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Medicine

Vaccines Adapted for Variants Will Not Need Lengthy Testing, FDA Says (nytimes.com) 103

Posted by msmash from the moving-forward dept.
The Food and Drug Administration said this week that vaccine developers would not need to conduct lengthy randomized controlled trials for vaccines that have been adapted to protect against concerning coronavirus variants. From a report: The recommendations, which call for small trials more like those required for annual flu vaccines, would greatly accelerate the review process at a time when scientists are increasingly anxious about how the variants might slow or reverse progress made against the virus. The guidance was part of a slate of new documents the agency released on Monday, including others addressing how antibody treatments and diagnostic tests might need to be retooled to respond to the virus variants. Together, they amounted to the federal government's most detailed acknowledgment of the threat the variants pose to existing vaccines, treatments and tests for the coronavirus, and came weeks after the F.D.A.'s acting commissioner, Dr. Janet Woodcock, said the agency was developing a plan.

"The emergence of the virus variants raises new concerns about the performance of these products," Dr. Woodcock said in a statement Monday. "We want the American public to know that we are using every tool in our toolbox to fight this pandemic, including pivoting as the virus adapts." Most of the vaccine manufacturers with authorized vaccines or candidates in late-stage trials have already announced plans to adjust their products to address the vaccine variants. The Moderna and Pfizer-BioNTech vaccines use mRNA technology that the companies have said can be used to alter the existing vaccines within six weeks, although testing and manufacturing would take longer. Moderna has already begun developing a new version of its vaccine that could be used as a booster shot against a virus variant that originated in South Africa, known as B.1.351, which seems to dampen the effectiveness of the existing vaccines. A fast-spreading coronavirus variant first observed in Britain has also gained a worrisome mutation that could make it harder to control with vaccines. That variant with the mutation was found in the United States last week.
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Vaccines Adapted for Variants Will Not Need Lengthy Testing, FDA Says More

Vaccines Adapted for Variants Will Not Need Lengthy Testing, FDA Says

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  • mRNA is an interesting technology. (Score:5, Interesting)

    by jellomizer ( 103300 ) on Tuesday February 23, 2021 @02:06PM (#61093370)

    Unlike previous vaccines, where we need to grow the virus. the mRNA we just need to send over its code, and we can create new vaccines at a much more rapid pace.

    • Re:mRNA is an interesting technology. (Score:5, Interesting)

      by feedayeen ( 1322473 ) on Tuesday February 23, 2021 @03:01PM (#61093524)

      To say that it's interesting is honestly an understatement. We potentially have the ability to generate immune responses to any arbitrary proteins provided that it is dissimilar enough to other essential ones to avoid autoimmune reactions with just it's DNA or RNA sequence. The time to create a treatment was on the order of a few weeks so if we can quickly isolate the right protein to target, many untreatable pathogens will be treatable. Long term, this could render drug resistance nearly impossible for viral, bacterial, and some eukaryotic pathogens if we can keep a patient alive long enough to sequence the pathogen, isolate the right target, generate the vaccine, and for the patients immune system to generate the antibodies. 30 years of research investment in sequencing and protein simulation could be about to pay off in spades.

      • Re: (Score:1)

        by Anonymous Coward
        Presumably we could also generate an immune response to one of the body's essential proteins, thus creating an entirely new class of lethal assassination tools.

        • Re: (Score:2, Funny)

          by feedayeen ( 1322473 )

          Yup, coming to a science fiction book near you and the frontrunner 2030 Russian presidential election candidate running against Putin.

        • Well I mean there's no point. We already have a large amount of toxic substances that we can cheaply produce to kill people to which there is no remedy. Why spend all the money to sequence out the needed code and production systems just to kill someone, when you can just do that with something we already have? I mean fuck, if you really just want someone dead, bullets still do the job quite nicely as don't require years of development. And if you just want a lot of people dead, plenty of nerve agents ou

          • Re: (Score:2)

            by mark-t ( 151149 )
            What about the possibility of something that's toxic only to one particular person, or toxic to everyone but a specific race?

            • Re: (Score:1)

              by rtb61 ( 674572 )

              You are confused there is only one human race. What you meant to say, what happens when it is toxic to a particular genetic trait, say sickle cell or say particular cells like say sperm or ova. Not doing additional testing sounds as suspect as fuck.

