Thread by @sailorrooscout

FANTASTIC news for your Friday! Phase 2/3 results of PAXLOVID, Pfizer’s COVID-19 oral antiviral shows the risk of hospitalization or death is REDUCED by NEARLY 90% in high-risk adults with COVID-19 when taken within three days of experiencing symptoms.

Let’s talk about that! 🧵

IMPORTANT NOTE: this protease inhibitor was originally developed for SARS-CoV in 2003 and has been repurposed! So first, let’s discuss the results. The scheduled interim analysis showed an 89% reduction in risk of COVID-19-related hospitalization or death from any cause compared

to placebo in patients treated within three days of symptom onset (primary endpoint); 0.8% of patients who received PAXLOVID™ were hospitalized through Day 28 following randomization (3/389 hospitalized with NO deaths), compared to 7.0% of patients who received placebo and

were hospitalized or died (27/385 hospitalized with 7 subsequent deaths). In the overall study population through Day 28, NO deaths were reported in patients who received PAXLOVID as compared to 10 deaths in patients who received placebo.

PAXLOVID is an investigational SARS-CoV-2 protease inhibitor antiviral therapy, specifically designed to be administered orally so that it can be prescribed at the first sign of infection or at first awareness of an exposure, potentially helping patients avoid severe illness

which can lead to hospitalization and death. How does it work exactly? It is designed to block the activity of the SARS-CoV-2-3CL protease, an enzyme that the coronavirus needs to replicate. Co-administration with a low dose of Ritonavir helps slow the metabolism of it to

remain active in the body for longer periods of time at higher concentrations to help combat the virus. PF-07321332 inhibits viral replication at a stage known as proteolysis, which occurs before viral RNA replication. In preclinical studies, PF-07321332 DID NOT demonstrate

evidence of mutagenic DNA interactions. At the recommendation of an independent Data Monitoring Committee and in consultation with the U.S. Food and Drug Administration (FDA), Pfizer will cease further enrollment into the study due to the overwhelming efficacy demonstrated in

these results and plans to submit the data as part of its ongoing rolling submission to the U.S. FDA for Emergency Use Authorization (EUA) as soon as possible. If approved or authorized, PAXLOVID, which originated in Pfizer’s laboratories, would be the first oral antiviral of

its kind, a specifically designed SARS-CoV-2-3CL protease inhibitor. Upon successful completion of the remainder of the EPIC clinical development program and subject to approval or authorization, it could be prescribed more broadly as an at-home treatment to help reduce illness

severity, hospitalizations, and deaths, as well as reduce the probability of infection following exposure, among adults. It has demonstrated potent antiviral in vitro activity against circulating variants of concern, as well as other known coronaviruses, suggesting its potential

as a therapeutic for multiple types of coronavirus infections. It’s now the second antiviral pill behind Merck’s to demonstrate strong effectiveness for treating Covid at the first sign of illness which was just approved by the MHRA: gov.uk/government/new….

So how does this all work? REMEMBER, this is NOT meant to REPLACE a vaccine. Vaccination is still our best tool to reduce the risk of infection, hospitalization, and death due to COVID-19. They’re PREVENTATIVES. IF infected, whether due to being unvaccinated OR a “breakthrough”

infection, and you are experiencing symptoms these antivirals can help immensely to reduce the risk of hospitalization EVEN further. With that said, here is to a BRIGHTER 2022! See: washingtonpost.com/health/new-cov… and pfizer.com/news/press-rel…. EDIT: Merck’s was repurposed not Pfizer’s.