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Novavax and the lack of Vaccine Choice

  • 19-08-2021 1:54pm
    #1
    Registered Users Posts: 8,913 ✭✭✭


    I seen recently that the EU have agreed a deal with Novavax for alot of vaccine supply in the third quarter of 2021.

    This is a vaccine I am particularly interested in taking and have been "holding off" getting a vaccination until this one arrives.

    There seems to be very little news about the roll out of this vaccine from an Irish perspective. Now that the Irish Authorities have done away with ordering more AZ and J&J - is it reasonable to conclude that Ireland will also turn it's nose up at the Novavax vaccine?

    I cannot understand why there is not more choice of vaccine available now considering much more availability. Surely, at this stage having a choice of vaccine might dwindle the numbers of vaccine hesitant folks somewhat. I consider myself in this category.



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Comments

  • Registered Users Posts: 32,136 ✭✭✭✭is_that_so


    We are participating in this purchase. The EMA have it under rolling review but they haven't even gone for FDA approval yet.





  • Registered Users Posts: 5,423 ✭✭✭Former Former Former


    Novavax isn't approved for use yet. That's why it's not available.



  • Moderators, Business & Finance Moderators, Motoring & Transport Moderators, Society & Culture Moderators Posts: 67,523 Mod ✭✭✭✭L1011


    The chances of you being offered this specifically are exceptionally slim.

    The logistics of handling for the picky would be incredibly difficult and expensive - unless, for instance, you're willing to be told that its only available at 8:30 in Bantry on one day a month and actually go there to get it.



  • Registered Users Posts: 8,913 ✭✭✭Danno


    Seems so, but why should that be the case? At the end of the day surely a basket of different vaccines should be on offer to whoever wants to pick what gets injected? Even if that meant travelling to a provincial centre as opposed to a county or a large town centre.



  • Registered Users Posts: 876 ✭✭✭bb12


    this is the vaccine i've also been holding out for. no interest in any of the others



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  • Registered Users Posts: 5,428 ✭✭✭Charles Babbage


    Although funded by the US government, there is no sign of Novavax being approved in the US as they cannot show that they can manufacture the vaccine to a consistent standard. They won't even seek approval in the EU until after they do so in the USA. This isn't a case of the Irish government "turning up its nose", it is a case of the manufacturer not being able to get its act together.



  • Moderators, Business & Finance Moderators, Motoring & Transport Moderators, Society & Culture Moderators Posts: 67,523 Mod ✭✭✭✭L1011


    Because we'd probably still be sub-50% and fighting awful logistics problems if that was offered.

    By the time this comes on the market, 90%+ of adults will be fully vaccinated and any catch up programme will be absolutely unable to offer choice as there wouldn't be enough people looking for each type in each place to actually justify opening a vial. If MVCs still exist they'll be doing boosters, not rolling this out to anyone.

    What are your reasons for deciding this is the only one for you, anyway? It could be a year away from approval.



  • Registered Users Posts: 4,325 ✭✭✭iLikeWaffles


    Why have you being holding out for it?



  • Registered Users Posts: 16,452 ✭✭✭✭astrofool


    It's different new but old technology to the current new quite old technology.

    Really it's because they don't like being told what to do and will be happier taking a less used (because mRNA has been used by billions) vaccine because they got to choose to do so. I've no doubt it will be proven as safe as the mRNA vaccines were during the phase 3 trials but without the mass rollout already happening benefit.

    Rational thinking is not part of the equation here so no point asking any rational questions.



  • Registered Users Posts: 4,325 ✭✭✭iLikeWaffles


    I think both of them can speak for themselves without being labelled as irrational thinkers prior to speaking for themselves.



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  • Posts: 0 [Deleted User]


    It is kind of irrational holding out for a vaccine that has not been demonstrated safe and effective yet, when there is one taken by billions that is both safe and effective.

    It is also a genuine choice, just not a rational one



  • Registered Users Posts: 4,325 ✭✭✭iLikeWaffles


    A senseless choice isn't really the issue, and I may agree on how logical that choice being made is but not without hearing and finding out if that choice is an irrational or a rational one. Far too much othering going on across all these covid threads, it doesn't actually help the situation nor does it add any value to the discussion.



  • Registered Users Posts: 32,136 ✭✭✭✭is_that_so


    The latest on it is a possible FDA approval request in the last quarter so it could well run into next year before it might be approved.



