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--- paxlovid [2022/01/06 15:39]
leonardo Replaced links: pfizer => pharmaceutical_companies:pfizer
+++ paxlovid [2022/08/27 12:52] (current)
mathew
@@ Line 4: / Line 4: @@
 ===== Authorizations =====
-  * 22 December 2021: [[https://www.fda.gov/media/155049/download|EUA]] in the USA for patients 12 years of age and older weighing at least 40 kg with mild-to-moderate COVID-19, and who are at high risk for progression to severe COVID-19, including hospitalization or death.
+  * 22 December 2021: EUA(([[https://www.fda.gov/media/155049/download]])) in the USA for patients 12 years of age and older weighing at least 40 kg with mild-to-moderate COVID-19, and who are at high risk for progression to severe COVID-19, including hospitalization or death.
+  * 31 December 2021: UK MHRA grants approval(([[https://www.gov.uk/government/news/oral-covid-19-antiviral-paxlovid-approved-by-uk-regulator]])) to Pfizer’s oral antiviral for Covid-19 for mild to moderate COVID-19 infected patients who are at an increased risk of developing severe disease.
+  * 16 January 2022: Canada’s health regulator has approved Paxlovid.((https://covid-vaccine.canada.ca/info/regulatory-decision-summary-detail.html?linkID=RDS00904))
 ===== Clinical Trials =====
@@ Line 20: / Line 22: @@
 || NCT05129475 | Food Effect Study to Evaluate the Effect of High-Fat Meal on the Relative Bioavailability of PF-07321332 Boosted With Ritonavir in Healthy Adult Participants ||
 || NCT05064800 | PF-07321332/Ritonavir and Ritonavir on Dabigatran Study in Healthy Participants ||
+==== Press Releases ====
+On Friday, November 5, 2021, Pfizer issued a stunningly optimistic press release for a new drug, stating "overwhelming efficacy" and a risk reduction of 89% for hospitalization and death from COVID-19.((November 5, 2021 | Pfizer | [[https://www.pfizer.com/news/press-release/press-release-detail/pfizers-novel-covid-19-oral-antiviral-treatment-candidate|Pfizer’s Novel COVID-19 Oral Antiviral Treatment Candidate Reduced Risk of Hospitalization or Death by 89% in Interim Analysis of Phase 2/3 EPIC-HR Study]])) The press release claimed that after 28 days there were 0 deaths in the treatment arm and 10 in the placebo arm, with 41 vs. 6 hospitalizations.
 ===== Adverse Events =====
 Adverse events in the PAXLOVID group (≥1%) that occurred at a greater frequency (≥5 subject difference) than in the placebo group were dysgeusia (6% and <1%, respectively), diarrhea (3% and 2%), and hypertension (1% and <1%), and myalgia (1% and <1%). The proportions of subjects who discontinued treatment due to an adverse event were 2% in the PAXLOVID group and 4% in the placebo group.
+The [[National Post]] reported that a component of the drug can "interact dangerously with a slew of commonly used medications, pumping up the potency of blood thinners, heart-arrhythmia therapies, epilepsy drugs and others. And the patients targeted for its use – those most at risk of serious COVID disease because of age and other health issues – are also the people most likely to be taking those 'contraindicated' medications."((Blackwell, T. (2022, January 25). //Pfizer anti-COVID pill’s dangerous interaction with common drugs will narrow its benefit, experts say.// National Post; Postmedia Network Inc. https://archive.ph/hfU0L))
 ===== Articles in Medical Journals =====
@@ Line 43: / Line 50: @@
 [[https://www.pfizer.com/news/press-release/press-release-detail/pfizers-novel-covid-19-oral-antiviral-treatment-candidate|PFIZER’S NOVEL COVID-19 ORAL ANTIVIRAL TREATMENT CANDIDATE REDUCED RISK OF HOSPITALIZATION OR DEATH BY 89% IN INTERIM ANALYSIS OF PHASE 2/3 EPIC-HR STUDY]] \\
 [[https://markets.businessinsider.com/news/stocks/pfizer-s-covid-19-franchise-could-push-revenue-past-100b-in-2022-analyst-1030999039|SVB Leerink analyst Geoffrey Porges forecasts Paxlovid revenues of $95 million in 2021, $24 billion in 2022, and $33 billion in 2023.]] \\
-[[https://www.pharmaceutical-technology.com/features/paxlovid-pfizer-covid-19-pill/ | Paxlovid: what we know about Pfizer’s Covid-19 pill]].
+[[https://www.pharmaceutical-technology.com/features/paxlovid-pfizer-covid-19-pill/ | Paxlovid: what we know about Pfizer’s Covid-19 pill]]. \\
+[[https://www.bloomberg.com/news/articles/2022-02-03/drug-maker-merck-s-antiviral-covid-pill-fumble-gives-pfizer-17-billion-win|Merck’s Covid Pill Fumble Gives Pfizer Potential $17 Billion Win]]
 ===== Sales =====
 ||  **Country**  |  **Doses Secured**  |  **Price**  |  **Date**  ||
@@ Line 52: / Line 59: @@
 ||Israel |   tens of thousands  |  ???  |  15 Nov 2021  ||
 ||USA |   10,000,000  |  ???  |  04 Jan 2022  ||
+An Alternate View
+Note that there is no peer-reviewed article available describing the clinical trial and its results, nor is there even an FDA Briefing Document that I (JMG) can find for review.  Literally everything we know about this medication so far has come from Pfizer, largely thru press releases and other communications.
+For a somewhat jaundiced view of this medication see
+https://joelshirschhorn.substack.com/p/paxlovid-what-we-should-know-about?r=1tk31&utm_campaign=post&utm_medium=web