The state of the vaccines

Discussion in 'Coronavirus Pandemic Discussions' started by CenterField, Aug 14, 2020.

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  1. CenterField

    CenterField Well-Known Member Past Donor

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    As you may have heard already from other threads, the vaccine made by Gamaleya, the Russian institute, nicknamed by Putin "Sputinik V" has released phase 1 and 2 results, published by The Lancet, and it claims 100% of seroconversion and no severe side effects; a phase 3 with 40,000 subjects is starting. These are good news, vaccine-wise, if, and it's a big if, we can trust information coming from Russia. This vaccine has already been approved by the Russian authorities, ahead of conclusion of phase 3, and mass-vaccination of the population is scheduled to start very soon (September or October), again, ahead of a phase 3 that will include placebo. So, the Russians are bold and imprudent, but if their vaccine is ultimately indeed safe and effective, they will earn a big advantage over Western (and other Asian) countries, given that they will likely achieve the end of their contagion much ahead of other countries, enabling their economy to be more competitive. The Russians have started a misinformation campaign, pretending that the Western vaccines can cause cancer. Predictable... I hope people don't pay any attention to these false claims. Anyway, if now a third vaccine (on top of the CoronaVac and the Novavax) indeed achieved (if we can trust the Russian info) above 97% of efficacy, it bodes well. The Russian vaccine is an adenovirus replicating vector vaccine given in two stages, one dose with the most common adenovirus, and a second dose with a rare strain, to avoid the issue of people being immune to the most common on. That's a clever approach.

    The Russians and Chinese, jumping ahead in mass campaign vaccinations (the Chinese have already started vaccinating their military and healthcare workers and are planning to extend it to other essential categories), may actually have a point. With the growing reports of a second infection, it is advisable to vaccinate people sooner rather than later, before the virus mutates too much, so that the contagion gets brought down for good, before a new strain complicates things. Of course a new strain might still reinfect a population that has been vaccinated against a previous strain, but conceivably, early diagnosis and contact-tracing might deal with that instead of trying to curb a contagion that has already affected millions of people. If you can get the main strain to die out with a strongly effective vaccine accepted by most of the population, it puts a country in much better shape to fight off a possible emerging mutated strain.

    Acceptance of a vaccine is key. I just looked at a survey in Brazil: 75% of their population said they will definitely accept a coronavirus vaccine, 20% said maybe (which is still hopeful; these maybe just want to see the safety data before they accept it), and 5% said they won't take it.

    This is likely to be a bigger acceptance rate than in the United States.

    It is interesting to look at the Brazilian survey because they are the second country hardest hit after the US, and they also have a similar political divisiveness there, with their president being called The Tropical Trump and having persistently tried to minimize the disease, and with almost half of their population being more progressive than the half (and some) that elected their president. I have no idea, though, about how active anti-vaxxers are in Brazil
     
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  2. CenterField

    CenterField Well-Known Member Past Donor

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    A study by the WHO plus a study by 21 researches have estimated that vaccines save 4 lives per minute and 250 million dollars in economic damage from diseases, per day.
     
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  3. CenterField

    CenterField Well-Known Member Past Donor

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    Very bad day for vaccines today.

    1) The Oxford/AstraZeneca vaccine phase 3 trials got paused due to the occurrence of a serious adverse reaction in a subject in the UK. This is not good but not necessarily terrible. But not good. The timeline of getting ready by the end of the year supposed no glitches. That's definitely a glitch. Why is it not terrible? Because in all large trials, sometimes there is unexpected illness that might be seen as an adverse reaction but might be unrelated. The right thing to do is to halt the trial and investigate, and that's what AstraZeneca is doing. So, we'll have to see what the investigation will show. I haven't found more details on this yet. There will be safety data review by the Data and Safety Monitoring Board. They will try to review fast, but it also shows that safety is being taken seriously with no corners cut. One bad point is that I had more hopes for this chimpanzee adenovirus vector than for the mRNA approach of Moderna and Pfizer, and the adenovirus approach doesn't need the -94 degrees that the Pfizer one requires.
     
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  4. CenterField

    CenterField Well-Known Member Past Donor

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    2) The SEC is looking at Moderna executives who sold shares to the tune of 90 million dollars in profits. It could be insider trading. Well, yeah, those things happen and why is it bad news for the vaccine? Because the chief medical officer of Moderna sold ALL his shares. ALL of them. So, is he thinking that the vaccine will fail? It would make sense to sell now, only if he thinks that his vaccine is no good, otherwise, the stocks would go up more and more if it's a successful vaccine. So what does he know that we don't?