  • Moderators, Science, Health & Environment Moderators, Society & Culture Moderators Posts: 60,065 Mod ✭✭✭✭Wibbs


    The current technology of mRNA vaccines is not "quite old". mRNA theory and tech is a couple of decades old but turned out not to be the magic bullet for various therapies it was once hailed as because of major concerns over safety. Investment backed right off after this was realised. The reason Moderna went into vaccines - which was one of the least profitable avenues before this pox hit - was because the lower doses involved were seen as much less risky. Other therapies Moderna developed were stopped at animal trials because they found it would never be safe enough for humans. Never mind that Moderna itself had been widely criticised for its sloppy scientific work and has been compared to an investment company scrambling around for a therapy that might work. <- linky from 2016

    Moderna has pushed off projects meant to upend the drug industry to focus first on the less daunting (and most likely, far less lucrative) field of vaccines — though it is years behind competitors in that arena.The company has published no data supporting its vaunted technology, and it’s so secretive that some job candidates have to sign nondisclosure agreements before they come in to interview. Outside venture capitalists said Moderna has so many investors clamoring to get in that it can afford to turn away any who ask too many questions. Some small players have been given only a peek at Moderna’s data before committing millions to the company, according to people familiar with the matter.

    “It’s a case of the emperor’s new clothes,” said a former Moderna scientist. “They’re running an investment firm, and then hopefully it also develops a drug that’s successful.”

    In nature, mRNA molecules function like recipe books, directing cellular machinery to make specific proteins. Moderna believes it can play that system to its advantage by using synthetic mRNA to compel cells to produce whichever proteins it chooses. In effect, the mRNA would turn cells into tiny drug factories.

    It’s highly risky. Big pharma companies had tried similar work and abandoned it because it’s exceedingly hard to get RNA into cells without triggering nasty side effects.

    Delivery — actually getting RNA into cells — has long bedeviled the whole field. On their own, RNA molecules have a hard time reaching their targets. They work better if they’re wrapped up in a delivery mechanism, such as nanoparticles made of lipids. But those nanoparticles can lead to dangerous side effects, especially if a patient has to take repeated doses over months or years.

    Novartis abandoned the related realm of RNA interference over concerns about toxicity, as did Merck and Roche.

    Moderna’s most advanced competitors, CureVac and BioNTech, have acknowledged the same challenge with mRNA. Each is principally focused on vaccines for infectious disease and cancer, which the companies believe can be attacked with just a few doses of mRNA. And each has already tested its technology on hundreds of patients.

    “I would say that mRNA is better suited for diseases where treatment for short duration is sufficiently curative, so the toxicities caused by delivery materials are less likely to occur,” said Katalin Karikó, a pioneer in the field who serves as a vice president at BioNTech.

    That makes vaccines the lowest hanging fruit in mRNA, said Franz-Werner Haas, CureVac’s chief corporate officer. “From our point of view, it’s obvious why [Moderna] started there,” he said.

    [Emphasis mine]

    Do I think mRNA vaccines will cause major issues down the line? I suspect not, though boosters every six months could add to the risks and the doom mongers Karens and Kens on arsebook and twatter are spreading nonsense, but it is equally a nonsense to claim so forcefully and confidently that they're long term safe after a year of actual use in the wild. You quite simply can't make long term predictions based on short term data. Oh but millions have been vaccinated. Grand, that shows short term safety over two doses. That's it. It's akin to having a stick of dynamite with a lit twenty minute fuse claiming after five minutes, well nothings gone bang so we're golden. Adding a hundred sticks of dynamite with the same fuse lit at the same time doesn't tell you anything about what may happen in fifteen minutes time.

    Oh and before pearls are sought out to be clutched and lazy "anti vaxx" labels are flung about as they so often are, I'm fully behind vaccines. They're one of the greatest inventions in human history and health and have saved countless milllions if not billions from injury and death and wiped out viruses that make covid 19 look like a slight momentary itch. I've also been vaccinated(J&J) against covid 19. I personally made the decision and choice to go the one and done J&J route as I prefered the method of delivery which has longer real world use and because of those I know who've been vaccinated the J&J produced the least amount of side effects by some distance compared to the Pfizer. Now most were mild, if noticable, two were pretty rough and have refused to go for the second jab because of their reactions.

    Rejoice in the awareness of feeling stupid, for that’s how you end up learning new things. If you’re not aware you’re stupid, you probably are.



  • Moderators, Science, Health & Environment Moderators, Society & Culture Moderators Posts: 60,065 Mod ✭✭✭✭Wibbs


    QFT. This vaccine lark is incredibly partisan with smug overload on both sides of the room.

    Rejoice in the awareness of feeling stupid, for that’s how you end up learning new things. If you’re not aware you’re stupid, you probably are.



