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  1. #576
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    From The Wire email
    Solving COVID
    1. Johnson & Johnson begins phase 3 trial of single-shot COVID-19 vaccine
    Johnson & Johnson has launched a phase three trial for its COVID-19 vaccine candidate and will enroll up to 60,000 participants. This is the fourth coronavirus vaccine candidate to enter phase three clinical trials in the United States but the first candidate hoping to provide protection with only one shot. Experts said a vaccine requiring just one dose would prove advantageous for delivering it to as many people as possible quickly. Johnson & Johnson CEO Alex Gorsky called this a "pivotal milestone," and the company said that if the vaccine proves to be safe and effective, it's expecting that "the first batches" could be "available for emergency use authorization in early 2021." [The Washington Post, The New York Times]
    2. At-home coronavirus test delivers results in 15 minutes
    Computer vision startup Gauss and biotech company Cellex have created the first COVID-19 test that can be done fully at home, Axios reports. While existing at-home tests still require sending test samples to a lab for analysis, this one coordinates with an app to deliver results at home in just 15 minutes. To take the test, people follow a video and swipe a nasal swab through both nostrils, then put it in a tube of solution. Drops of that solution head into a rapid test cassette, which delivers lines as a visible test result. People then take a picture of those lines and upload it to Gauss' app, and it uses AI to determine results in about 15 minutes, Axios describes. The Food and Drug Administration still has to approve the test, though it could grant it an emergency use authorization, which would get it out into the world earlier by avoiding much of the typical approval process. [Axios]
    3. Moderna will likely know by November if its coronavirus vaccine works
    Moderna is aiming to have its coronavirus vaccine available to the public early next year. Stephane Bancel, CEO of the Cambridge, Massachusetts-based biotech company, told The Boston Globe that Moderna originally planned to determine its vaccine's effectiveness in October. But because infection rates have been slowing, that's becoming "less and less probable." "We've said November," Bancel said. Determining a vaccine's effectiveness requires a good amount of coronavirus infections out there, as a developer needs to know if the vaccine protects people from a virus better than a placebo. The Food and Drug Administration requires a vaccine to prevent at least 50 percent of infections to be considered effective. More than 25,000 people are currently enrolled in Moderna's phase three trial across the country. If everything pans out, Bancel said Moderna will seek an emergency use authorization from the FDA to speed up the vaccine's approval process. Then Moderna can ship the doses it has already produced to the federal government. [The Boston Globe]
    4. FDA approves startup's portable coronavirus test kit
    Visby Medical, a startup in Silicon Valley, last week became the first company to receive an Emergency Use Authorization from the Food and Drug Administration for a portable PCR coronavirus test kit, Reuters reports. PCR testing, considered one of the most accurate diagnostic tools for infectious diseases, usually requires a large, expensive machine to run results, but Visby's product can reportedly fit in a person's palm. The medical equipment company's founder and CEO Adam de la Zerda said he hasn't settled on a price for the kit, but the goal is to make it affordable. For now, the EUA will allow Visby's kit to be used in clinical labs, where it can process a nasal swab and detect COVID-19 in 30 minutes. Eventually Visby aims to sell it directly to consumers for in-home use, per Reuters. [Reuters]
    5. The FDA will reportedly roll out tougher standards for COVID-19 vaccine approval
    The Food and Drug Administration is poised to roll out new, rigorous standards for an emergency approval of a coronavirus vaccine. The standards are expected to be much tougher than those used for the controversial emergency clearances of potential COVID-19 treatments hydroxychloroquine and convalescent plasma. Manufacturers will be asked to follow vaccine trial participants for at least two months after they receive their second shot, two individuals familiar with the situation told The Washington Post. The agency will also reportedly be looking for at least five severe COVID-19 cases in the placebo group for each trial, as well as some cases of the disease in older people to see if the vaccine works. The new standards would make it less likely for a vaccine to be approved by November, but they also could ease any growing concerns about vaccine safety. [The Washington Post]

  2. #577
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    Synthetic biologists have created a slow-growing version of the coronavirus to give as a vaccine

    Live vaccines defeated smallpox and polio. One company claims a weakened coronavirus could do the same for covid-19.

    https://www.technologyreview.com/202...-as-a-vaccine/

  3. #578
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    https://www.theguardian.com/world/20...of-death#img-1

    Small study but having the flu and covid at the same time basically doubled mortality rate

  4. #579
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    Seasonality of Respiratory Viral Infections: Will COVID-19 Follow Suit?
    https://www.frontiersin.org/articles...20.567184/full

  5. #580
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    Seasonality of Respiratory Viral Infections: Will COVID-19 Follow Suit?
    https://www.frontiersin.org/articles...20.567184/full
    Sure did this summer, didn't it?

  6. #581
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    Sure did this summer, didn't it?
    You didn't read

  7. #582
    Alleged Michigander ChumpDumper's Avatar
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    Didn't have to. A lot of people were saying it would be seasonal in March.

    It wasn't.

    I'm going to say the main difference maker will be just how stupidly the American public acts going forward.