    Ethically, the US government injected 2.5 billion dollars into Moderna, and that's part of how the valuation of their stock has happened. And now, executives cash on this to fill their own pockets; it's like they are benefiting of *our* tax-payers money.

    Moderna said these stock option sales were planned two years ago. But apparently that's not true; the executives made changes to the plan right before certain announcements related to the vaccine. It doesn't look good.

    Both these issues undermine public confidence which is already low. Two thirds of Americans said they don't want to try these vaccines too soon.
     
  5. Adfundum

    Adfundum Moderator Staff Member Donor

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    Thanks, CF, hope you continue to keep us informed on this.
     
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  6. gnoib

    gnoib Well-Known Member

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    The Oxford vaccine Phase 3 was stopped because one of the folks showed rather bad side effects.
    Grrrrrrrrrrrrrrrrrrr.
    That is one of the promising prototypes, or was.

    We are in for the long haul. We can not bend science to our wishes.
     
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  7. gnoib

    gnoib Well-Known Member

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    It is about the percentage. Even if you do 20,000 for a phase 3, one is very bad news. We are talking about hundreds of millions, who would use that vaccine.
    Good news, they were honest about it.

    I am rather interested in Curevac, their mRNA and their technology around it.

    You should look into it. They have several vaccines in Phase 2 and 3, from Rabbies to Overran cancer.
    I think they are on to something.
    By the way, a Teslar owned company builds the bio reactors for them.
    Musk war recently in Germany and made it a point to visit Curevac, that contract must be rather huge by now, with 240 million doses in contract with the EU alone.
    Germany invested 300 millions in that company and when it went public middle of August, it raised over 240 millions and they got an other injection of capital last week from the German government.
    If their vaccine works, they are doing phase 2 and 3 at the present, they are finishing 2 and starting 3 at the same time, you got a new player on the market, which has its own tech and patents, owned by the German Government, to some part.
    Than consider Germany's pharma industry, the potential they have to produce the vaccine in mass production.
    Oh, by the way, those little glass containers vaccines come in, there is a company which has the absolute monopoly for them, its a German family business.
    You can have the best vaccine of all times, but you have to have the ability to produces it, 100 of millions, store them, bottle them and so on.
    The biggest problem will be logistics and world wide politics, nationalism and so on. A vaccine by the end of the year, no problem, but than?
     
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  8. CenterField

    CenterField Well-Known Member Past Donor

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    Yes, I see it listed in my link posted in my OP. Funded by the German government, the European Commission, a German bank, and the Gates foundation. Fingers crossed for it.
     
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  9. CenterField

    CenterField Well-Known Member Past Donor

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    What makes me nervous about the AstraZeneca decision is that they did not disclose to the national agencies of other countries (or to the press, for that matter) what kind of reaction or illness the British volunteer has experienced. I've just confirmed with my contacts at Fiocruz in Brazil, which was coordinating the Brazilian branch of the phase 3 study, that AstraZeneca just told them to stop and didn't disclose the reason, and did not disclose it to ANVISA either (the Brazilian FDA). I wonder why all the secrecy. Did the British volunteer die??? That might explain, in terms of PR and stock value (which tumbled 8% anyway), that they would want to first see if they can rule out that the issue happened because of the vaccine, to then announce it together with the exculpatory evidence. But the secrecy makes me suspect that the reaction or illness was pretty bad.
     
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  10. Derideo_Te

    Derideo_Te Well-Known Member

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    https://www.bbc.com/news/world-54082192

     
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  11. Bowerbird

    Bowerbird Well-Known Member

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    Don’t worry the Uni of QLD vaccine is not far behind but it is so new that they may delay because there is no precedent
     
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  12. StillBlue

    StillBlue Well-Known Member

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    Or it could be simply patient privacy laws.
     
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  13. CenterField

    CenterField Well-Known Member Past Donor

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    Patient privacy would not be affected if no patient-identifying information were released. Talking about what reaction happened, without identifying the patient, is perfectly possible.
     