  • Posts: 0 [Deleted User]


    They’re going for UK approval next month apparently



  • Registered Users Posts: 33,574 ✭✭✭✭listermint




  • Registered Users Posts: 435 ✭✭godzilla1989


    For anyone that's unsure, a comparison here of all vaccine's

    Novavax is on the bottom



  • Posts: 0 [Deleted User]


    Higher efficacy, including against variants, substantially lower rates of side-effects, milder side effects, and a technology that's been in real-world use since the 80s. I wouldn't consider those to be minor or irrational considerations. As someone who is vaccine hesitant because of long-term safety concerns, particularly amidst talk of biannual boosters and immunity that begins to wane at six weeks (but hopeful about mRNA technology being long-term safe and effective for a host of ailments), the last point there is particularly poignant.

    YMMV. I've actively encouraged vulnerable relatives to get vaccinated and you won't find me ragging on people who have chosen to take any vaccine on offer. They've made what they consider to be the best decision for them. And so have I.

    This article has some interesting info re: how and why Novavax approval is taking so much longer than BioNTech or Moderna did.

    It seems strange to me that people whose ostensible goal is to see as many people as possible vaccinated would not be relieved to hear that there is in fact a vaccine in the pipeline that is likely to heavily reduce vaccine hesitancy, and instead prefer to continue casting those who are vaccine hesitant (but have taken every prior vaccine they've been offered and are expressing interest in a different vaccine that will soon be approved) as insane crystal healers or selfish idiots. It's a strange hobby.



  • Moderators, Science, Health & Environment Moderators, Society & Culture Moderators Posts: 60,065 Mod ✭✭✭✭Wibbs


    It doesn't negate the point I made. As it stands while the current crop of vaccines have helped in bringing down serious illness and death in a very positive way, they're not close to ideal yet. Efficacy is dropping over time as we're seeing in Israel. They're still protective as the majority of those in hospital and dying are unvaccinated so that's very a good thing, but they seem to be not so good at preventing transmission with the delta variant.

    What's odd about this pox is how short a time immunity is sticking around. This goes for the vaccinated and recovered. Compared to the "original" SARS, which it is 80% similar to SARS Covid 19, antibodies were present in the recovered for years after. One bit of good news is that those original SARS recovered may help create a much better vaccine. It's been found that those who recovered from SARS who are then vaccinated against Covid 19 show a much stronger immune response and better again also show an immune response against other coronaviruses that may jump to humans in the future. This could be the magic bullet to nail this pox's coffin shut. Link -> https://www.nejm.org/doi/full/10.1056/NEJMoa2108453

    The antibodies are high-level and broad-spectrum, capable of neutralizing not only known variants of concern but also sarbecoviruses that have been identified in bats and pangolins and that have the potential to cause human infection. These findings show the feasibility of a pan-sarbecovirus vaccine strategy.

    Rejoice in the awareness of feeling stupid, for that’s how you end up learning new things. If you’re not aware you’re stupid, you probably are.



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  • Registered Users Posts: 534 ✭✭✭Ekerot


    Always love your posts on this site Wibbs, informative yet clear cut enough to seeing the perspective from both sides.



  • Registered Users Posts: 435 ✭✭godzilla1989


    Yeah that's a good post from him

    Was a good read.



  • Moderators, Science, Health & Environment Moderators, Society & Culture Moderators Posts: 60,065 Mod ✭✭✭✭Wibbs


    +1. Much of this, online at least is a defence to authority, "science" so long as it agrees with the position, a gra for the novel and not a little of some having a near allergic over reactive response to what they see as "anti vaxx". Are there anti vaccine types about? By god there are, but taking the allergy/immune system analogy further some need to recognise the difference and not overreact to the wrong thing. To quote a part of that article your linked:

    Based on the results of Novavax’s first efficacy trial in the U.K., side effects (including but not limited to fatigue) aren’t just less frequent; they’re milder too. That’s a very big deal for people on hourly wages, who already bear a disproportionate risk of getting COVID-19, and who have been less likely to get vaccinated in part because of the risk of losing days of work to post-vaccine fever, pain, or malaise. Side effects are a big barrier for COVID-vaccine acceptance. The CDC reported on Monday that, according to a survey conducted in the spring, only about half of adults under the age of 40 have gotten the vaccine or definitely intend to do so, and that, among the rest, 56 percent say they are concerned about side effects. Lower rates of adverse events are likely to be a bigger issue still for parents, when considering vaccination for their children.

