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
• m-RNA- Messenger RNA (m-RNA) are small snips of genes that instruct a cell on which proteins to make. m-RNA is being used to instruct cells to make proteins found on the spikes on the new coronavirus, as a new technology for a COVID-19 vaccine
• 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.

Spreadability

The Virus Moves from Hot Spots to All Spots

This week we watch again in actual horror and dread as the SARS-CoV-2 virus continues to spread across America, causing more disease, loss of life, and long-term disability than in nearly any other nation.  As of now, over 160,000 of us have lost their life.   On August 1, 2020 in America, 1,244 people were killed by this virus.  On that same day, the total number of people who died from this virus in Spain was 0, in Germany 0, in France 11, in Australia 7, and in Japan 1.

The ominous trends being seen in America have to do with the Midwest, including here, and in rural counties.   As discussed in the Michael Osterholm interviews here on Real Answers, without actually achieving control of the virus, it will continue to spread to every corner of our land.  We discussed the concept of the virus appearing in hot spots like a painter placing dollops of paint on an easel, and then spreading it to color the whole easel, and I asked, will our nation one day be coated all over with this virus, and Dr. Osterholm said, yes, certainly.  Tragically, we are right now watching this prediction come true.  Even very isolated, sparsely populated rural counties are seeing rises in infection, and the CDC continues to warn that MN, WI, IN, OH, and CO are appearing to be the next very intense areas of infection.

At some point, as the virus spreads, it will likely cover the whole easel, or nearly every county of our country.

And once again, every day, our country gets to choose, let the virus rage, or do what so many countries have achieved, Identify then Isolate the Infected, and stop or close to stop the dying from SARS-CoV-2, in a manner that could be sustained until a vaccine truly ends the nightmare.

The Data on How Contagious are Children

We all know that much depends on how easily this virus spreads from person to person.

We all also know that thankfully, at least for now, the virus when it infects children, is far less likely to cause serious disease.

The fact that so very few children get seriously ill, and that the younger the child, the less likely serious illness is to happen, has long offered hope that maybe there just isn’t as much virus in infected children as adults, and even, that they do not catch it or spread it as well.

That hope has grown to an assertion from many directions.  Public policy on schools has been predicated on the conclusion that kids don’t catch COVID-19 or spread COVID-19 enough to raise concern about gathering 55 million students into indoor spaces for many hours a day.   This policy has been proposed not only by our government but also by some scientific associations.

Again, in our interviews with Dr. Michael Osterholm, it was with clear intention that I crafted a question to be extremely specific on this point:  Do we currently have data to tell us that children are less likely to spread COVID-19 and if so is that tendency more pronounced with lower age?  His answer at that time, a few weeks ago, was No.

Just since that interview two events have changed his answer.

The main event was the publication of a major, major study of how the virus spreads in a large population of over 60,000 people.  The study was conducted in South Korea, and looked at the fate of spread of SARS-CoV-2 from 5,706 people known and proven to be infected with this virus.

The study examined the results of testing 59,073 people these 5,706 infected folks had contact with.

A table of their findings is at the end of this post.

What they found was central to the question, do children spread this virus?:

1. As seen in nearly all studies, and certainly in real life, this virus is indeed contagious.
2. In a home, the chance you would catch COVID-19 from someone in your home with the illness was 11.8%
3. Outside your home, the chance you would catch COVID-19 from contacting someone infected with the virus was far lower, 9%
4. Outside your home, the chance of catching COVID-19 from contacting someone with the virus rose slightly with age.  As noted the overall rate if catching it out of the home was 1.9%.  But if the source of the infection was a person 0-39 years old the risk was about 1%, rising to 2% if 40-60 years old.  If the infected person was over 70 years old, the risk of catching it from them rose to nearly 5%.
5. Now to our question.  In the home, children were proven to clearly spread the virus.  If you lived in a home with a child aged 10-19 years old, your chance of catching this virus was 18.6% or close to 1 in 5!  For 20-49 year olds that risk of spreading it  dropped to about 10%, but rose again in older sources of infections, climbing back up to 18% for people in their 70’s being the source of the virus.
6. For children, in the home, ages 0-9 years old, there were two important observations.  Not many infected kids under 10 were found in this population, only 57 out of the 5,706 infected in the study, or about 1% of the population infected.  And of these 57, only 3 were a source of someone else’s infection, for a spread rate of 5.3%.

