CoronaVirus - Possible Vaccines and Treatments

Discussion in 'COVID-19' started by paulF, 25th Mar, 2020.

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  1. Shazz@

    Shazz@ Well-Known Member

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    Here is a link to the WHO initiated trial- Solidarity
    “Solidarity” clinical trial for COVID-19 treatments

    Treatment options under study:

    Remdesivir was previously tested as an Ebola treatment. It has generated promising results in animal studies for Middle East Respiratory Syndrome (MERS-CoV) and severe acute respiratory syndrome (SARS), which are also caused by coronaviruses, suggesting it may have some effect in patients with COVID-19.

    Lopinavir/Ritonavir is a licensed treatment for HIV. Evidence for COVID-19, MERS and SARS is yet to show it can improve clinical outcomes or prevent infection. This trial aims to identify and confirm any benefit for COVID-19 patients. While there are indications from laboratory experiments that this combination may be effective against COVID-19, studies done so far in COVID-19 patients have been inconclusive.

    Interferon beta-1a is used to treat multiple sclerosis.

    Chloroquine and hydroxychloroquine are very closely related and used to treat malaria and rheumatology conditions respectively. In China and France, small studies provided some indications of possible benefit of chloroquine phosphate against pneumonia caused by COVID-19 but need confirmation through randomized trials.
     
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  2. Shazz@

    Shazz@ Well-Known Member

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    Here is a recent press release by CSIRO- who are in the process of developing and starting to test possible vaccines here in Australia. On this site, there is also a very good Q&A session that was presented on Sky News that you can watch.
    CSIRO begins testing Covid-19 vaccines - CSIRO

    Some important points:
    • I posted on another thread the process of approving a treatment here in Australia.
    What I didn't mention in this post is the number of different phases involved in a clinical trials process. Basically, the above post is regarding a drug undergoing phase 3 trials. Human trials involve phase 1-4. Phase 1 trials involve assessing the right dose, and phase 2 trials is basically a pilot study to phase 3 trials, where efficacy and possible side effects is assessed in a small number of patients. Phase 3 trials is a large scale trial on efficacy and SAFETY, and based on this data, the vaccine either registered or not. Anything before Phase 1 studies is basically test tube and animal testing.
    • The good news is that the amount of research in understanding this virus from a molecular level has increased exponentially- this means they are almost ready for human trials. At the moment, they are still doing animal testing and its likely not til end of April-May that they are ready for human trials testing.
    • The other good news is that testing efficacy of the vaccine would be relatively quick as viruses have short life cycles (for e.g cancer trials are much longer as the disease takes years to form).
    • However, it's the SAFETY of the vaccine that would take the longest to test. Even though the vaccine can potentially cure the virus or prevent the virus from infecting us, how do we know that the vaccine won't cause any other issues?
    • The experts from the panel stressed that BOTH efficacy and safety are important. To have the vaccine approved for us, they will still have to undergo the proper regulatory processes.
    With that in mind, unfortunately, the vaccine could still be at least 18 months away (even if they fast-track the regulatory process).
     
    Last edited: 4th Apr, 2020
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  3. geoffw

    geoffw Moderator Staff Member

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    @Shazz@

    The link doesn't work - it should be https: not hattps:

    To clarify, CSIRO was just discussing a vaccine, not a treatment as I understand. You refer to a drug - but is a vaccine a drug per se?

    Is it possible that, given the situation, regulatory authorities might fast track the development of a vaccine? This seems to be happening in the US.
     
  4. Shazz@

    Shazz@ Well-Known Member

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    Sorry, fixed the link. Drug- same as vaccine. But I edited the post.

    yep, regulatory process can be fast tracked, but regulatory requires efficacy and safety data- this cant be fast tracked- this is where the delay will come from.
     
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  5. The Y-man

    The Y-man Moderator Staff Member

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    FYI - "drug" and "vaccines" are very different....

    Drugs are basically a chemical concoction that relieves the symptoms, but relies on the body's immune system to overcomes the virus.

    Vaccines are a modified ("weakened') form of the virus which elicits an immune reaction form the body, so that the body develops immunity against the virus.

    The Y-man
     
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  6. Shazz@

    Shazz@ Well-Known Member

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    Apologies- yes that is correct.
    I was talking about it in the context that it’s the same during the regulatory process when assessing data on efficacy and safety.
     
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  7. geoffw

    geoffw Moderator Staff Member

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    In that context, a drug which is being assessed as a cure, which is also being used for another purpose, has a shorter path because it has already been assessed as safe to use.They still have to be tested for efficacy. I guess there's potentially more tests if it's determined that a drug can be useful in a higher dose than that which has been previously be tested. It's these drugs where regulatory processes can be sped up - hydroxychloroquine has been allowed emergency use to treat Covid-19 in the US.

    Some recent work looking at the efficacy of hydroxychloroquine, which has been touted as a treatment, hasn't been encouraging, though it's only another small trial and so not conclusive:
    A small trial finds that hydroxychloroquine is not effective for treating coronavirus

    Personally, that's a pity - my wife takes that drug for a different reason.
     
