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It seems like they tested for antibodies, but this article makes no mention of challenges to the real virus. It's important to remember that vaccines for previ

It seems like they tested for antibodies, but this article makes no mention of challenges to the real virus. It's important to remember that vaccines for previous coronaviruses (SARS/MERS) had reports of generating anitbodies, but also causing immunopathic responses or immune enhancement syndrome: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3335060/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3335060/ https://www.pnas.org/content/117/15/8218 https://www.pnas.org/content/117/15/8218 >Is it safe? It's really really to early to say yes or no, and the fact that the article tries to make a claim either way, is worrying. Vaccines for new families of viruses traditionally take years or decades to develop. We still don't have vaccines for retroviruses like HIV/Herpes (and it may not be possible due to the nature of those viruses). I've had all my vaccinations; I'm not an anti-vaxer. But I do have concerns on trying to push out any novel vaccine in less than two years without adequate testing. Although this virus has killed many, the risk factor for it is nowhere near high enough to warrant an emergency vaccine. There are trials underway for inhaled steroids that look very promising, and there's a good chance this virus will burn out in our population long before a truly safe vaccine comes to market. Having a viable treatment option seems much more valuable and safer than vaccinations in this particular case.

Trasmatta 6y ago
> We still don't have vaccines for retroviruses like HIV/Herpes HIV is so fundamentally different that it doesn't make sense to include it as a comparison here. > there's a good chance this virus will burn out in our population long before a truly safe vaccine comes to market. The virus isn't just going to "burn out" anytime soon. 143k deaths in the US already, and we likely haven't even hit 10% of the population being infected yet. Treatments will help pull the death rate downwards, but without a vaccine we're likely looking at multiple hundreds of thousands more deaths.
- djsumdog 6y ago
  > HIV is so fundamentally different Coronaviruses are very different. We've rarely had any this deadly before. All vaccines are different; they're not one blanket thing. Smallpox vaccines are attenuated virus (a virus that has mutated to be benign in humans; in the case of Smallpox, the first vaccine by Jenner was injecting people with Horsepox). Most Influenza vaccines are heat treated/inactivated virus. In all cases, vaccines try to produce antibodies and force our immune systems to develop a memory for a virus we haven't actually been exposed to. As shown in the links above, this might not work at all for coronavirus. To some extent, the actual interactions of vaccines, are somewhat opaque. This In A Nutshell video shows a very small part of the adaptive immune system, greatly simplified: https://www.youtube.com/watch?v=BSypUV6QUNw https://www.youtube.com/watch?v=BSypUV6QUNw > The virus isn't just going to "burn out" anytime soon Exponential growth doesn't go on forever. It has to hit an inflection point: https://www.youtube.com/watch?v=Kas0tIxDvrg https://www.youtube.com/watch?v=Kas0tIxDvrg The more deadly a virus is, the faster it does burn out. It runs out of hosts to infect or everyone develops an immunity. SARS/MERS may have had lower outbreaks because of how much more dangerous they were. If you graph fatalities on a logarithmic scale, you'll see we're already well past the inflection point in the US: https://aatishb.com/covidtrends/?data=deaths https://aatishb.com/covidtrends/?data=deaths The cases are going up, but the fatalities are not, indicating there may be a lot of over-counting. Keep in mind people who test positive but die of a car wreck are counted as COVID19. All these people getting surgery after 3 months are required to get tested just for their surgery, and a positive antibody test counts as an active case, even if they're not sick or have the virus at all. It's so bad in the UK they've stopped reporting fatality numbers due to issues with the data.
  - DiogenesKynikos 6y ago
    > Coronaviruses are very different. We've rarely had any this deadly before. SARS and MERS. > Keep in mind people who test positive but die of a car wreck are counted as COVID19. I'd like to see evidence that this has happened, that's it's not some freak outlier, and that it has any meaningful impact on the reported death toll. Looking at excess mortality, it looks like deaths have been under-reported, if anything. It's getting tiresome to see people trotting out the anecdote about someone getting in a car wreck and being counted as a CoVID-19 death.
    - fiftyfifty 6y ago
      > Keep in mind people who test positive but die of a car wreck are counted as COVID19. In Colorado there was lawsuit over this, because there was a case of a college age man dying of alcohol poisoning but he tested positive for Covid-19 so was counted as a Covid-19 death per CDC regulations. So the Colorado Health Department now tracks two numbers: people that died with Covid-19 and people that died because of Covid-19. As of right now the first is 1,752 deaths and the second is 1,615 deaths. Statistically it's not a huge difference, you can see the numbers here: https://covid19.colorado.gov/data/case-data https://covid19.colorado.gov/data/case-data
      - xienze 6y ago
        > Statistically it's not a huge difference 8.5% isn’t significant?
        DiogenesKynikos 6y ago
        These numbers aren't directly comparable. They're reported on different timescales, because determining cause of death takes longer than determining that someone who died had CoVID-19.
    - KaiserPro 6y ago
      In the UK, there are the daily public health england tallies, which are unrelaible and include anyone who has died and tested for covid. Then there are the stats from the ONS where they have actually verified that covid is the cause. The numbers are not very different.