            • Just want to address this spot since there are people who are legitimately concerned about the possibility:

              It's exceedingly unlikely that you'll ever find something toxic only to the person or group you want dead. These vaccines induce autoimmune reactions to proteins. Given that these are effective against multiple variations of the spike protein, the immune response is against a class of very similar proteins. At this point any potential protein to target will also cause reactions among millions of people

      • You do realize the Oxford vaccine which is based on a virus was ready by 30th January 2020? Our ability to manipulate DNA and RNA was gone from chariots to the internal combustion engine in less than a decade.

        • Re: (Score:2)

          by sjames ( 1099 )

          Of course, the Oxford/AstraZeneca vaccine appears to be significantly less effective. To the point that many in Europe are insisting on Pfizer instead.

          • Its a litttle more complicated than that. For the first and second generation of COVID mutations its plenty effective. 90ish percent after 2 shots. The problem is the newer british and south african variants in the third generation of the virus seem to be somewhat less so.

            It'll still reduce the effectiveness of the vaccine. You'll get sick. But you probably wont get the mortal-danger type of sick. Your absolutely better off with it in your arm then without it. But you'd want to eventually get around to the

      • provided this all doesn't backfire by causing horrible long term side effects.
    • "send over its code" Hey there What license is that code under?

    • Re: (Score:2)

      by hey! ( 33014 )

      Plus the delivery vehicle (lipid nanoparticles) is exactly the same. The only question is whether the newly targeted protein segments yield effective protection; it'll be like just having to do the phase II trial.

    • Hello, handsome! Follow the link, and I wouldn’t let you fall asleep tonight! ==>> v.ht/OauMm
  • Regardless of how the experts spin the usefulness of the vaccines not using mRNA this is a major plus for Moderna and Pfizer-BioNTech offerings.

    • mRNA is an other tool that these companies can now work with. However like any tool, they may not work all the time for every job.

    • Re: (Score:2)

      by xevioso ( 598654 )

      Right, so, when it comes time for me to get a vaccine, it makes sense for me to *not* get the Johnson and Johnson one, because it cannot be updated so easily. There's already reports of people asking about this in Britain, because they want to have the choice between the homegrown Oxford one and the "posh" Pfizer one.

      Getting a vaccine is like installing a new operating system. It's easier to update my existing operating system, say, Moderna, to deal with a new virus variant, because Moderna might provide

      • People here kept insisting that you will have a choice of vaccine.

        Name a person who has had a choice between two. A single person. Anyone? Didnt fucking think so.

        • People here kept insisting that you will have a choice of vaccine.

          Name a person who has had a choice between two. A single person. Anyone? Didnt fucking think so.

          Not completely sure how narrow your definition of "choice" is, but I could have chosen between Moderna and Pfizer by choosing where I got the vaccine at. There was an issue where some people accidentally got the second shot instead of the first, which caused some issues in the supply chain, but yeah - I had a choice. If everyone at every immunization center had to have a choice of either, they'd have to produce twice the number of individual vaccines, or else pre-register way in advance.

          Though I'm not qu

      • Re: (Score:2)

        by Whibla ( 210729 )

        Right, so, when it comes time for me to get a vaccine, it makes sense for me to *not* get the Johnson and Johnson one, because it cannot be updated so easily.

        No, not really. Your immune system doesn't really care which type of vaccine you took to prime it.

        There does appear to be a difference in efficacy between the various vaccines, but this is probably down to a combination of factors (e.g. adjuvants, delivery mechanism and, possibly, dosage) . However, as far as I can tell, all the vaccines stimulate all the various parts of the immune system (e.g. neutralising antibodies, T cells, and 'memory' cells, among others) to a certain degree before they are eliminate

  • Has it actually been confirmed yet that the original vaccines DON'T work against the new strains? Even a month ago I heard differently from multiple countries' studies.

    • Re:wait a minute (Score:4, Informative)

      by jellomizer ( 103300 ) on Tuesday February 23, 2021 @02:37PM (#61093448)

      They work against some of the strains, but not all of them have been confirmed. Also some of the Vaccines work better on the new strains than others.

      I am sorry we cannot give you a simple Yes/No answer. I know the world wants us to say. Take this and you will be perfectly safe, or don't take it because you will get sick. But immunology is a complex topic.

