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Medicine

Moderna Starts Trial of an Omicron-specific COVID-19 Vaccine (theverge.com) 82

Moderna gave its omicron-specific COVID-19 vaccine to the first participant in a clinical trial, the company announced Wednesday. The report comes a few days after Pfizer / BioNTech launched a trial of its shot targeting the fast-spreading variant. From a report: The announcement coincides with the release of data showing that the two-dose series of Moderna's original vaccine struggled to block the omicron variant of the virus, which has mutations that help it dodge those antibodies. A booster shot restored much of its ability to neutralize the virus -- and while that protection weakened over time, it still stuck around for at least six months. Still, Moderna CEO Stephane Bancel said in a statement that the omicron variant is enough of a threat that the company plans to move forward with the variant booster.
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Moderna Starts Trial of an Omicron-specific COVID-19 Vaccine

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  • by Rei ( 128717 ) on Thursday January 27, 2022 @10:09AM (#62211507) Homepage

    "Multivalent".

    • World peace sounds easier

      • by Rei ( 128717 )

        I simply don't get what's so difficult about this. Every year flu vaccine manufacturers give us multivalent vaccines based on the latest flu strains. And yet here we are, with the "easily updatable" mRNA vaccines, in a pandemic, and only offering a single two-year-old spike from before the disease even started adapting spread in to humans to any significant degree.

        I just don't get it. There's now ample evidence to show that with enough antigenic diversity, people can develop pan-sarbecovirus immunity, as

        • I agree, for the anti-vaxxers there's just not much we can do. The rest of us want a multivalent vaccine, we'll take it as needed (hopefully once a year) just like the flu shots. Time is on our side, we can show its safety and efficacy and eventually, perhaps, the antivax crowd will realize how ridiculous they are acting.

          Sarcasm Mode. Or our balls will fall off and they'll point their fingers and laugh at us. Or they'll die off. Either way the world will keep turning, with or without us. I just wish people

        • Because vaccine development takes time and money. The reason there hasn't been a race to develop another vaccine is because the existing ones basically work even against newer strains and they are already on the shelf. This report looks very much like the vaccine manufacturers are figuring they might as well have a go at developing an updated strain-targeted vaccine even if the existing vaccines are still effective as a booster. Seems like a good idea to me, since they will be in a better situation to re
          • The Omicron Variant was first discovered in July (IIRC), they are testing now (six months) it might be ready in two. Omicron will be done and over by then as we are already getting word of new variants. Yay!

            • Um, no it was late in November [wikipedia.org].
              • I didn't recall correctly. Update my timeline accordingly. Easy enough, and my point remains, just shorter timeline.

                I'd also like to point out it only took a month from isolation to being 73% of cases in the US

                Omicron now 73 percent of U.S. COVID-19 cases

                https://www.pbs.org/newshour/h... [pbs.org]

                We're not containing anything. And all those vaccinated people haven't helped reach herd immunity. With natural immunity being the best form and longest lasting, we're not getting out of this until 70% (or more) have had it. Current Vaccine tech is only temporary supp

        • by zeeky boogy doog ( 8381659 ) on Thursday January 27, 2022 @03:06PM (#62212897)
          It's because, contrary to the assertions of morons, the development of the mRNA covid vaccines is NOT rushed.

          The flu vaccine is the only one I know of where the "formula" (which 2/3/4 sets of antigens it presents) is changed without normal review or testing because the process is done so regularly that we know in advance that it's safe. Both Pfizer and Moderna have done "test runs" of both variant and multivalent vaccines against delta and beta. This was not taken beyond trials because it was found that these did not offer enough of an increase in benefit to be worth the disruption in supply (they did offer increased neutralization titers against those, but the improvement vs a booster was a factor of roughly 2), but proving that these sort of changes are safe did grease the skids for the coming omicron shot.

