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COVID-19 Update July 16, 2020: The Moderna Vaccine, Report on their Peer Reviewed Study

By Dr. Arthur Lavin

Glossary

  • Virus– a type of germ that consists solely of a bit of genetic material (DNA or RNA) wrapped in a protein coat.  The coat gets the genes into the target cell where the genes force the cell to make zillions of new viruses, and on it goes.
  • Coronavirus– a species name of a number of different viruses.  Called corona because its protein coat is studded with spike shapes that form a crown, halo, or corona of spikes
  • SARS-CoV-2– the specific name of the new coronavirus
  • COVID-19-the name of the illness that the new coronavirus is causing
  • Endemic– an illness always present in a region.  One could say strep throat is endemic in the US
  • Epidemic– a sudden burst of an illness that comes and goes over a limited time
  • Pandemic– an epidemic that bursts across the world not just one region
  • Spreadability– how contagious is the disease, how many people will end up infected
  • Symptoms- the experience of being ill, for example- fever, cough, headaches, loss of smell etc.
    • Asymptomatic– literally means “without symptoms”.  For COVID-19 it refers a person infected with the virus but has no and will have not symptoms
    • Presymptomatic– This is a person who was infected with SARS-CoV-2, and will feel sick, but hasn’t yet
  • Severity– what harm does the disease cause, in terms of  how sick you get and how many it will kill
  • Mask- a mask is a loose-fitting cloth or textile that covers the mouth and nose loosely.  A surgical mask is a mask used in surgery
  • Respirator-  for the purposes of the COVID-19 pandemic and other respiratory illnesses, a respirator is a mask that fits very snugly or tightly to the user’s face.  An N95 mask is a respirator.
  • Personal Protective Equipment (PPE)- PPE are any item that covers any part of the body with the design and intent of keeping viruses in the environment from infecting the wearer of the PPE. PPE’s include all masks (which includes respirators), face shields, eye shields, gloves, gowns.
  • Ventilator- a ventilator is a machine that can force a person unable to breathe to inhale and exhale and control both effectively.  They are sometimes called respirators, but during this pandemic the word respirator is now reserved for reference to a tightly fit mask.
  • Live Virus Swab– this is the swab which attempts to swipe live virus from one’s nose or throat to see if you are currently infected.
  • Antibody Test- (aka serology test) this is the blood test which looks for antibody to the SARS-CoV-2 virus to see if you have been infected in the past.

Treatment

The New England Journal of Medicine published a study on a promising vaccine for COVID-19.

Here is the link to the study: https://www.nejm.org/doi/pdf/10.1056/NEJMoa2022483?articleTools=true

And, here is a summary of what they did, what they found, and what it means.

What is this Vaccine

The vaccine is being created at a company called Moderna, a private company in Massachusetts.

This vaccine is a type of vaccine called an mRNA vaccine, which is a new concept in making vaccine.

The first vaccines ever made were all live vaccines.  A weaker form of a live virus would be placed into the body, infect the recipient, so that if the real disease showed up, the body would already know that virus and prevent deadly infection.  We still use live vaccines- the MMR and chickenpox vaccines are examples.   Only viral illnesses, you will note, can use live vaccines.

Most vaccines are what we have called dead vaccines, but technically they are protein vaccines, they typically take a protein that we find out the body uses to recognize the germ, and inject that into the body.   The body indeed recognizes the protein and makes antibodies and other mechanisms to recognized that protein, so when the virus (and for these vaccines it can be bacteria too) appears, the body is once again ready to go, and you don’t get sick from the infection.  There are many of these protein vaccines, they include the old tetanus shot, the newer HPV vaccine and many others.

The new mRNA vaccine is related to the protein vaccine, like the tetanus shot.  The difference is that it delivers a tiny genetic signal for our cells to make a specific protein.  That protein, is like in other protein vaccines, a protein that we have learned that if the body recognizes it, it will destroy the germ and protect you from its infection.

Now, what is mRNA?  You have heard of DNA, the molecule our genes our made of.  It turns out the main job of DNA is to signal what proteins the body wants to make.  Birds have DNA that direct the creation of proteins that will manufacture wings and feathers.  Fish have DNA that direct the creation of proteins that will make scales and fins.  DNA itself does nothing, but once its signals are activated, a symphony of directions to make a myriad of proteins creates life, bodies, minds.

DNA sits in the middle of our cells, and proteins are made outside that nucleus.  To make it work, DNA is copied into a form of genetic material called RNA.  The first copy is messenger RNA (mRNA) that takes the signal to the part of the cell outside the nucleus.  That messenger RNA is then copied into translational RNA (tRNA) that is a ribbon of information that is read by a tiny structure called the ribosome.  The ribosome reads the signal on the tRNA and picks amino acids in an exact sequence dictated by the code of the tRNA.

