COVID-19 Vaccine While the U.S. FDA Dawdles

It's not like we're in the middle of a pandemic or anything, right?

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The Pfizer/BioNTech COVID-19 vaccine was approved today by the Medicines and Healthcare products Regulatory Agency (MHRA) for use in the United Kingdom. The Telegraph reports U.K. Health Secretary Matt Hancock's observation that the vaccine's approval is a "day to remember in a year to forget" and he further described the vaccine as a "victory for science." Vaccinations in Britain will likely begin next week.

Meanwhile the U.S. Food and Drug Administration (FDA) continues to dawdle while the COVID-19 pandemic accelerates. The agency's Vaccines and Related Biological Products Advisory Committee (VRBPAC) won't get around to considering the Pfizer/BioNTech request for emergency use authorization for their vaccine until Dec. 10.

What happens next if the VRBPAC reviews the data and finds that the vaccine is safe and effective? Last Wednesday, Peter Marks, the in-house official who heads up the FDA's Center for Biologics Evaluation and Research suggested that issuing emergency authorization "could be from days to weeks. It's possible it could be within days, but our goal is to make sure it's certainly within a few weeks."

How is it that the U.K.'s regulatory authorities were able to move so quickly? They reviewed the safety and efficacy results from the clinical trial as they came in on a rolling basis. However, the FDA has not taken the data for the new vaccines on a rolling basis. Pfizer/BioNTech submitted their final data for FDA review on Nov. 20.

It is probably the case that the VRBPAC meeting was scheduled for Dec. 10 because it seemed unlikely that the companies could accumulate enough data before then to submit an application for emergency use authorization. However, due to the accelerating pace of the pandemic, the data came in much faster.

So why the hell didn't the FDA reschedule the vaccine evaluation committee's meeting for at least this week, given that the data necessary for evaluation was submitted nearly two weeks ago? It's not like there's a pandemic or anything going on.

While we wait for agency action, the companies are evidently ready to ship out the vaccine the day after they receive FDA approval.

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  1. There are no treasures of American journalism at reason, just liars owned by rich businesspeople.

    1. Where are you pulling that quote from?

      (Yes, I ended the sentence with a preposition. I hope this doesn’t hurt my chances of replacing Dalmia on the Reason staff.)

      1. Fantastic work-from-home opportunity for everryone… Work for three to eight hrs a day and start getting paid in the range of 7,000-14,000 dollars a month… Weekly payments…… EASY ONLINE EARNING

  2. Even when there is an emergency there is still Bureaucracy that must be followed. Just like the Arecebo observatory instead of getting a few cables out there to temporarily stop its collapse they had meetings to see how to fix it now its totally destroyed. bereaucracy will be mankinds down fall

    1. The fact that they were able to put it back together after Goldeneye has to mean something, right?

    2. Yeah, it would probably have been cheaper to get some extra support cables in place.

      However, It may well have been safer for personnel to let the collapse happen and repair the damage after the fact.

    3. I am now making more than 350 dollars per day by working online from home without investing any money.Join this link posting job now and start earning without investing or selling anything.

      Follow Instructions Here……….. Home Profit System

    4. By the time the bureaucracy acknowledged there was a problem, Arecibo was beyond repair. They then turned their contemplation to “dismantling it safely” — and the ungrateful wretch beat them to it by collapsing. Safely. At least no one was hurt.

  3. Radley Balko
    Given the overwhelming whiteness of libertarianism, it also feels especially tone deaf to fire one of the magazine’s two non-white writers — and an award-winning immigrant journalist who writes about immigration — because she’s too critical of Donald Trump.

    Reason= Racist Trumptards

    1. I still can’t believe that is the narrative she went with.

      1. I’m not. That’s just how bad the journalist bubble is. A website that went full on TDS is considered pro Trump.

    2. Balko is a huge Woke race baiter. Fuck him and all identitarians.

      Shikha was a terrible columnist. My absolute least favorite ever at Reason. And that had nothing to do with her politics. Her entire schtick was hyperbole. I’m not at all surprised that she resorted to unfounded accusations on the way out the door. Good riddance.

      1. I think reason could not afford her anymore.

    3. LOL she was a terrible writer. No logic, no coherent thoughts, just diarrhea of the virtual pen.

      Her job is done since she painted libertarians as…..whatever she is…..all throughout the election.

  4. just like HIV bwaaa haa haaaaaa ~~ Fauci

    1. Didn’t he refuse to contact trace gay men? Compared to a respiratory virus, that would have been a piece of cake.

  5. Would you buy a car that was designed and built in 8 months?

    1. I would if I needed to drive my mother to the hospital and I desperately needed a car.

    2. Yes, dependent upon price and alternative options.

      There is more inherent risk in any product that bypasses regulatory requirements and brought to market relatively quickly. But isn’t that acceptance of higher societal risk for increased individual choice and autonomy kind of a central tenant of libertarianism.

    3. Depends: how long does it normally take to design and build a car and why does it take as long as it normally does?

      For instance, if it normally takes 4 years to design and build a new car because it genuinely takes that long for car companies to actually do all the engineering and work out any issues with the design then no, I wouldn’t want to buy a car that was designed and built in 8 months.