    Don’t get me wrong—the Pfizer and Moderna vaccines have been extraordinary lifesavers in this pandemic, and we may well be heading into a new golden age of vaccine development. (This week, BioNTech started injections in an early trial for an mRNA vaccine for melanoma.) But even the best experts at predicting which drugs are going to be important get things wrong quite a bit, overestimating some treatments and underestimating others. Pharmaceuticals are generally a gamble.

    But here’s what we know today, based on information that we have right now: Among several wonderful options, the more old-school vaccine from Novavax combines ease of manufacture with high efficacy and lower side effects. For the moment, it’s the best COVID-19 vaccine we have.

    That would be largely my view too. Would I have taken the mRNA vaccines if nothing else were available? Yes, being 53 the risk/reward is still in play. Even though my chances or serious illness, hospital and death are very low. I think it far better to have little or no symptoms if, rather when I'm exposed to this pox(though chances are I have been already as in the early part of this year I lost my sense of smell and taste. Well I've no taste anyway... 😁. That's not come back, save for of all things the smell of fresh cut grass). Still because I had a choice I went for the J&J. One and done, older tech and not mRNA based. Well at least I had that choice. Today and going forward I would not. The Irish gov have set their stall out and it's all mRNA. No choice. Odd, given the mRNA stuff requires two jabs compared to the one of J&J, is much harder to store and costs more. Hopefully when newer and better vaccines come along like the Novavax, enterprising people will bring some in and give back some choice. I'd certainly be willing to pay for that choice.

    However - and this is defo going to have some pearls clutched - If I were under 30, with no comorbidities, obesity, asthma, diabetes, chronic illness would I go for vaccination? Unless I was living with the vulnerable or anti vaccine types, quite honestly no, I wouldn't. And I certainly wouldn't be vaccinating children. Pigeons --- Insert cat. For me anyway that so many parents are lining up to vaccinate their teenage kids with a vaccine and vaccine tech that's only been in play for a year beggars my belief tbh. I'd be 100% behind it if the risk to that age group was real, but it's not. It's beyond tiny. Plugging a 20 year old male of average weight and height with no chronic illness into this risk calculator from the University of Oxford https://qcovid.org/Home/AcademicLicence?licencedUrl=%2Fcalculation (it doesn't allow for any age below 19) and the results are:

    COVID associated death 0.0001% 1 in 1000000 0.0001% 1 in 1000000

    COVID associated hospital admission 0.0031% 1 in 32258 0.0031% 1 in 32258

    These are the big numbers of absolutely miniscule risks and this lack of risk is reflected in real world stats too. If the vaccines stopped or massively reduced transmission I'd have more enthusiasm going on, but they don't, not nearly to the degree needed and certainly not warranted in young people and it's increasingly looking like we'll need boosters after six months. So the same kids are going to need more of this next Spring? How long will this go on, when the actual illness is about as likely to affect them as a random lightning strike?

    Rejoice in the awareness of feeling stupid, for that’s how you end up learning new things. If you’re not aware you’re stupid, you probably are.



  • Registered Users Posts: 16,452 ✭✭✭✭astrofool


    Just on the last point, vaccines reduce transmission, studies show this to be about 80% (there are numerous studies, but here is an article from nature COVID vaccines slash viral spread – but Delta is an unknown (nature.com))

    Delta has a higher R0 without vaccinations in play (believed to be about 8) and the vaccines seem to effectively reduce this to almost 1, even with restrictions relaxed.

    The maths about % chance of getting the disease has also changed with most believing you will be exposed when restrictions are fully relaxed, so the choice for everyone becomes between getting exposed without vaccine protection vs. getting exposed with vaccine protection.

    Hopefully Novavax comes online in sufficient numbers and as expected, but it will be it's own roller coaster of updates and new findings as the other vaccines have been and there will undoubtedly be updates to the mRNA vaccines that reduce side effects and give better protection (I'm sure there's forums that were dedicated to the yearly updates of the flu vaccine and it's novel side effects, those who were interested in these things before it became so mainstream).

    Personally, I'm honestly not worried about the long term effects of mRNA (they could have picked a better name, as Liam Neeson says, just wait till they find out that SARS-COV2 is full blown RNA being injected into your living cells), and neither seem to be the scientists who worked on it, the mRNA itself is absent from the body a while post dose leaving just the antibody and t-cell memory, there is no concerns about build up in the body or rejecting future versions (which matters for adenovirus), it would be like me worrying about the effect of an apple I ate a year ago on my body. But I do understand that some people are worried by this and new technology is just not liked by some (whether it's nostalgia or just going with what they know and trust).



