How many people do you know that waited to have kids until after they got more financially secure? So, they work and put money away, buy the house, and then find they have trouble conceiving or bringing a child to term.
Data from the 2006–2010 National Survey of Family Growth studies of women under the age of 44 show that 7.3 million women, or their partners, used infertility services, 1.5 million married women were barren and 3.1 million married women had difficulty in becoming, or remaining, pregnant.
Treatments for infertility can carry significant health risks to the mother and child. Including gynecologic and breast cancer for the mother, increased odds of having twins or more multiple births resulting in low birth weight, premature birth, and other hazards to mother or child(ren).
Occupational routes of exposure include inhalation, skin absorption, and swallowing/ingestion. Chemicals can be carried home on the employee’s hair, skin or body fluids of worker, contaminated clothing or materials from workplace. It’s the most natural thing in the world to hug your partner when you get home from work but any chemical contamination you brought with you is no on her or him.
Women working during pregnancy can expose their baby to chemicals that can cross the placental barrier resulting in spontaneous abortion, stillbirths, low birth weight, premature birth, or miscarriage. Some chemically caused adverse reproductive health effects are permanent, and some are reversible when exposure ceases. Some effects are dependent on exposure during certain stages of pregnancy.
For example, exposure to some chemicals during the first 3 months of pregnancy cause birth defects or miscarriage while exposure during the last 6 months could cause premature labor, slow fetal growth or may adversely affect the development of the baby’s brain.
After the baby is born exposures to some chemicals can contaminate their breast milk. As the child grows birth defects, such as physical abnormalities present at birth may become apparent. Other effects on the child include transmissible mutations, brain tumors, malformations, learning disabilities, developmental disorders, and childhood cancer.
Workplace reproductive hazards can cause health problems for the potential parents that have been linked to sex hormone imbalance, reduced fertility or infertility, Menstrual cycle and ovulatory disorders in women. Reproductive hazards affecting men may cause reduced fertility or infertility, erectile dysfunction, and affect sexual function. Sperm or semen can be affected by workplace hazards. Some chemicals can concentrate in semen.
The main problem facing our workforce today is that there are so many chemicals currently being used that have not been studied or the study results are inconclusive, so the chemical never gets classified as a reproductive hazard.
According to OSHA there are more than 1,000 Reproductive toxins identified in animal studies, but most have not yet been studied in humans. Where adverse effects on the ability to bear healthy children have been linked to occupational exposures while the employee is still working for the employer where they were exposed they are reported to OSHA via the annual summary of work-related injury and illnesses as “All other illnesses”.
The American Chemical Society’s Chemical Abstract Service, CAS, assigns each unique, new chemical identified by their scientists a CAS # for inclusion into the database, which is updated daily. The registry maintains current and accurate data for over 150 million unique chemical substances.
In 2017 the Service reported that 15,000 new substances were added daily. The Environmental Protection Agency reported that, on April 16, 2019 they had 500 cases under review. Since the Frank R. Lautenberg Chemical Safety for the 21st Century Act of 2016 was passed on June 22nd the EPA has reviewed 2,017 new chemicals (not on the Toxic Substances Control Act Inventory), or less than 3 completed reviews per day.
Chemicals are being processed into nanoparticles so small they slip through the skin with potential to create new and unpredictable reproductive and other adverse health effects. For example, Titanium Dioxide is a very common chemical, used in a lot of different products and processes. It has been amply studied and found to be nontoxic. However, when manufactured as a nanoparticle studies show it is carcinogenic.
The bottom line is that when your Safety Data Sheet says it has no information regarding reproductive hazards it does not mean the chemical has no reproductive hazard. It means that the manufacturer does not know one way or the other.
Since reproductive toxins adversely effect both men and women not hiring women or firing pregnant women is not only against affirmative action laws but an ineffective way to manage employee family health.
The most effective way to protect your male and female employees from such toxins is to replace them with safer chemicals. If that is not possible your next step is to identify all locations and methods of contact between the chemical and the employee and reduce or eliminate them.
For example, if you have a heated process that increases the amount of chemical that can be inhaled you have two options:
Find a way to create the product without heating in the process.
Enclose the process to completely capture all of the vapor or gas emitting from the heated areas/machinery.
Keep in mind, while employees gave up the right to sue their employers when Worker’s Comp laws were passed their spouses, significant others, and children did not. I’m not a lawyer and have not researched case law but, if an additional reason is really necessary now that you are informed, it is something to think about.
When you have employee exposures to reproductive toxins you must work with a Certified Industrial Hygienist. It is not possible to attain Certification without a strong background in chemistry, toxicology, and epidemiology.
Before going back for my master’s degree in industrial health from the University of Michigan I was a Chemical Hygiene Officer for 6 years in Molecular Biology labs. We extracted and worked with DNA and RNA so most of the chemicals we used were intended to change the genetic material.
If you have concerns about the hazards of the chemicals your employees use everyday please contact me, I can help.
OSHA has required air or noise sampling, they only accept sampling data from a CIH.
Your concerns are related to employee exposures to chemicals on site, especially when chemical exposures include:
Adverse health effects that are not immediately apparent, such as cancer or reproductive hazards.
You are planning a process and need to identify hazards when chemical additives mix, or the process calls for heat or pressure.
Employees express concerns about exposures to chemicals and you want to put their mind at ease or prevent/prepare for an OSHA Complaint Investigation.
You don’t have a strong background in chemical hazards and have questions.
You have concerns about employee exposure to noise, have extended work shifts when employees are exposed to noise (it reduces the Action Level and Permissible Exposure Level.)