      But, if it normally takes 4 years because of wasteful, unnecessary bureaucratic red tape and they were able to produce a perfectly safe, reliable car in 8 months once all that red tape was cleared away then yes, I would be willing to buy a car that was designed and built in 8 months.

    4. they were in the past and it should be easier today but life gets complicated

    5. We build race cars in the off-season. Only have 4 or 5 months to get it done.

    6. If I spent 1 billion on it, sure.

    7. If I spent 1 billion on it, sure.

    8. Sure. Now the very first intergalactic space ship to use a FTL drive, I might need to think about that for a second or two.

    9. If that car would prevent me from catching and spreading a deadly disease I would.

    10. The P-51 Mustang fighter was designed that fast. According Wikipedia “The prototype NA-73X airframe was rolled out on 9 September 1940, 102 days after the contract was signed, and first flew on 26 October.”

  6. Why has Reason been silent when libertarian business owners and managers have been arrested for merely engaging in business (i.e. defying totalitarian lockdowns by Democrats)?
    https://triblive.com/news/world/nyc-bar-owner-who-defied-coronavirus-restrictions-arrested/

  7. They’re not dawdling, they’re defending their turf. They have to remind you who’s in charge here and they’re making it plain they’re not taking orders from nobody, they’ll release the vaccine when they’re goddamn good and ready and not when someone tells them they have to. The more you bitch, the slower they’ll release it just to make the point that nobody tells them what to do.

    1. the withholding will continue until morale improves.

    2. Sadly, you’re exactly right. You see this in the unwillingness to move the meeting date forward, and in the declaration that the approval will come “days to weeks” after that. Every additional day they decide to sleep on it costs 1,000 to 2,000 lives. But, you have to show that you’re in charge, and there may be a cost to that. Hope it’s not someone you care about.

      1. I know a high ranking hospital manager who has been told the vaccine will begin shipping mid-December.

        1. Thanks. I really hope they’re right.

      2. God rot those people. Pfizer requested emergency use authorization November 20. Britain approved it yesterday, December 2 — twelve days later — and it’s shipping now. FDA says they’ll meet to see if it can be approved December 10, and the earliest it can be shipped is December 15, 25 days after submission — and that’s if it’s approved on the 10th. It’s pitchforks and torches time, citizens.

  8. It’s not like we’re in the middle of a pandemic or anything, right?

    It’s not like 99.9% of people survive covid or anything, right ?

    1. It’s more like 99.3%. And that 0.7% is pretty damn huge when we’re talking about three and a half million. Do the maths. And that doesn’t even count the people who spend literally months in the hospital, only to be released in a debilitated condition.

      An acquaintance died yesterday. Liver failure due to COVID-19. She was only 35.

      1. It’s lower than that and you know it. Based on all available data so far the total fatality rate is below 0.3%

        1. It’s even lower than that if you factor out all the deaths from people who were more than half dead to begin with.

          1. What is half dead? Or more than half dead? Define that for me.

            1. There’s a big difference between half dead and all dead. Now, half dead is slightly alive. Now all dead, well, with all dead, there’s usually only one thing that you can do… go through his clothes and look for loose change.

            2. People like my grandma, shitting herself in her wheelchair, as Big Nursing Home extracted every last dollar and shred of dignity she had.

          2. Apparently from all available data, the only covid deaths occurred in a big car accident as people were driving to the OMG It’s Panic Time session at the Covid Lockdown Is Good Convention.

        2. No it is not. 0.3% fatality rate means that roughly 100 million people have already been infected which is utter bullshit and is not supported by any ‘available data’ because it is utter bullshit and not true.

          It doesn’t surprise me that you R’s are completely swallowing this manure because that what you clowns have been doing all year. One lie after another after another and every new lie supported by the pile of existing lies you clowns have previously told each other. The party of stupid has REALLY become stuck on stupid this year.

            1. I guess if we’re missing 8 for every one we catch, we gotta multiply by 9.

              So 13.6M x 9 = ?

              122.4M

              Say the “experts”

            2. That data was from MARCH. When testing had just started and when there were very few cases and when the first antibody tests were being conducted with very large false positives and negatives. That does not mean that is the same % going forward from March.

              Of course the fucking ratio gets repeated and repeated and repeated every month by the circle jerk of R media. So it keeps appearing like its new and that the disease is somehow 80%+ asymptomatic. Which just reinforces the stuck on stupid bullshit of ‘this is just a cold’.

              1. The Centers for Disease Control and Prevention (CDC) calculated that by the end of September there had really been as many as 53 million Americans contract the deadly bug — just under eight times the confirmed cases reported at the time.
                ———————
                Right in the article. Nearly at the top of the article.

                In March it was 10 cases for every one we caught. We’re all the way up to 8 cases missed for every one we caught. Such progress!

                1. No they didn’t calculate anything. Because they are not collecting serological results since those tests were approved in early May. They are using the same output results from March and simply extrapolating the then current caseload.

                  Bluntly I really don’t know why the CDC is so obviously incompetent with covid. Mindblowingly incompetent with even basic statistics and public health and it has pervaded every damn thing they’ve done this year.

