Pharmaceutical companies are now publicly acknowledging that a vaccine-centric strategy will not be sufficient to overcome the COVID-19 pandemic as TrialSite has reported for over 1.5 years. The most recent declaration wasn’t from some up-and-coming biotech seeking to monetize a novel therapy during the pandemic nor some lightweight but rather the Chief Executive Officer of the world’s most powerful COVID-19 vaccine producer—Pfizer.

That’s right. Pfizer’s CEO Albert Bourla recently tweeted “Success against #COVID19 will likely require both vaccines & treatments. We’re pleased to share that we started a Phase 2/3 study of our oral antiviral candidate—specifically designed to combat SARS-Cov-2 in non-hospitalized, low-risk adults.”

Bourla’s tweet pointed to a recent Pfizer press release announcing the advancement of this targeted antiviral to Phase 2/3 clinical trials.

A Massive Nascent Market

TrialSite had declared for many months now that one reason for the intensified pressure against ivermectin was to clear the market of any low-cost competition for higher-priced, novel therapeutics. After all, Doctor Anthony Fauci and the federal research apparatus already declared over $3 billion will be spent on these companies.   

That’s because 90%+ of all worldwide COVID-19 cases are mild-to-moderate in symptom: primary care physicians have pleaded since last spring for a focus on caring for early SARS-CoV-2 infection. They note that this would be key to keeping most infections from progressing to a more severe situation.

That’s why so many independent physicians have embraced off-label drugs to help patients. Early on hydroxychloroquine was used and of late prescriptions for ivermectin have exploded. While the Food and Drug Administration (FDA) and Center for Disease Control and Prevention (CDC) now warn against any use of ivermectin except for clinical trials, partially due to reports of a 3-fold increase in calls to poison control centers.

TrialSite recently accessed the data from the Association of Poison Control Centers and identified that the data is quite different than the government is letting on. In fact, hand sanitizer is considerably more dangerous than ivermectin based on the TrialSite data review.

But the stakes to clear out any generic competition are too great. TrialSite estimates that at a minimum this antiviral early-onset market for mild-to-moderate COVID-19 could hit a few billion per year and that number could grow to several billion a year with market access around the world.

Given COVID-19 more than likely will hang around for at least a couple more years, if not permanently a vaccine will not probably be the answer to eradication but rather one of a handful of medical tools used to control and manage the virus so humans can seamlessly coexist.

The Pharma-Gov. Complex

So, the $3+ billion Fauci has already mentioned represents a key target for the pharmaceutical companies that seek to socialize or externalize as many costs as possible under the guise of pandemic and the PREP Act explained by TrialSite recently. The Act ensures the companies and the entire health delivery value-chain have no liability and that rather, all liability goes to the government providing a very limited pool of funds for consumers—and that’s all they wrote.   America’s visionary politicians can be thanked for that gift.

TrialSite chronicled the NIH, ACTIV, and U.S. HHS and BARDA spend all last year which led to a literal cash trough for select pharmaceutical companies. Demonstrating the intense bias toward novel pharmaceuticals, the pandemic revealed just how connected the NIH and pharmaceutical companies are at the hip. While many physicians hoped to test ivermectin last year, for example, tens of billions were spent on just a few companies as TrialSite reported.

Yes, the NIH completely failed to not only embrace antivirals (other than ensuring Gilead’s remdesivir—rejected by the World Health Organization—was accelerated through the emergency use authorization (EUA) and then approval process). But numerous repurposed compounds were identified that could have been acted upon, however, the NIH opted to spend what TrialSite suspects is not of $20 billion on a few vaccines and monoclonal antibody products.

Again, under cover of no liability due to the PREP Act, the U.S. taxpayer continued their subsidization of pharma most recently with Merck, the New Jersey pharmaceutical company that received $356 million in taxpayer funding at the end of 2020 while recently under the current POTUS secured a $1.2 billion guaranteed contract should the investigational candidate be authorized on an emergency use basis or formally approved. Merck has been actively crisscrossing the globe ensuring their own ivermectin, used to treat billions of people against River Blindness, never sees approval.

TrialSite did recently reported on preclinical research at Texas A&M which revealed that the investigational MP18 destroyed Merck’s molnupiravir in a head-to-head lab test.

The early-stage investigational product worked so well that San Diego-based Sorrento Therapeutics has licensed the investigational product and will aggressively seek an IND by the end of the year.

Roche is also working on a COVID-19 antiviral known as AT-527 in partnership with Atea Pharmaceuticals. The two have a Phase 3 clinical trial  (NCT04889040) at over 204 trial sites all over the world, not including America. The study should be done soon.

Pfizer First Patient First Dose

Pfizer announced an important milestone in the world of clinical trials, that is the first patient first dosage—including the first dosing using PF-07321332—an investigational orally administered protease inhibitor antiviral therapy designed specifically to combat COVID-19 in non-hospitalized, symptomatic adult participants who have confirmed diagnoses of COVID-19 and aren’t at risk for severe illness which could lead to hospitalization or death.

While Pfizer has led all COVID-19 vaccine sales approaching the tens of billions, that isn’t enough for investors’ appetite for pandemic monetization. As mentioned previously the stakes are too big for them to ignore hence why CEO Albert Bourla’s tweets telling the world the truth—those vaccines likely won’t be sufficient to overcome the pandemic. He is a smart man. After all, at the helm, his company will generate over $30 billion from the one vaccine product.

Global Pfizer Program

The PF-07321332 study is part of a global clinical development program, consisting of multiple ongoing and planned clinical trials to evaluate this early-intervention, outpatient therapeutic candidate for potential use in a broad population of patients. The first registrational trial in this program, a pivotal Phase 2/3 study of PF07321332/ritonavir in non-hospitalized, symptomatic adult participants who have been diagnosed with SARS-CoV-2 infection and are at increased risk of progressing to severe illness, began enrolment in July 2021.

Final Competitive Thoughts

While Roche seems furthest along, they don’t appear to focus, at least not yet, on the lucrative U.S. market. While Merck indirectly via Indian sub-licensees is backing a real-world care program using molnupiravir in Vietnam even though the drug is not authorized on an emergency basis or approved anywhere. This caught TrialSite’s attention yet received no press whatsoever. While physician societies yell and scream about licensed physicians treating consenting patients with ivermectin in America Merck actually uses an experimental drug on a population in a pilot even though the drug isn’t approved, and the clinical trials continue. That accounting can be read here. Well, at least some elites in the rich countries might just say behind closed doors—“it’s only Vietnam.”

In the meantime, the FDA and CDC will continue to collaborate with medical societies and industry to keep non-profitable options such as ivermectin as far away from the American public as they can.  

Pfizer’s CEO doesn’t go on and send out a tweet such as this one without being very serious. The vaccine-centric strategy isn’t sufficient to overcome COVID-19 and the American public will soon enough be subjected to not only the third booster (and possibly another one after that—a version 2.0) but also an antiviral regiment key to inhibit the vast, overwhelming number of COVID-19 cases. Critical care physicians knew this was needed last spring. 

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