deleted 6y ago
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chimprich 6y ago
> Vaccines for new families of viruses traditionally take years or decades to develop. Traditionally many things used to take an awful lot longer than it does now (e.g. gene sequencing). Technology advances. Also, this vaccine was based on an earlier one developed for MERS so they weren't starting from scratch. > We still don't have vaccines for retroviruses like HIV/Herpes That's completely irrelevant because they're very different viruses. Vaccination for a coronavirus should be a lot easier. > But I do have concerns on trying to push out any novel vaccine in less than two years without adequate testing It is undergoing extensive testing. Tens of thousands of people are currently being given the vaccine. The timeline is not really relevant; what counts is the testing that is carried out. I'm sure the Oxford University team has given proper consideration to safety.
- wycy 6y ago
  > That's completely irrelevant because they're very different viruses. Vaccination for a coronavirus should be a lot easier [than for retroviruses like HIV/Herpes]. Why is that? Uneducated guess: because of the rapid mutations of those viruses and the way they go dormant and hide?
  - Trasmatta 6y ago
    There's no known natural immunity for HIV. Vaccines work by triggering an immune response, but if there isn't an immune response that works, a vaccine won't be effective.
    - djsumdog 6y ago
      It's a bit more complicated than that. HIV does generate antibodies. Your body does fight HIV and remove it from your system. (The rapid test for HIV tests for those antibodies. If you test positive, you still need a viral load test). The trouble with HIV is during the infection process, it has an reverse transcriptase enzyme and an integrase enzyme, the two of which allow it to build DNA sequences and alter the host DNA. It permanently alters the host, allowing the virus to continue reproducing. There are some people for which this modification does nothing (long term non-progressives), but the for the majority of human beings, their immune system collapses within a few months or years (without treatment).
lymeeducator 6y ago
I agree. There are so many variables whose interaction is influenced by each individual's unique immune expression, that we need to measure more of those variables for everyone to start identifying common patterns. I would hope that each vaccine volunteer has a minimum amount of testing (>= https://science.sciencemag.org/content/early/2020/07/15/science.abc8511 https://science.sciencemag.org/content/early/2020/07/15/scie...) before and after each vaccine dose. It would also be very beneficial to measure their HLA genetic SNPs (see GSK's MERS vaccine induced narcolepsy in 2009). Transparency and increased measurement of immune data will help improve and/or customize vaccines so that they are effective and safe.
preordained 6y ago
I find it disturbing that a post like this gets downvoted. You've said nothing off-the-wall here. A downvote is not a rebuttal or an unceremonious verdict on the validity of your thoughts. Seriously not a fan of downvotes for this reason...just a blight on public discourse. To get back on topic, I'd really like someone to explain in some way that makes sense to me (because I've heard none--maybe I'm just incorrigible, thought) how a mandatory vaccine is justifiable for a disease with an extremely high survival rate that elderly people who've already exceeded the average life expectancy are disproportionately at risk for.
- coldpie 6y ago
  Don't worry about early downvotes too much. It doesn't show grey based on percentage of downvotes, it shows grey when it goes below 1 point. So if one guy votes it down soon after it's commented, it goes grey. Others usually come along to correct it.
- CyanLite2 6y ago
  You're only looking at the death rate. Take a look at the hospitalization rate (~20% for all age groups) and the amount of resources it takes to just keep one person alive. ICUs and hospital staffs are stretched to the brink. People indeed are surviving, but at great expense, and the hospitals have said they can't keep this up much longer. In Houston, TX there was a doctor who had worked 117 days straight and had to be relieved by Army Medical personnel (https://abc13.com/health/85-soldiers-arriving-to-help-treat-covid-19-patients/6317426/ https://abc13.com/health/85-soldiers-arriving-to-help-treat-...). There's just not enough ICU beds and medical staff to go around. Once we run out of hospital resources, the death rate will jump 5-10x. If that happens, you're talking 20+ million deaths in the U.S., on pace with the 1918 pandemic if not worse. If you think the economy is bad now, wait til 20+ million people suddenly aren't shopping anymore. Lastly, consider all of the people who have "recovered" but haven't really recovered, this includes the young 20-30 yr old crowds. There's hundreds of support groups now focused on post-corona-syndrome where people are 100+ days into the recovery but still have symptoms, including brain damage, neurological issues, strokes, kidney failures, shortness of breath, etc. It seems as if the older people are dying, and the younger patients are surviving, but with long-term damage.
CyanLite2 6y ago
>We still don't have vaccines for retroviruses like HIV/Herpes Good thing this isn't a retrovirus. >But I do have concerns on trying to push out any novel vaccine in less than two years without adequate testing. They started on this vaccine about 9 years ago, originally for the first SARS/MERS. They just gave it to 1,077 people and all 100% produced the desired effect, and the worst symptom reported was fatigue/headache that resolved on its own within 24 hours, or sooner if taken Tylenol/paracetamol. We're losing ~150,000 people worldwide EVERY MONTH to this virus, how many more months/deaths should we wait until we're sufficiently satisfied that it's safe?