          It's actually a legitimate question in regulatory terms. The flu vaccine can be changed without full review because they're just substituting different known antigens (different H and N). But how much of a change in the mRNA sequence is "yearly flu shot" level and how much is "new round of approvals" level? For example it would seem to me that a small number of changes (D614G, E484K, L452R) should "obviously" not require a new round of approvals, but... if not 1 or 2 or 3 substitutions, then how many?
          • by tlhIngan ( 30335 )

            It's because, contrary to the assertions of morons, the development of the mRNA covid vaccines is NOT rushed.

            The flu vaccine is the only one I know of where the "formula" (which 2/3/4 sets of antigens it presents) is changed without normal review or testing because the process is done so regularly that we know in advance that it's safe. Both Pfizer and Moderna have done "test runs" of both variant and multivalent vaccines against delta and beta. This was not taken beyond trials because it was found that the

      • Or a vaccine for the flu or common cold? Lol
        • by Rei ( 128717 )

          Um... we have flu vaccines.

          There's work to make better ones, of course (main problem is that influenza is just so incredibly diverse... even true influenza, let alone influenza-like illnesses in general).

          Colds are even more diverse, representing clades that aren't even remotely related.

    • Safe and Effective. So far I've been getting what I want, though I wouldn't mind getting it sooner.

      That said, never let perfect be the enemy of good. I won't be 1st in line for this (I'm not high enough risk) but I'll be next in line. I've got family that's much higher risk.
  • just in time (Score:5, Insightful)

    by trybywrench ( 584843 ) on Thursday January 27, 2022 @10:19AM (#62211551)
    just in time for the omicron wave to die
    • by Luckyo ( 1726890 )

      This is just first clinical trial. It won't make it in time.

      But it may be important to have this in case Omikron becomes the new predominant source of variants in the future should a much more lethal variant pop up.

    • Re:just in time (Score:4, Insightful)

      by LostMyAccount ( 5587552 ) on Thursday January 27, 2022 @10:31AM (#62211605)

      I mean there is that, but it does make you wonder if a Omicron tailored vaccine would be useful for whatever variant comes after Omicron, since it seems like Omicron is replacing the others.

      Is the next variant after Omicron likely to similar enough that an Omicron targeted vaccine is beneficial? Maybe bonus points if the trend towards less severe illness continues, balancing out any loss of relative effectiveness.

      Part of the problem with the original vaccines seemed to be that the waning effectiveness and perhaps lesser effectiveness against Delta was compounded by Delta having some worse severity.

      It also makes me wonder about the longer term life cycle of virus mutation. Is the delta between the first variant and the first major mutation always larger than subsequent mutations? In more traditional vaccine development, the timelines would seem to suggest that by the time vaccines were developed, a virus would have seemed to have gone through its most significant variation and more or less stabilized, making the vaccine more likely to achieve meaningful results. Maybe the mRNA vaccine is so quick to develop vs. traditional vaccines that we sort of jumped the gun so to speak, not that we had much choice or there still wasn't significant benefits.

      • Is the delta between the first variant and the first major mutation always larger than subsequent mutations?
        Nope. It is random.

        The omicron variant is supposedly "bred" in an immune system handicapped person (you say compromised?). Which was probably sick longer than a year, but asymptomatic - aka did not feel sick.

        That was a breeding ground for probably 1000ds of variations of the virus.

        In more traditional vaccine development, the timelines would seem to suggest that by the time vaccines were developed, a v

      • by dgatwood ( 11270 )

        I mean there is that, but it does make you wonder if a Omicron tailored vaccine would be useful for whatever variant comes after Omicron, since it seems like Omicron is replacing the others.

        Is the next variant after Omicron likely to similar enough that an Omicron targeted vaccine is beneficial?

        A lot of the mutations in COVID have occurred independently in different strains that don't seem to be derived from one another. So there's a pretty good chance that the mutations in omicron will end up in future strains as well (or at least some large-ish subset of them) even if those future strains aren't direct descendants of omicron.

        That said, the omicron variant has largely displaced most or all of the other variants (presumably because of ample vaccine-induced and infection-induced immunity to previ

    • will stop being overwhelmed to the point of disaster. There's still going to be a *lot* of disease out there.