    Quote me on it.

  8. #583
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    Trump threatens to block stricter COVID vaccine standards —

    declaring ‘tremendous trust’ in big Pharma ('s campaign donations)


    https://www.rawstory.com/2020/09/tru...in-big-pharma/


  9. #584
    dangerous floater Winehole23's Avatar
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    This KHN article includes nuts and bolts info about the data and safety monitoring board for COVID-19 vaccines.

    Moderna, AstraZeneca, Johnson & Johnson and Pfizer have each released protocols that include details on when their DSMBs would review unblinded information about trial participants, and at what points they could recommend pausing or stopping trials. The vaccine data and safety board organized by NIAID advises a broader oversight group consisting of the drug companies sponsoring the trial and representatives from NIAID and HHS’ Biomedical Advanced Research and Development Authority that reviews the DSMB recommendations. Ultimately, the drug company has final authority over whether to submit its data to the Food and Drug Administration.

    Moderna and Johnson & Johnson are each aiming for their vaccines to have 60% efficacy, which means there would need to be 60% fewer COVID cases among vaccinated individuals in their trials. AstraZeneca’s target is 50%. The FDA has said any coronavirus vaccine must be at least 50% effective to secure approval from regulators. While the parameters of their clinical trials have similarities, there are some differences, including when and how many times the DSMB can conduct interim reviews to assess whether each vaccine works.

    Pfizer is similarly aiming for its vaccine to be 60% effective.
    https://khn.org/news/these-secret-sa...ccine-winners/

  10. #585
    my unders, my frgn whites pgardn's Avatar
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    Synthetic biologists have created a slow-growing version of the coronavirus to give as a vaccine

    Live vaccines defeated smallpox and polio. One company claims a weakened coronavirus could do the same for covid-19.

    https://www.technologyreview.com/202...-as-a-vaccine/
    My bolded above is absolutely wrong.
    See the history of smallpox and polio and you will understand the role the live virus and attenuated virus played in making proper vaccines.

  11. #586
    my unders, my frgn whites pgardn's Avatar
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    Didn't have to. A lot of people were saying it would be seasonal in March.

    It wasn't.

    I'm going to say the main difference maker will be just how stupidly the American public acts going forward.

    Quote me on it.
    This is what people on this board like Snake use so disingenuously.
    If we go back and look at the timeline of what we thought and what we got wrong upon looking back... its a big list.
    So just lump it all together and pretend what we now know, was what we thought we knew 6 months ago.

  12. #587
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    This is what people on this board like Snake use so disingenuously.
    If we go back and look at the timeline of what we thought and what we got wrong upon looking back... its a big list.
    So just lump it all together and pretend what we now know, was what we thought we knew 6 months ago.
    You didn't read it either. It doesn't say what you and Chump think it says.

  13. #588
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    So just lump it all together and pretend what we now know, was what we thought we knew 6 months ago.
    You thought people were dying from secondary infections even though we knew they weren't 6 months ago.

  14. #589
    Alleged Michigander ChumpDumper's Avatar
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    You didn't read it either. It doesn't say what you and Chump think it says.
    It says maybe it will become seasonal and maybe it won't.

    Also herd immunity is a thing.

    Great stuff.

  15. #590
    Got Woke? DMC's Avatar
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    You thought people were dying from secondary infections even though we knew they weren't 6 months ago.
    Careful, he'll hit you with the ELISA creator narrative, and fall short of impressing you.

  16. #591
    my unders, my frgn whites pgardn's Avatar
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    You thought people were dying from secondary infections even though we knew they weren't 6 months ago.
    I did?

    Was probably a good guess at the time.
    When was it that I posted this?

  17. #592
    my unders, my frgn whites pgardn's Avatar
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    Careful, he'll hit you with the ELISA creator narrative, and fall short of impressing you.
    Or the Editor of Time magazine will correct me.
    You feel good being a liar? Its fulfilling?

  18. #593
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    DMC defending Boots and gets curb stomped.

  19. #594
    Got Woke? DMC's Avatar
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    Or the Editor of Time magazine will correct me.
    You feel good being a liar? Its fulfilling?
    Trying to compare notes?

  20. #595
    Got Woke? DMC's Avatar
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    DMC defending Boots and gets curb stomped.
    no

  21. #596
    my unders, my frgn whites pgardn's Avatar
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  22. #597
    Got Woke? DMC's Avatar
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    I did?

    Was probably a good guess at the time.
    When was it that I posted this?
    Because you've grown so much since then. I mean, we all have.

  23. #598
    my unders, my frgn whites pgardn's Avatar
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    Trying to compare notes?
    What have I lied about.
    Besides just imitating your ridiculous claims about what "we" have accomplished.

  24. #599
    my unders, my frgn whites pgardn's Avatar
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    Because you've grown so much since then. I mean, we all have.
    You have grown very old very quickly.
    Thats about it.

  25. #600
    Got Woke? DMC's Avatar
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    What have I lied about.
    Besides just imitating your ridiculous claims about what "we" have accomplished.
    You've been lying to yourself for years about your IQ.

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