- edanm 6y ago
  I feel like your reply is a bit dismissive of a very real problem. I don't understand anything about biology/vaccines or anything else relevant - but there have been several stories in history of medicine that was thought to have no side effect, that ended up being taken off the shelves because it was more dangerous than first thought. If we're going to inject a few hundred million (if not a few billion) people with something, we need to be really really sure it won't harm then, and considering the fact that COVID has a mortality rate of 1%-ish, the vaccine has a huge burden of proof. And more importantly to anything that I say as a non-expert - most experts on these issues seem to think you need at least ~10 months of human trials, if not more.
  - mbreese 6y ago
    > I don't understand anything about biology/vaccines or anything else relevant - but there have been several stories in history of medicine that was thought to have no side effect, that ended up being taken off the shelves because it was more dangerous than first thought. That’s the entire point of a Phase one trial. Vaccine studies may be a little different in their numbering, but the intent of a phase one trial is to figure out if the treatment is safe. The effectiveness is a separate question. https://www.cdc.gov/vaccines/parents/infographics/journey-of-child-vaccine.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fvaccines%2Fparents%2Finfographics%2Fjourney-of-child-vaccine-text.html https://www.cdc.gov/vaccines/parents/infographics/journey-of...
linuxftw 6y ago
Where do you draw the line between 'vaccine' and some other, similar but distinct technology? For me, the things being developed are not 'vaccines' but are a different thing entirely with a similar intended purpose.
srj 6y ago
Some balance needs to be struck. In addition to the virus being harmful to health, the mitigation measures in place to reduce spread are highly disruptive to society. I don't think we can wait until the risk is zero, after all the risk of allowing the virus to continue is far from zero. You talk about unknowns, we don't know the long-term impact of the disease either. Damage to the heart and lungs, oxygen deprivation of the brain, the impact extends beyond a boolean live or die.
iso1210 6y ago
> Although this virus has killed many, the risk factor for it is nowhere near high enough to warrant an emergency vaccine. There might be a benefit in pushing it out to over 75s who are at severe risk from the virus (IFR 19%), or even over 65s (3%). Agree that it's not worth the risk of a barely understood vaccine on kids.
KaiserPro 6y ago
> Although this virus has killed many, the risk factor for it is nowhere near high enough to warrant an emergency vaccine. There are trials underway for inhaled steroids that look very promising, and there's a good chance this virus will burn out in our population long before a truly safe vaccine comes to market. I think your perception of the numbers are a little off here. In the UK, we were loosing 1100 people a day entirely through covid (https://coronavirus.data.gov.uk/ https://coronavirus.data.gov.uk/) That was most from a few hot spots like london. (less than 10% of the population.) We were very close to overwhelming hospitals. when a hospital system is overwhelmed you get a very large spike in deaths, because stuff that's treatable isn't treated without lockdown, those deaths would have grown exponentially. Something like 200-400k preventable deaths. so, if we want to get out of lockdown, we need to have something to reduce the spread of the virus. One way is heard immunity (thats what the US is doing, and its not going very well) another is vaccine. Now, given the UK example, if the vaccine causes 10 deaths, and 1000 severe reactions(ie hospitalised) thats still better than the 200k deaths and close to a million cases with complications Deaths arn't the whole picture, its the people that recover with life altering injuries as well.
- JJzD 6y ago
  The WHO says there is only one worse thing than a bad pandemic, and that's a bad vaccine. Because not everybody is exposed to the pandemic, but in principle everyone is exposed to the vaccine. That doesn't counter your point, but we'll need up to phase 3, to have enough coverage to make sure your statistics hold. But indeed, the risk seems to be balanced against 5 years waiting for any long term symptoms to show.
  - IgorPartola 6y ago
    When did the WHO say that? I’m not disagreeing, just have not seen them talk about it like this.
  - pixelbash 6y ago
    It seems like there's a real chance everyone will be exposed to this pandemic sooner or later. My take is calculate the risks and act accordingly. Arguing moral priors first and statistics second is best reserved for when people aren't already dying in droves.
agency 6y ago
The article actually _does_ mention challenges to the real virus, at the end of the "What are the next steps in the trial?" section: > There are also calls to perform "challenge trials"[1] in which vaccinated people are deliberately infected with coronavirus. However, there are ethical concerns due to a lack of treatments. [1] https://www.bbc.com/news/health-53426367 https://www.bbc.com/news/health-53426367
ageitgey 6y ago
You are misunderstanding the point of this study. This is a Phase 1 study designed to show that the vaccine itself doesn't directly make people sick and to measure their antibody responses via blood tests. The on-going Phase 2/3 trials in the UK, South Africa and Brazil are designed to establish the efficacy of the vaccine under viral challenge. The idea is that you vaccinate a bunch of people (and an equally-sized control group) and wait around until a subset of them test positive for the virus. Then you unblind the groups and make sure that the people who got sick were in the control group. You also check for ADE (antibody dependent enhancement) to make sure the vaccine doesn't amplify the strength of the virus. All your questions are valid, but this study doesn't claim to answer them. Those results are still forthcoming. Additionally, the risk of ADE is well understood and carefully considered in the design of these trials. (Disclaimer - I'm a participant in the UK Phase 2/3 trial)