  14. CenterField

    CenterField Well-Known Member Past Donor

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    I know, that's why I said this, in post #103: "Because in all large trials, sometimes there is unexpected illness that might be seen as an adverse reaction but might be unrelated. The right thing to do is to halt the trial and investigate"
     
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  15. StillBlue

    StillBlue Well-Known Member

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    I understand that and I am by no means conversant with British and EU laws on this but the problem is that it was a single patient. As such the patient could be identified because of follow up care and then his/her condition known to all. For example. Bob did not keep secret that he was vaccinated. Bob misses work because he has to return to the doctor. The Globe prints "Vaccine test halted because patient unable to maintain an erection!" Next day Bob goes to work and his "good friends" put two and two together and offer him a large assortment of sex toys. Bob can deny it all he wants but is in for a ribbing none the less.
     
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  16. CenterField

    CenterField Well-Known Member Past Donor

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    Fair point. But somehow, I think it's more like a corporate decision to avoid further damage to the stock value, than a concern for Bob and his erection or lack thereof.
    Especially, in a trial with 30,000 patients. There will always be side effects, and they'll be reported in bulk "3% of fever, 2% of fatigue/malaise" etc. Bob could have missed work because of something else. Saying that one person in 30,000 had trouble with erection doesn't identify Bob.
     
  17. CenterField

    CenterField Well-Known Member Past Donor

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    Sorry, but this pandemic is no laughing matter.
     
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  18. CenterField

    CenterField Well-Known Member Past Donor

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    *If* we could believe in what the Chinese say and *if* we could be sure that a delivery of a batch of vaccines to another country won't include counterfeit product, one would have to say that it looks like the Chinese vaccines are the frontrunners, the most effective, and the safest.

    https://www.yahoo.com/news/chinese-vaccine-tested-safely-hundreds-105541153.html

    I have contacts in one of the BRICS countries and might be able to travel there and get one of the Chinese vaccines once they are approved there. I have considered doing this, since the AstraZeneca trial has stalled (for now; hopefully the glitch will be solved and it will resume), and the mRNA concept from Moderna and Pfizer is unproven. I don't expect these vaccines to be as efficacious as an inactivated virus vaccine like the Chinese CoronaVac. The Chinese are allegedly achieving immunogenicity with seroconversion to high levels of neutralizing antibodies, above 90%. Now they are saying that with their emergency approval they've already administered the vaccines to hundreds of thousands of people and no one caught the coronavirus, and nobody had a serious reaction.

    But I also think, well, would I be sure that I'd be getting the real thing, or a counterfeit vial? Would I be sure that the vaccine is really safe, or have they suppressed the cases of bad reactions?

    While I do respect some of the Chinese scientists and believe that they have proficient Virology and Immunology groups, I do not trust the Chinese government and certainly I do not trust the Chinese mafia that manages to introduce so much counterfeit material into their exports.

    For example, it's been said that the KN95 respirators that they sell to Americans, are 90% counterfeit, without the inner layer of blown melt that actually filters the small particulates, so they are little more than cloth masks. Lots of them imitate the real product made by the legitimate makers, down to all the markings and to (fake) copies of approval certificates.

    How would one know if a vial of Chinese vaccine does contain the CoronaVac, or is counterfeit? I suppose that exporting vaccines has a bit more of a safety structure and checks and balances as it will be done directly to governmental agencies, but I wouldn't put it past the Chinese to still manage to fool the system. Maybe it's paranoia, but one never knows, with the Chinese.
     
  19. CenterField

    CenterField Well-Known Member Past Donor

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    You can laugh all you want but as a healthcare worker who sees people dying of this devastating disease every day, don't count on me to laugh with you. Just last night, one of our own staff died of it. I learned of his passing this morning so I'm definitely not in a laughing mood.

    And I post from the standpoint of medical sciences, not from the standpoint of partisan politics. I deplore these imprudent gatherings the same, both the ones featuring protesting leftists, and the ones featuring political rallies for rightist politicians, and everything in between. When I deplore some of Trump's actions on this, I do because of the negative impact on public health, but I also praise him for what he's done right, and I criticize (and/or praise) governors and mayors just the same, regardless of their party affiliations.

    I remain surprised at our inability to fight off this common enemy in a united way. A HUGE part of the reason why we've responded so poorly to this pandemic, is our political divisiveness. In the past, when we faced a common enemy like in a foreign war, the whole country would put the partisan bickering on hold and would engage in a concerted and homogeneous war-time effort to defeat the common enemy. This virus is our common enemy, and a powerful one that has killed more Americans already than three Vietnam wars put together.

