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Medicine

FDA Vaccine Advisers 'Disappointed' and 'Angry' That Early Data About New Covid-19 Booster Shot Wasn't Presented For Review Last Year (cnn.com) 168

Posted by msmash from the how-about-that dept.
An anonymous reader writes:

The pharmaceutical company Moderna didn't present a set of infection data on the company's new Covid-19 booster during meetings last year when [FDA] advisers discussed whether the shot should be authorized and made available to the public
That data suggested the possibility that the updated booster might not be any more effective at preventing Covid-19 infections than the original shots. The data was early and had many limitations, but several advisers told CNN that they were concerned about a lack of transparency.

Specifically, Moderna hid data on actual infection rates among patients who were administered the original booster and those who got the bivalent vaccine. The data showed that the original booster resulted in slightly fewer infections than the bivalent version - though CNN points out that "the primary purpose of the study was not to study infection rates but to do immunogenicity analyses, taking blood from participants and examining their antibody responses to the vaccine."

CNN reports that Moderna "shared the infection data with the FDA and posted the study manuscript before the agency's panel meeting in June," but with an FDA spokesperson complaining that they received the preprint less than a day prior to the advisory committee meeting, and "therefore not provided in an adequate timeframe for it to be included in the agency's meeting materials..."

1.9% of the study participants who received the original booster became infected. Among those who got the updated bivalent vaccine -- the one that scientists hoped would work better -- a higher percentage, 3.2%, became infected.

Both versions of the shot were found to be safe. This infection data was far from complete. The number of study subjects who became infected was very small, and both the patients and the researchers were aware of who was getting the original shot and who was getting the new booster.... [S]ix FDA and CDC advisers interviewed by CNN said that this infection data wouldn't have changed how they voted, because the data had such limitations, but it still should have been presented to them.

Research released by the New England Journal of Medicine found that "boosting with new bivalent mRNA vaccines targeting both the BA.4-BA.5 variant and the D614G strain did not elicit a discernibly superior virus-neutralizing peak antibody response as compared with boosting with the original monovalent vaccines. Limitations of our study include the small sample size and follow-up period of our groups. We also note that the between-group comparisons were not controlled for factors such as age, vaccine type, and health status, which may have had an effect on antibody responses. These findings may be indicative of immunologic imprinting, although follow-up studies are needed to determine whether antibody responses will deviate over time, including after the administration of a second bivalent booster."


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FDA Vaccine Advisers 'Disappointed' and 'Angry' That Early Data About New Covid-19 Booster Shot Wasn't Presented For Review Last More

FDA Vaccine Advisers 'Disappointed' and 'Angry' That Early Data About New Covid-19 Booster Shot Wasn't Presented For Review Last

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  • Pretty sure that's not just fraud, it's conspiracy (Score:4, Insightful)

    by He Who Has No Name ( 768306 ) on Monday January 16, 2023 @12:45PM (#63212998)

    I'm not sure we have laws for conspiracy and malicious deception on that scale. Can we just hang the board of directors?

    • That should have been carried out when they announced massive price hikes.

      • Re: (Score:2)

        by shanen ( 462549 )

        Hmm... I sort of agree with you, but it's still a rather shallow FP branch.

        I think it's just par for the course when you create a bad motivational system. Healthcare should be about making people healthy, not about the money, Lebowski. [Where is Lebowski when you need him? His page on Slashdot is empty of entries.]

        So imagine you are a giant pharmaceutical company trying to decide what kind of vaccine research you want to do. One branch could lead to one-and-done vaccines, while the other direction promises

    • Re:Pretty sure that's not just fraud, it's conspir (Score:4, Insightful)

      by joe_frisch ( 1366229 ) on Monday January 16, 2023 @01:25PM (#63213138)
      It may be more like regulatory capture than actual fraud. The FDA should have done a more thorough review, but the medical industry is so huge, that its difficult to review effectively. Anyone capable of doing a real review is, was, or will be involved in that industry.

      • No it should be the drug companies responsibility to give all relevant information, and if its not there is something wrong with the system. It is inefficient, and probably impossible for the FDA ask every possible question. There should be a statement that the submission should be true and complete to the best of the companies knowledge. If nobody here is being criminally charged on fraud or an equivalent crime on what probably made them billions, it shows how corrupt the system is.

    • Haven't you heard there's no such thing as a conspiracy?