      The people who are often knowledgeable about the topic and are telling you the truth, are often people that we don't want to listen to, because they don't want to give you the simple answer, but a big long complex speech with numbers and statistics.

      • I am sorry we cannot give you a simple Yes/No answer. The answer is pretty simple: not enough data. When enough data are available, a simple template, already seen, can be used to answer: "Vaccine X is Y% effective against strain Z in population W".

      • Re: (Score:3)

        by njvack ( 646524 )

        I know the world wants us to say. Take this and you will be perfectly safe, or don't take it because you will get sick. But immunology is a complex topic.

        The people who are often knowledgeable about the topic and are telling you the truth, are often people that we don't want to listen to, because they don't want to give you the simple answer, but a big long complex speech with numbers and statistics.

        You don't need a complex speech with numbers and statistics. There is lot of data on these vaccines, and that data is clear: Any of the available vaccines will greatly protect you from getting seriously sick or dying if you're exposed to the COVID virus. The short- and medium-term risk of taking any of the available vaccines is extremely small, and the main possible known risk (allergic reaction) is easily treatable. That's it. That's what you need to know, and to communicate.

        There's other stuff where the d

        • Re: (Score:3, Interesting)

          by carton ( 105671 )

          Not sure what you're aggressively countersignaling here with "That's what you need to know, and to communicate." The OP asked about "new strains," which you only mentioned in terms of "future planning." The OP did not make any hints of being a deplorable "anti-vaxer," yet you seem to have copied the standard antivax-shut-it-down rant at them.

          I don't come here to be told what I do and don't need to know, or to be instructed in how to stay on message. I understand why you're doing what you're doing, but I

      • there seems to be some kind of information blackout going on, even hardly getting info on the state in the country here, and basically zero about the neighbouring ones . So when i look it up it turns out the situation isnt all that good - xept for Israel giving green badges to people who are allowed outside (o irony ??) b/c they have been settled but all their data is on Pfizer - South Africe has stopped AstraZeneca b/c its as good as throwing money in the sea for their variant which, logically speaking wil

    • Re: (Score:1, Offtopic)

      by guruevi ( 827432 )

      No, the vaccines work against the new strains as well. It would have to biologically adapt quite a bit for it to not work. It's the same mechanism where flu shots typically work for 2-3 seasons, the current strain of coronaviruses mutate slower than flu.

      This is just the current administration re-confirming what we already knew. As Ned Price (AP reported) said: All of this work was done in the previous administration - you guys are taking credit for stuff that the previous administration did.

    • Has it actually been confirmed yet that the original vaccines DON'T work against the new strains? Even a month ago I heard differently from multiple countries' studies.

      IANAEMBOARQP* but my understanding is they work well enough.

      Basically the point of the vaccine is to train the body to generate an overwhelming immune response that wipes out the virus before it really gets established.

      The variants are different enough that the immune response is substantially smaller, however, it still appears to be sufficiently overwhelming to work. That being said, if it's not quite sufficient for a big portion of people, or if the variants get better at avoiding immune responses from th

    • It has been confirmed there are strains they are less effective against, notably the South African variant. Most vaccines still work against it, but with less efficacy, worst off was AstraZeneca that failed to show any efficacy against it, that's an outlier though and built a bit differently from other anyway.

    • Has it actually been confirmed yet that the original vaccines DON'T work against the new strains? Even a month ago I heard differently from multiple countries' studies.

      The modRNA vaccines (Pfizer, Moderna), which are also the easy ones to tweak, work by making a few of your cells produce the target spike protein. That means that the set of immunities your body makes due to the vaccine should be exactly the same set of immunities it would make to that protein if you were infected with real COVID.

      So the expe

      • You do realize that tweaking the DNA sequence in the carrier virus of the Oxford AstraZeneca vaccine is just as trivial? Probably not but news flash it is.

        • Isn't there concern about your body responding too well against the viral vector if it's only been a short amount of time since it was last used, potentially compromising the effectiveness? Thought I read something about that, but not 100% sure.

        • You do realize that tweaking the DNA sequence in the carrier virus of the Oxford AstraZeneca vaccine is just as trivial?

          Yes.