The publication of this study was presented to Dr. Osterholm and he went public stating that now we know, children transmit the virus, and now when asked, he will state as clearly as humanly possible, if we gather students with COVID-19 infection into classrooms, the illness will spread for sure.

Experiences with Children Spreading COVID-19

In addition to this landmark study, several experiences demonstrate that children spread this virus.  Three examples should prove the point:

1. Schools in Israel.  Israel is one of the nations that succeeded in bringing their daily new case count down to close to zero, so in May they re-opened their schools, and promptly experienced outbreaks.  Sources familiar with reports in Israel tell me that nearly all the outbreaks were in high schools, consistent with the difference in contagiousness below and above age 10.
2. US Summer Camps.  A number of camps, many of which took big steps to stop the spread of the virus, saw major outbreaks in overnight camps.  One camp in Georgia in June documented that 44% of the campers caught COVID-19 while at camp.  In that camp, 6-10 year olds saw a rate of contagion of 51%, 11-17 year olds 44%, 18-21 year old 33%, and 22-59 year olds 29%.  Cabin size offered almost no protection.  Cabins keep to 1-3 campers each suffered nearly 40% of campers getting infected.  For cabins with over 16 campers, the rate of infection was about 50%, not much different.
3. US Schools.  It is August 6, so some schools in America have opened for business, and three states report outbreaks of COVID-19 in schools, some within the first day of class.  We know of one teacher who died from catching COVID-19 in a school.

A Word on the 0-9 year old and their ability to Spread COVID-19

The South Korean study suggests that 0-9 year olds don’t spread this virus well.  And in their study they clearly do not spread it as well as 10-19 year olds.  But the point to be made here is that they do spread it.  Spend some time with a 4 year  old at home infected with COVID-19, and per this study, you have a 5% chance of catching it from them.   This risk is further supported by real life experiences in US summer camps.  The experience in Israel suggests that younger children do not spread the virus as well in school settings.

Severity

Tragically the point needs to be made once again that COVID-19 clearly has two faces.

It has the safe face, nearly 50% of those infected do not get sick at all.  That is very safe.

It has the deadly face, and yet about 20% of those infected will end up needing oxygen, and so far about 160,000 Americans have lost their life to this infection.  That is not safe at all.

And, as with all deadly infections, the sequence is always the same.  First comes the infection, then if ill enough, the hospitalization, then if ill enough, death.  So across the nation, sharp rises in numbers of cases is always followed by jumps in hospitalizations, and then once the disease has caused enough damage, big jumps in death.  We are seeing all three happening across the nation right now.

Treatment: Vaccine Update

New vaccines for COVID-19 continue to make progress.

As we near the possibility of an immunization to prevent COVID-19, many are asking, how will we know if it’s a good idea?

At Advanced Pediatrics we are following the development of the COVID-19 immunizations very closely, and will be asking two questions about the immunizations, the same two questions we ask about any proposed intervention:

1. Does it Work?
2. Does it Cause Harm?

As families in the practice have known, we take our job of finding the answers to these two questions very seriously.  To that end, we do not allow any drug or pharmaceutical company to come to our office or send to our office to promote any product, any time.  We want to be sure that you know any recommendations we make to you for use of any drug, immunization, test, is based as purely on the facts as possible and as free of other influences such as marketing, fear, popularity, etc.

On the issue of recommending an immunization, our practice has a proven track record of careful investigation of the two questions, does it work, and does it cause harm.   In the case of the chickenpox vaccine, our questions led to conversations with the then president of the American Academy of Pediatrics and the top researcher of the vaccine, Dr. Gerson of Columbia.

