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      Team behind the Russian vaccine publishes some details of early trials

      John Timmer · news.movim.eu / ArsTechnica · Saturday, 5 September, 2020 - 20:14 · 1 minute

    Image of a women in medical protective gear holding a box of samples.

    Enlarge / MOSCOW, RUSSIA - SEPTEMBER 4, 2020: Medical staff with newly delivered boxes containing COVID-19 vaccine in a cold room at No2 Outpatient Clinic in southern Moscow. (credit: Stanislav Krasilnikov / Getty Images )

    Russia has been one of the countries hit hard by the COVID-19 pandemic. But its response to that has been a bit... unusual. As many other countries have, Russia worked to develop its own vaccine. But while that development was still in progress, it announced that it wasn't going to wait for detailed safety data , and instead roll the vaccine out to millions. Shortly afterwards, it became clear that the country was actually going to run a standard phase 3 clinical trial , albeit a large one, involving 40,000 people.

    It was hard to judge whether any of this was reasonable, because few details of the vaccine itself were available. But that changed somewhat on Friday, as the people who developed the vaccine published the results of the initial clinical trials. And so far, it seems to be about as effective as some of the other ones that have been made it past initial trials.

    Two viruses better than one?

    As our earlier coverage mentioned, the vaccine is composed of two different engineered viruses. These contain the backbone of an innocuous virus, called an adenovirus, engineered to include the gene that encodes the major surface protein from the SARS-CoV-2 virus. This protein, called Spike, is what the coronavirus uses to latch on to and enter cells. The use of adenovirus allows the immune system to learn to recognize the Spike protein while the body only experiences a harmless adenovirus infection.

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      FDA Commissioner botched risk numbers when talking about post-COVID plasma

      John Timmer · news.movim.eu / ArsTechnica · Tuesday, 25 August, 2020 - 21:00 · 1 minute

    Image of a man speaking from behind a podium.

    Enlarge / FDA Commissioner Stephen Hahn, speaking at the press conference in which he badly mangled statistics. (credit: Pete Marovich/Getty Image )

    After several days of rumors with ever-growing hype, the Trump administration announced on Sunday that the Food and Drug Administration was granting an Emergency Use Authorization (EUA) for a COVID-19 treatment. The move was controversial from the start, with reports indicating that the EUA was opposed by a number of health experts, including Francis Collins and Anthony Fauci. The press conference didn't settle matters, with a growing chorus of scientists saying that the data presented in support of the EUA had been misrepresented .

    On Monday night, FDA commissioner Stephen Hahn acknowledged that he had made a significant error in presenting the benefits of the treatment, and he followed that with an apology on Tuesday . But Hahn pushed back on indications that the approval of the treatment on the eve of the Republican National Convention was motivated by political pressure.

    Wrong kind of risk

    The treatment at issue involves taking the antibody-containing plasma from those who have recovered from a SARS-CoV-2 infection (convalescent plasma) and giving it to those currently suffering from COVID-19 symptoms. At Sunday's press conference, the principle justification for allowing this treatment under an EUA was a 35 percent drop in mortality for those receiving plasma in the first three days of treatment—specifically, Hahn said 35 of 100 people "would have been saved" by this treatment.

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      Fired scientist back to peddling anti-vaxx COVID-19 conspiracy theories

      Jennifer Ouellette · news.movim.eu / ArsTechnica · Friday, 8 May, 2020 - 17:50 · 1 minute

    After her research career effectively ended, Dr. Judy Mikovits has re-emerged as an anti-vaccine activist.

    Enlarge / After her research career effectively ended, Dr. Judy Mikovits has re-emerged as an anti-vaccine activist. (credit: YouTube)

    Back in 2011, we covered the strange story of biochemist Judy Mikovits, who co-authored a controversial (and subsequently retracted) paper in the journal Science and eventually lost her prestigious position with a research institution. Now Mikovits is back in the news, having spent the ensuing years reinventing herself as a staunch anti-vaccine crusader.

    The COVID-19 pandemic has given her a new conspiracy to tout, this time targeting Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases at NIH, who has become a prominent public spokesperson during the outbreak. Two interviews in particular have been spreading rapidly on social media, prompting YouTube and Facebook to remove both video clips for spreading medical misinformation during a global pandemic—a violation of their current policies

    In 2007, Mikovits met Robert Silverman at a conference. Silverman had co-discovered a retrovirus known as XMRV, closely related to a known virus from mice. He told her he had found XMRV sequences in specimens from prostate cancer patients, although other labs, using different sets of patients, could find no evidence of a viral infection. Nonetheless, this prompted Mikovits to use the same tools to look for XMRV in samples from patients suffering from chronic fatigue syndrome (CFS)—a disorder some had claimed was purely psychosomatic.

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