          But the Oxford / AstraZeneca vaccine uses a live adenovirus as the carrier, with a lot of the mechanism in place. (It is missing one piece of machinery to make one compound it needs to form new virus particles - getting it from its culture during manufacture and {hopefully} thus not reproducing in the patient. If it co-infects a cell with a functional adenovirus it may pick up the mi

    • https://www.bbc.com/news/world... [bbc.com] ? as some guy downstairs says "theres not enough data" - i assume Israel will have to keep up the levels it has for at least six months and counting then some conclusions can be made (assuming a new strain doesnt overrun it all) but im a total lamer - im mostly stuck on the origins-theories like "since its only about 30.000 letters and it mutates once every x days '&&' transmission rate directly corellates to the chances at extra mutations hence (statistically spea

  • So if 10 variants appear, we may need 20 shots? I realize some vaccines will work on multiple variants, but not all.

    • Yeah, I have a plan for that scenario. My plan is to just die.

    • Re:Ey Ey Ey! Vaccine Industrial Complex (Score:4, Informative)

      by Thelasko ( 1196535 ) on Tuesday February 23, 2021 @02:48PM (#61093472) Journal

      So if 10 variants appear, we may need 20 shots? I realize some vaccines will work on multiple variants, but not all.

      An immunocompromised patient in Boston showed dramatic mutations in the virus over the course of 5 months. [npr.org] Many of the mutations looks similar to the mutations in the UK and South Africa. So it appears the virus is mostly staying on a single development path, and there aren't too many forks. Research into immunocompromised COVID patients may reveal likely new strains before they enter the wild, and allow the vaccine development to work ahead.

      • Re: (Score:3)

        by Tablizer ( 95088 )

        The longer the virus is floating and infecting around the world, the more that "creative" variants will emerge. Evolution is relentless.

        We may be seeing the "low hanging fruit" of mutations now, but eventually the sheer power of brute-force randomness will give us odd and dangerous variants.

        • Re: (Score:2)

          by Petrini ( 49261 )

          I always understood those mutations to drive towards less death, not more. SARS-CoV-2's major advantages are the length of the infectious period prior to symptoms and asymptomatic spreaders. If it became more dangerous - causing symptoms earlier, then we're back to early SARS. There, you were only infectious after you started symptoms, so isolation and quarantining was easier.

          That's my understanding from talking with doctors. Mutations rarely spread as widely and cause more deaths when they become more

          • Re: (Score:1)

            by Tablizer ( 95088 )

            In the longer run, yes, but within the time frame of a decade or so, a 3% death rate is not enough to make much of a difference.

        • We may be seeing the "low hanging fruit" of mutations now, but eventually the sheer power of brute-force randomness will give us odd and dangerous variants.

          Getting the virus under control will reduce the number of iterations the virus has dramatically.

          Virus mutations are a lot like mining Bitcoin when you think about it. Each person infected with the virus is a processing unit searching for a new viable mutation. We need to shrink the pool of processors.

    • So if 10 variants appear, we may need 20 shots?

      If 10? There are quite a few recognized variants, and 10 is a certainty now or soon in the future. But who gives a shit if it takes 20 shots (it won't because the variants can be covered by multiple vaccines and several vaccines can be combined into one shot)? But even, if it takes a shot every few weeks for a year, or every month for a couple years, what is the real downside?

    • Vaccination for multiple variants could be given in a single shot or pair of shots. It will complicate the manufacturing a little bit, but this is something that's already done for the annual "quadrivalent" flu vaccine for example. The mRNA vaccine can be adjusted fairly quickly, so if it's fast-tracked by FDA some of us might be getting multivalent shots this summer.

      The rate of mutations is related to how many people are infected at a given time, so it should slow down as case numbers fall. Hopefully the d

    • Re: (Score:2)

      by Whibla ( 210729 )

      So if 10 variants appear, we may need 20 shots? I realize some vaccines will work on multiple variants, but not all.

      In the same way that flu vaccines cover multiple H & N variants within the same shot, to cover the year's predicted common variants, it's entirely possible that multiple variants of this coronavirus vaccine will be combined into a single shot.

      However, most of the population do not really need to receive a flu vaccine, and they are generally reserved for the elderly and the immune-compromised. I suspect that the same will hold true for this coronavirus too.

      Once a 'low risk' individual has received their

  • This new vaccine will cure Corona, the common cold, influenza, cancer, hearth disease and obesity.

