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Posts tagged with "Covid-19"

  • Clinical Trials

    Lilly’s Monoclonal EUA

    I’ve been meaning to write about what has to be called a regulatory mystery. Eli Lilly obtained an Emergency Use Authorization for its monoclonal antibody (bamlanivimab) against SARS-Cov-2, but (as detailed in this post) the dosage that they applied for was 700mg. Which is one-quarter of the dose that showed any efficacy against the primary… Read More
  • Covid-19

    Good News on T-Cell Response

    There are several recent preprints and publications that bear on the T-cell immunity story for the coronavirus pandemic, and I wanted to highlight these, since it’s been a big part of the story that’s needed more information for a long time now. Here, for one, is a multi-institute study from the UK. The authors are… Read More
  • Covid-19

    Vaccine Efficacy Data!

    Earlier this morning, Pfizer and BioNTech announced the first controlled efficacy data for a coronavirus vaccine. And the news is good. You may recall that these vaccine trials are set up to get to a defined number of coronavirus cases overall, at which time the various monitoring committees lock the door and unblind the data… Read More
  • Covid-19

    Don’t Make Mine Mink

    Update: importantly, the follow-up news on this story argues that there’s less to worry about than appeared at first. The mutation described below has not actually appeared again in the last two months, and it ability to evade vaccine-raised neutralizing antibodies is still in doubt. There’s a situation in Denmark that deserves some epi… Read More
  • Covid-19

    The Scientific Literature’s Own Pandemic

    One side effect of the coronavirus has been an explosion of lower-quality publications in the scientific literature. This has come in several forms, some more excusable than others. In the former category are the papers that were rushed out earlier this year, observational studies that sometimes investigated possible therapies as well. These were o… Read More
  • Clinical Trials

    The Latest Antibody Data From Lilly and From Regeneron

    We have a new paper in the NEJM from the Eli Lilly effort on monoclonal antibodies against the coronavirus. And there’s no reason not to be up front about it: it’s disappointing. This is the BLAZE-1 trial (mentioned in this recent post), which is studying non-hospitalized patients. It was another trial (ACTIV-3) where this antibody… Read More
  • Covid-19

    More Antibody Data

    Unfortunately, we’re getting a dose these days of “That’s why you run clinical trials”. Word came Monday evening (Peter Loftus in the WSJ, and a Lilly statement) that the ACTIV-3 trial being run by the NIH has shown lack of efficacy for the combination of the Eli Lilly/AbCellera anti-coronavirus antibody (bamlanivimab, LY-Co… Read More
  • Covid-19

    The Vaccine Tightrope

    We’re getting closer to having to deal with a number of tricky issues around the first Emergency Use Authorizations (EUAs) for coronavirus vaccines. These have never quite come up in this way before, because (for one thing) EUAs for vaccines are relatively rare events, and (for another) we’ve never had so many simultaneous vaccine trial… Read More
  • Clinical Trials

    The SOLIDARITY Data

    OK, we have some more to think about this morning. The large SOLIDARITY trial from the WHO has reported more interim data on its investigation into repurposed drugs for the coronavirus pandemic. And some of this we already knew, but some of it’s a real surprise. One drug reported on is hydroxychloroquine. This showed no… Read More
  • Covid-19

    Immunity and Re-Infection

    For months now, people have been watching closely to see if it’s possible to get re-infected with the coronavirus. It’s taken a while for the signal-to-noise to get better, but by now there’s no doubt that the answer is yes, it’s possible. We’ve just had the first of these in the US, a man in… Read More