                  And yes you have to drill down into the stuff they do release re say serological testing for covid at CDC to see that they are simply rereleasing old data/results without an audit trail or anything to record when something new actually happened. The NYPost ain’t drilling down at all. They and the rest of the media are simply lapping up the press releases from CDC to reassure themselves that Top Men are on it. And you will buy whatever political spin your side of the media laps up.

                  1. They did the same thing re the aircraft carrier. A PERFECT opportunity to actually see how the infection progressed in a captive contained population that is kind of required to comply with public health stuff. Instead they did a study in conjunction with the Navy that only admitted in small print and statisticsese that all their results were crap and their methodology was so poor that they would’ve failed a Stats101 class.

      2. Sorry to hear about your friend.
        And sorry, I’m not sure I could not care less about covid.

      3. Yeah, diseases suck. That doesn’t mean you get to tell people what to do. Sorry about your acquaintance.

        1. I’m not telling anyone to do anything, other than to not dive head first into the conspiracy swamp.

          1. That was more of a general “you” than specifically aimed at you. As far as I can tell, you aren’t for lockdowns or mandates.

      4. So she died w covid and previous liver disease and you blamed the politically convenient one.

        https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/liver-disease.html

      5. Sorry about your friend but liver damage is not a symptom of COVID.

        1. You’re wrong. There are at least three quite different ways covid can attack. The most well-known and common one is respiratory. The second is vascular which then leads to neurological/kidney/heart stuff as well. And the third is digestive which can lead directly to liver damage. Indirectly, liver damage can also result from all three channels if the liver is weakened anyway (which can include anything from hepatitis/cirhossis to ‘fatty liver disease’ which is massively underdiagnosed)

          The liver and covid19

          1. And from what I’ve read – this virus seems to mainly create a vascular disease but via mainly respiratory transmission.

          2. Correct. The disease is systemic and can result in multi organ system failure including endovascular, hematologic, cardiogenic, neurological, renal, hepatic, and gastrointestinal pathology.

            For example the hemotology associated effects.

            https://www.hematology.org/covid-19/covid-19-and-coagulopathy

      6. Sad but she’s an outlier.

        Bottom line very high survival rate.

        The reaction is hysteria.

        ESPECIALLY with the kids.

      7. According to the stats released by Johns Hopkins, who have been tracking this since the beginning, the fatality rate over the last week (defined as deaths/diagnosed case) is 1.01%. One out of every hundred people who get sick enough to be diagnosed will die. All the other numbers are just WAGs.

    2. You’re ignoring the people that survive but suffer permanent lung or heart damage from the virus.

      And what does it matter what the death rate is if we’ve got a vaccine that’ll improve everyone’s odds? Your argument is an anti-lockdown argument, not anti-virus.

      Your tune would surely be different if you had lost someone to this thing. Try a little empathy.

      1. A very small percentage yet again.

      2. “Try a little empathy.”

        Much easier said than done, I’m afraid.

      3. We don’t know if the vaccines will improve everyone’s odds. If the studies are correct, they will improve the odds that more people in a group which has had the vaccine will not get sick. That doesn’t mean that the vaccine itself won’t harm some members of that group more than the virus would.

        Your tune would surely be different if you had lost someone to this thing.
        Why? Don’t you think people have considered that possibility?

      4. How many exactly?

        “You’re ignoring the people that survive but suffer permanent lung or heart damage from the virus.”

        1. Yeah, people keep coming out with that little tidbit to keep us scared. But I never hear anything about how prevalent such outcomes are. Or how prevalent similar complications are with other viruses for a little context. I suspect that if there were a large number of such cases we would be hearing about it a lot more.
          In any case, such facts (true or not) are irrelevant to the sensible arguments against lockdowns, etc.

          1. The prevalence of this and other diseases is well documented despite what you “hear”.

            1. What is the prevalence relative to other common illnesses (flu, mono, varicella, etc.)?… genuinely asking.

              I feel like such complications are often dismissed out of hand, and also over-hyped to induce caution. I honestly don’t know, and I’m not trying to push a narrative around it one way or the other.

              When the Power 5 conferences went through with decisions to have a college football season, there was a lot of concern in news reports about myocarditis. I have not read anything in weeks (maybe months) now about the condition, and it seems the concerns have mostly vanished, at least from the general population.

            2. I’m talking about the relatively rare complications from this and other viruses. You are right, I should go find real data. But if it were anything but very rare, I would expect we would be beaten over the head with it a lot more than we are.

        2. What fucking difference does how many make? Some are acting as though if the virus doesn’t kill you, no big deal. That is emphatically not the case.

          1. No if the rate is very small then it is not a big problem for the entire system. You have to consider all of this stuff in context. What is currently worth spending valuable resources on and what can be handled later.

            There seems to be a faction of people who cannot get past the misery (which you have to do to be effective), cannot put it in context within the problem space. It is tragic that anybody is made to suffer but the fact that they are suffering does not mean we should lose our minds to hysteria.

      5. Again. Outliers. And flu does the same.

        So if you didn’t care then, I will conclude your claims of ’empathy’ to be full of shit.

        It’s false-virtuous, moral bull shit signalling since the beginning. Everyone’s an asshole in 2020.

        1. So Rufus, let’s just toss the fucking vaccine in the ocean. Why try to protect a bunch of worthless outliers? They’re really not even human.

