CATER Mask
Decisions
January 13, 2021
Coronavirus Likely to be Around Forever
South African Strain Could Pose a Threat to
Antibody Treatments
World Death Rate Accelerating
Two More Days to Submit a Proposal on Masks to
BARDA
_____________________________________________________________________________
Coronavirus Likely to
be Around Forever
The CEO of Covid-19 vaccine maker Moderna warned
Wednesday that the coronavirus that has brought
world economies to a standstill and overwhelmed
hospitals will be around “forever.”
Public health officials and infectious disease
experts have said there is a high likelihood
that Covid-19 will become an endemic
disease, meaning it
will become present in communities at all times,
though likely at lower levels than it is now.
Moderna CEO Stephane Bancel appeared to agree
Wednesday that Covid-19 will become endemic,
saying “SARS-CoV-2 is not going away.”
“We are going to live with this virus, we think,
forever,” he said during a panel discussion at
the JPMorgan Healthcare
Conference.
Health officials will have to continuously watch
for new variants of the virus, so scientists can
produce vaccines to fight them, he said.
Researchers in Ohio said Wednesday they’ve
discovered two new variants likely originating
in the U.S. and that one of them quickly became
the dominant strain in Columbus, Ohio, over a
three-week period in late December and early
January.
Pfizer researchers said its
vaccine developed with BioNTech appeared to be
effective against a key mutation in the U.K.
strain as well as a variant found in
South Africa.
Moderna’s vaccine has been authorized by
the Food and Drug Administration for use in
Americans who are 18 years old and
older. Additional studies still needed to
be completed in children,
whose immune systems can respond differently to
vaccines than those of adults.
U.S. officials are racing to distribute
doses of both
vaccines, but it will likely take months before
the U.S. can vaccinate enough people to achieve
herd immunity, meaning the virus won’t have
enough new hosts to spread. Still, Bancel said
Wednesday he expects the U.S. will be one of the
first large countries to achieve “sufficient
protection” against the virus.
There are already four coronaviruses that are
endemic across the world, but they aren’t as
contagious or deadly as Covid-19, according to
the World Health Organization.
South African Strain Could Pose a Threat to
Antibody Treatments
A mutated and more
infectious coronavirus strain first identified
in South Africa is “disturbing” and could pose a
threat to antibody treatments that are used to
prevent people from falling seriously ill from
Covid-19, White House health advisor Dr. Anthony
Fauci said Tuesday.
New coronavirus strains first identified in the
United Kingdom and South Africa have
caused some concerns among scientists who
say the mutated variants are highly infectious,
though they don’t appear to be any deadlier
compared with previous strains.
So
far, health experts have said there’s no
evidence the
mutations alter the effectiveness of current
vaccines. However, there’s some concern that the
variant found in South Africa, known as 501Y.V2,
might be more resistant to monoclonal
antibodies, which have helped some people fight
the virus when administered early on in their
infection.
Through discussions with health experts in South
Africa, Fauci said preliminary data shows
there’s “more of a threat” the strain would
evade some of the protections antibody
treatments provide.
“It could be having some impact on protection
for the monoclonal antibodies and perhaps even
for the vaccine. We don’t know that” Fauci,
director of the National Institute of Allergy
and Infectious Diseases, said during a Q&A
session at Schmidt Futures’ Forum on
Preparedness.
He
added that researchers in laboratories at the
National Institutes of Health and across the
country are quickly trying to determine the
possible impact of the strain found in South
Africa.
“People ask me, ‘Are you worried about it?’
These are not the kind of things I worry about,
but it’s the kind of thing that I take very
seriously,” Fauci said.
As
viruses spread, they’re expected to mutate over
time as the spikes on their surfaces change,
the Centers for Disease Control and
Prevention says. The
501Y.V2 variant gets its name from the
N501Y mutation found
in the spike protein that the virus uses to gain
entry into cells within the body.
This mutation is also seen in the variant U.K.
health authorities identified in December, known
as B.1.1.7. While both variants found in the
U.K. and South Africa shared the N501Y mutation,
they are different, according to the
World Health Organization.