In fact, the experience with the chickenpox vaccine is instructive when approaching consideration of mass immunization against COVID-19.

The salient fact about chickenpox immunization was that chickenpox in childhood is overwhelmingly a safe experience, not many children come to harm from this disease.  And so an immunization better be extremely, extremely safe to justify use for such a largely harmless disease.

This is not the situation with COVID-19.  COVID-19, as noted, can be harmless, but it can also be gruesome and deadly.  The need for this immunization is extremely compelling, hundreds of thousands of lives here in the US and around the world hang in the balance.

So how does one go about ensuring that a new immunization is safe, particularly under the extreme reality of need for relief and protection?

One approach that impressed me deeply was offered by Dr. Joshua Sharfstein in this week’s JAMA, the Journal of the American Medical Association.  Here is his  great guide to this question: https://jamanetwork.com/journals/jama/fullarticle/2768156

Dr. Sharfstein asks, with Drs. Lurie and Goodman, all from Johns Hopkins, what are the key considerations we should be thinking about right now, to ensure that any new COVID-19 immunization is safe?  They propose 4:

1. Proof it Works, including in Key Populations.  This answers our first question, does it work?   The answer is only yes if the immunization reduces the chance of getting infected, and if infected of serious illness, complications, and death.  The essay makes the important point that proof of working needs to be demonstrated in a variety of groups of people- the young, the old, the medically complex, as well as various communities including those of color and Native.  As of today, we do not have the ability to prove this level of it working using antibody levels, we will need to see how it actually performs in the community to know it works.
2. Proof it is Safe, including in Key Populations.  This answers our second question, does it cause harm?  The special nature of mass immunization puts extra pressure on this question, since the proposition is that billions of people will be exposed to this intervention.  One problem with safety is that by definition, studies cannot study a billion people, but the essay makes the point that if you test an immunization on many thousands of people, major harms will become apparent.   Special attention to the safety of any proposed COVID-19 immunization will need to be paid to how safe it is in children, in pregnant women (for the pregnancy and the fetus), health care workers, front-line workers.   A special note was made of seeing how it impacts the development of the Kawasaki-like syndrome in children from COVID-19, MIS-C.  One special note of caution is raised in animal studies of coronavirus immunization.  Some of these studies suggest that some animals immunized, who go on to have an infection with a coronavirus anyway, can end up sickerthan animals not immunized.  So safety studies in humans need to establish that people immunized who may still get the SARS-CoV-2 viral infection, will not be sicker, an unfortunate consideration, but if proven not to happen would be very reassuring.
3. Informed Consent Option Prior to Proof of it Working and Safe.  The FDA has two options to release a new COVID-19 immunization for use in public before final approval, before truly proving that it reliably works and is safe across a large population.   One such option is called compassionate use, and this idea is based on situations when people are facing deadly danger, and are willing to seek the protection of an immunization before it is proven fully safe and effective.  Only immunizations that have some convincing preliminary proof of safety and efficacy would be considered for compassionate use.  A similar but more widespread path to use prior to final approval is through the FDA’s Emergency Use Authorization, or EUA, program.  Under EUA, a new COVID-19 immunization product could be released for use by the whole nation, despite not proving efficacy and safety to full measure.  The authors suggest that informed consent be obtained for anyone being offered a new COVID-19 immunization that has not yet achieved full, formal FDA approval, including use if compassionate use or EUA programs.
4. Comprehensive Safety Monitoring.  No study can see what happens when a billion people receive the immunization.  Events that happen one in a 100,000 or one in a million times, cannot be detected reliably in studies of 10-30,000 people.  And so the essay calls for very, very careful observation of everyone who gets a COVID-19 immunization once they are available to the wide public.  Final FDA approval and release to nationwide use does not mean our two questions are finally answered, the US should commit to very careful observation of the impact.  In 2009, during the H1N1 influenza pandemic, a new flu shot for this germ was developed, and the US did in fact closely observe millions of doses once released for public use.