You need someone to create/deliver a training in complex chemical exposures and their controls for your employees that will show that you are not adding controls just to make their lives more difficult.
Practical Safety and Health also has a Mentor Program for Safety Managers. For an annual negotiable fee we provide:
A familiarization walk through with your Safety Manager to see you processes and review your Safety Data Sheets so that, when you call with questions, we can provide an answer in context with your workplace conditions.
Onsite sampling at 25% off the normal hourly rate.
Assistance with identifying changes in your workplace that may require a re-assessment of employee exposures.
Give us a call at 920-944-9143 or email at cih@psahs.millennium-innovations.com
Reusable versus disposable PPE. Both have their assets and defects.
Disposable
Must be kept in stock and a system to identify and respond when the stock runs low or exceeds the expiration date.
The distributor must be relied upon not to run out of the gloves you need.
The manufacturer must be relied upon not to change the glove thickness without effective notification to customers.
The method of disposal must take into consideration whether vaporization of chemicals from the large surface area of the glove could create a secondary source of contamination. Disposal should be into a receptacle with a lid that is emptied at least once a day.
Where there is more than one type of glove material due to different resistant properties of different chemicals employees must be well trained to know which glove is to be used for the chemicals.
The potential for using the wrong glove is higher for disposable gloves because the employee who needs to resupply the gloves can grab the wrong box. This can go unnoticed for quite a while as the next employee may continue to grab the same color, etc. box of the wrong material.
Reusable
Employees are more likely to use the right glove because it is kept near the use location.
The interior of the glove is more likely to become contaminated because the glove is left near the source of contamination, the reason the glove is needed.
Employees must be carefully trained when to use this type of glove and when NOT to use them. Once gloves are on, especially if they are comfortable for consistent compliance, employees may leave them on rather than change gloves for a new task.
The PPE must be cleaned between uses in a way that does not create employee exposure.
After cleaning the PPE must be moved, dried, and stored outside the contamination area to prevent recontamination. This location must be convenient enough for consistent employee compliance in wearing their PPE.
Ensuring the gloves are the right size for the employee is even more important in reusable gloves as an employee might not complain to the right person and end up wearing the wrong size for a while with the same adverse effects as mentioned for the disposable gloves.
A viral invader triggers an immune
response that creates an antibody specific to the viral antigen. The antibodies attack the antigens by binding
to them to prevent them from binding to healthy body cells. Antibodies remain in your system for several
months after you recover, during this time you are immune to the virus. The COVID-19 virus has been found to have a short post recovery antibody duration.
You’ve seen pictures of COVID-19, it’s a ball with a
lot of spikes all over it. Those are the
viral antigens. Think of the protein
spike on the virus as a hand and the antibody as a glove. There is a glove receptor on the cell along
with other receptors that fit feet, knees, ears, etc. Only the hand spike will fit the cell’s
glove. A vaccine helps the body’s immune
system to create antibody gloves so that, if we are exposed to the virus the
glove antibodies are ready to get to that hand before it can get to the cell’s
glove. Resource.
You may have heard the term ‘Herd Immunity’. This
occurs when a large percentage of the population becomes immune to the
disease. Basically, you starve the virus,
you give it nowhere to go therefore it dies out. There is a threshold proportion of the
population that must be immune for herd immunity to work.
The Mayo
clinic says that, 70% of the US population, over 200 million people, would have
to be infected and recovered so they were all immune at once to create herd
immunity naturally. The narrow post
recovery immunity window creates serious barriers to natural herd immunity.
Vaccines have been successful in creating herd
immunity for polio, smallpox, diphtheria, and other deadly and contagious
diseases. It is estimated that we will
need to vaccinate 80% of the country almost all at once, given the short
antibody production window. This would
be difficult for COVID-19 due to the short post infection.
There are two types of vaccines:
Protein based vaccines:
Deliver the immune
system stimulating antigen to the body via several vector types. Measles, mumps and rubella vaccines contain
live but weakened viruses, polio vaccines contain inactivated, dead, viral
material, and hepatitis B uses bits and pieces of the virus to generate an
immune response. However, there is a
risk of preexisting immunity which means your immune system can clear the
vector before it even gets started. Several
protein based vaccines developed in America and China have generated “less than
impressive” antibody levels.
To get a protein based vaccine
to the people who need it:
Get a live virus
Grow a culture
Find the right genetic material
Test it
Insert it into a vector,
Grow the vector,
Test the vaccine
Get Federal approval
Grow cultures
Start distribution of temperature
sensitive cells.
Gene based vaccines:
Use the genetic instructions
on how to make the antigen from the viral, DNA or mRNA stimulating antibody
production. DNA must wait until the cell is dividing,
enter the cell’s nucleus, create mRNA, and then get it back out of the nucleus
to form the antigens. Much less
efficient. (I’ve worked with RNA, did
you know the enzymes on your hands will eat your RNA sample?) On the other hand, 95% of the cells that
encounter the mRNA will take it up and make the antigen, a very efficient
process.
You can create a
transport vector from a dead virus, a nanoparticle, or a less harmful virus that’s
been engineered to not replicate. From
the articles it sounds like the nanoparticle is the best bet as the other 2
require cultures, etc. and controlled temperature delivery systems as well as
concerns about preexisting antibodies disabling your vector.
These vectors can be
used regardless of the original virus so you can generate a ‘fleet’ of vectors
at the same time as you are isolating and replicating the genetic sequence for
the target antigen. For COVID-19 it’s
the protein spike used by the virus to bind to a specific receptor spot on one
of our body’s cells in order to inject its DNA.