    So when I see you rejoicing and laughing about this, I cringe and find it profoundly distasteful. I guess your attitude is an expression of the sad times we've been going through. We get what we deserve. We've been so divided that we're seeing the consequences, and apparently, the lesson is not even close to being learned.
     
    Last edited: Sep 9, 2020
  20. Derideo_Te

    Derideo_Te Well-Known Member

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    :applause:

    Just a heads up, some trolls are not worth wasting your time since they are just trying to provoke a reaction out of you.
     
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  21. CenterField

    CenterField Well-Known Member Past Donor

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    Welcome to my Ignore list. You deserve it. Enjoy!
     
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  22. CenterField

    CenterField Well-Known Member Past Donor

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    Now we know what happened to the AstraZeneca patient. It was a woman. She has transverse myelitis, an inflammatory syndrome that affects the spinal cord and is often sparked by viral infections. It is still unclear if the timeline supports that it was caused by the vaccine. She is expected to recover.
     
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  23. CenterField

    CenterField Well-Known Member Past Donor

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    The Governor of São Paulo State, the state responsible for the Instituto Butantan that has partnered with Sinovac to test the CoronaVac inactivated virus vaccine for Covid-19, has confirmed that the vaccine has delivered seroconversion for the elderly at a rate of 98%, in the Brazilian portion of the phase 3 trial (9,000 Brazilian volunteers have received the vaccine; others are being tested in the Philippines to complete Sinovac's phase 3 recruitment).

    By now it looks like the CoronaVac is by far the most promising of all the vaccines. Other Chinese vaccines being tested (they have 3 more on phase 3) have had around 90% efficacy for the elderly.

    In view of the favorable results, the Governor said that they will start vaccinating the Brazilian population in December 2020. Their agreement with Sinovac includes transfer of technology so that the Instituto Butantan, a world-famous and extremely prestigious biotech institute that exists for more than one century and is one of the word's biggest vaccine-makers), will be making the vaccine for Brazilians.

    I'd trust much more the CoronaVac made in Brazil than the one made in China (who knows if the latter would be counterfeit?).
     
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  24. CenterField

    CenterField Well-Known Member Past Donor

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    Transverse myelitis is rarer than Guillain-Barré. It can take much longer to recover from (months to years) and many don't recover.

    So this is bad. Normal incidence of TM in the general population is 1.34 to 4.6 cases per million. So one case in 20,000 vaccine trial volunteers is bad.

    When it's caused by a virus, it's usually herpes viruses such as varicella zoster (the virus that causes chickenpox and shingles), herpes simplex, cytomegalovirus, and Epstein-Barr; flaviviruses such as West Nile and Zika; influenza, echovirus, hepatitis B, mumps, measles, and rubella.

    The Oxford vaccine uses a chimpanzee adenovirus. Well, at least adenoviruses are not a common cause of TM so let's hope the woman that showed up with it, had it due to some other virus or some other cause. However post-vaccination auto-immunity *is* one of the known causes of TM.

    Here are some other causes of TM:

    Immune system disorders. These disorders appear to play an important role in causing damage to the spinal cord. Such disorders are: aquaporin-4 autoantibody associated neuromyelitis optica, multiple sclerosis, an abnormal immune response to cancer, and yes, post-vaccine syndromes like I said above.

    Bacterial infections such as syphilis, tuberculosis, actinomyces, pertussis, tetanus, diphtheria, and Lyme disease. Bacterial skin infections, middle-ear infections, campylobacter jejuni gastroenteritis, and mycoplasma bacterial pneumonia have also been associated with the condition.

    Fungal infections in the spinal cord, including Aspergillus, Blastomyces, Coccidioides, and Cryptococcus.

    Parasities, including Toxoplasmosis, Cysticercosis, Shistosomiasis, and Angtiostrongyloides.

    Other inflammatory disorders that can affect the spinal cord, such as sarcoidosis, systemic lupus erythematosus, Sjogren’s syndrome, mixed connective tissue disease, scleroderma, and Bechet’s syndrome.

    Vascular disorders such as arteriovenous malformation, dural arterial-venous fistula, intra spinal cavernous malformations, or disk embolism.

    ----------

    But if I had to guess, I'd say it was the vaccine that caused it. Too much of a coincidence.

    This is bad.
     
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  25. signalmankenneth

    signalmankenneth Well-Known Member

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    Any vaccine Trump tries to promote before the election without lengthy trials, is probably unsafe and dangerous too?!!

    [​IMG]
     
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