This is the fifth (and, for now, final) post in the third set of miniseries about COVID-19 and humans.

These are exciting times for BioChemE’s.

After all, everyone wants a vaccine for COVID-19.  The US is dropping big bucks on (what it considers to be) the five most promising vaccine candidates.  (23 different candidates are undergoing clinical evaluation around the world, as we speak. )

We have Moderna.  (You should know that Bob Langer, PhD, is one of the co-founders of this company.) It’s been testing its mRNA coronavirus vaccine that it conceived literally 63 days after the Chinese published the genetic sequence of the virus in January 2020.  Their Phase I clinical trials finished in April.  45 subjects received one or two doses; all of them produced antibodies that bond to the virus, and a significant (but smaller) number produced antibodies that neutralize the virus.  Phase 2 began in June, with patients all receiving the same dose.  And, now they are beginning Phase 3, with many more subjects.

Now, don’t think that just because Moderna has progressed to Phase 3, all is a bed of roses.  Because while antibodies were produced as hoped, 21% of those in Phase 2 reported at least one side-effect (not necessarily life-threatening). 

Moderna has a positive history, too.  It’s developed about 10 mRNA vaccines- and another 10 mRNA drugs.  (mRNA is genetic information that is necessary to produce proteins.)  What is unique about their approach is that the mRNA induces our bodies to produce the materials to fight the virus (in this case, that’s the spike proteins that are native to the novel coronavirus)- instead of injecting the proteins (or whole viruses) themselves, which may not be compatible with our bodies. That way, when our body finds out there’s a spike protein, our immune system cranks up and produces antibodies and T cells (a variety of white blood cell types) to destroy it.

There’s also the Oxford University candidate.  (It made a deal with Astra-Zeneca in April to manufacture and distribute the Oxford vaccine on a non-profit basis.  And, they are currently ramping up to have 2 billion doses available next year)  This approach to a vaccine  is radically different from Moderna’s.  It involves the  insertion of genetic material from the surface spike protein of SARS-CoV-2 into a chimpanzee adenovirus (i.e., one of the common cold virus species)- and that combination induces human immune response via antibodies and killer T-cells.

Oxford compressed the normal 5 y routine for vaccines down to 5 months to execute an 1100 person human trial in April. (Without getting very technical- the Oxford team was working on a MERS vaccine, which used a protein very similar to the spikes in SARS-CoV-2, and had already completed human trials.  Going after the SARS coronavirus was simply a parry.)  Now, it’s about to examine efficacy among 10000 human subjects.  It expects to know by September if the concept is 80% effective against contracting the disease.  (The FDA  [USA]has emergency standards saying that being 50% more effective than a placebo and effecting a response by the immune system will be enough to get COVID-19 vaccine approval.  Other countries have been more reticent about their standards.)

(There’s plenty more choices.  As I said that there were 23- CanSino from China, Johnson and Johnson,  among others.  There is going to be a whole panoply of vaccine choices.)

But, I still worry, as I said Friday.  I’ve heard of tests that remind me of the sort run by the Soviet Union upon which I reported in the early 1970s.   One of the tests I recall was the Soviets infecting 100 folks with pneumonia and providing the test regimen to half of them.  It is an effective test to see if the regimen is successful- but it demonstrates the lack of worth we place on human life.

That is the sort of testing that has been bandied about now.  (You do recall that TheDonald is willing to gamble on the lives of little children- pushing schools to open up with no safety protocols- as well as their teachers, support staff, and their families at home- just to prop up the economy upon which he rests the value of his presidency.)

The normal therapeutical evaluations involve separating folks into two pools, each with thousands of volunteers.  Half get a viable vaccine, the other half get a placebo.  The problem is how long it takes these folks to encounter a COVID-19 sufferer. And, then compare how many of each group succumbed to the disease.  That sort of protocol takes months or years.

Infecting a 1000 folks with the virus and treating half with the proper vaccine provides much faster results. While the NIH (National Institutes of Health) has guidelines,we now know such safeguards are easily corrupted; after all, TheDonald corrupted the CDC guidelines for safe school opening.

Scary- but exciting- times.

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