And the gene based vaccine is more like a natural infection.
To get a gene based
vaccine to the people who need it:
Find the right genetic material
Start replicating it
Test it/manufacture nanoparticle
vectors
Insert the material into a
vector to create the vaccine
Test it
Get federal approval, continue
to create vaccine
Potential for temperature stable
vaccines
Gene-based vaccines are ‘plug and play’. Once you have the genetic material of
interest you can go immediately into testing.
Unlike the protein based vaccine this type of vaccine also stimulates
the cytotoxic T cell response. Imagine
air support for your armored division.
“You’re not giving them the protein—you’re giving
them the genetic material that then instructs them how to make that spike
protein, to which they make an antibody response that hopefully is protective,”
University of Pennsylvania vaccinology professor Paul Offit, MD, explained in
a JAMA livestream in
June.
So far Americans have been using protein-based
vaccines. For example, Measles, mumps
and rubella vaccines contain live but weakened viruses, polio vaccines contain
inactivated, dead, viral material, and hepatitis B uses bits and pieces of the
virus to generate an immune response. The
development, approval, and production time required for protein-based vaccines
can take quite a while.
“This research has
been going on since 2002 creating the genetic modifications to stabilize the
spike protein for a robust and safe antibody response. The people who jumped on this right away are
the people who had vaccine platforms that were conducive for this that were
simply sitting there,” said Louis Picker, MD, associate director of the Oregon
Health & Science University’s Vaccine and Gene Therapy Institute. “All they
had to do is basically figure out what part of [the virus] they were going to
put in the vaccine and then run with it.”
These vectors can be used regardless of the original
virus so you can generate a ‘fleet’ of vectors at the same time as you are
isolating and replicating the genetic sequence for the target antigen. For COVID-19 it’s the protein spike used by
the virus to bind to a specific receptor spot on one of our body’s cells in
order to inject its DNA.
January 10, 2020 Chinese researchers posted the mRNA sequence for
COVID-19 on a preprint server making it available to everyone shaving weeks to
months off the development of a vaccine.
The U.S. started its first clinical trials in April during which
volunteers received the first vaccine developed by a private company, Moderna, Inc and a government agency, the National
Institute of Allergy and Infectious Diseases (NIAID). That’s the bright side.
Because of the speed with which the gene virus can
be developed having the mRNA sequence greatly accelerated the process. In fact, the first four vaccines submitted for FDA approval are mRNA
vaccines. Due to the shortened approval
process the number of
To date the FDA has only approved protein-based vaccines, which are
grown. This takes time and resources and
can be difficult to scale up, especially in a pandemic situation. Protein based vaccines must be kept at a
specific temperature creating problems in transport and delivery. The logistics of growing and distributing
several hundred million vaccinations in a few months in order to create herd
immunity are daunting. Especially as the
process may still be ongoing when the earlier immunized people now need their
booster`
As discussed, the gene based vaccine can go in several different
types of transport including manufactured nanoparticles that can be stored
until needed. The genetic material can be
duplicated on a massive scale by PCR and then inserted into the transport
medium. Some studies show that mRNA,
messenger RNA, can be stored at room temperature greatly decreasing large scale
distribution to places without refrigeration trucks or on site refrigeration.
“This research has
been going on since 2002 creating the genetic modifications to stabilize the
spike protein for a robust and safe antibody response. The people who jumped on this right away are
the people who had vaccine platforms that were conducive for this that were
simply sitting there,” said Louis Picker, MD, associate director of the Oregon
Health & Science University’s Vaccine and Gene Therapy Institute. “All they
had to do is basically figure out what part of [the virus] they were going to
put in the vaccine and then run with it.”
In order to safely speed up the vaccine testing
process it is necessary to enroll a much larger number of volunteer
participants in the clinical trials.
Over the last 10 years the usual number of volunteers in studies when
going for Food and Drug Administration approval tops out under 16,000 while
accelerated testing requires many more.
The mRNA tests used by Pfizer and BioNTech will enroll approximately
60,000 volunteers.
Before federal approval is sought vaccine development follows
specific stages, or phases:
Pre-clinical testing, using cells or animals,
if the vaccine produces an immune effect it goes on to
Safety Trial, also called Phase 1. The vaccine is tested on a few human and if
it works
Expanded Safety Trials, Phase 2. The vaccine is given to hundreds of people of
different races, genders, and age.
Efficacy trials, Phase 3. Thousands of people are given the vaccine or
a placebo and watched for side effects and immunity.
A recent research
letter in the Journal of American Medical Association described the U.S.
Food and Drug Administration, FDA, approval process to license a total of 21
new vaccines over the last 10 years.
This process is called the Biologics Licensing Applications, BLA.
There are three parts to this approval
Investigational New Drug Submission, for human
testing, involving a clinical development period between 6.1-10.5 years, with a
median of 8 years (median means most of the submissions took 8 years)
BLA submission for FDA review a process taking
10.8-21 months
FDA approval
Average time from start to market was 8 years, 12 of the vaccines
were for well understood illnesses, influenza, meningitis, and whooping cough. The follow up period to identify adverse
health effects was 6-12 months, median 6 months. The vaccines were approved based on the
results of between 5 and 13 clinical trials, median 7, including:
1-3 pivotal effectiveness, median 1, results
for the approved vaccines were between 79.6 and 98%
1 lot to lot consistency
The number of patients included in these trials ranges from 4,576
to 15,997. The trials used a variety of
methods to prevent bias, including
Randomized participant selection
Masking
– keeping the study
group assignment hidden after the vaccine is administered
Placebo comparator groups
Clinical primary endpoint, either lab
confirmed infection or antibody immune response.