  • They are correct to be (Score:3, Insightful)

    by JoshuaZ ( 1134087 ) on Monday January 16, 2023 @12:45PM (#63213000) Homepage
    It doesn't look like the data would substantially have changed things. The vaccines are safe and effective. But every single thing like this makes people distrust the vaccines more. Ultimately, transparency is important not just at a moral level, but because transparency really helps convince people.

    • Re: (Score:2, Insightful)

      by saloomy ( 2817221 )

      The vaccines are safe and effective.

      CDC Investigating ‘Safety Concern’ Linked to Pfizer Covid Vaccine [nationalreview.com]

    • Re:They are correct to be (Score:5, Insightful)

      by Brain-Fu ( 1274756 ) on Monday January 16, 2023 @01:17PM (#63213114) Homepage Journal

      Data-hiding is egregious. It doesn't just "make people distrust the vaccines more," it makes the conspiracy-theorists right. Even if the vaccine is still safe and effective (but maybe a little bit less effective than hoped), this evidence proves that we were lied-to by omission, which is exactly the kind of thing the anti-vaxxers accuse the industry of doing. Maybe the anti-vaxxers are still not right about everything they claim, but they are now provably right about this claim.

      The distrust caused by revelations like this is significant, and will lead many people to make bad decisions that harm themselves and others. We simply cannot abide behavior like this from the pharmaceutical companies that we rely on to fight disease.

      An apology is simply not good enough, we need punishment for the people who engaged in data-hiding.

    • > The vaccines are safe and effective

      Vaccines prevent the contraction and spread of disease.

      The laws that shield vaccine manufacturers don't apply to therapeutics. Some administrative lawmaking semantics to pretend to change a scientific definition won't protect them from fraud claims and damages because the statutes have their own definitions sections.

      Pfizer is already the most criminally-fined entity in the history of humanity and before this is over the company will be destroyed and the executives tr

      • Re: (Score:2)

        by HiThere ( 15173 )

        I think you need to recheck your facts, and I'm certain you need to recheck your definitions. A quick search showed that Pfizer has indeed had to pay a huge fine....for overcharging Britain's NHS on drugs. And any reasonable person would count their vaccine against COVID as a vaccine.

        Also, blood thinners come with their own problems. One doesn't want to use them without supervision. Even aspirin can cause problems, and aspirin was/is available to anyone who wanted it.

        The thing you're worried about is a

    • All things considered, vaccination and the human body are a lot more variable than I think folks possibly understand. It takes people years to even come close to understanding how this stuff works with the human body. The long story short of it is the bivalent booster is still very good to get, and still very effective overall; it's just that it's not *quite* as good at preventing initial infection of the disease. However, it's fantastic at preventing hospitalization and severe disease--which is ultimately

      • "A room full of vaccinated individuals is going to fair much better than a room full of unvaccinated folks if someone walks in with covid, that's for damn sure."

        That is not for sure at all.

        https://twitter.com/nycHealthy... [twitter.com]

        • Unfortunately that post doesn't share numbers in terms of how much the vaccine protects against infection. That said, we don't really have much data on XBB1.5 other than they're still highly recommending the bivalent booster to offer the best protection against XBB1.5. Lab studies have still shown it to be highly effective against severe disease with XBB1.5. Actual transmission numbers I can't find easily.

          Source I could find: https://coronavirus.jhu.edu/from-our-experts/what-you-need-to-know-about-xbb-1-5-o
    • It's interesting that you say "The vaccines are safe and effective." It's just the catchphrase that you repeat that has no structure behind it. Just keep repeating it over and over again. That's how it works. That will make the vaccine safe and effective. The entire point of this article is that the vaccine is not effective. Hilarious, you. You're a funny one Mr. Grinch.

    • Re: (Score:2)

      by fintux ( 798480 )

      Yea, from the article: "First, the numbers were very small: The study analyzed only hundreds of patients, and only 16 became infected.". That means random events make big differences in the results. Also: "the participants and the researchers knew who was receiving which shot". If the participants hear they got an updated vaccine, they might be more likely to have risky behavior. Third, the test protocol wasn't designed for real life efficacy to begin with (which pretty much led to these two problems).

      Still

  • Fixing some popcorn (Score:5, Funny)

    by OffTheLip ( 636691 ) on Monday January 16, 2023 @12:45PM (#63213002)
    This should be an intelligent and fruitful discussion.

    • Hold on, have to run to the store for bleach and syringes.

      • And erect plexiglass barriers, stand 6' away, wear three cloth masks outdoors, and wash your hands and packages 15 times a day.

        There, now you are ready!