Fauci has previously said the mutated Covid-19
variations could pose a risk to the coronavirus
therapeutics. Unlike vaccines, which trigger an
immune response that attacks different parts of
the virus, monoclonal antibodies target a very
specific component, Fauci told California
Gov. Gavin Newsom in
late December.
Eli Lilly Chairman
and CEO Dave Ricks told CNBC
earlier Tuesday that he expects the
company’s monoclonal antibody treatment to be
effective against the variant found in the U.K.,
though the one in South Africa could pose more
challenges. Eli Lilly’s drug was given emergency
authorization in the U.S. in November and was
followed by another drug from Regeneron.
“The South African variant ... is the one of
concern. It has more dramatic mutations to that
spike protein, which is the target” of these
antibody drugs, Ricks said on “Squawk
Box.” “Theoretically,
it could evade our medicines.”
The CDC has yet to identify any strains of the
501Y.V2 variant in the United States, though the
agency has found at least 72 cases with the
B.1.1.7 strain found in the U.K. as of Monday,
according to data from the CDC.
World Death Rate Accelerating
The United States reported more than 4,200
deaths Tuesday, bringing the nation’s total to
more than 381,000 deaths since the onset of the
pandemic, according to Washington Post
data.
The single-day death total, which is a record, and peak levels of new infections and hospitalizations are grim milestones for a country still reeling from the attempted insurrection at the U.S. Capitol last week.
President Trump has announced sweeping changes to coronavirus vaccine rollouts, quickly making all vaccine supplies accessible, encouraging states to provide shots to residents 65 and older and cautioning states with slow vaccine rollouts that they could lose some of their supply to faster-moving states.
More than 92 million people around the world
have been infected with the coronavirus since it
emerged in Wuhan, China, in December 2019 and
more than 1.9 million have died, according to
Post data.
Increasing infections, deaths and virus
mutations are pushing world leaders to implement
new approaches to quelling the impact of the
virus.
Switzerland on Wednesday announced firmer
restrictions aimed at slowing the spread of the
virus and its mutations, banning events and
closing restaurants and nightlife establishments
while avoiding a full
lockdown, Reuters reported.
“Infection rates are stagnating at a very high
level and with the new, much more infectious
virus variants, there is a threat of a rapid
resurgence,” the government said in a statement
to the news outlet.
Switzerland, which has had less stern
coronavirus measures compared with other
countries, has reported more than 487,000
coronavirus infections and more than 8,400
related deaths, according to data from Johns
Hopkins University.
Entertainment, sports, and leisure
establishments will remain closed until the end
of February.
In addition, Switzerland, which was the first
country in continental Europe to start
immunizing its citizens with the Pfizer-BioNTech
vaccine, will require companies to allow its
employees to work from home when feasible,
according to Reuters.
In Russia, President Vladimir Putin ordered mass
vaccinations beginning next week, Reuters
reported. Russia has recorded more than 3.4
million infections and nearly 62,000 deaths.
The country was hit with a second wave of
infections starting in September but refrained
from imposing a nationwide lockdown, opting for
focused restrictions, according to the news
outlet.
The threat of the variants emerging from the
U.K. and South Africa has erased the possibility
for German and Danish residents to see eased
restrictions. Health measures were set to relax
in Germany on Feb. 1, but Health Minister Jens
Spahn said the risk the U.K. variant could pose
could extend them for two or three
months, Deutsche Welle reported.
Germany will also require travelers from other
countries with high case counts to be tested
upon entering the nation, according to Reuters.
Concerns about infection rates grew among Danish
lawmakers as more than 200 cases of the new
variant had been verified in the country,
triggering leaders to extend its business and
gathering restrictions by three weeks, according
to the Local.
Prime Minister Mette Frederiksen told Parliament
on Wednesday that the extension of the
restrictions were needed to prevent spread of
the U.K. mutation.
https://www.washingtonpost.com/nation/2021/01/13/coronavirus-covid-updates/
Two More Days to Submit a Proposal on Masks to
BARDA
BARDA DRIVe, in partnership with the National
Institute for Occupational Safety and Health
(NIOSH), seeks to understand the barriers and
challenges associated with the next generation
of innovative mask designs. The Mask Innovation
Challenge is an initiative that aims to support
the development of innovative masks that can
protect Americans from respiratory pathogens.