- yomly 6y ago
  Thank you for participating and for sharing these details!
- capkutay 6y ago
  It's still good to see such questions being raised in the community, especially when someone knowledgeable on the matter (such as yourself) has an educated response.
- lbeltrame 6y ago
  It is slightly different than a regular Phase 1 study because there's a control arm. I suspect they want to use the data as a complement to the Phase 2/3 results in the unfortunate case the volounteers end up positive for the virus.
- drited 6y ago
  The OP was critiquing the media reporting on the study not the study itself so I think your suggestion that the OP misunderstood the point of the study is off base. The OP did not claim that the study sought to answer the questions posed. The article does answer the question 'Is it safe?' with the word 'Yes' so I believe you are actually in agreement with the OP and the OP did understand that it is really early to say that, hence the critique.
ineedasername 6y ago
It's my understanding that phase 1 trials of this sort are designed simply to show that the potential vaccine generates a response in the recipient and doesn't causes any significant adverse effect. Phase 2 & 3 are where the the potential efficacy of the virus and the issues you raise are explored.
IgorPartola 6y ago
> Although this virus has killed many, the risk factor for it is nowhere near high enough to warrant an emergency vaccine. I strongly disagree with this sentiment. In the ideal world we would have both a treatment and a vaccine, but a vaccine is much preferable: even if it grants immunity for only a year it still allows for better logistics than a treatment. A treatment is also an unknown cost while the cost of producing a vaccine is fairly well know. Also there are loads of people who are at high risk and cannot survive COVID if they got it. Herd immunity and actual immunity from a vaccine is their only option for staying alive. Lastly, your comment makes it sound like steps are being skipped here. They are not. This vaccine along with others is undergoing the same three phase study approach as any other candidate for any other virus. The difference is that sometimes phase 1 and 2 are combined which puts the people in those trials at risk, but based on your comment I don’t see that as being one of your concerns (based on the part about how well yeah a lot of people died but it doesn’t warrant an emergency vaccine). It does not cause risk to anyone else and for successful phase 1 & 2 trials you can assume the vaccine is safe for the populations tested in phase 3. Once all three are cleared, the vaccine is just as safe as any other. I know to a lot of people it may feel like corners are being cut but I have seen zero evidence for that. We are saving time by doing things like combining phase 1 & 2, expediting review and paperwork by prioritizing these candidates over other drugs, and in this particular case by manufacturing the vaccine while it’s still in trials, gambling that it will actually work. So far the Oxford vaccine looks to be the most promising of all so I would say it’s a good gamble, but then again only a small portion of that $1.2b is mine (coming from US tax dollars and AstraZenica coffers). A true emergency vaccine is the only one that’s currently approved for use: it’s been approved as an experimental vaccine by the Chinese military for use by the military for one year. That particular vaccine doesn’t have phase 2 or 3 results actually published and the preliminary data from phase 2 doesn’t look as good as the Oxford one. That is the kind of thing I would personally hold off on, but not something that’s gone through all three phases and been independently reviewed.
jaredhansen 6y ago
The article doesn't go into it, but the actual paper[1] states that this vaccine has "has previously been reported to be immunogenic and protective against pneumonia in a rhesus macaque challenge model", and cites to [2]. [1] https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31604-4/fulltext https://www.thelancet.com/journals/lancet/article/PIIS0140-6... [2] https://www.biorxiv.org/content/10.1101/2020.05.13.093195v1 https://www.biorxiv.org/content/10.1101/2020.05.13.093195v1
starfallg 6y ago
>>Is it safe? >It's really really to early to say yes or no, and the fact that the article tries to make a claim either way, is worrying. This is exactly what the phase 1 trial (the result which were just released) tries to establish - >Phase I trials were formerly referred to as “first-in-man studies” but the field generally moved to the gender-neutral language phrase "first-in-humans" in the 1990s;[5] these trials are the first stage of testing in human subjects.[6] They are designed to test the safety, side effects, best dose, and formulation method for the drug.[7] Phase I trials are not randomized, and thus are vulnerable to selection bias.[8] https://en.m.wikipedia.org/wiki/Phases_of_clinical_research https://en.m.wikipedia.org/wiki/Phases_of_clinical_research
lowwave 6y ago
Can some one please explain to me. Why are we focused on vaccine. Seems like vaccine is about 40% - 60% effective. With highly infectious disease is vaccine even effective? Would be good to hear from some one with a bit more medical knowledge
blackrock 6y ago
> But I do have concerns on trying to push out any novel vaccine in less than two years without adequate testing. This sounds like how you get zombies. I’ve seen this movie before.
zajio1am 6y ago
> We still don't have vaccines for retroviruses like HIV/Herpes Herpes is not retrovirus. It just have a latent phase where inactive viral DNA is in the cytoplasm of infected neurons.