      I saw a video of some stupid git on Bill Maher saying she was done with Covid, somebody interspersed clips of nurses talking about the number of deaths and how it's getting to them. Recent ones. The one that got me was when a nurse said "some days the number who don't make it is bigger than the number who do, and that's when it hits me...".

      We lost around 2400 yesterday.
      • There's some loss of perspective here. Total death rate is only 10% to 20% higher than before COVID. I suspect nurses are being exposed to more pressure and panicky attitudes while doing their jobs, and the unfamiliar additional stress is causing them to see the problem as worse than it is. I think that if I were in the same conditions, I would not do better.
      • Not 2400 in one hospital, so shes not talking seeing that many body bags. Just a number on her screen.

        Also nurses are not trained coroners , so are not qualified to determine the cause of death which can be something else.

  • ... will it offer enough protection against the Omega variant?
    • Re:Yes but (Score:5, Funny)

      by Junta ( 36770 ) on Thursday January 27, 2022 @11:01AM (#62211759)

      For that we need Chalton Heston's blood.

    • by deKernel ( 65640 )

      Until they come out with the booster to cover all from alpha to omega variants, I will continue to follow the kindergarden rules that I was taught:

      1) I keep my fingers out of other people's moist orifices
      2) I wash my hands frequently
      3) I don't cough on people, and I don't hang with people that cough on me

      With those rules, I will enjoy my life. Others can do whatever they want.

    • by gtall ( 79522 )

      Tell you what, why don't you go off and do the studies real quick and get back to us on that?

  • by Klaxton ( 609696 ) on Thursday January 27, 2022 @10:55AM (#62211711)

    New versions of flu vaccines are distributed every year and as far as I know they don't have to undergo a set of clinical trials just because the virus variants were tweaked. So why does this have to happen with Covid?

    • The flu vaccine just flips between a couple of strains that have been around for a long time. They have no clue which strain will be dominant for a year, they just take a guess. If you look up how effective the flu vaccine actually is, it isn't very. Not saying high risk people shouldn't take it, but there is a pretty good chance it won't do anything for you in any given year.

      The COVID vaccine uses a fairly different approach (mRNA). It probably should be monitored a little closer.

      And just FYI, there is a n

      • by Klaxton ( 609696 )

        These mRNA vaccines have been administered to hundreds of millions of people, they are safe. The Omicron version would presumably have the exact same delivery mechanism, with just a tweaked encoding for the slightly different spike protein.

        The flu vaccines are grown in chicken eggs over many months, that's why they have to guess at what strains will be dominant way ahead of time. Here we have a much easier and faster way to modify and deploy vaccines. There may be a good reason for requiring new clinical tr

        • Re: (Score:1, Troll)

          by cheekyboy ( 598084 )

          Well, peanuts are 100% safe too, billions eat em every day.
          If you die from a peanut, you're a peanut denier.

          • by Klaxton ( 609696 )

            You are welcome to show evidence that someone has died from receiving a mRNA vaccine.

            • VAERS shows 1206 people died within 2 days of receiving the COVID vaccine. You're telling me those are _all_ coincidences?

              • by Klaxton ( 609696 )

                I'm telling you that number doesn't mean anything. If you are vaccinating a million people per day, many of whom are elderly and otherwise vulnerable, some number of them will have died after a couple of days regardless.

      • by Strider- ( 39683 ) on Thursday January 27, 2022 @02:39PM (#62212811)

        The COVID vaccine uses a fairly different approach (mRNA). It probably should be monitored a little closer.

        I suspect that the mRNA techniques will become commonplace pretty shortly. The interesting thing with both the Moderna and BioNTech vaccines is they were both created within the first week of the SARS-Cov2 genetic sequence being published. Everything since then has been testing, production, and logistics. mRNA technology has the promise of allowing for effectively on-the-spot/boutique/custom vaccines being made. I can foresee a day when any reasonably sized hospital will have the ability to fab up custom vaccines for everything from novel viruses to cancer treatment, to anything else you can think of.

