Ivermectin Delivered by A Novel Product

Innovative product can cut need for COVID vaccines and boosters

Moving beyond words is a new vote of confidence in using ivermectin to fight COVID with an innovative injectable product.

There is good reason to have hope for a new way to deliver IVM to millions of people to fight COVID variants.  It offers a very sound alternative to vaccines.

With all of the considerable controversy about using IVM for treating and preventing COVID, something has slipped the attention of its supporters and critics.  A relatively small French company has spent the past year or more developing an injectable product of IVM for prophylactic use and have it last in the body for months.

It has successfully completed a safety study for relatively high doses of IVM over long periods.  The company tested IVM taken daily in oral form to simulate the continuous release of the active substance by a long-acting injectable.  It found the results fully supportive of their injectable approach.

If the company is able to get the commercial product into the market and, if needed, get regulatory approval, their product could compete against COVID vaccines and avoid the need for the new Pfizer and Merck antiviral treatment drugs.

This product would circumvent the many problems people face in getting IVM pills, in terms of its scarcity and cost.  But the new product would probably require a prescription and a doctor, nurse or pharmacist to administer it.  And so, it might be relatively expensive, though likely cheaper than vaccines and new Big Pharma drugs.

One can imagine that this innovative product could be just like annual flu vaccines in how it is administered to large numbers of people in a multitude of places, including medical offices, drug stores and supermarket pharmacies.  And it would be wonderful if medical insurance covered it like it does for flu shots.

Here is some more information about this venture:  The company is MedinCell.  It has received financial support from the French government.  It was started with the help of the Bill and Melinda Gates Foundation.

Safety addressed

At its website it is possible to download a March 2021 lengthy and detailed assessment and review of IVM focusing on its history of intense global use and safety.  The title is Medical Safety of Ivermectin.  Here are the conclusions:

“Hundreds of millions of human subjects have been treated with ivermectin for curative or prophylactic purposes worldwide over the last 3 decades.  The reference list of this report demonstrates that a large body of data is available, which allows for a detailed analysis of ivermectin medical safety.  Undoubtedly, uncertainties remain regarding ivermectin pharmacological effects and mechanisms of action, but when removed, this is not anticipated to alter the main conclusions of this report in any significant way as they rely on an extensive and consistent body of medical publications.  Taking into account all the above, the author of the present analysis of the available medical data concludes that the safety profile of ivermectin has so far been excellent in the majority of treated human patients so that ivermectin human toxicity cannot be claimed to be a serious cause for concern.”

About product design

The company is based on the use of what they call BEPO® technology in the form of a pre-filled syringe, ready-to-use, with 24-month stability at room temperature.  It creates the formation of a small subcutaneous deposit, fully bioresorbable, at the time of injection.  This material acts as a mini pump that releases IVM regularly until it disappears or absorbs completely.

The core mechanism is the controlled and extended release of the active pharmaceutical ingredient, such as IVM.  The company claims a significant reduction in the quantity of medication required as part of a chronic treatment.  The BEPO® technology makes it possible to control and guarantee the regular delivery of a drug at the optimal therapeutic dose for as long as several months starting from the subcutaneous or local injection of a simple deposit of a few millimeters, of the fully bioresorbable medicine.

Optimism by the company

Here is an optimistic statement about the prophylactic strategy for using IVM in the pandemic:

"Our hypotheses are being confirmed, says Christophe Douat, CEO of MedinCell: the pandemic continues, and vaccination may not be enough to stop it.  The body of clinical data and scientific knowledge supporting the efficacy of ivermectin at a therapeutic dose against Covid-19, in particular as a prophylaxis, continues to grow.  In this context, our treatment, based on a widely known molecule, which could be stored at room temperature and which aims to offer protection for several months after a simple injection against Covid-19 and its variants, could become a key tool of the anti-Covid arsenal.  Our goal is still to have a product ready in 2022. "

In addition to wide preventive use by the population, the product could also be administered to people identified as Covid-19 contact cases to protect them.  Here is another potential benefit: Assume that some people may continue to get ill with late stage COVID infection, even with a regular dose of IVM and come down with lung and breathing problems.  But research and clinical evidence shows that the anti-inflammatory property of IVM can treat such lung issues and prevent death.  Having IVM in the body for months could either prevent or greatly mitigate such late-stage problems, the major cause of hospital COVID deaths now.

Conclusions

For those of us who have embraced the use of IVM as a prevention strategy this novel product could be of tremendous global importance, especially as new COVID variants inevitably become a problem.

Moreover, there is increasing recognition that repeated COVID vaccine booster shots are not justified because they can weaken immune systems and, inevitably, lose their effectiveness within short periods.  It is good news that the limits of boosters are being recognized by some people and organizations.  For example: Boosters “can be done once, or maybe twice, but it’s not something that we can think should be repeated constantly,” Marco Cavaleri, the European Medicines Agency head of biological health threats and vaccines strategy, said recently. “We need to think about how we can transition from the current pandemic setting to a more endemic setting.”

And the World Health Organization just said: “a vaccination strategy based on repeated booster doses of the original vaccine composition is unlikely to be appropriate or sustainable.”

Along this same line of thinking was this observation in a recent detailed analysis: “A plausible conclusion is that aggressive vaccination campaigns accelerate the pace at which an individual’s immune system reaches an ‘aged’ status due to exuberant generation of memory B cells in response to the artificial stimuli induced by repeated vaccination… An even more worrisome possibility is that these vaccines, both the mRNA vaccines and the DNA vector vaccines, may be a pathway to crippling disease sometime in the future.”

The injectable IVM product should be seen as a potential alternative to vaccine shots not only because they are increasingly ineffective, but also because of their increasingly documented adverse health impacts and deaths.  If COVID is to be seen as endemic, like the flu, then this new product merits serious support.

The question to be followed is if and how Big Pharma takes actions to stymie the French company’s efforts to fully commercialize their IVM injectable product in many countries.