Trasmatta 6y ago

> We still don't have vaccines for retroviruses like HIV/Herpes HIV is so fundamentally different that it doesn't make sense to include it as a comparison here. > there's a good chance this virus will burn out in our population long before a truly safe vaccine comes to market. The virus isn't just going to "burn out" anytime soon. 143k deaths in the US already, and we likely haven't even hit 10% of the population being infected yet. Treatments will help pull the death rate downwards, but without a vaccine we're likely looking at multiple hundreds of thousands more deaths.

djsumdog 6y ago
> HIV is so fundamentally different Coronaviruses are very different. We've rarely had any this deadly before. All vaccines are different; they're not one blanket thing. Smallpox vaccines are attenuated virus (a virus that has mutated to be benign in humans; in the case of Smallpox, the first vaccine by Jenner was injecting people with Horsepox). Most Influenza vaccines are heat treated/inactivated virus. In all cases, vaccines try to produce antibodies and force our immune systems to develop a memory for a virus we haven't actually been exposed to. As shown in the links above, this might not work at all for coronavirus. To some extent, the actual interactions of vaccines, are somewhat opaque. This In A Nutshell video shows a very small part of the adaptive immune system, greatly simplified: https://www.youtube.com/watch?v=BSypUV6QUNw https://www.youtube.com/watch?v=BSypUV6QUNw > The virus isn't just going to "burn out" anytime soon Exponential growth doesn't go on forever. It has to hit an inflection point: https://www.youtube.com/watch?v=Kas0tIxDvrg https://www.youtube.com/watch?v=Kas0tIxDvrg The more deadly a virus is, the faster it does burn out. It runs out of hosts to infect or everyone develops an immunity. SARS/MERS may have had lower outbreaks because of how much more dangerous they were. If you graph fatalities on a logarithmic scale, you'll see we're already well past the inflection point in the US: https://aatishb.com/covidtrends/?data=deaths https://aatishb.com/covidtrends/?data=deaths The cases are going up, but the fatalities are not, indicating there may be a lot of over-counting. Keep in mind people who test positive but die of a car wreck are counted as COVID19. All these people getting surgery after 3 months are required to get tested just for their surgery, and a positive antibody test counts as an active case, even if they're not sick or have the virus at all. It's so bad in the UK they've stopped reporting fatality numbers due to issues with the data.
- DiogenesKynikos 6y ago
  > Coronaviruses are very different. We've rarely had any this deadly before. SARS and MERS. > Keep in mind people who test positive but die of a car wreck are counted as COVID19. I'd like to see evidence that this has happened, that's it's not some freak outlier, and that it has any meaningful impact on the reported death toll. Looking at excess mortality, it looks like deaths have been under-reported, if anything. It's getting tiresome to see people trotting out the anecdote about someone getting in a car wreck and being counted as a CoVID-19 death.
  - fiftyfifty 6y ago
    > Keep in mind people who test positive but die of a car wreck are counted as COVID19. In Colorado there was lawsuit over this, because there was a case of a college age man dying of alcohol poisoning but he tested positive for Covid-19 so was counted as a Covid-19 death per CDC regulations. So the Colorado Health Department now tracks two numbers: people that died with Covid-19 and people that died because of Covid-19. As of right now the first is 1,752 deaths and the second is 1,615 deaths. Statistically it's not a huge difference, you can see the numbers here: https://covid19.colorado.gov/data/case-data https://covid19.colorado.gov/data/case-data
    - xienze 6y ago
      > Statistically it's not a huge difference 8.5% isn’t significant?
      - DiogenesKynikos 6y ago
        These numbers aren't directly comparable. They're reported on different timescales, because determining cause of death takes longer than determining that someone who died had CoVID-19.
  - KaiserPro 6y ago
    In the UK, there are the daily public health england tallies, which are unrelaible and include anyone who has died and tested for covid. Then there are the stats from the ONS where they have actually verified that covid is the cause. The numbers are not very different.