I would personally add one more item to think about  and study to establish  new COVID-19 immunization is safe.  That has to do with novel immunization technologies.  Up until now, immunizations have delivered protection with two main strategies:

1. Inject the live germ, let it infect, get protected from future exposures, always a weakened version of the live germ.
2. Inject a protein from the germ, induce protection by the immune response to this recognized protein.

Now the COVID-19 new immunizations will be introducing three new ideas for getting our immune systems to think the SARS-CoV-2 virus is present and creating immunity:

1. An m-RNA approach.  We discussed this in a prior post.  This involves injecting a bit of genetic code that codes for production of the spike protein of the SARS-CoV-2 virus.  Once my body activates the m-RNA in the immunization, I will make that spike protein, and now it is like any other injection of the protein of a virus or germ that provokes my immune system to create protection.   The difference here is that a bit of genetic code is being placed in the body to start the process.  Another difference is that m-RNA has to be delivered in complex droplets of lipids, another novel feature of these immunizations.
2. Live viral vaccines using a safe virus that is engineered to make the desired protein to induce immune protection.  The live viral vaccines we use include measles and chickenpox, where actual measles or chickenpox viruses are injected, reproduce and in all ways convince the body you have measles or chickenpox, without getting sick.  Here instead of injecting live but weakened SARS-CoV-2 virus, the idea is to inject a live virus known to be harmless, but design it so as it copies itself, it makes key SARS-CoV-2 proteins inducing immune protection.
3. A third innovation is just like the live viral concept in innovation number 2, just above.  But in this instance, the stand in live virus is also very much weakened.

These last two innovations are called Vectored Vaccines, because the technical term for a dummy virus standing in for the real SARS-CoV-2 virus, yet still making SARS-CoV-2 proteins, is a vector.

Now, innovation #1 and #3, the m-RNA idea, and the weakened vector idea, have never been used commercially in humanity.  The 2nd innovation, a very much full-strength vector vaccine has been used in Ebola epidemics, very effectively and very safely, even after widespread use.

My point here is that in addition to the 4 safeguards listed above, a fifth that needs to be taken is to see if there are any new risks with use of m-RNA, or weakened vector, innovations.

We at Advanced Pediatrics will do all in our power, including consulting with national experts, to try to answer our two questions once again, does any proposed new COVID-19 immunization work, and is it safe, looking at all 5 of these concerns.

BOTTOM LINES

1. The COVID-19 Pandemic is spreading quite aggressively across the United States.  This of course represents the choice made on a national level to allow this to happen, as demonstrated by the success of dozens of nations to halt the spread and sustain the halt.  Our spread is  now wide enough that rural counties are being affected and concerns about Ohio and other Midwestern states erupting into hot spots are raised.  Given current trends in our country, it is likely every place will experience COVID-19 in active spread.
2. The question of whether children can catch and can spread COVID-19 appears to be settled. They catch it.  They spread it.  For children 10-19 years old the evidence is compelling and establishes they spread it at least as well as adults, perhaps better than young adults.  Outbreaks at summer camps dramatize these facts. As do serious outbreaks in even the few schools that have opened in 3 different states.
3. The chance that any school opening during a time when the SARS-CoV-2 virus is actively spreading in that community would induce an outbreak of COVID-19 that could endanger the life of teachers, staff, and family is now very, very real.   We live in a community where COVID-19 is actively spreading, the Cuyahoga County Commissioner of the Board of Health has gone on record urging all schools in our County to not open now, and not until the spread of COVID-19 drops substantially.
4. WIth respect to severity, COVID-19 is a disease that can cause terrible harm and much death, it deserves to be avoided.
5. Progress towards a COVID-19 immunization is happening.  Advanced Pediatrics will be attending to the proof that any proposed such immunization works reliably and addresses the full range of safety concerns before any is offered through this office or recommended by us.  Our hope is that we do achieve a highly reliable, extremely safe new immunization and end this pandemic.

To your health,
Dr. Arthur Lavin