          Remember we’re not talking about lockdowns. We’re talking about the vaccine.

          1. The point isn’t that we shouldn’t care about the outliers, just that they should not be the driver of policy. I can’t speak for Rufus, but I certainly hope that these vaccines do benefit people who are more at risk. But for healthy people who are unlikely to get seriously ill from covid, a brand new barely tested vaccine doesn’t seem like a good bet.

            1. So If you don’t think the vaccine is for you, don’t get vaccinated. I don’t care what you choose for yourself.

              The article is about the FDA slow playing approval. Get it out there and let folks who want/need it take it.

              It’s not as if availability is gonna work down to you or me anytime soon anyhow. Those who fit the list get it and we all learn something from their reaction. Win/win.

              1. Yeah, fair enough. It’s hard to remember where these long threads started, so my response was a little off the original topic I guess.
                I’m all for faster approval. I’m concerned that people will be forced or strongly “nudged” to take it, which would not be good. Faster drug approval is fine because people should be allowed to take risks with their own health. It should not make it easier for others to force relatively untested treatments on you. I’m sure you don’t disagree.

                1. My youngest is a nurse in a Covid ICU. On the one hand, she’ll be among the first to be given access. On the other hand, I doubt it’ll be an option.

                  There’s no way in hell that anybody at the FDA can possibly think they’ll get away with not approving it – or them I guess. They’re just pissing away time. Let’s see what we’ve got.

    3. Even if COVID is a complete scam, that’s not the government’s position, is it? So the bureaucratic incompetence (or malice if you prefer) is still a valid complaint.

  9. I have friends who still insist the vaccine go through normal cautious approval channels, despite the pandemic. The sacredness of the FDA has been hammered into the brains of an awful lot of people.

    As the only one in my circle of friends who actually works in medical, I find the FDA to be a major pain in the ass, contributing little if anything to the health of America. They had one good event decades ago, when one person went off the reservation and would not approve Thalidomide. Did not follow FDA procedures. She’s a hero because she ended up being right (for the wrong reasons). Since then the FDA has been worshiped.

    But what they do is nothing. Commonsense safety regulations are fine. I have no problem with them. But an FDA audit consists of nothing more than checking that the right signatures are on the right pieces of paper. That is all. Drugs have to be safe and efficacious. The former is good. The latter tuns out to be problematic.

    My former company released a product in Europe last year, will release in most of Asia this year. Fully tested and approved. But release in the US is still ten years off, and they only got approved for US *testing* after it was approved and released in Europe.

    That the vaccine is on a fast track is quite frankly amazing. But it’s not fast enough. The vaccine DOES need testing, but we have testing already. The FDA is just overly cautious to the point they wouldn’t approve anything at all if they could get away with it.

    1. The FDA is often an impediment. I have what, a couple years ago, was a just approved implantable lens (IOL). It was designed and manufactured by Abbott Labs. At the point in time it was approved here, it had been in use around the world for 12 years. Turns out, there is a host of lens designs that will never be introduced in the US market because the $1B+ cost of approval cannot be justified by the relatively limited demand. In many ways, we do live in a third world country.

      1. In many ways, we do live in a third world country.

        We certainly have the bureaucracy and the government competence of a third world country. And getting worse by the day.

    2. It’s kind of like asking the National Highway Traffic Safety Administration how to avoid an oncoming semi that’s crossing into your lane. By the time you get your answer, you’re as flat as a pancake.

  10. I wouldn’t be surprised if the FDA continues to “dawdle” until January 21st. Because Orange Man Bad. If they approve the vaccine prior to that the EVUL Orange Man will take credit and they can’t have that. Better that “millions of people die” or some such horseshit than the Orange Man be able to even remotely take credit for anything.

    Which shows how full of shit they really are. If the pandemic is really as bad as their fear mongering claims it is, then they shouldn’t care about who gets to take credit for the vaccine. But you’ve got shit weasels like Andrew Cuomo stating outright that the vaccine rollout should be slowed down until after Orange Man Bad is out of office. These people are fucking pathetic.

  11. The US is already nearly halfway to achieving herd immunity, which is typically achieved when 70% have been infected (and the risk of transmission declines as more people have been infected, or receive vaccines, even if just 20%, 30%, 40% or 50% have been infected).

    More than 10% of North Dakotans and 9% of South Dakotans have already tested positive for covid, as have more than 5% of people in 22 states, and more than 4.2% of all Americans.

    Previous studies (including one by CDC) found that between 3 – 10 times more Americans have been infected with covid (than have tested positive).

    As such, the empirical evidence indicates that 15% – 35% of Americans have already been infected with covid.

    We’ll hear lots of positive advocacy for herd immunity (by Big Pharma, WHO, CDC, FDA, Democrats and left wing media) now that vaccines are about to be distributed (arguing that vaccines can quickly achieve herd immunity, but only if/when mandated by Big Brother), but nobody wants to admit that we’re already nearly halfway to achieving herd immunity (without any vaccine).