        • And erect plexiglass barriers, stand 6' away, wear three cloth masks outdoors, and wash your hands and packages 15 times a day.

          There, now you are ready!

          You mean everything the medical experts said you should do (except for the plexiglass) and which was shown by the facts to reduce infection rates? That's crazy!

        • Last time I needed surgery for an infected tooth I told the surgeon that he didn’t need to wear a mask.

          • The surgeon wears a mask to prevent arterial blood spray from you squirting into his mouth and nose, and to prevent him from drooling, "singing moistly", and casting boogers into your open wound. Goggles or a visor prevent arterial spray from hitting his eyeballs. They also prevent tears from falling into your open wound -- even though tears are sterile.

          • >"Last time I needed surgery for an infected tooth I told the surgeon that he didnâ(TM)t need to wear a mask."

            That wouldn't be wise. Masks are primarily to prevent the spread of bacteria in droplets, not airborne viruses (for which they offer poor results). Surgical fields are mostly at risk of bacterial contamination. Airborne viruses are primarily respiratory-contracted.

            Respirators are used when needing good protection from airborne viral transfer.

      • Don't forget to piss in it, too.

  • So these fuckheads were making money hand over fist and they STILL had to lie about the performance of the bivalent version.

    How are we every going to prevent sociopaths from running these companies ?

    • There is no way to prevent sociopaths from running these companies. Sociopaths have too much of an advantage over their competitors when climbing the corporate ladder, and too much motivation to get these positions.

      The only thing we can do is keep holding them accountable, and keep punishing them for behavior like this. It is not easy to do, since they have the money and power to externalize blame and dodge punishment. But doing nothing just lets them get away with it and encourages more behavior like th

      • Re: (Score:2)

        by HiThere ( 15173 )

        But just punishing the companies doesn't work. You ALSO (perhaps mainly) need to punish the executives in charge.

      • It is not easy to do, since they have the money and power to externalize blame and dodge punishment.

        That is why I have come to believe the legal system should be free. That is everyone gets a lawyer paid for and no one should be able to pay for their own. The legal system has become a function of wealth and not one of justice.

        If we want a fair society that needs to change.

    • Re: (Score:2)

      by sinij ( 911942 )

      How are we every going to prevent sociopaths from running these companies ?

      Well, one thing you DON'T do is grant them indemnity.

  • Fines (Score:5, Insightful)

    by ThurstonMoore ( 605470 ) on Monday January 16, 2023 @12:49PM (#63213018)

    They should have the living fuck fined out of them and possible jail time.

    • Re:Fines (Score:5, Insightful)

      by Ritz_Just_Ritz ( 883997 ) on Monday January 16, 2023 @12:59PM (#63213056)

      Nothing is going to happen to them. Only a few months ago just talking about this fraud would have gotten you kicked off of social media and shunned as a conspiracy theorist.

      And here we are. Those who greased the correct politicians were rewarded. The rest of us were lied to.

      Fuck these people. There isn't even an attempt to hide the blatant corruption.

  • Follow the money. Has anyone noticed there is a lot of commercials now encouraging boosters are paid for by Moderna and Pfizer? It's been huge profits. I wonder how far down the rabbit hole anyone will go on this. I'm assuming not too far. Might be interesting who in the governments/doctors/etc, who had influence on encouraging boosters have heavy investment in the companies. I'm thinking this will be a quick dog and pony show and it will end with some low level marketer person who "forgot" to submit

    • Re: (Score:2)

      by HiThere ( 15173 )

      Sorry, they may have clear motives, but the vaccines aren't permanent. They lose effectiveness from about 6 months after the shot. And the virus keeps mutating.

      OTOH, having had the vaccine will probably keep you from having a severe case of COVID. Not just for 6 months, but for considerably longer. We don't know how long. Unfortunately, this doesn't mean you won't develop long COVID. My sister still can't remember the day of the week, though she says she thinks she's getting better. (That said, she h

      • Sorry, they may have clear motives, but the vaccines aren't permanent. They lose effectiveness from about 6 months after the shot.

        They will keep you out of the hospital. In terms of serious illness, the vaccines have turned out to be highly durable.

        See this study: [jamanetwork.com]

        "COVID-19 vaccines were highly and durably effective against severe disease as measured by hospitalizations and deaths, but did not protect against milder infections beyond a few months"

  • Repay the money (Score:4, Insightful)

    by quonset ( 4839537 ) on Monday January 16, 2023 @01:04PM (#63213074)

    If they received money for this they should be made to repay it, plus interest.