Of the 21 approved vaccines, 4 were granted accelerated approval;
however, this letter did not provide any information on that process. The FDA published a “Development and Licensure of Vaccines to Prevent COVID-19” guidance document on June 30, 2020. It requires at least a 50% efficacy in
preventing or decreasing the severity of COVID-19. Where there are known or potential serious risks
from the approved vaccine the FDA may require post marketing studies.
The New York Times Coronavirus
Vaccine Tracker shows 55 clinical trials, on humans, and 87 vaccines in
pre-clinical trials, on cells or animals, as of November 27, 2020. Because of the mRNA sequence provided in
early January Chinese researchers to other countries the development of the
gene based vaccine was on the fast track.
By March pre-clinical trials were
in progress with 13 of the vaccines reaching the final testing stage. Other methods used to speed up research
include conducting trials to test safety and trials to test dosage were
conducted simultaneously instead of consecutively. To offset the faster Emergency Use
Authorization process, the number of trial participants is greatly increased,
up to 60,000/trial, starting in the pre-human trials instead of starting small,
15,000/trial, and then moving to expanded testing if the vaccine is
effective.
The reason most of you are reading this blog is because you want
to know
Can the accelerated authorization of COVID-19 approval provide a vaccine that works?
Will the accelerated process provide enough time for the vaccines to be sufficiently tested for adverse health effects?
How long will the immunity last for COVID-19 from a vaccine given the relatively short immunity after recovering from the illness? In other words,
Will we be required to get booster shots?
How many and how frequently?
How long will it take to create and deliver the vaccine?
Not all of the answers are available right now. There are 260 COVID-19 vaccines in
development with over 70 in the approval process. We have our questions and we do have
resources to find the answers for the ‘winners’ in the COVID-19 vaccine race.
The FDA has provided a webpage for it’s Coronavirus
Treatment Acceleration Program, CTAP, and the National Institutes of
Health, NIH, has a website for the
partnership between the government and private and public research labs working
on creating a COVID vaccine. The NIH website has an April 2020 article that
answers a lot of questions and describes an unprecedented partnership with
goals and guidelines. I recommend
bookmarking both sites and using the above questions when reviewing the data.
My source for factual information on COVID is the JAMA
Network. It requires a membership
but I’m not a doctor and I found it easy to set up a free membership for a lot
of access. You can also set up an email
service that provides links to the main articles being released.
A great deal of my information on Gene based vaccines came from
this article.
OSHA’s at the door, do you know where your data is?
It is not unusual for an employer to be aware of the employee exposure sampling requirements of standards such as 1910.95 Occupational Noise Exposure, or 1910.1026 Hexavalent Chromium. However, many employers are unaware that this sampling triggers the documentation content and duration requirements of 1910.1020.
The records must contain sufficient data to meet the requirements of 1910.1020 Access to employee exposure and medical records which requires the following information to be retained for 30 years:
The sampling results
The sampling strategy
Description of the analytical and mathematical methods used
If an employee’s exposure requires any calculation, such as the employee leaves to participate in a work activity outside the scope of his normal work so his average exposure is calculated based on what it would have been if he had remained, then that calculation must be included in the report.
Background data relevant to the interpretation of the results
Make and model of the equipment used
Last factory calibration documentation
Pre and post calibration results for the equipment on the sampling day
Few businesses can afford to keep an Industrial Hygienist, IH, on staff, so they bring in a consultant to conduct the sampling. The quality of consultants in the field can vary a lot which means the quality of the documentation they provide must be evaluated before you hire your consultant.
Your best bet is hiring a Certified Industrial Hygienist, CIH, because the certification process requires the IH to prove they have, and maintain, the skills and knowledge required. Only those who meet certain minimum requirements are allowed to take the 8 hour certification exam. When OSHA requires a business to conduct sampling, they stipulate it be done by a CIH.
When you get a report it should contain all of the requirements listed above for 1910.1020. Most reports will include a table comparing the results to occupational exposure limits and a discussion about them. A CIH will usually include a description of the adverse health effects of the sampling target as well as a detailed description of the production, process, equipment, exposure source, and ambient conditions (doors open, fans on and direction of breeze), and anything directly or indirectly affecting employee exposure.
This level of detail is most important because, whether the employee is over occupational exposure limits or not, you must be able to identify changes in the production, process, equipment, exposure source, and ambient conditions that could increase or decrease employee exposures. So, it is very important to be able to put your hands on these records at any time.
When sampling results indicate the requirement for a written program the documentation of the results should be kept with that program, usually as an appendix or in the same electronic or paper file or notebook.
However, when the results indicate employee exposures are below occupational exposure limits it is not uncommon for the documentation to be lost within a few years, or even months. Especially if they are only in paper form. Even if they are in electronic form when they are kept on the Safety Manager’s laptop they can be deleted or not make the transition to the next Safety Manager.
As a result, it is not possible to prove to OSHA or a Worker’s Compensation investigation that the employee was below occupational exposure limits and you have to pay to have the sampling repeated. But, more importantly, it is not possible to identify potential changes in work processes or conditions that could increase employee’s exposure above the limits so you can address the problem in the planning stages. If you missed that golden opportunity then, at least, you know you have to have the sampling done again.
By the way Simple Safety Coach, a safety management software company that I co-founded, has an electronic file cabinet right on our dashboard where sampling documentation and the most current written programs can be accessed in seconds. Even if your Safety Manager is away on vacation you can provide the right documentation at the right time!
