If you really want to get down in the weeds about how the FDA controls information and makes sure its advisory committees vote the way it wants them to, this is must reading. It is very long and very detailed, discussing some aspects of how FDA hid information about the Pfizer-BioNTech vaccine from its advisers, the media and the public.
I was happy that the author confirmed that the committee members who asked too many questions were not invited back by FDA for the next two Covid vaccine sessions. I especially recall that the single consumer member got canned. I watched all three meetings, and it seemed that FDA packed the advisory committee with almost half temporary members, many of whom were government employees.
2 comments:
SARS-CoV-2 variants B.1.351 and B.1.1.248: Escape from therapeutic antibodies and antibodies induced by infection and vaccination 2021.02.11
See discussions, stats, and author profiles for this publication at:
https://www.researchgate.net/publication/349243484
https://www.biorxiv.org/content/10.1101/2021.02.11.430787v1
bioRxiv is receiving many new papers on coronavirus SARS-CoV-2. A reminder: these are preliminary reports that have not been peer-reviewed. They should not be regarded as conclusive, guide clinical practice/health-related behavior, or be reported in news media as established information.
New Results Comment on this paper
SARS-CoV-2 variants B.1.351 and B.1.1.248: Escape from therapeutic antibodies
and antibodies induced by infection and vaccination
Preprint · February 2021 DOI: 10.1101/2021.02.11.430787
Markus Hoffmann, Prerna Arora, Rüdiger Groß, Alina Seidel, Bojan Hörnich, Alexander Hahn, Nadine Krüger, Luise Graichen, Heike Hofmann-Winkler, Amy Kempf, Martin Sebastian Winkler, Sebastian Schulz, Hans-Martin Jäck, Bernd Jahrsdörfer, Hubert Schrezenmeier, Martin Müller, Alexander Kleger, Jan Münch, View ORCID ProfileStefan Pöhlmann
doi: https://doi.org/10.1101/2021.02.11.430787
SUMMARY
The global spread of SARS-CoV-2/COVID-19 is devastating health systems and economies worldwide. Recombinant or vaccine-induced neutralizing antibodies are used to combat the COVID-19 pandemic. However, recently emerged SARS-CoV-2 variants B.1.1.7 (UK), B.1.351 (South Africa) and B.1.1.248 (Brazil) harbor mutations in the viral spike (S) protein that may alter virus-host cell interactions and confer resistance to inhibitors and antibodies. Here, using pseudoparticles, we show that entry of UK, South Africa and Brazil variant into human cells is susceptible to blockade by entry inhibitors. In contrast, entry of the South Africa and Brazil variant was partially (Casirivimab) or fully (Bamlanivimab) resistant to antibodies used for COVID-19 treatment and was less efficiently inhibited by serum/plasma from convalescent or BNT162b2 vaccinated individuals. These results suggest that SARS-CoV-2 may escape antibody responses, which has important implications for efforts to contain the pandemic.
Don’t miss the Global Update from experts on ivermectin posted on the FLCCC.net website. Fabulous line up of docs moderated by Dr. Mobeen Syed. Featured docs Eli Schwartz from Israel, Hector Carvallo from Argentina, Pierre Kory USA, Tess Lawrie UK, and the wonderful Marc Wathelet from Belgium. An engaging discussion not to miss. Cheers.
Post a Comment