    We keep hearing how private indusry is so much better than government, we're still waiting.

  • >"those who got the bivalent "vaccine." The reason is obvious: The data showed "

    Of all the people I personally know who got COVID-19 in the last month, 3 had taken the bivalent vaccine and 2 did not. Anecdotal, yes, but interesting nonetheless.

    It is also interesting that there is no option for getting the new vaccine component (omicron-specific) WITHOUT ALSO getting the almost three year old vaccine along with it, designed for Alpha, which has been gone for years. Personally, I think it is reckless to

    • It's been studied.

      https://jamanetwork.com/journa... [jamanetwork.com]

      "COVID-19 vaccines were highly and durably effective against severe disease as measured by hospitalizations and deaths, but did not protect against milder infections beyond a few months, even with booster vaccinations"

  • I'm sure the anti-vaxxers will be all over this. So tiresome.

    I have long ago given up on having any reasoned discussion about vaccines anywhere online.

    • I'm sure the anti-vaxxers will be all over this. So tiresome.

      I have long ago given up on having any reasoned discussion about vaccines anywhere online.

      Fortunately, they keep [imgur.com] dying [imgur.com] so we won't have to hear from them ever again.

    • The fascinating thing is that companies who are deceptive, corrupt and thieving are somehow able to come up with a vaccine that is effective, and also a rather impressive technical marvel.

  • I am so Angry but... (Score:4)

    by jellomizer ( 103300 ) on Monday January 16, 2023 @01:18PM (#63213118)

    This makes me angry... But as a honest American, I will hold my my opinion on why I should be angry until the trustworthy contaminators give me the direction on how I should be angry about this.

    If I am a right leaning individual, I hate all government regulations so the obviously moral and smart company (otherwise they wouldn't be so large now) wouldn't do anything to harm us, and they left it out for our best interest. So I should be angry about this being an issue, it is just the Left trying to put more regulations on honest companies.
    Or perhaps because I told that the company is rig of the government to poison the people, so I see this a further proof of said companies moral failings.

    If I am a left leaning individual. All companies are Evil, and really need to be micromanaged by the Government to make sure they don't do anything against our interests. So I should be angry that they tried lied to us.
    Or because the Vaccine is still safe and effective even with that data, it doesn't matter that much, because we want everyone to get the vaccine anyways, so we should be angry at those trying to dig up any dirt to help stop the virus.

    We can't be angry at the company for misleading us, and not really go into a big fuss about it, because the information is mostly for a different group of people to help make the decision if it is safe, then what we are really qualified to judge.

    However some fast talking contaminator will pop onto TV, one who I see who has an opinion about every other topic, to let me know how to approach the issue, Because I don't want the other guys to have the upper hand.

    • This makes me angry... But as a honest American, I will hold my my opinion on why I should be angry until the trustworthy contaminators give me the direction on how I should be angry about this.

      That's actually kinda rational.

      All we have right now is a report from one commentator (CNN) and a correspondence to a medical journal that most of us aren't really qualified to digest.

      Assuming the pure facts are correct there's still a lot of questions that most of us don't have the information or the experience to answer.

      The best play is to find trustworthy analysts and read them with a critical eye.

    • If I am a right leaning individual, I hate all government regulations so the obviously moral and smart company (otherwise they wouldn't be so large now) wouldn't do anything to harm us, and they left it out for our best interest.

      I don't know anyone who trusts corporations or companies, but I do know plenty of people that know that no matter how bad a company is, the government is worse. This has been objectively proven true countless times in history.

      The whole stance of the "vaccine hesitant" has been based on a lack of trust; in both corporations AND the government...and viola, here's why.

  • Boosters Boosters Boosters! (Score:4, Interesting)

    by Fly Swatter ( 30498 ) on Monday January 16, 2023 @02:39PM (#63213398) Homepage
    Otherwise known as Money Money Money!

    I got vaccinated, I lived through the second dose's symptoms which was worse than the first shot. My body knows how to fight the virus thanks to the vaccine - but damn if I am going to get another shot after that. BTW I don't get flu shots yearly either. If you want to great, but I'm done.

    If I get sick and die then that is the way it is meant to be. I am living my life and not worrying about this crap anymore. The choice should be yours.

  • Moderna hid data

    At that point, you're committing fraud if it can be proven that you knowingly withheld information about the efficacy of your product. Congress may have granted immunity for the use of the vaccines/boosters but that doesn't protect you from illegal activity.

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