Noise is one of the most common occupational hazards in any industry. While the manufacturing sector is 13% of the American workforce this sector has 72% of all recordable hearing loss cases. Not only does the employee suffer from reduced or lost hearing our economy loses an estimated $242 Million/year in worker’s compensation for the disability. (OSHA Regional Emphasis Program)
The first attempt to regulate noise hazards in American workplaces was in 1969 in the Walsh-Healey Public Contract Act. At the same time the Bureau of Labor Standards added a construction occupational noise standard to the Construction Safety Act, which became the OSHA Construction standards, CFR 40 1926, in 1971.
The exposure limit was set at 90dBA 8-hour Time Weighted Average with a 5dBA exchange rate. This limit was based on the American Governmental Industrial Hygienists Association, ACGIH, Threshold Limit Value, TLV. The Current TLV is 85dBA with a 3dBA exchange rate.
How does noise work? You don’t have to take a physics class to know the phrase ‘sound waves’. This is a correct term to use when talking about noise.
You know when that car drives up beside you with the radio blaring and you can feel your car vibrate? It’s because noise creates pressure and pressure travels outward in a wave.
That sound pressure is funneled into your ears and down into that snail looking cochlea where there are tiny little cilia that are called ‘hair cells’ because that’s what they look like.
The cochlea is full of liquid and the fibers. When the pressure waves go down the ear canal the pressure is transferred to the cochlea which cause the hair cells to move, like seaweed under a wave.
So, here’s the interesting thing, not all the hair cells move! The frequency of the sound determines how far up the spiral of the cochlea the sound wave will go and which hair cells are moved. That information is transmitted via the auditory nerve as frequency and volume.
Have you ever noticed that when you turn your car on in the morning the radio sounds really loud? This is because, by the time you headed for home you had tired your cilia out. Seriously, it’s called Auditory Fatigue, and overnight they rested up, hopefully, in the quiet of your house or while you were sleeping.
This is also called a Temporary Threshold Shift, meaning, the threshold at which you can hear a sound has to be louder just to get the cilia to react. Now, when the radio sounds just fine, the loss may be permanent, a Standard Threshold Shift.
The easiest way to define the difference between the two is to think about the grass in your yard. If you walk across the grass and then turn to look behind you, you can see your feet have pushed down the blades of grass (like noise pressing down the cilia in your ears), but after a while the grass straightens up. This is a temporary threshold shift.
If your yard is on the corner and you don’t have a fence, people will ‘cut the corner’ over and over again until they have worn a path in your yard where grass no longer grows. This is a Standard, or permanent, threshold shift. It is also called Noise Induced Hearing Loss.
As we ‘shelter in place’ as a means of controlling the spread of the Novel Corona Virus, first diagnosed in November of 2019, it is a good time to evaluate not just COVID-19 but viruses in general. But first, a little perspective on the numbers game.
The following reasons indicate that COVID-19 fatality rate will be far lower than the 2% or higher currently proposed:
The mortality rate is the number of patients who die divided by the number of patients known to have the disease.
Most people infected develop mild symptoms and may not even go to the doctor. They are not counted, which artificially increases the mortality rate.
The fatalities are often associated with our elderly and with people who have an underlying medical condition, comorbidity, similar to seasonal influenza fatality cases.
Given the national and international travel it is most likely that there are a great many cases that have already come and gone. This means that the denominator, identified population infected, will continue to grow at a rate much faster than the number of fatalities.
An article in the New England Journal of Medicine states “If one assumes that the number of asymptomatic or minimally symptomatic cases is several times as high as the number of reported cases, the case fatality rate may be considerably less than 1%.”
We have an excellent example of a worst-case scenario provided by the Japanese when they quarantined a cruise ship with over 3,700 people and only had 707 people test positive and only managed to kill off 6 people, mostly over 80 years old, which gives us a 0.8% fatality rate. This IS higher than the yearly influenzas fatality rate, 0.1- 0.2% but much less than the last SARS outbreak which took 2% of those infected.
So, what did the Japanese do wrong?
Confined all passengers to their rooms but did not do anything to the ventilation system, which was not effective in removing virus particles and did not provide 100% outside air to each room.
Allowed staff, including those testing positive and those actively ill, to eat together and sleep in quarters where they could spread the infection amongst themselves. Then had them prepare and deliver food.
Did not instruct, or did not enforce, staff to use the PPE provided properly. Instagram pictures showed crew delivering food with one of the respirator straps hanging under his chin.
Pictures show passengers lining up for testing without face masks or gloves, so they were exposed to infected passengers and touching potentially contaminated surfaces at the testing site as well as from and to their rooms. As well as standing next to potentially infected passengers and crew.
The following reasons indicate that COVID-19 fatality rate will most likely be far lower than the 2% or higher currently proposed:
5. Only 707 people out of 3,700 tested positive for the virus. Yes, they are following the passengers and yes, some are now testing positive, but you would expect a much higher affected population for an easily transmissible disease.
6. Most people infected develop mild symptoms and may not even go to the doctor.
7. The fatalities are often associated with our elderly and with people who have an underlying medical condition, similar to flu fatality cases
8. Given the national and international travel it is most likely that there are a great many cases that have already come and gone. This means that the denominator, identified population infected, will continue to grow at a rate much faster than the number of fatalities.
Corona viruses have crown-like spikes on their surfaces and are divided into 4 main subgroups:
Alpha
Beta
Gamma
Delta
There are 4 human coronaviruses that cause the common cold:
2 are Alpha
229E
NL63
2 are Beta
OC43
HKU1
Colds are not fatal.