Through the following Request for Information,
BARDA and NIOSH are soliciting input on judging
criteria and testing methodology for the Mask
Innovation Challenge, as well as identify
potential stakeholders that are interested in
supporting the challenge.
Interested parties should read the solicitation
in full and prepare a response to be submitted
to DRIVeComments@hhs.gov by 5:00PM
EST on 01/15/2021 for consideration.
McIlvaine Company has submitted a response as
shown below.
DEVELOPMENT OF EVALUATION CRITERIA
What do you see as the most important criteria
to evaluate the effectiveness of a community
mask that is to be used by the general public?
Examples might include assurance of consistent
fit, comfort, airflow resistance, ability to
protect the wearer and stop particles from
escaping the mask, cost, etc. .
Answer:
We are addressing these questions
on a daily basis in our Coronavirus
Mask Decisions.
One segment
has been grouped as CATER
which stands for Comfortable Attractive,
Tight fitting , Efficient, and Reusable. Another
group has been identified as disposable
efficient
and tight fitting.
Another group is disposable, efficient,
and loose fitting. A fourth group is disposable,
efficient, loose fitting but with a brace which
makes them tight fitting.
A fifth group is industrial respirators.
The most important criterion is to provide
everyone with tight fitting efficient masks.
This can be done within just a few months with a
combination of the above mask types and
initial heavy reliance on medical masks
made tight with a brace. The goal is to fit
everyone with a mask which has a FFE (fitted
filter efficiency) of 90%.
Extensive quantitative testing has shown that a
surgical mask with a brace can equal an N95
mask. An N95 mask can achieve a 98% fitted
filter efficiency. Billions of surgical masks
are being produced. If the wearers also used the
reusable brace they
could average 90% FFE. So 10% emission
from the transmitter and 90% removal by the
recipient means that he inhales only 1% of the
virus. This 99% virus reduction is more
protection than vaccines and would allow quick
return to normal activity.
McIlvaine has a forecast showing that a
combination of mask types can provide the
necessary protection worldwide. In the second
quarter there would be a need for 9 billion
surgical masks (Upgraded Disposable). Three
billion braces would be needed.
CATER mask production should accelerate to a
production rate of over 2 billion per quarter by
the end of 2022.
In addition, please provide feedback on the
following evaluation criteria: i.e.
Feasibility – Submission demonstrates a
reasonable rationale for the design of the mask,
intuitive design that can be used without
fitting or prior training and contains
components that are easily accessible.
Answer:
The combination will immediately provide
FFE 90 masks for everyone
Some brace and masks suppliers have up to five
sizes to insure a tight fit.
We are proposing safe bubbles where
everyone entering has to have an FFE 90 mask. We
have suggested developing
more qualitative fit testing protocols
including one using light leakage.
Operators of the Safe Bubbles are responsible
for limiting entrance to those who are wearing
the right masks appropriately.
Some Safe Bubble Operators such as large retail
stores and Fitness Centers can create revenues
by selling masks and providing qualitative fit
checks along with a certificate which will allow
individuals to access
other Safe Bubbles.
Innovation
- Submission advances the state of the art in
filtration efficacy, comfort, and utility of
masks used by the general public.
Answer: McIlvaine is providing a continuously
updated Decision Guide including innovations and
the discussion of those innovations in webinars.
·
Filtration Efficiency: Nanofibers, Membranes and
bicomponent non wovens offer media alternatives
to meltblowns. All of these are being analyzed
and reported in Coronavirus Mask Decisions.
The NY Times published a long article on
Chinese face mask media production and quoted
McIlvaine as a source.
·
Comfort:
McIlvaine created the acronym CATER
(Comfortable, Attractive, Tight Fitting,
Efficient, Reusable) to describe a class of
masks which protects immune depressed
individuals as well as the general public from
air pollution, wildfire some, pollen etc. More
than a decade of research has been undertaken to
achieve all the CATER attributes.
