COVID-19 Updates – Pfizer COVID 19 FDA Authorized Pill “Paxlovid” Explained, and an Update on Monoclonal Antibodies and the Omicron Variant.

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    Professor Roger Seheult, MD of MedCram, examines Paxlovid, how it works, and its efficacy against severe disease and hospitalization. He also takes a look at monoclonal antibodies and how they interact with the Omicron variant and can assist with avoiding hospitalization and severe illness. 


    Pfizer COVID 19 FDA Authorized Pill “Paxlovid” Explained

    In this 144th update video, Roger Seheult, MD of MedCram illustrates how Pfizer’s Paxlovid works, its efficacy, and its side effects. An oral medication that received FDA emergency use authorization to help reduce severe illness and hospitalization from COVID-19, Paxlovid consists of 1 tablet of Ritonavir and 2 tablets of Nirmatrelvir per dose. Dr. Seheult reviews how the SARS-COV-2 (COVID-19) virus infects and reproduces in human cells. He then shows how Paxlovid acts as a protease inhibitor by binding to protease and preventing its replication in the cell. For more information on the biochemistry and synthesis of Paxlovid, see this video.

    Dr. Seheult reviews the Pfizer Phase 2 and 3 clinical trials, a randomized, placebo-controlled double-blind study of 1219 participants. Clinical trial data for Paxlovid show that if taken within 3 days of symptom onset, hospitalizations and death were reduced by 89% and if taken within 5 days of symptom onset, reduced by 85%.  However, there was no data available for patients treated with Paxlovid beyond 5 days of symptom onset. More information on this trial can be found in this press release.

    Next, he covers Paxlovid availability. With over a million new cases of Omicron predicted in early 2022, Pfizer produced 180,000 doses in 2021 and plans to produce 120 million doses for worldwide distribution in 2022. He notes that the US purchased 10 million doses for 5.3 billion US dollars. Refer to this article for more information on Paxlovidå, and this article on Paxlovid’s efficacy against severe disease and Omicron variant.


    Monoclonal Antibodies: Omicron Update

    In our 145th update video, Roger Seheult, MD of MedCram examines monoclonal antibodies, how they interact with the omicron variant, and how they can assist with reducing hospitalization and severe illness.  First, he takes a look at how the SARS-COV-2 (COVID-19) virus infects human cells. He explains how monoclonal antibodies bind to the spike protein thereby neutralizing the virus and rendering it unable to attach to the ACE-2 receptors. Next, he identifies the key requirements for effective use of antibodies. These include symptomatic infection with COVID-19 for less than 10 days and risk for progression to hospitalization and/or  severe illness due to comorbid risk factors. There are currently 3 monoclonal antibody infusions that have been given emergency authorization for use by the FDA from Lilly, Regeneron and GSK. More details on these are found in this fact sheet, clinical data, and article

    He notes that due to changes in the spike protein of the virus, such as in a variant like Omicron, the monoclonal antibodies may not be able to bind and lose efficacy in neutralizing the Omicron variant.  It has been found that the monoclonal antibody infusions from both Lilly and Regeneron have no significant efficacy against the Omicron variant, whereas GSK infusion does neutralize the Omicron variant.

    The doctor also mentions other COVID-19 treatment options available including Paxlovid and Molnupiravir, but mentions they only have a 5-day symptomatic treatment window vs. 10 days using monoclonal antibodies. He references this video from MedCram on If You Get COVID-19: Optimizing the Immune System for more information. 


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