There are currently 3 corona viruses that jumped species from animals to humans:
2019 Novel Corona virus, also called: nCoV, COVID-19, SARS-CoV-2, and HCoV-19
Strains: SARS-CoV-2 nCoV-WA1-2020 (MN985325.1) and SARS-CoV-1 Tor2 (AY274119.3)
origin Wuhan Hunan seafood market in 2019
SARS Severe Acute Respiratory Syndrome, also called: SARS-CoV.
origin South Eastern China, 2003-2004.
MERS Middle Eastern Respiratory Syndrome, also called MERS-CoV.
The CDC states that camels are the reservoir, but bats are most likely the source. Saudi Arabia, 2012
The above mutated viruses can be fatal.
Comorbidities are preexisting conditions that make the patient more likely to contract the disease and/or more likely to have a more severe reaction. Comorbidities for corona viruses include:
*The basis for the 14-day Medical observation period for people who have been exposed.
**SOB Shortness of Breath
R0 pronounced R nought, also known as the Reproductive Number, is the average number of people who will be infected by one person. An R0 that is less than one is good, the higher the R0 the more people one infectious person can infect. This measurement of infectivity is calculated by:
The likelihood of contact between the infectious person and the susceptible person.
How the disease spreads, aerosol, direct contact, etc.
How long it can survive outside of the body.
The Hang Time, for aerosol transmission, how long the infectious particle remains in the breathing zone of other people.
If, and how long, asymptomatic people are infectious.
Where the disease is found.
Social, demographic, and cultural characteristics will make the R0 vary between locations. ***MERS R0 for 2014 in Jeddah was 3.5-6.7 while in Riyadh it was 2.0-2.8
The R0 for smallpox, polio, and rubella range between 5 and 7. Ebola, while thought to be very contagious, has an R0 of only 1.5-2.0 this disease is transmitted by contact with blood. Whooping cough is transmitted via aerosol inhalation and it’s R0 is 5.5. Measles particles have a 2-hour Hang Time which plays a major factor in the very high infectious rate of 12-18 R0.
It should be noted that R0 assumes everyone is susceptible, there is no immunity, and only relates to how many people will eventually be infected.
**Click on the picture to view the MicrobeScope graph
Transmission
When the virus in the person ends up outside of the person this is called viral shedding and it is how a virus is shared to the people around you.
Direct Transmission: Inhalation
Whether we are speaking, sneezing, coughing, or just sitting there breathing, we are exhaling liquid particles from our respiratory system. Have you ever watched the Outbreak movie starring Dustin Hoffman? Do you recall the scene in the theater where the exposed and now sick and infectious lab tech is coughing, and spewing out droplets that are shown floating around the theater inhaled via the nose and into the mouths of the people around him? No? Well, now Is probably not the best time to go watch that movie.
That scene stuck with me and this Novel Corona virus, COVID-19, potential pandemic got me thinking about the accuracy of that mode of transmission of a virus. So, I did a little research, citations below, and found out that there are a LOT of variables that come into play with airborne transmission of infectious material.
Mode of transmission: a cough has a lot less Volume, 6×10-8ml, than a sneeze, 1.2×10-5ml, so the sneeze is more effective means of transmission.
Viruses are 17-300nm long, 1,000x smaller than bacteria, 300 to 10,000nm, which are smaller than human cells. So you can imagine how many will fit in a sneeze or cough droplet
2.The number of coughs and sneezes that occur before you can get the heck away! This is both concentration and duration of exposure.
3.Which virus they have because they each have different parameters
4.Viral load: how much virus is being shed (given off), as in how many viral particles are there in the droplets?
This depends on the virus. Influenza A has a peak shedding the first day of acute respiratory symptoms and the number of particles decrease steadily after that.
We know that COVID-19 is infectious long symptoms appear and that some people do not develop symptoms but can still transmit the disease. We do not know how infectious they are but there have been reports of active infections that have been traced to asymptomatic people.
5.The force of the cough or sneeze compared to how close you happen to be standing next to them.
6.Where the particulate gets deposited in your body, did it hit the target? They float around until they collide with a cell with compatible receptors and receptor binding proteins.
a. Respiratory viruses that produce coughs, sneezing, mucous producing, headaches and fever, usually target the cells that line the respiratory tract or gut.
b. HIV targets Lymphatic T-Cells which is like taking out the security guard before robbing the bank.
7.As with chemicals ‘the dose makes the poison’. Arsenic can make your hair shiny or it can kill off an inconvenient witness. Same with viruses, where is the tipping point, the dose that gets you sick?
a. If you inhale, get deep into the lungs, Influenza A 0.7-3.5 Plaque Forming Unit, PFU’s, 50% exposed will get sick.
b. If the virus just gets into the nasal mucosa then you need 89-224PFUs to really feel it.
8.Where the virus laden particulate is deposited depends on the size of the droplet containing the virus which depends on how much water evaporates which depends on the difference in humidity between where the particle came from, nice hot moist body, and where you are, which is usually much less humid and colder.
Remember when hang time applied to footballs or basketballs, or how long an athlete stays in the air after jumping? Well, forget it, we’re safety professionals now. Hang time means how long an infectious particle will stay in the air where the people you are responsible for are exposed.
So, particle deposition depends on
a. Size, the larger the particle the faster it falls, contaminating some surface.
Evaporation makes the cells smaller.
Aggregation, viral particles sticking together makes them larger.
b. Smaller particles can stay suspended for several minutes to be inhaled and small enough to the target cells in your respiratory system.
