Loading ...JOE KERNAN CNBC SQUAWK BOX HOST DECLARES VACCINES ALL BUT A FAILURE
Starting the Anti Viral narrative now !
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Meanwhile I will post this in a comment in case you are a Gold investor and haven’t got $5 which is possible
the antiviral wars heat up between Merck, Pfizer, and potentially Roche, as it becomes more apparent to broader segments of the population that a COVID-19 eradication via mass vaccination won’t help society overcome the pandemic—even after hundreds of billions of taxpayer dollars have been spent. CNBC’s Squawk Box discussed this unfolding situation recently with ex-U.S. Food and Drug Administrator (FDA) Scott Gottlieb. Now on Pfizer’s Board, Gottlieb joined CNBC’s Joe Kernan to discuss Pfizer’s antiviral investigational product for COVID-19 currently in clinical trials. Kernan started the show by outright declaring that with so many vaccine nuances, the frustration mounts as it turns out the vaccine isn’t “the panacea we all hoped for….” The host further declared, “it’s not even close.”
With waning effectivity, the delta virus, and powerful viral load leading to rampant breakthrough infections and even breakthrough hospitalization, the Squawk Box host was noticeably honest about the current situation. Of course, Scott Gottlieb, with tenure at the FDA, offers some evidence as to the close dynamics between regulators and industry.
Gottlieb defended the vaccine, declaring that no one can be certain how long immunity will last, if a third jab will lead to longer immunity, or perhaps, whether the Pfizer vaccine regimen could evolve into an annual flu shot-like scenario. But Gottlieb also emphasized that the vaccine is accomplishing what developers set out to do: protect people from worse infections, hospitalization, and more. That statement is only partially true; the U.S. government allocated many tens of billions, if not considerably more, of taxpayer dollars into the mass vaccine strategy under the early assumption that the vaccine would strop viral transmission, leading to herd immunity.
This clearly isn’t the case. Meanwhile, POTUS vilifies the unvaccinated as the worldwide cause of viral strain mutation. The CNBC host undoubtedly understands the deep chasm growing in America—and he is clearly concerned. But the emergence of antivirals now can slowly supplant the vaccination strategy.
Antiviral Action
As TrialSite has emphasized during much of the pandemic, most COVID-19 cases remain mild to moderate and would benefit tremendously from early treatment, including safe and effective antivirals. The NIH should have focused on this drug class from the start—many experts called out for this approach. TrialSite shared when the NIH announced billions more would be spent on a few pharmaceutical companies, including Merck.
Clearing the Market of Ivermectin
One challenge faced by the pharmaceutical makers was the perceived nuisance called ivermectin. While dozens of studies have indicated some benefit worldwide, a couple of major clinical trials are now underway in America—one sponsored by the NIH/NIAID (ACTIV-6) and one by the University of Minnesota (COVID-OUT). Off-label physician prescriptions of ivermectin skyrocketed from about 3,000 per week before the start of the pandemic to nearly 90,000 per week most recently. Mass media, government health agencies, and the pharma industry (Merck) launched a highly orchestrated information war to vilify the drug—one that has been administered to hundreds of millions of people in the tropics to overcome certain parasite-borne diseases.
But ivermectin remained a threat to the industry as the inevitable race for antiviral treatments targeting COVID-19 led to the current smear campaign.
Squawk Box host Joe Kernan got the point of antivirals. Raising the possibility that a safe and effective pill taken a couple of times a day could interfere with viral replication, antivirals essentially turn COVID-19 into nothing more than a flu-like condition.
Trying to Catch Merck
It probably wasn’t a coincidence that the Pfizer Board member and forward FDA commissioner were on an investor show; Pfizer recently announced new details associated with its COVID-19 antiviral investigational therapy research program.
The company already forecasts $33 billion for its vaccine product alone—an unprecedented amount of money for one pharmaceutical product. Now the American drug producer goes for possibly several billion more in what would represent a very lucrative market.
TrialSite has chronicled the development of PF-07321332, Pfizer’s investigational SARS-CoV-2-3CL protease inhibitor antiviral therapy, specifically designed to be orally administered. So, it can potentially be prescribed at the first sign of infection or first awareness of exposure without requiring patients to be hospitalized. Protease inhibitors, like PF-07321332, are designed to block the activity of the main protease enzyme that the coronavirus needs to replicate. Co-administration with a low dose of ritonavir is expected to help slow the metabolism, or breakdown, of PF-07321332 for it to remain active in the body for longer periods at higher concentrations to help combat the virus.