  8. Shazz@

    Shazz@ Well-Known Member

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    Yes, existing drugs can take a shorter pathway. The study you have quoted only had 30 or so patients enrolled- there are way too many variables to see any conclusive results. Most likely a phase 1 study.
    To put into perspective, the Solidarity trial by WHO that is currently trialing existing drugs will be recruiting several thousand patients. At the moment they have over 70 countries participating. A couple of countries that have started includes Canada and Norway, who are hoping to recruit 400 and 700 patients respectively.
    The trial also mentions a recruitment finish date of March 2021.
    ISRCTN - ISRCTN83971151: Public health emergency SOLIDARITY trial of treatments for COVID-19 infection in hospitalized patients

    Sorry to hear about your wife
     
  9. SatayKing

    SatayKing Well-Known Member

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    A very, very small rant. My neighbour. Banging on about how there will be vaccine in a couple of months Covid-19 because some news article reported a "breakthrough."

    What a load of...............uneducated tripe.

    You can kill most of these things in a petri dish but that does not translate to being effective in humans unless further research is undertaken which takes many, many months.

    Media please stop rubbish reporting or at a minimum extensively qualify it.
     
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  10. geoffw

    geoffw Moderator Staff Member

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    Your neighbour may also be confused about the difference between a treatment (usually a drug, after a person is infected) and a vaccine (to prevent infection). A number of the "breakthroughs", including some touted by public figures, are treatments rather than vaccines, and to be fair to the media, some people get them mixed up.

    This has been raised often, but to repeat, a vaccine would be 12-18 months away. A treatment by an existing approved medication could be faster, and some medications have had approval to be used in limited circumstances.
     
  11. SatayKing

    SatayKing Well-Known Member

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    You're being generous @geoffw. My neighbour is an Alan Jones fan.
     
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  12. paulF

    paulF Well-Known Member

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    Another encouraging treatment that could be available in as early as this month.

    "You just got approval from the FDA to start trials. What's the timeline looking like to make that more widely available for people who are sick?

    We're in a whole new world now with how clinical trials are being conducted in the era of this pandemic. Traditionally, it would take about six weeks from the time that the FDA offers what's called a "safe to proceed" notice to the time that the first patient can receive an experimental treatment.

    In this case, we're hoping that we can significantly shorten that. It is my hope that within the month of April, we can get the first patients treated with this new therapy.

    So even just within the next few weeks?

    That's my hope, because all of us who are on the front lines recognize how critical the need is, and how we just don't have time to wait for any delays in getting any potential effective therapies to patients who need it."

    Seattle research institute launches fast track Covid-19 immunotherapy trial
     
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  13. Shazz@

    Shazz@ Well-Known Member

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    This is talking about a trial in Seattle.....not in Australia. Again, we are talking about a phase 2 trial (only 100 patients will be tested)

    That aside, being enrolled in a clinical trial is not the same as ‘having treatment available’.
     
  14. paulF

    paulF Well-Known Member

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    So any reason why a trial drug/therapy that works in Seattle wouldn't work in Australia or any other place on the planet?

    Re-read the article

    "In this case, we're hoping that we can significantly shorten that. It is my hope that within the month of April, we can get the first patients treated with this new therapy.

    So even just within the next few weeks?

    That's my hope, because all of us who are on the front lines recognize how critical the need is, and how we just don't have time to wait for any delays in getting any potential effective therapies to patients who need it."
     
  15. Shazz@

    Shazz@ Well-Known Member

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    Well in this case, this drug is being developed by a small biotech firm in Seattle. To be available in other countries, it would have to be mass produced and shipped out. They wouldn’t do that if the drug doesn’t actually work (which is why they are doing the phase 2)
     
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  16. The Y-man

    The Y-man Moderator Staff Member

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    ... AND be approved in the destination country.

    There are for example even supplements available in Canada that can not be purchased here.

    The Y-man
     
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  17. geoffw

    geoffw Moderator Staff Member

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    It's not a drug, it's an immunotherapy. Patients are treated with a sort of cell, according to the article. Though the article doesn't specify the source of the cells.
     
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  18. Shazz@

    Shazz@ Well-Known Member

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    The term drug can be used broadly to describe a range of different medications i.e.. vaccines, biologics, anti-virals, over the counter, immunosuppressants, drug therapy, immunotherapy, prescription medicine etc.

    According to google: a medicine or substance used to cure, mitigate, treat, or prevent a disease.
     
    Last edited: 7th Apr, 2020
  19. paulF

    paulF Well-Known Member

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    @Shazz@ , again, read the article. They are trying to boost the immune system of hospitalised patients using our own bodys natural killer cells in order to give the immune system a boost giving the patients a better chance of surviving hospitalisation. No new drug.
     
  20. Shazz@

    Shazz@ Well-Known Member

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    :) I have.. not enough information in the article. If patients with Covid-19 have low amount of NKF cells, where are they going to get these cells from? Another article on this said something about supplements that can boost NKF cells.
    Anyway, let’s agree to disagree.