        Completing the journey on these mRNA research that started with the original SARS virus, is probably the greatest biomedical triumph of this pandemic. It's completely game changing technology.

    • Even if safety were a done deal, a trial would still be needed to quantify efficacy. My impression was that upcoming mRNA vaccine like this one would not need to be as big as the original trial because efficacy can be measured to a necessary degree with a much smaller trial than that required to demonstrate safety. Actually we don't even have to depend on trials for safety data anymore since so many people have taken the vaccine for actual clinical purposes.
      • by Klaxton ( 609696 )

        I think you are correct. Looking into this further I am seeing that the trial will involve 1,420 people and "evaluate whether the omicron-specific vaccine is safe and generates a strong immune response". Not the fullscale set of trials.

        https://www.nbcnews.com/health... [nbcnews.com]

    • "as far as I know" is your issue here.

      All formulations must go through standard safety and Immunogenicity trials.

    • by Qwertie ( 797303 )

      I'd like to see an explanation of the legal hurdles to a variant-specific booster. I assume the process of approving a variant vaccine is almost, but not quite, as onerous as approving the original vaccine. I have heard that a tweaked vaccine can be created in about one day - so it's amazing that it takes two months to get to the point of injecting the first volunteer.

      FDA rules have needed reform since before the pandemic started. [substack.com] By the time this shot is available, omicron will have mostly died out or b

      • by Klaxton ( 609696 )

        I had looked around a little further and saw this article that may interest you;
        https://www.nbcnews.com/health... [nbcnews.com]

        It looks like much less extensive trial than the original;
        "The drugmakers said they aim to enroll up to 1,420 healthy adults ages 18 to 55 in the trial, which will evaluate whether the omicron-specific vaccine is safe and generates a strong immune response."

  • by devslash0 ( 4203435 ) on Thursday January 27, 2022 @01:41PM (#62212539)

    Q. How many different Covid vaccines does it take to survive?
    A. for n in 1 to INF...

  • Omicron infections are already declining. Omicron outbreak will be long over by the time vaccines hit the market.
    • But that won't stop them from making money on this. That's the point. Squeeze every little profit out of the current vaccine until moving onto the next.

      Pfizer and Moderna never updated their vaccines for Delta even though it was deadlier. Even though they claimed mRNA technology makes it easy to tweak a vaccine.

      Now Omicron is blowing through this tissue paper vaccine and now they are finally ready to start rolling out an updated vaccine.

      Instead of tweaking the vaccine. How about developing a va
      • Of all the vaccines that mankind has developed, very very few actually stop transmission. If they knew how, do you really believe they don't on purpose, to make more money? Aside of that being conspiracy theory land, don't you think that the one vaccine producer with the sterilising vaccine would get to replace all others? If not then why not?
    • It also implies that the existing line of vaccines are not effective against Omicron.
  • Don't they like DayQuil/NyQuil?
  • COVID-19 vaccines look like they will always be against disease only, and not against infection or transmission.

    The reason is that COVID-19 does not induce viremia (the virus circulating in the blood stream), where antibodies can neutralize it quickly. It is a mucosal tissue infection. Vaccines against viremic viruses significantly reduce infection and transmission, such as polio, smallpox and measles.

    The other thing is that this virus keeps drifting fast, like influenza, changing antigenically. We had thre

  • As someone who came from another world the ability for Humans to embrace amazingly counter productive practices never ceases to amaze me.

    Here we have nature creating the ideal vaccine against SARS CoV 2, the omicron variant; and over here we have the spectacle of humans creating a vaccine AGAINST the natural vaccine. I have to admit, this is one of the most foolish things I've seen you humans do in my lifetime. I guess it takes an outsider's view to admire the excess here or you guys would have figured this

The opossum is a very sophisticated animal. It doesn't even get up until 5 or 6 PM.

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