    1. the big problem is that infected does not equal immune. there have been several confirmed cases of second infections, even among some who had symptoms both times. and early testing showed that those who had an asymptomatic infection (the bulk of the reason for the actual being higher than the tested) did not have antibody levels high enough to prevent another infection, and the antibody levels dropped faster afterwards. that is to say they have enough to show up on an antibody test, but not enough to actually protect them. since then, there has been little work to quantify the impact of that on immunity.

      in other words….. we can’t reasonably assume that the 10-30% of people who have antibodies by your back of the envelope assumptions are actually immune. we have reasons to believe that at least a good portion of them are not.

      1. “we have reasons to believe that at least a good portion of them are not.”

        That’s bull shit. There have been very few cases worldwide that have been reinfected.

        Also antibodies always fade. Always. Then you get T cell and other mechanisms giving your body memory of how to fight the infection.

        1. Also most every human alive has partial immunity.

          1. https://www.medrxiv.org/content/10.1101/2020.09.05.20187435v1.full.pdf

            “In sharp contrast, patients of moderate or severe disease induced vigorous virus-specific GC B cell responses and associated TFH responses; however, the virus-specific TH1 and CD8+T cells were minimally induced in these patients. These results therefore uncovered the protective immunity in COVID-19 patients and revealed the strikingly dichotomous and incomplete adaptive immunity in COVID-19 patients with different disease severity, providing important insights into rational design of COVID-19 vaccines. ”

            in other words….. people with few or mild symptoms do not develop a lasting immunity. you guys need to learn to find out what the people who study this stuff have figured out instead of what some quack on twitter thinks without studying a GD thing.

            1. If you have had any corona virus you have some partial immunity. Almost every human alive has interacted with a corona virus at some point. You get T and B cell activity. There has been vanishingly few people that have been recorded as been re-infected.

              From your paper: Here, we characterized SARS-CoV-2-specific B-cell and T-cell responses in 10 asymptomatic patients and 49 patients with other disease severity (mild, n=10, moderate, n=32, severe, n=7)

              59 total participants? LOL.

              1. how many participants in your study? what objective test did you do to make the assertions you keep pulling out of your ass?

                1. Immunology text books for the T & B cell stuff? Also a look at places that were hit with MERS, SARS-Cov-1, they have all gotten off fairly light.

                  1. Give me the number of reinfections.

                  2. so…. you don’t have any studies and are making crude assumptions based on other things that you do not fully understand….. in other words, you are pulling it out of your ass and cannot back up your claims.

                    1. How many cases of reinfection are there? Exactly.

                      Cross immunity is a thing. It is not made up. etc.

                    2. everything you are saying is made up. having your BS laid bare, you are now jumping to a completely unrelated claim about cross immunity.

                    3. How many cases of reinfection are there exactly? I stand by all of what I said to include the cross immunity. Refute it or not.

        2. https://www.nature.com/articles/s41591-020-0965-6

          “These data suggest that asymptomatic individuals had a weaker immune response to SARS-CoV-2 infection. The reduction in IgG and neutralizing antibody levels in the early convalescent phase might have implications for immunity strategy and serological surveys.”

          i await you providing data to back up the BS you just pulled out of your ass……

      2. The second infections argument is like the asymptomatic one. It’s rare. In fact the former, is even rarer.

        And we know through several studies, including Iceland, durable antibodies happen. Then then the T-cells play their part.

        This is a medical hysteria in which people should go prison. From Neil Ferguson to those academics that peddled the PCR tests.

        1. can you cite your source, because here is a study that demonstrates the exact opposite of what you claim?

          https://www.medrxiv.org/content/10.1101/2020.09.05.20187435v1.full.pdf

      3. It seems reasonable to assume that this virus will behave similarly to all of the other closely related viruses that we have a lot of experience with. We don’t need to act like it’s a complete unknown. Unless you can find some evidence that a lot of people are getting reinfected, it’s just silly. A small number of people have been confirmed to be reinfected out of many millions of infections, of the most closely monitored and tested disease ever. If it were common, we would know about it.

        1. this is the problem with the age of internet enabled stupidity. people read some generic concepts from Wikipedia, and assume they understand everything about how something works. from the beginning, we knew that this virus was uncommon in how many people could carry it asymptomaticly. but because people read on Wikipedia how the body typically responds to a virus, they falsely assume all those asymptomatic (not what normally happens) respond the exact same way as a full blown heavy infection (what normally happens.)

          we don’t know that those with mild or no symptoms have the same immunity afterwards, because that is not how it normally works. and, now that we have this more unique situation with covid, there are already several studies suggesting that the mild or no symptom cases do NOT develop any significant long term immunity.

          https://www.medrxiv.org/content/10.1101/2020.09.05.20187435v1.full.pdf

          this isn’t anecdotal or strained derivative logic…. this is real science. this is looking at the data, and the way the immune system works. most notable, is the lack of T cell response which is the major component of long term immunity. the asymptomatic cases make up the majority of the presumed untested cases. (minus, of course, the fiasco with testing in the beginning.) they get some antibodies to show up on a test, but they are not actually immune.

          1. I will look at that. I don’t know what you think I was claiming, but I don’t think I disagree with anything you say here. I don’t think we will have a good understanding of it for some time yet. There hasn’t been time enough and too many things are too politicized right now.

