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COVID-19 Update September 3, 2020: An Urgent Clarification on the COVID-19 Vaccine

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.

 

The Call for Preparing for a COVID-19 Vaccine: It is Good to be Ready, but We have No Vaccine, Yet

On September 2, 2020, the CDC ordered all states and territories of the United States to prepare facilities to be ready to deliver vaccine for COVID-19 by November 1 of this year.

Real Answers is taking the unusual step to post a clarification on this order, because it raises hopes for something that simply does not yet exist, a safe and effective COVID-19 vaccine.

There is a world of difference between securing a room to administer the COVID-19 vaccine, and having one.

As of today, the nation has many rooms to administer COVID-19 shots, but no COVID-19 vaccine.

There are plenty of proposed COVID-19 vaccines.  But there is a world of difference between having a good lead, and having a working vaccine.

As posted in Real Answersit is highly encouraging to see the progress being made towards a COVID-19 vaccine.   The fact that a number of new products have shown early promise is so much better than new products failing at the start.

But science is littered with almosts.  Many, many drugs, and many, many vaccines get invented, and many of them show great promise, only to find as they are tried out in the real world that they do not work nearly as well as hoped, or even worse, cause some tragic harm that simply was not predicted.

The Urgency of Finding the Rare Product that Works, and Safely, from the Field of Promising Products

It’s not just in science that we find so many almosts. Look at any list of inventions and you will find piles of leads that looked great, but just didn’t work out.

This is why doing lots of tests, on lots of people is so crucial when developing any new medical intervention, including vaccines.

To illustrate, assume a vaccine for a problem is invented.  And let’s say it causes a real problem in 1 in 10,000 people given the vaccine.

Now, say this vaccine is tested in 500 people, it is very likely you will never learn about the 1 in 10,000 problem.   Most complete evaluations of a new vaccine require testing in 30,000 people, and even with a large study like this, only about 3 people will develop the problem out of 30,000, on average.

That means a 1 in 10,000 person problem may not even be noticed in the standard large trial of even 30,000 people.

Now, take that same vaccine and give it to 30 million people, 3,000 people will come to that harm!

So that is why so many companies are developing so many new vaccines for COVID-19, to be sure we have many products to try out, and do the careful study of to find the one, or more, that can be proven they really work and really cause no serious harm.

As of Today, We Have Not Completed this Work Yet, Not Really Close

That is right, as of today, we really have no vaccines for COVID-19 that we can be confident works and is very, very safe for millions of people of a broad range of ages.

Without having an actual vaccine that we know works and is safe in hand, setting up spaces to deliver it by November 1 is a moment in misleading us, not of science.

Keep Your Eye on the Facts, Which Will Be Available

The good news, as noted above, is that there are many good, trustworthy leads on the path to a COVID-19 vaccine.

Again, as noted above, leads are not the same as a working, safe vaccine.

But good work is being done to see:  Will any of these leads be found to be a COVID-19 vaccine that does in fact work, and is in fact safe.

The good work, being done right now, will yield trustworthy results.  We will in fact be able to know how each vaccine actually performs.

We will know, if 100 people get this or that COVID-19:

  • How many will be fully protected from this deadly disease?
  • How many will be only partially protected, but enough so that this disease presents little danger to them?
  • How many will have minor side effects, such as fever or sore arm?
  • How many will have major side effects, meaning problems that cause lasting harm?

We will be keeping a very close eye on the facts, and will know when the answers to these critical questions are known, and will keep readers of Real Answers informed on when we have those answers and when we do not.

As of September 3, 2020, we do not have answers to these questions, not at all, and the idea that we will by November 1, and have vaccine that we know these answers available across the nation by then seems extremely unlikely.   We simply do not have a known, working, safe COVID-19 in hand yet.

BOTTOM LINES:

  1. Progress to relief from the pandemic by a working, safe vaccine is progressing.  There is good reason to hope we will have such a vaccine.
  2. We DO NOT have such a vaccine in hand today, and it is NOT yet established that we will in 8 weeks.
  3. The CDC call for all of the nation to now prepare to give a safe, working COVID-19 vaccine by November 1 is a call to give a vaccine that has not yet been proven to be available, and all indications strongly suggest, will NOT be available by then.  In essence, the call is an exercise in preparing rooms without any reason to believe we will be able to use those rooms by then.
  4. Our impression, at this time, is that there is a realistic reason to hope that a safe, working COVID-19 vaccine will be available in some months, but it is NOT realistic to hope that the vaccine will be proven and in hand in a few weeks.
  5. The medical landscape, even across very recent history, is littered with hopes and leads that turned out not to work.  Even with the emergence of many candidate COVID-19 vaccines, no one believes all these leads will turn out to work and not cause harm.  That means no one really knows if any of them will.

We at Advanced Pediatrics are keeping, and will continue to keep, a very close eye on the progress being made, with a special eye on the four questions listed above.   Good people are in position to evaluate any vaccine that claims to be safe and effective, to judge, has the vaccine proven the answers to these four questions.

If and when a vaccine is proven to work, AND is proven to be safe, we will be glad to share that news.  Until then, we will hold all pronouncements to a very simple standard: reality.   This pronouncement fails that standard.

To your health,
Dr. Arthur Lavin

 

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