deleted 6y ago

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chimprich 6y ago

> Vaccines for new families of viruses traditionally take years or decades to develop. Traditionally many things used to take an awful lot longer than it does now (e.g. gene sequencing). Technology advances. Also, this vaccine was based on an earlier one developed for MERS so they weren't starting from scratch. > We still don't have vaccines for retroviruses like HIV/Herpes That's completely irrelevant because they're very different viruses. Vaccination for a coronavirus should be a lot easier. > But I do have concerns on trying to push out any novel vaccine in less than two years without adequate testing It is undergoing extensive testing. Tens of thousands of people are currently being given the vaccine. The timeline is not really relevant; what counts is the testing that is carried out. I'm sure the Oxford University team has given proper consideration to safety.

wycy 6y ago
> That's completely irrelevant because they're very different viruses. Vaccination for a coronavirus should be a lot easier [than for retroviruses like HIV/Herpes]. Why is that? Uneducated guess: because of the rapid mutations of those viruses and the way they go dormant and hide?
- Trasmatta 6y ago
  There's no known natural immunity for HIV. Vaccines work by triggering an immune response, but if there isn't an immune response that works, a vaccine won't be effective.
  - djsumdog 6y ago
    It's a bit more complicated than that. HIV does generate antibodies. Your body does fight HIV and remove it from your system. (The rapid test for HIV tests for those antibodies. If you test positive, you still need a viral load test). The trouble with HIV is during the infection process, it has an reverse transcriptase enzyme and an integrase enzyme, the two of which allow it to build DNA sequences and alter the host DNA. It permanently alters the host, allowing the virus to continue reproducing. There are some people for which this modification does nothing (long term non-progressives), but the for the majority of human beings, their immune system collapses within a few months or years (without treatment).

lymeeducator 6y ago

I agree. There are so many variables whose interaction is influenced by each individual's unique immune expression, that we need to measure more of those variables for everyone to start identifying common patterns. I would hope that each vaccine volunteer has a minimum amount of testing (>= https://science.sciencemag.org/content/early/2020/07/15/science.abc8511 https://science.sciencemag.org/content/early/2020/07/15/scie...) before and after each vaccine dose. It would also be very beneficial to measure their HLA genetic SNPs (see GSK's MERS vaccine induced narcolepsy in 2009). Transparency and increased measurement of immune data will help improve and/or customize vaccines so that they are effective and safe.

preordained 6y ago

I find it disturbing that a post like this gets downvoted. You've said nothing off-the-wall here. A downvote is not a rebuttal or an unceremonious verdict on the validity of your thoughts. Seriously not a fan of downvotes for this reason...just a blight on public discourse. To get back on topic, I'd really like someone to explain in some way that makes sense to me (because I've heard none--maybe I'm just incorrigible, thought) how a mandatory vaccine is justifiable for a disease with an extremely high survival rate that elderly people who've already exceeded the average life expectancy are disproportionately at risk for.

coldpie 6y ago
Don't worry about early downvotes too much. It doesn't show grey based on percentage of downvotes, it shows grey when it goes below 1 point. So if one guy votes it down soon after it's commented, it goes grey. Others usually come along to correct it.
CyanLite2 6y ago
You're only looking at the death rate. Take a look at the hospitalization rate (~20% for all age groups) and the amount of resources it takes to just keep one person alive. ICUs and hospital staffs are stretched to the brink. People indeed are surviving, but at great expense, and the hospitals have said they can't keep this up much longer. In Houston, TX there was a doctor who had worked 117 days straight and had to be relieved by Army Medical personnel (https://abc13.com/health/85-soldiers-arriving-to-help-treat-covid-19-patients/6317426/ https://abc13.com/health/85-soldiers-arriving-to-help-treat-...). There's just not enough ICU beds and medical staff to go around. Once we run out of hospital resources, the death rate will jump 5-10x. If that happens, you're talking 20+ million deaths in the U.S., on pace with the 1918 pandemic if not worse. If you think the economy is bad now, wait til 20+ million people suddenly aren't shopping anymore. Lastly, consider all of the people who have "recovered" but haven't really recovered, this includes the young 20-30 yr old crowds. There's hundreds of support groups now focused on post-corona-syndrome where people are 100+ days into the recovery but still have symptoms, including brain damage, neurological issues, strokes, kidney failures, shortness of breath, etc. It seems as if the older people are dying, and the younger patients are surviving, but with long-term damage.

CyanLite2 6y ago

>We still don't have vaccines for retroviruses like HIV/Herpes Good thing this isn't a retrovirus. >But I do have concerns on trying to push out any novel vaccine in less than two years without adequate testing. They started on this vaccine about 9 years ago, originally for the first SARS/MERS. They just gave it to 1,077 people and all 100% produced the desired effect, and the worst symptom reported was fatigue/headache that resolved on its own within 24 hours, or sooner if taken Tylenol/paracetamol. We're losing ~150,000 people worldwide EVERY MONTH to this virus, how many more months/deaths should we wait until we're sufficiently satisfied that it's safe?