            I will look at what you linked, but one thing I would like to note is that studies looking at antibodies and t-cells are all well and good, but that is still a bit detached from reality. If we aren’t seeing a lot of people getting second infections in the wild, there is some reason to think that there is some longer term immunity. Again, we need more time to really know. But assuming the worst seems to be the go-to at the moment. The working assumption ought to be what seems most likely given past experience.

            1. i apologize if i misinterpreted your words. my point is that many people are acting like they are fully qualified epidemiologists based on a few google searches, and they are spreading dangerous amounts of misinformation.

              the key point that many seem not to fully grasp is the large percentage of asymptomatic cases…… that does not really fit with past experience, but it is the reason so many people have detectable antibodies without having symptoms. we don’t know if these people are having “secondary” infections, because we didn’t know they caught it the first time. assuming these people are immune is assuming things we don’t actually know to be true.

              studies with antibody and t cell responses might not be ideal, but it does give us a more objective way to presume things for those cases that do not fit the pattern of what typically happens. right now, there are too many people making assumptions to support the outcome they desire.

              everyone is tired of all off this….. tired of the isolation, and the masks, and not being able to go to large gathering events, and all the things most of us know we should do to “do our part,” and even more tired of the government abusing and overstepping it’s power to try and make us do it. this issue has been a tough one, from a libertarian perspective, because while fighting the overreach of government is an obvious choice for us, too many find it too easy to jump too far in that fight and start obscuring the underlying science. but, much like passing out heroine at high schools would turn people off to the idea of ending the drug war, declaring you will not and do not want to take ANY precautions is damaging the message of personal liberty and responsibility.

      4. “there have been several confirmed cases of second infections”

        Yes, several out of over ten million. As of mid November, 24 had been. Even if the estimates that it’s 10 times that are true, let’s do some math. Heck, let’s make it 100 times that for 2400 reinfections in mid November. There were 55000000 cases confirmed by mid-November and we’ll pretend there aren’t a ton of undetected ones. So that means 0.78% of the world had been infected. You’d expect reinfections to occur in hotspots, but let’s assume there’s ideal mixing instead, so the chance of someone getting reinfected is P(RI)=0.0078^2*(1-F) where F is the immunity factor. The number of reinfections is equal to that times the world population, so 2400=0.0078^2*(1-F)*7500000000 yeilds F=.99474. So if you want to “fix” your 10-30% range without your doom scenario… using 100x the actual confirmed reinfections and conservative estimates on total infections, you’d get 9.9474%-29.8422%.

        That’s not a “good portion.” And yes, F will reduce over time, but so far reinfection is not a significant factor in anything.

        1. That’s 24 worldwide, fyi.

    2. Reason for the big push that having covid does not immunize from covid in the future, they want to force everyone to take all vaccins its the only way to make it profitable i mean useful

      1. If having the virus doesn’t give you long term immunity, is it reasonable to assume that a vaccine would?

        1. they do take it into consideration in factoring the dosage….. to try and ensure a sufficient immune response…. but we don’t know yet how long immunity will last. we only have data to show it will last for 7 months, because that is the amount of time we have tested. best estimate based on family of virus is about 2-5yrs.

    3. Even more amazing is that if Trump today demanded that the red tape be cleared, and the vaccine released, folks like Bailey would be the first to say he is politicizing the vaccine and delegitimize his efforts. Heads, Bailey gets to criticize Trump’s government. Tails, Bailey gets to criticize Trump.

      1. The president has no such authority.

        1. USC Title 3 Chapter 4 gives him that authority.

  12. They are slow because they are the government, and there’s no incentive to be good, quick, effective, efficient . . . any of those things. What are they going to do, fire you? No motivation to be any better than barely mediocre, so that is what you get.

    I have never worked with a government employee (outside of the military) who would be judged to be competent in the private sector equivalent of their job. Even the ones that may have started out above average regress to the mean eventually.

  13. It will get approved and many will eventually get the vaccine. This isn’t a death sentence for most it’s not like you’re hiding out from Ebola. Take whatever precautions you think are necessary in the meantime. The most important advice is to go live your life and stop acting like we’re in a war. You’re letting the feds and states get too much control that you won’t get back.

  14. “So why the hell didn’t the FDA reschedule the vaccine evaluation committee’s meeting for at least this week?”

    A far more important question (that Reason refused to investigate, just like Hunter Biden’s e-mails and the millions of Biden votes that suddenly appeared overnight in six swing states) is:
    “So why the hell didn’t any drug companies reveal the success of their covid vaccines until after the election?”

    The correct answer is because Trump protected US taxpayers and stood up to Big Pharma by refusing to continue paying outrageously excessive prices for drugs via VA, Medicare and Medicaid.

    But of course, Bailey and Reason trashed Trump and campaigned for the corrupt, senile and nonlibertarian Biden.

  15. No, we are close to the end of a pandemic and in many places, past the end of it. In most of Europe and the NE US, at least, this is now an endemic virus.

    1. Check out Ivor Cummins latest video. They have a log plot of infections (derived from deaths/hospitalizations…so cleaner data than PCR tests) vs mobility data in England. Several points

      1. At no point – even in the spring – was the rate of infections doing anything but decelerating.

      2. When the mobility data was going up the infection rate was going down. The opposite was true as well.

      3. No ties to a change in the Gompertz character of the infection rate could be found for land marks like when a lock down was started or when things were opening up.