Indirect, or Surface transmission
In some scenarios contact transmission is the most important route, in others it’s airborne infectious particles. Hands that touch contaminated surfaces can then self-inoculate you if you touch your face, the mucous membranes of the eyes, nose or mouth.
Factors influencing having enough viable infectious material on a surface to be transferred to your face or mucous membranes depends on several factors:
Strain variation, for example, one strain of COVID-19 is only viable on cardboard for 8 hours while the other one can transmit an infection within 24 hours. Since you cannot test every surface the time listed in the table is the longest.
The titer (concentration of virus) on the surface
The surface type.
The suspending medium
Mode of deposition
Temperature
Relative humidity
The test method, does the media the sample is transferred to have the right mix of nutrients for it to grow? If not, you get a false negative.
Some test methods will only tell you if it’s there, not if it is still infectious.
Assessing different responses for different countries.
United States’ CDC response to SARS
CDC worked closely with WHO and other partners in a global effort to address the SARS outbreak of 2003. For its part, CDC took the following actions:
Activated its Emergency Operations Center to provide round-the-clock coordination and response.
Committed more than 800 medical experts and support staff to work on the SARS response.
Deployed medical officers, epidemiologists, and other specialists to assist with on-site investigations around the world.
Provided assistance to state and local health departments in investigating possible cases of SARS in the United States.
Conducted extensive laboratory testing of clinical specimens from SARS patients to identify the cause of the disease.
Initiated a system for distributing health alert notices to travelers who may have been exposed to cases of SARS.
United States response to COVID-19, first case confirmed on January 21, 2020:
The CDC could not get tests approved by the FDA
The test developed by the CDC had “technical challenges”.
The FDA instructed laboratories that they could develop tests but not use them without first passing the FDA’s “approval, clearance, or authorization” process.
February 24th state government labs petitioned the FDA for permission to develop and use their tests.
The FDA permitted an emergency streamlining of the regulatory approval process and directed the labs to provide less paperwork for clearance, an EUA application.
February 29th the FDA allowed tests to be used provided the EUA application was submitted within 15 days. For more information see the JAMA article.
Initially the CDC limited testing to only those with known exposure.
March 3rd Vice President Pence instructed the CDC to remove limits on testing.
March 16th the FDA announced that it would allow states to over see state government developed tests.
The FDA has also allowed private sector companies a fast track to getting more COVID-19 test kits produced.
As of March 19th 71,000 people have been tested and there are more than 7,000 cases.
Thousands of tests are being tested by government health labs.
The tests will be used to spot new outbreaks and decide where to put resources.
In the absence of an ability to identify people who have COVID-19 or who have been in sufficient contact to have contracted COVID-19 cities and states are
Closing schools.
Posting attendance limits for meetings and entertainment.
Sports leagues are canceling events.
Restaurants are closed.
South Korea’s response to COVID-19, first case confirmed on January 21, 2020:
January 27th summoned representatives from over 20 non-government controlled medical companies to a conference where top infectious disease experts instructed them to develop and produce an effective COVID-19 test.
Fast tracked regulatory approval process.
February 3rd, less than 7 days later, one company’s test was approved and February 12th a second company’s test was approved
By March 19th over 290,000 people have been tested and spot checked the results to ensure the tests were effective.
This allowed them to aggressively track down and test anyone exposed to patients that tested positive.
South Korea has been removed from some country’s prohibited travel lists.
Italy’s response to COVD-19, first case confirmed on February 20, 2020 during the peak of their influenza cases along with an unusually high number of pneumonia cases.
February 21st the first person to person infection is identified.
The first country to ban flights from China. Which could have led to travelers coming by other routes and not disclosing they were at risk.
Italy has Emergency Medical System for cities like Milan and the Lombardy region and has created a screening process for patients presenting with COVID-19’s symptoms or from areas with known cases of COVID-19. They coordinate
Patient flow to hospitals and specialized facilities.
Address specific issues about bed resources and emergency department overflow.
March 8th the number of cases increased by 50%.
March 9th Italy placed residents, 60 million, on lockdown.
March 10th Italy has tested over 42,000 people, more than other European countries.
Italy has one of the oldest population in world.
It also has 24 of the 100 European cities listed on the Swiss air monitoring platform IQAir, 24
Italy has the largest outbreak outside of Asia.
Italy’s mortality rate was 4% on March 10th.
1Journal of Occupational and Environmental Hygiene, 2: 143–154 ISSN: 1545-9624 print / 1545-9632 online Copyright c 2005 JOEH, LLC DOI: 10.1080/15459620590918466 Toward Understanding the Risk of Secondary Airborne Infection: Emission of Respirable Pathogens Mark Nicas,1 William W. Nazaroff,2 and Alan Hubbard1 1School of Public Health, University of California, Berkeley, Berkeley, California 2Department of Civil and Environmental Engineering, University of California, Berkeley, Berkeley, California
2Viable Viral Efficiency of N95 and P100 Respirator Filters at Constant and Cyclic Flow Paul D. Gardner,1 Jonathan P. Eshbaugh,2 Shannon D. Harpest,2 Aaron W. Richardson,2 and Kent C. Hofacre2 1U.S. Army Edgewood Chemical Biological Center, Aberdeen Proving Ground, Maryland 2Battelle Memorial Institute, Columbus, Ohio Journal of Occupational and Environmental Hygiene, 10: 564–572 ISSN: 1545-9624 print / 1545-9632 online Copyright c 2013 JOEH, LLC DOI: 10.1080/15459624.2013.818228
3Chan KH, Peiris JS, Lam SY, Poon LL, Yuen KY, Seto WH. The effects of temperature and relative humidity on the viability of the SARS Coronavirus. Adv Virol 2011;734690.