  • Moderators, Science, Health & Environment Moderators, Society & Culture Moderators Posts: 60,065 Mod ✭✭✭✭Wibbs


    Astrofool: Personally, I'm honestly not worried about the long term effects of mRNA (they could have picked a better name, as Liam Neeson says, just wait till they find out that SARS-COV2 is full blown RNA being injected into your living cells), and neither seem to be the scientists who worked on it, the mRNA itself is absent from the body a while post dose leaving just the antibody and t-cell memory, there is no concerns about build up in the body or rejecting future versions (which matters for adenovirus), it would be like me worrying about the effect of an apple I ate a year ago on my body. But I do understand that some people are worried by this and new technology is just not liked by some (whether it's nostalgia or just going with what they know and trust).

    It's certainly nada to do with some posited fear of "new technology", as far I'm concerned anyway. I'm a big fan of it as a general principle and I despise nostalgia with a vengeance. RNA isn't the issue. Viral vector vaccines do essentially the same thing. Hell, catching a headcold does the same thing. The issue is the vector. As noted a couple of years ago in that article I linked previously.

    Delivery — actually getting RNA into cells — has long bedeviled the whole field. On their own, RNA molecules have a hard time reaching their targets. They work better if they’re wrapped up in a delivery mechanism, such as nanoparticles made of lipids. But those nanoparticles can lead to dangerous side effects, especially if a patient has to take repeated doses over months or years.

    This delivery method was considered so risky it set back the whole area of mRNA therapies within the industries, a direction that was once hailed as The Next Big Thing and with big money behind it. Investors left, as did many other big names in the pharmaceutical business. The ones that remained, chastened by the earlier failures for the tech to live up to its promise moved into the not nearly so lucrative arena of vaccines, because they reckoned the lower doses and one off applications would be less risky. The real world use of this technology in humans is pretty much a year old. It's hardly tinfoil hat territory to be wary of possible long term issues, when the long term quite simply doesn't exist yet and today immediate side effects are higher than for the non mRNA vaccines. That is undeniable. It certainly doesn't exist for annual if not biannual boosters going forward.

    Rejoice in the awareness of feeling stupid, for that’s how you end up learning new things. If you’re not aware you’re stupid, you probably are.



  • Registered Users Posts: 16,452 ✭✭✭✭astrofool


    It is definitely an industry that was looking for a killer app that just happened to come along in the form of a worldwide pandemic :)

    They're still trying to figure out the process for cancer treatment, and development in the vaccine area will likely cross-benefit there, but beyond the potential for allergic reactions (which have been significantly decreased and tend to be of the time) there just isn't the potential for long term side effects that there was when the lipid technology was first developed. I would almost say you were burdened by the knowledge of the early days, which for any research area is full to the brim of failures, given where the industry is now headed, we could start seeing it replace a lot of the older vaccines (or of course we fully exit the pandemic and all funding dries up and it becomes a what if).



  • Posts: 0 [Deleted User]


    I'd be interested in seeing your source for this part: "there just isn't the potential for long term side effects that there was when the lipid technology was first developed."

    Even many pro-mRNA injection scientists who think the balance remains in favour of vaccination have expressed concerns about the long-term safety of the LNP.



  • Registered Users Posts: 16,452 ✭✭✭✭astrofool


    I'm not surprised, experience from the early days in a new technology sector tends to stick with people, I also think it's confusing "long term usage" with "long term safety".

    i.e. the risk of a severe allergic reaction is 1/1M, which for a yearly vaccine is probably fine and manageable, but probably less so for a daily injection or treatment course (like would happen with cancer where different other drugs can heighten the effect of allergens) but again, all these are reactions that happen at the time of exposure to LNP, post dose, if the person gets no further injections, there is no material present to cause any "long term" issues as seems to be getting alluded to, e.g. in 10 years time it pops up and causes an arm to fall off.



  • Posts: 0 [Deleted User]


    Thank you, but I was actually after the source you got the information from rather than an extended version of the opinion.

    Would be great if you’d post a link or whatever to something explaining how “there just isn’t the potential for long term side effects”.

    Its a big claim that I haven’t seen even the most ardent pro-mRNA vaccine experts make.



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  • Registered Users Posts: 16,452 ✭✭✭✭astrofool


    Honestly, there's a lot of papers out there to read through going back a number of years, I found this blog to provide a good summary, but if you search for "nano lipid carriers" you'll get a good selection:

    Understanding the nanotechnology in COVID-19 vaccines | CAS

    Funnily enough, many years ago I was working with someone (me on the IT side) who was looking at these as a delivery mechanism for cosmetics, which looks like it may come true.

    There was another paper covering allergens that I can't place right now, but, as I said, search using the above and there will be a number of papers.



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