      1. Yeah, I just saw that last night.

  16. This is not true: “as the COVID-19 pandemic accelerates”

    Infections are rolling over all over the world. Death rates have turned over in Europe. In fact, the deaths attributed to C19 are within the error bounds of excess mortality for most every country in Europe. They were way above those curves in March/April.

    What is happening is that is it finding places that have been lightly hit, once you get local burn out (or community immunity) it is pretty much over in that area. Combine that with the fact that corona is seasonal and you get a slight uptick in the rates. In the US the midwest is getting hit but the infections for about 7 states all of which nosed over during the same week (~ Nov 20th).

    It is clearly in the endemic phase, the epidemic is largely over.

    1. wishful thinking does not reality make.

      1. It’s obvious from even a data source like worldinfometers, that the numbers are rolling over…before lock downs were implemented.

        You can go look for yourself.

        1. Also go to EuroMomo and look at the current mortality numbers compared to the historical excess mortality bounds. They are right on the edge of the upper bound with no acceleration in infections. In the end, the winter mortality will look like a bad flu season.

        2. i suggest that you go and actually look at the data before making statement like this:

          https://covidtracking.com/data/charts/us-currently-hospitalized

          i specifically linked to those hospitalized because this undercuts the BS arguments about increased testing. the number of people who have to go to the hospital is not impacted by how many tests we do. we have 30,000 more people in the hospital for covid than at any time in the pandemic, and the trend is still going up.

          1. No, but testing everybody who comes to the hospital WILL increase that number.

            Very few states differentiate “Came to hospital for covid” vs “Came to the hospital for something else and is covid positive”, but the ones that do show about 25% of people aren’t there for covid.

            1. are you really suggesting that 25% of the people who are hospitalized with covid just happen to have it when they show up? what kind of BS logic is that? for that to even remotely make sense, 25% of the population would have to have an active covid infection. people with other conditions are more likely to die from covid, but not more likely to have it.

              1. That’s exactly what the states who break it down are saying, yes. Iowa is one such state.

                https://coronavirus.iowa.gov/pages/hospitalization-analysis

                795 primary covid
                329 secondary covid

                Regardless, when a bug is in X% of the population, you would EXPECT that X% of your hospitalizations to have the bug present, even if it has nothing to do with why you are there. The midwest got up to 18% or so positive rate during this past spike.

                This is also ignoring the fact that many people get the bug WHILE IN THE HOSPITAL. If 15-20% of “cases” are coming from people catching it in the hospital (as is true in the UK), then the percentage of cases “with” rather than “of” are very high.

                1. And since we’re dialing our testing up WAY to high, we don’t need 25% of people to have an ACTIVE infection at all. Any infection in the last month or so will be enough to trigger a positive result.

                2. 1. 25% of the population does not have an active infection….. so your “X%” argument is garbage.

                  2. after the garbage argument, you unwittingly describe what you were really talking about without even knowing it….. tacking it on like an “and on top of that.” those with the secondary diagnosis are the people catching it in the hospital.

                  3. irregardless….. this still sounds like a good argument for trying to limit and control the spread. if people with underlying conditions, who have higher risks, are catching it in the hospitals…. maybe we should care about how many people are going to the hospital with covid….. maybe we should not be throwing around garbage wishful thinking to promote allowing uncontrolled infections……

                  1. So you’re ignoring the fact that 30% of the people in the hospital with covid in Iowa are there for something else?

                    Handwave all you want but the facts on the ground remain.

          2. Foo, I see the chart and yes it has an increased rate. I can’t find this but am curious if others have a link they can share what is the total us hospitalization rate look like currently compared to just the Covid numbers above? Is it going up also? Is it level because reclass? Is it down?

            Thanks

          3. The case numbers are rolling over that is a trivial fact that even somebody as blinkered as you can verify. Corona is also seasonal, this is prime respiratory virus season, every fucking year. But like I said one glance at the Excess Mortality data will show you that Europe is within – barely though – the expect min/max of excess deaths.

            1. In the US, according to your chart the death numbers are also rolling over. But I knew that…did you?

              1. Actually that bit concerns me. It makes little sense for death numbers to start decelerating at the same time as confirmations; there should be a delay. I think some of this is holiday reporting nonsense.

                Also it’s regional. New cases are decreasing quickly in the Midwest, but still increasing in other regions (the latest wave struck in the Midwest first, so they were just ahead on the epi curve).

            2. i just showed you the data that what you are claiming is false.

          4. That’s a good site. I like that they have regional breakdowns. That’s the only way to look at US numbers. The US as a whole isn’t in one situation. Some regions are through the epidemic. Some are still having their first wave. That’s why it looks the way it does.

            And you are quite right, hospitalizations and deaths are the numbers that matter.

    2. Europe is declining, but several countries there have gone back to draconian lockdowns (which I don’t support, incidentally) but yesterday the US had its highest death toll of the entire pandemic – 2,831 according to Worldometer. As of October 3, the US suffered 300,000 excess deaths since January 26, according to the CDC. Two-thirds of those were directly from Covid. I don’t know what curve that might be above or below but it’s a lot of people.

      https://www.cdc.gov/mmwr/volumes/69/wr/mm6942e2.htm

      If anyplace in the US should fit your description of local burn out it should be New York City, but infections are rising again there and they’re reopening a field hospital. And that’s with tighter restrictions than most places. If they had crowded bars and restaurants as we do in the Midwest, they’d be as swamped as we are with hospitalizations and deaths.