edanm 6y ago
I feel like your reply is a bit dismissive of a very real problem. I don't understand anything about biology/vaccines or anything else relevant - but there have been several stories in history of medicine that was thought to have no side effect, that ended up being taken off the shelves because it was more dangerous than first thought. If we're going to inject a few hundred million (if not a few billion) people with something, we need to be really really sure it won't harm then, and considering the fact that COVID has a mortality rate of 1%-ish, the vaccine has a huge burden of proof. And more importantly to anything that I say as a non-expert - most experts on these issues seem to think you need at least ~10 months of human trials, if not more.
- mbreese 6y ago
  > I don't understand anything about biology/vaccines or anything else relevant - but there have been several stories in history of medicine that was thought to have no side effect, that ended up being taken off the shelves because it was more dangerous than first thought. That’s the entire point of a Phase one trial. Vaccine studies may be a little different in their numbering, but the intent of a phase one trial is to figure out if the treatment is safe. The effectiveness is a separate question. https://www.cdc.gov/vaccines/parents/infographics/journey-of-child-vaccine.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fvaccines%2Fparents%2Finfographics%2Fjourney-of-child-vaccine-text.html https://www.cdc.gov/vaccines/parents/infographics/journey-of...

linuxftw 6y ago

Where do you draw the line between 'vaccine' and some other, similar but distinct technology? For me, the things being developed are not 'vaccines' but are a different thing entirely with a similar intended purpose.

srj 6y ago

Some balance needs to be struck. In addition to the virus being harmful to health, the mitigation measures in place to reduce spread are highly disruptive to society. I don't think we can wait until the risk is zero, after all the risk of allowing the virus to continue is far from zero. You talk about unknowns, we don't know the long-term impact of the disease either. Damage to the heart and lungs, oxygen deprivation of the brain, the impact extends beyond a boolean live or die.

iso1210 6y ago

> Although this virus has killed many, the risk factor for it is nowhere near high enough to warrant an emergency vaccine. There might be a benefit in pushing it out to over 75s who are at severe risk from the virus (IFR 19%), or even over 65s (3%). Agree that it's not worth the risk of a barely understood vaccine on kids.

KaiserPro 6y ago

> Although this virus has killed many, the risk factor for it is nowhere near high enough to warrant an emergency vaccine. There are trials underway for inhaled steroids that look very promising, and there's a good chance this virus will burn out in our population long before a truly safe vaccine comes to market. I think your perception of the numbers are a little off here. In the UK, we were loosing 1100 people a day entirely through covid (https://coronavirus.data.gov.uk/ https://coronavirus.data.gov.uk/) That was most from a few hot spots like london. (less than 10% of the population.) We were very close to overwhelming hospitals. when a hospital system is overwhelmed you get a very large spike in deaths, because stuff that's treatable isn't treated without lockdown, those deaths would have grown exponentially. Something like 200-400k preventable deaths. so, if we want to get out of lockdown, we need to have something to reduce the spread of the virus. One way is heard immunity (thats what the US is doing, and its not going very well) another is vaccine. Now, given the UK example, if the vaccine causes 10 deaths, and 1000 severe reactions(ie hospitalised) thats still better than the 200k deaths and close to a million cases with complications Deaths arn't the whole picture, its the people that recover with life altering injuries as well.

JJzD 6y ago
The WHO says there is only one worse thing than a bad pandemic, and that's a bad vaccine. Because not everybody is exposed to the pandemic, but in principle everyone is exposed to the vaccine. That doesn't counter your point, but we'll need up to phase 3, to have enough coverage to make sure your statistics hold. But indeed, the risk seems to be balanced against 5 years waiting for any long term symptoms to show.
- IgorPartola 6y ago
  When did the WHO say that? I’m not disagreeing, just have not seen them talk about it like this.
- pixelbash 6y ago
  It seems like there's a real chance everyone will be exposed to this pandemic sooner or later. My take is calculate the risks and act accordingly. Arguing moral priors first and statistics second is best reserved for when people aren't already dying in droves.

agency 6y ago

The article actually _does_ mention challenges to the real virus, at the end of the "What are the next steps in the trial?" section: > There are also calls to perform "challenge trials"[1] in which vaccinated people are deliberately infected with coronavirus. However, there are ethical concerns due to a lack of treatments. [1] https://www.bbc.com/news/health-53426367 https://www.bbc.com/news/health-53426367

ageitgey 6y ago

You are misunderstanding the point of this study. This is a Phase 1 study designed to show that the vaccine itself doesn't directly make people sick and to measure their antibody responses via blood tests. The on-going Phase 2/3 trials in the UK, South Africa and Brazil are designed to establish the efficacy of the vaccine under viral challenge. The idea is that you vaccinate a bunch of people (and an equally-sized control group) and wait around until a subset of them test positive for the virus. Then you unblind the groups and make sure that the people who got sick were in the control group. You also check for ADE (antibody dependent enhancement) to make sure the vaccine doesn't amplify the strength of the virus. All your questions are valid, but this study doesn't claim to answer them. Those results are still forthcoming. Additionally, the risk of ADE is well understood and carefully considered in the design of these trials. (Disclaimer - I'm a participant in the UK Phase 2/3 trial)