Race for Post-Exposure Prophylaxis
Now Pfizer declares its intention to catch up with Merck and their Molnupiravir product presently in Phase 3 trials, including a household contacts study. In these studies, individuals in the home exposed to the pathogen can enter these studies to determine if the investigational product can work as post-exposure prophylaxis.
Merck has received $356 million in taxpayer money to support the development of Molnupiravir, as well as an additional government secured $1.2 billion procurement contract should the investigational drug be either authorized on an emergency basis or approved.
Pfizer announced the Phase 2/3 EPIC-PEP (Evaluation of Protease Inhibition for COVID-19 in Post-Exposure Prophylaxis) study to evaluate the investigational novel oral antiviral candidate PF-07321332, co-administered with a low dose of ritonavir, for the prevention of COVID-19 infection. This Phase 2/3 trial is part of a global clinical research program and is enrolling individuals who are at least 18 years old and live in the same household as an individual with a confirmed symptomatic SARS-CoV-2 infection.
“With the continued impact of COVID-19 around the world, we believe that tackling the virus will require effective treatments for people who contract, or have been exposed to, the virus, complementing the impact that vaccines have had in helping quell infections. If successful, we believe this therapy could help stop the virus early – before it has had a chance to replicate extensively – potentially preventing symptomatic disease in those who have been exposed and inhibiting the onset of infection in others,” said Mikael Dolsten, MD, Ph.D., Chief Scientific Officer and President, Worldwide Research, Development and Medical of Pfizer. “Given the continued emergence and evolution of SARS-CoV-2 variants and their immense impact, we continue to work diligently to develop and study new ways that our investigational oral antiviral candidate could potentially lower the impact of COVID-19, not only on patients’ lives, but also the lives of their families and household members.”
The EPIC PEP Study
The Phase 2/3 EPIC-PEP trial is a randomized, double-blind, placebo-controlled study and will enroll up to 2,660 healthy adult participants aged 18 and older. Participants will be randomly assigned (1:1:1) to receive PF-07321332/ritonavir or placebo orally twice daily for 5 or 10 days. The primary objective will assess safety and efficacy for the prevention of confirmed SARS-CoV-2 infection and its symptoms through Day 14. PF-07321332 is an oral antiviral SARS-CoV-2-3CL protease inhibitor, which has an encouraging pre-clinical profile, including potent in vitro antiviral SARS-CoV-2 and broad coronavirus activity. Results from the Phase 1 clinical trial demonstrated that PF-07321332 was safe and well tolerated.
In addition to this study, the global EPIC program consists of multiple ongoing clinical trials, including one in SARS-CoV-2 infected patients who are at high risk of severe illness (including hospitalization or death), which began in July 2021, and another in infected patients who are at standard risk (i.e., do not have risk factors for severe illness), which began in August 2021.
About PF-07321332/ritonavir
PF-07321332 is an investigational SARS-CoV-2-3CL protease inhibitor antiviral therapy, specifically designed to be administered orally so that it can potentially be prescribed at the first sign of infection or at first awareness of an exposure, without requiring patients to be hospitalized. Protease inhibitors, like PF-07321332, are designed to block the activity of the main protease enzyme that the coronavirus needs to replicate. Co-administration with a low dose of ritonavir is expected to help slow the metabolism, or breakdown, of PF-07321332 for it to remain active in the body for longer periods of time at higher concentrations to help combat the virus.
In March 2021, Pfizer progressed PF-07321332 to a Phase 1 study in healthy adults to evaluate the safety, tolerability, and pharmacokinetics of the investigational compound. In July, it progressed to a Phase 2/3 trial, EPIC-HR (Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients), to evaluate efficacy and safety, in combination with ritonavir, in participants with a confirmed diagnosis of SARS-CoV-2 infection who are at high risk of progression to severe illness. In August, Pfizer initiated a Phase 2/3 trial, EPIC-SR (Evaluation of Protease Inhibition for COVID-19 in Standard-Risk Patients), to evaluate efficacy and safety in participants with a confirmed diagnosis of SARS-CoV-2 infection who are at standard risk (i.e., do not have risk factors for severe illness).
PF-07321332 is the first orally administered coronavirus-specific investigational protease inhibitor to be evaluated in clinical studies.
There is no orally administered therapy currently approved for post-exposure or pre-emptive treatment of COVID-19.