Science has found a way to figure out which protein on a virus our immune system can attack.  For SARS-CoV-2, that protein is the protein in the spikes you’ve seen on any image of the virus.  These are the many spikes that form a crown, hence coronavirus.

Step 1 is finding that protein, the spike protein.

Step 2 is creating a ribbon of mRNA that will tell the cell to make that protein.

Step 3 is putting that tiny, tiny ribbon of mRNA in a capsule that our cells will take up, release, and then have that ribbon of mRNA tell our cells to make the spike protein.

mRNA is much, much easier to make than a protein, and once you can manufacture one strip of RNA it is a lot easier to make other strips, so a manufacturer can create an mRNA for nearly any protein, very, very fast.

In this case, once the genetic code of the SARS-CoV-2 virus was defined, which was on January 10, 2020. Moderna began making the mRNA for the spike protein and this was completed in 45 days.   This trial for this vaccine began on March 16, 2020, just 66 days after the genetic code for this virus was first posted.   This took 2 months instead of several years, the power of mRNA development efficiency!

What the Study Did

Given all that, the next step was to take the little package of mRNA that holds the code to make the spike proteins of the COVID-19 virus, inject them into a small group of people kind enough to volunteer, to see if the injected mRNA really led to each person making the protein, if each person would make an antibody to that protein, and if the antibody made would be made in sufficient level to protect someone from getting COVID-19.

In this study a total 45 volunteers received two doses of this early trial COVID-19 vaccine, currently called mRNA-1273.

Each of the 45 volunteers received two doses of mRNA-1273, either in Seattle or Atlanta.  Some of the volunteers got a low amount of mRNA-1273, some a high dose, some an in-between dose (25, 100, or 250 micrograms).  Doses were 29 days apart.

Each of the 45 volunteers were monitored for side effects and blood tests taken to measure two main outcomes:

  1. How much antibody to the spike protein, the one called S-2P, was made?
  2. How did T-cells, the masterminds of the immune system, respond, did they create memory to demolish this protein if seen again?

Safety

None of the 45 volunteers experienced any serious side effects, none.

No one developed fever after the first vaccine dose.

After the second vaccine dose, no one in the low dose group had a fever but about half of those in the middle and high dose did.

Common side effects for both doses included local irritation, headache, fatigue, muscle aches, and pain locally.  One participant did develop hives.

Antibody Production

Everyone of the 45 volunteers made lots of antibody to the spike protein of the SARS-CoV-2 virus, usually by Day 15 after the first dose.  The higher the dose of the mRNA in the vaccine, the more antibody the volunteer made.

The study also looked at the ability of the antibodies in the volunteers to attack a virus designed to look like the SARS-CoV-2 virus, and to kill colonies of the actual SARS-CoV-2 virus in the lab.  By 43 days after the first vaccine, volunteers blood could drop the infectivity of the SARS-CoV-2 virus, in the lab, by 80%

T-cell Impact

T-cell activation was demonstrated by use of this vaccine.

BOTTOM LINES

  1. A company, Moderna, has published in a highly esteemed, peer reviewed journal, results of using a COVID-19 vaccine in 45 healthy volunteers who had no evidence of prior infection with SARS-CoV-2 virus.
  2. The vaccine uses the new technology of delivering a small ribbon of messenger RNA, or mRNA, to get the recipient’s cells to make the protein the body uses to recognize and destroy the SARS-CoV-2 virus.
  3. In this small sample of 45 people, the vaccine caused no dangerous side effects, but most people were uncomfortable.
  4. The vaccine, now called mRNA1273, succeeded in stimulating every volunteer to make antibody to the desired protein, and activate their T-cells against this virus.
  5. The antibodies created by those who got this vaccine, worked in the lab to bind to the target protein of the SARS-CoV-2.  The ability to bind to the viral target protein has been a highly reliable indicator the vaccine will protect the recipient from getting ill from that virus, in the instance of influenza and RSV.
  6. For the first step in a trial of a new vaccine, this is excellent, excellent news.  BUT WE ARE NOT THERE YET.
  7. The next step is for Moderna to test this vaccine, “mRNA1273” on 30,000 people to get a real idea on side effects, antibody production, and T-cell activation.
  8. At some point seeing how people immunized with this COVID-19 vaccine will need to be observed to see, does this vaccine work, really work?  Not cause much harm?  Actually keep those of us who get this vaccine from coming to harm from COVID-19?

 

WE DO NOT KNOW IF THIS, OR ANY VACCINE, WILL REALLY WORK.

That is, stop our deadly risk of getting very ill from COVID-19.

Only vaccines that pass this first phase trial, of course, can possibly offer this hope.  SO it is great news one has done so well in Step One.

Let us hope this, or another, passes Phase 2 and Phase 3, and we can have a real end to this catastrophe.

To your health,
Dr. Arthur Lavin

 

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