4van Doremalen N, Bushmaker T, Munster VJ. Stability of Middle East respiratory syndrome coronavirus (MERS-CoV) under different environmental conditions. Euro Surveill 2013;18. pii: 20590.
According to the Chinese government’s statistics COVID-19 currently has 2% mortality rate, SARS was 10% and, the usual influenza mortality rate is 0.1%.
We live in a progressively “smaller” world. Before we could fly it would have taken months to travel to America from China. During the trip infections contracted there would have already played out or create an obvious need for quarantine upon arrival. Now you can fly almost anywhere in the world in less than a day, not including stop overs in crowded airports.
One of the reasons the Coronavirus called COVID-19 is so concerning is that the person is contagious up to 5 days before they even know they show symptoms. Some people are contagious and never develop symptoms. The CDC has established three tier categories based on distance from an infectious person.
Transmission of Infectious Material
1. From the inhalation or contact of germ laden droplets sneezed or coughed out from a person up to 6 feet away.
2. From surfaces such as tables, door handles, etc. that someone touches then transfers to their eyes, nose, or mouth, or to something that goes in their mouth.
For specific steps to reduce the transmission of airborne pathogens, viruses such as COVID-19, influenza strains and colds in your workplace go to the Simple Safety Coach blog.
The Four Major Stages of Disease
Incubation: invasion of the body by microorganisms and replication of the organisms causing infection.
Prodromal: symptoms are not very specific or severe, they are still walking around infecting people.
Peak: the worst expression of symptoms and discomfort.
Recovery: symptoms have almost completely gone, and the pathogen has been mostly eliminated from the body.
Influenza
The CDC states that flu season is from October to April and estimates that between 10/01/2019 – 2/08/2020 there have been:
26,000,000 – 36,000,000 flu illnesses
12,000,000 – 17,000,000 flu related doctor visits
250,000 – 440,000 flu hospitalizations
14,000 – 36,000 flu deaths, 0.1%
Contagious period: the day before symptoms appear until symptoms disappear and 24 hours after a normal temperature without the aid of medicine.
Note: you are still contagious when on medications for the flu.
Duration: a couple of weeks. Flu symptoms also come on much more quickly than colds, which tend to build up, like an orchestral crescendo. Which explains the pulsing headache.
Sources of exposure: droplets of moisture in the air on surfaces from sneezing or coughing.
Viability outside of the body: flu viruses on hard surfaces can cause infections up to 48 hours. They are infectious on the hands for 5 or more minutes.
Routes of transmission: inhalation of droplets, contact of droplets with the mouth, nose or eyes, and transfer of droplets from surface to the mouth, nose or yes via your hands.
Symptoms: – Fever or feeling feverish – Achy muscles, especially in your back, arms and legs – Runny or stuffy nose – Sore Throat – Cough – Chills and sweats – Weakness and fatigue – Headaches
Colds
Are caused by conventional human coronaviruses are not fatal without having additional factors making them more fragile than average.
Contagious period: the day before symptoms appear until symptoms disappear and 24 hours after a normal temperature without the aid of medicine.
Duration: 7 -10 days.
Sources of exposure: droplets of moisture in the air on surfaces from sneezing or coughing.
Viability outside of the body: cold viruses on hard surfaces can cause infections up to 24 hours. They are infectious on hands up to an hour.
Routes of transmission: inhalation of droplets, contact of droplets with the mouth, nose, or eyes, and transfer of droplets from surfaces to the mouth, nose, or eyes via your hands.
Symptoms: – Runny nose – Sore throat – Cough – Sneezing – Headaches – Body aches
2019 Novel Coronavirus, COVID-19
According to an NBC news article on February 12, 2020 “Chinese health officials said Wednesday the death toll from the novel coronavirus has reached 1,113. It stood at 1,016 the day before.
Officials at China’s National Health Commission said there were now 44,653 confirmed cases in mainland China.
More than 500 cases have been recorded outside mainland China so far – 2 of them fatal. One person died from the virus in the Philippines on February 1 and another in Hong Kong several days later.
Contagious period: the virus replicates prodigiously in the upper respiratory tract and individuals are infectious up to 5 days before symptoms appear. The coronavirus SARS-CoV, for example, was most infectious during the peak stage of the illness. COVID-19 symptoms can appear 2 to 42 days after exposure.
Duration: 7 – 10 days.
Sources of exposure: droplets of moisture in the air on surfaces from sneezing or coughing.
Viability outside of the body: flu on hard surfaces can cause infections up to 48 hours.
Routes of transmission: inhalation of droplets, contact of droplets with the mouth, nose, or eyes, and transfer of droplets from surfaces to the mouth, nose or eyes via your hands.
Symptoms: -Fever -Cough -Shortness of breath
There are 3 paths a COVID-19 infection has taken so far:
Mild illness with upper respiratory tract symptoms
Non-life-threatening pneumonia
Severe pneumonia with acute respiratory distress syndrome, ARDS The estimated fatality rate at this time is 1-2%, SARS was 10%. However, not all of the information required for an accurate fatality rate is available at this time.
Keep an eye on this Blog for 2 more articles:
Part One on the general characteristics and infectivity of viruses.
Part Two on how to decide on a safe distance (is it 3, 4, 6, or more feet?), PPE: protection or a new source of exposure, and safe and simple decontamination of surfaces.