    The drawbacks? You'll have to work until you retire with 150 years.

  • soon everyone is going to look & feel like a pin cushion with all the vaccines needed, i am thinking this shit is getting way out of hand and just say "fuck it" no fucking vaccine for me, i will just accept my fate come what may
  • Considering that the COVID-19 vaccines are the VERY FIRST time the mRNA technology has been approved for general use; and that was after a much shortened testing period. We have no long term safety data on ANY mRNA vaccine.

    Sure, two mRNA vaccines have now been approved, let's cut the testing further. Brilliant.

    The other traditional/old methods of vaccine development have at least been around and used for decades; and we understand the strengths and weaknesses of them. But I guess being old is not sexy

    • It isn't just that this is faster. It is much, MUCH faster. It also doesn't ruin any delivery vectors for the future.

    • Re: (Score:1)

      by guruevi ( 827432 )

      This is just like saying we don't understand genetically modified corn when we've literally been genetically modifying corn for centuries. It's just the same thing as developing a regular vaccine but guided to be faster, call it 3D printing for vaccines.

      • To suggest there is some equivalent between using selection to modify an organism and injecting random bits of DNA into it is wrongheaded.

        When you can show a way of naturally selecting a tomato plant to get a grouper gene the produces anti-freeze in it or corn that is resistant to round-up then we can talk about it being nothing more then a short cut. The possible things that could go wrong due to cross pollicization alone are bad, but what about trans species viral vectors? What does it do to an echo syst

        • Re: (Score:1)

          by guruevi ( 827432 )

          There are other plants that have "anti-freeze" proteins, pretty much any plant that can survive or grow in winter has them. Cross-breeding is a matter of some (long) process of the preferred nature which we have been doing, specifically to grow plants well into cold weather, that's how we know what proteins and hormones to add.

          The issue you mention with disease isn't unique to direct modifications of the gene. It's a problem we've had for the last 150 years with banana cultivars before we even knew what gen

    • It's not new technology its been in development for decades in the first instance. In the second instance the trial period was shortened due to not having to hang around between the stages. For example normally recruitment of volanters takes months, took days. Second the trials cost a lot of money so the risk of going to full trials had not been deemed commercially viable, the pandemic changed that calculation. Finally RNA is as fragile as hell and won't last long in the body. Hell the Pfizer jab needs to b

    • Considering that the COVID-19 vaccines are the VERY FIRST time the mRNA technology has been approved for general use; and that was after a much shortened testing period. We have no long term safety data on ANY mRNA vaccine. What is the testing period that will quell your outrage? the actuarial tables comparison between when vaccinated vs unvaccinated people die?

    • It's mRNA in a lipid envelope, man. You ate a whole ton of it today and your body made a whole slew of it, too.

    • The scale of testing of the COVID vaccines has been huge, the same size has reached much larger sizes, much more quickly. Speed is not sign of a lack of testing when the sample size is large. It actually increases that statistical confidence in the results.

      The modified vaccine will be compared against the existing vaccine in trials not a placebo so side effects are actually monitored in both.

  • To elicit an antibody response may be well understood -- its a cheap dog and pony show, but the entirety of the immune system is not by any means understood - it has many, many elements. When a response is elicited for a protein, what happens if Salmonella, Botu, Strep, Listeria. etc etc. appears? Bottom line is your system is already stressed and it is unknown what will happen with other antigens. If you now claim the immune system is more ready for these also, the activation may be due to just the adju
  • might as well go all in! Do all the phase 3 testing on society now!
  • Not getting it. Most SAFE vaccines take 5 years, and even then people have issues. This mRNA crap is brand new, the vaccine was rolled out QUICKLY and, the makers cannot be held liable. And if you look, you'll find that Bill Gates is HEAVILY invested in pharmaceuticals, along with members of congress, the senate etc.
    • Whats the bet these vaccines are shall we say basically not tested, and someone somewhere is interpretting the numbers and coming to the conclusion it must work even if time has not run out during a trial.
  • Did they get a phone call from Boeing ?
    Who needs testing ?
  • Obviously having people whizzing about is a good idea not. Spreading disease, pollution, aresholes trying to find another crooked country to send jobs overseas... how many more examples do i need to share ?

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