yomly 6y ago
Thank you for participating and for sharing these details!
capkutay 6y ago
It's still good to see such questions being raised in the community, especially when someone knowledgeable on the matter (such as yourself) has an educated response.
lbeltrame 6y ago
It is slightly different than a regular Phase 1 study because there's a control arm. I suspect they want to use the data as a complement to the Phase 2/3 results in the unfortunate case the volounteers end up positive for the virus.
drited 6y ago
The OP was critiquing the media reporting on the study not the study itself so I think your suggestion that the OP misunderstood the point of the study is off base. The OP did not claim that the study sought to answer the questions posed. The article does answer the question 'Is it safe?' with the word 'Yes' so I believe you are actually in agreement with the OP and the OP did understand that it is really early to say that, hence the critique.

ineedasername 6y ago

It's my understanding that phase 1 trials of this sort are designed simply to show that the potential vaccine generates a response in the recipient and doesn't causes any significant adverse effect. Phase 2 & 3 are where the the potential efficacy of the virus and the issues you raise are explored.

IgorPartola 6y ago

> Although this virus has killed many, the risk factor for it is nowhere near high enough to warrant an emergency vaccine. I strongly disagree with this sentiment. In the ideal world we would have both a treatment and a vaccine, but a vaccine is much preferable: even if it grants immunity for only a year it still allows for better logistics than a treatment. A treatment is also an unknown cost while the cost of producing a vaccine is fairly well know. Also there are loads of people who are at high risk and cannot survive COVID if they got it. Herd immunity and actual immunity from a vaccine is their only option for staying alive. Lastly, your comment makes it sound like steps are being skipped here. They are not. This vaccine along with others is undergoing the same three phase study approach as any other candidate for any other virus. The difference is that sometimes phase 1 and 2 are combined which puts the people in those trials at risk, but based on your comment I don’t see that as being one of your concerns (based on the part about how well yeah a lot of people died but it doesn’t warrant an emergency vaccine). It does not cause risk to anyone else and for successful phase 1 & 2 trials you can assume the vaccine is safe for the populations tested in phase 3. Once all three are cleared, the vaccine is just as safe as any other. I know to a lot of people it may feel like corners are being cut but I have seen zero evidence for that. We are saving time by doing things like combining phase 1 & 2, expediting review and paperwork by prioritizing these candidates over other drugs, and in this particular case by manufacturing the vaccine while it’s still in trials, gambling that it will actually work. So far the Oxford vaccine looks to be the most promising of all so I would say it’s a good gamble, but then again only a small portion of that $1.2b is mine (coming from US tax dollars and AstraZenica coffers). A true emergency vaccine is the only one that’s currently approved for use: it’s been approved as an experimental vaccine by the Chinese military for use by the military for one year. That particular vaccine doesn’t have phase 2 or 3 results actually published and the preliminary data from phase 2 doesn’t look as good as the Oxford one. That is the kind of thing I would personally hold off on, but not something that’s gone through all three phases and been independently reviewed.

jaredhansen 6y ago

The article doesn't go into it, but the actual paper[1] states that this vaccine has "has previously been reported to be immunogenic and protective against pneumonia in a rhesus macaque challenge model", and cites to [2]. [1] https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31604-4/fulltext https://www.thelancet.com/journals/lancet/article/PIIS0140-6... [2] https://www.biorxiv.org/content/10.1101/2020.05.13.093195v1 https://www.biorxiv.org/content/10.1101/2020.05.13.093195v1

starfallg 6y ago

>>Is it safe? >It's really really to early to say yes or no, and the fact that the article tries to make a claim either way, is worrying. This is exactly what the phase 1 trial (the result which were just released) tries to establish - >Phase I trials were formerly referred to as “first-in-man studies” but the field generally moved to the gender-neutral language phrase "first-in-humans" in the 1990s;[5] these trials are the first stage of testing in human subjects.[6] They are designed to test the safety, side effects, best dose, and formulation method for the drug.[7] Phase I trials are not randomized, and thus are vulnerable to selection bias.[8] https://en.m.wikipedia.org/wiki/Phases_of_clinical_research https://en.m.wikipedia.org/wiki/Phases_of_clinical_research

lowwave 6y ago

Can some one please explain to me. Why are we focused on vaccine. Seems like vaccine is about 40% - 60% effective. With highly infectious disease is vaccine even effective? Would be good to hear from some one with a bit more medical knowledge

blackrock 6y ago

> But I do have concerns on trying to push out any novel vaccine in less than two years without adequate testing. This sounds like how you get zombies. I’ve seen this movie before.

zajio1am 6y ago

> We still don't have vaccines for retroviruses like HIV/Herpes Herpes is not retrovirus. It just have a latent phase where inactive viral DNA is in the cytoplasm of infected neurons.