Formulating COVID-19 Synthetic Vaccine Doses

This is my third and final post describing a COVID-19 synthetic vaccine. Future posts will return to the usual fare of books, stories, and anecdotes. But this last serious post wraps up a full disclosure of how to make a COVID-19 vaccine, so here goes.

The thing is, you can’t just make a vaccine. You have to inject it, and it has to immunize. So the last step in this process is called formulation. I’ve formulated injectables for–let’s see–about 47 years now, so I ought to know how. Shown at left is a photo of the most recent vaccine I worked on, an anti-cancer vaccine targeting the hormone hCG (there are links below for more information about it).

But before I get into formulation details, let me show you just how well these vaccines work. The graph at right shows an hCG synthetic-peptide vaccination (black arrow) that raised high levels of anti-cancer antibodies within just three weeks and increased by a thousand-fold a few weeks after that. High antibody levels persisted for six months and probably lasted more than a year, though the experiment was ended before that. The two white insets show ISMS (injection site macro-pathology scores) at or below 1.0, which the FDA defines as very little ouch going on. Wouldn’t you like to be protected for six months to a year from COVID-19 right about now? I know I would. By next year, COVID-19 may have done its damage and disappeared, only to be replaced by some new threat coming along. No worries though, we can always make a whole new synthetic peptide targeting the next microbe in three days.

All vaccines are formulated with some added materials (adjuvants) that aid the immune response by creating a depot of material that stays at the injection site for weeks or months. All the while white blood cells come and go, getting more and more riled up and producing more and more antibodies. There are dozens of formulation components out there, and most immunology labs have some on hand. I’ve used quite a number of them myself. Things like alum, squalene oil, gels, and mineral powders, plus immunostimulants like muramyl dipeptide or cytokines thrown in for good measure. It’s a bit of a grab bag of possibilities, but most immunology labs have these things or can get them. The slowest step is to test them in a quality assurance (QA) program to guarantee their safety–but what I’m talking about here assumes you’ve already got the materials certified clean and ready-to-go.

So let me be specific here, because there are many ways to do things wrong, and only a few ways to get the right blend of immune-enhancing ingredients. Here’s my favorite formula (you can skip this part if you don’t have a PhD in biochemistry):

  1. Solid immunogen
  • Peptide-DT conjugate: 0.5 grams
  • Calcium sulfate hemihydrate: 2.0 grams
  • Dextran sulfate (Na): 0.15 grams
  • Water: 1.5 grams (ccs)

Mix these to a thick suspension, dry to a solid block, grind to a fine white powder, sieve to 45-to-150 micrometer particles.

  1. Water-in-oil emulsion

Suspend the fine powder in saline containing 0.125 mg/mL nor-muramyl dipeptide (an immunostimulant). Combine two parts of this with three parts of emulsion oil (squalene + mannide mono-oleate 4:1) and mix vigorously. Your vaccine emulsion is ready to inject!

That wasn’t so bad now, was it? Many vaccine labs have the chemicals and equipment on hand to do this. The next step is animal testing by immunizing white rabbits or mice. These doses can be prepared quickly as shown below, where an emulsion is being made by pushing back and forth between two syringes until your thumbs ache.

For human dose preparation, industrial emulsion-makers, large-scale sterile facilities, and other quality-control techniques are required. No one wants to give a dose of one microbe while protecting against another.

So there you have it. We’ve made our peptide conjugate, mixed in our favorite adjuvants, and now we’re ready to vaccinate a lot of people. The benchtop recipe above could dose five to ten thousand people, and the process can be scaled up to industrial strength for hundreds of thousands or millions of doses. But in the short term, wouldn’t it be nice to use smaller batches to protect hospital staff from getting or giving the virus, as well as first responders and other at-risk people? With this vaccine, all of that can happen within a timespan of a few weeks to a few months, depending on whether you take a little time off to sleep. Given the viral threat hanging over us, who’s really sleeping all that much these days anyway?

Please don’t let the conversational tone I use here fool you. I’m quite serious about this vaccine. Deadly serious, given COVID-19 is out there killing people and this vaccine could be saving lives right now. It’s just that I’m retired and don’t have a laboratory of my own. It might take me months-to-years just to find a funding source and begin operations. On the other hand, there are many organizations around the world that have the right facilities and personnel to make this happen.

My task is finding them and convincing them to give this method a try. Wish me luck.

Below are links for more detail on this kind of vaccine. If you wade through the data in links 2 and 3, you will see that my colleagues and I have made this type of vaccine work in humans before.

  1. First, a link back to my previous COVID-19 postings on my blog site. You can learn a lot about my scientific background by visiting my home page and wandering its links (contact info too).
  2. An old business plan for CG Therapeutics Inc., with details of our cancer vaccine clinical trials (a large pdf, give it time to download).
  3. An old slideshow on CG Therapeutics’ technology with even more vaccine details (a larger pdf).

I have even more information, including a full IND (Investigational New Drug) application that I helped prepare for the now-defunct CG Therapeutics. It wouldn’t take long to repurpose that 319-page document to present this COVID-19 vaccine to the FDA. Any takers?

About Tom Hopp

Thomas P Hopp is a scientist and author living in Seattle. He writes medical thrillers, natural disaster novels, and the Dinosaur Wars science fiction series.
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