      Indiana has done an overall antibody prevalence study based on random sampling and found Covid antibodies in 10.7 percent of the population. That leaves a whole lot of people left to get infected. Yes, about 99.7 percent will live but 0.3 percent dying represents many thousands of people with the case numbers we have now, and you see this in yesterday’s highest-ever death total for the pandemic. Maybe some people have pre-existing immunity and won’t get it. Good; I hope that’s true. But there’s nothing I see going on in the US indicating that’s starting to take hold.

      I don’t support governments locking people down. It doesn’t work because it’s not sustainable, and too many things are essential, anyway, and can’t be shut down. But we need reasonable public health policies such as capacity restrictions and cancellations of large events, with financial support for those adversely affected.

  17. I have had extensive dealings with government regulatory agencies. Mostly, the EPA and OSHA; however, I have had a few dealings with the FDA. I have also had dealings with these agencies’ counterparts in Japan in Korea.
    One of the biggest differences between agencies in the U.S. and other countries is the technical competence of the folks who are making decisions. When dealing with regulators in Japan and Korea, I was almost always dealing with a degreed chemist or biologist (often with a Ph.D.). These folks were empowered to make decisions.
    When dealing with regulators in the U.S., the person I dealt with usually had a degree in political science or gender studies who neither had the authority nor the knowledge to make decisions. Instead, they would coordinate endless meetings (mainly with other non-technical folks) to determine who might be able to make a decision.
    One event really stands out. I had requested that the EPA approve a change in an adhesive I was using from Sodium Hydroxide (Lye) to Ammonium Hydroxide (Household Ammonia). My company spent $30,000 for expedited treatment. Each time I called to inquire about my request, I was routed to a different person–Never a real chemist–Who had never heard of my request. It was like ground hog day.
    Failing to get EPA approval, we decided to manufacture the product in Japan. I filled-out the paper work, and within a few days received approval from a Ph.D. Japanese Chemist. As a result, several million dollars of manufacturing work went to a factory in Japan instead of a factory in Minnesota.
    As for the expedited EPA approval? As far as I can tell, the EPA pocketed the money and never actually reviewed my request.

  18. It has been a while since I heard anything about Russia’s vaccine:

    https://apnews.com/article/europe-moscow-coronavirus-pandemic-vladimir-putin-europe-093e3ef365591e9eafde5874253b04cf

    “Russian President Vladimir Putin on Wednesday ordered the start of a ‘large-scale’ COVID-19 vaccination by late next week, with doctors and teachers to be the first in line to receive the Sputnik V shots, which have yet to complete advanced studies needed to ensure its effectiveness and safety in line with established scientific protocols.”

    1. Sort of like the American vaccines?

  19. I guess the British are just more tolerant of pricks.

    1. And this is why we need an upvote button. Edit button first though.

  20. I get paid more than $120 to $130 per hour for working online. I heard about this job 3 months ago and after joining this i have earned easily $15k from this without having online working skills. This is what I do… Here is More information.

  21. There is no urgency at the FDA because they’re shit from top to bottom.

  22. America’s FDA has killed far more people than it has saved. If ought not exist.

    In the 1980’s, the FDA withheld advertising of the aspirin regimen. Doctors all over the country had individually discovered that taking an 80 mg aspirin pill once daily would save approximately 10,000 lives per year. The FDA withheld approval for advertising that fact for three years costing America the lives of 30,000+ people.

    More recently, the FDA and only the FDA could approve tests for COVID. They granted the CDC the singular power to develop such a test – denying anyone else. The CDC developed a faulty test, and the FDA approved it. It wasn’t until late March 2020 that a valid test existed in America. Here again, the FDA is directly responsible for 10’s of thousands of lives lost due to the lateness of delivery of a COVID test.

    That brings America to today. The FDA is now studying the facts they could have requested in June and will determine at some future date when and if the vaccines developed under Trump’s Warp Speed program can be released to the public. Meanwhile foreign countries are distributing the vaccines to their citizens. FDA’s actions amount to delaying herd immunity for weeks – taking 10’s of thousands of lives.

    If there is a single government organization outside the CIA that has killed more people than the FDA, I cannot find it. America’s FDA should be abolished.

  23. It’s great to hear after some time hope everything will get into normal …

  24. The delays in the US are because we had to hold back the vaccines until a week after the election so Trump didn’t get credit.

    Otherwise, we would have been further along…but stopping the mean tweets was more important than getting a vaccine out to the public.

  25. There is a propaganda pandemic, not a covid pandemic. A pandemic is when 8-9% of those who contract the virus die. We are pin-balling between 2-3%. SARS, the 1968 Asian flu and the 1918 Spanish flu were true pandemics. This is nothing more than a manufactured crisis designed to destroy the world’s economic and financial systems and replace it with the great green garbage machine. A year from now, vaccines or not, not much will be different…there will still be foolish lockdowns, insidious masking and all the other nonsense that make people slaves to the government tyrants.

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