The performance of these masks is
detailed in Coronavirus Mask Decisions.
·
Utility: Medical masks with a brace which is
preferably one which is commercially available
but can be 3 rubber bands provides immediate
availability of FFE 90 masks for everyone.
CATER masks are
the long term solution but they can
slowly gain market share as production ramps up.
Barriers -
Submission addresses barriers and
limitations of currently available masks and
proposed innovations are based on scientific and
technical merit
Answer:
The combination of mask types will
eliminate the supply barrier. It will
start initially with those which are
available to meet FFE 90 but which are
not
as comfortable or attractive as desired.
These will be steadily replaced with CATER
masks.
Coronavirus
Mask Decisions also includes analysis of
technical phenomena not commonly understood.
For example, a cough droplet captured on
the interior of a medical mask will evaporate
and virus will escape around
the mask periphery.
Design and Desirability - Submission
demonstrates how the proposed solution meets the
needs of the users and shows how it could
integrate into production now or in the future.
Answer: Coronavirus Mask Decisions
is reviewing all the different designs. For
example, some reusable masks include insertable
filters. This extends mask life and reduces
cost. The designers of CATER Masks without
insertable filters cite comfort and utilitarian
advantages where the whole mask is the filter.
The use of antimicrobials can insure that the
mask surface does not become a transmission
source.
Mask cleaning is another subject which has been
continually researched and is important. Since
virus is inactivated after a period it is
possible to cycle masks. H2O2, alcohol, UV light
and other options are also available.
Mask fit is very important.
New quantitative and qualitative
measurement methods are being investigated.
Training courses need to be made
available. McIlvaine is initiating discussions
with educational institutions to create courses
on the subject. Physical therapists or trainers
at Fitness Centers could take the course and
insure that mask wearing expertise becomes
readily available.
TESTING PROTOCOLS:
Please provide feedback to NIOSH on the
following questions regarding performance
criteria and testing protocols for novel mask
designs. Please provide supporting rationale for
any suggestions submitted
For the evaluation of novel mask designs in a
laboratory setting, what performance criteria
would you recommend and how would you structure
a test? Examples might include criteria for
evaluation of fit factors, percent allowable
particle penetration through the filter
material, percent allowable particle
concentration escaping the mask, maximum
inhalation, and exhalation airflow resistance,
etc.
Answer:
All of these criteria are of importance
and addressed in Coronavirus Mask
Decisions.
Details are quickly available in key word
searches of the Daily Alerts and the
intelligence system.
When you click on fit, links to 117
articles appear
Search the Daily
Coronavirus Alerts
Enter one or more keywords to search for using
the Zoom Search Engine.
Note that '*' and '?' wildcards are supported.
Search for: Results
per page:
Match: any
search words all
search words
Search results for: Fit
117 results found.
12 pages of results.
Sorted by relevance / Sort
by date
1. McIlvaine
Coronavirus Market Alert
... Immediate
Opening of the Economy with CATER 95 Masks Here
are Some of the Many Fit Testing
Companies More Transmissible Virus Found in UK,
EU and SA Trane Revenues Up ...
Terms matched: 1 - Score: 310 - 22
Dec 2020 - URL:
http://www.mcilvainecompany.com/coronavirus/subscriber/Alerts/2020-12-21/Alert_20201221.html
2. McIlvaine
Coronavirus Market Alert
... Now
than Vaccines but Fail to Qualify the Term to
Mean "Efficient and Tight Fitting"
FDA will No Longer Review Chinese Masks for
Addition to the Approved List Qualitative ...
Terms matched: 1 - Score: 264 - 16
Oct 2020 - URL:
http://www.mcilvainecompany.com/coronavirus/subscriber/Alerts/2020-10-15/Alert_20201015.html
3. McIlvaine
Coronavirus Market Alert
... so
We Need the Safe Bubble Initiative New Methods
are Needed to Assure a Tight Fit on
Every Mask Worn in Public Suppliers of
Disposable Masks are Focused on Increasing
Production ...
Terms matched: 1 - Score: 212 - 4
Jan 2021 - URL:
http://www.mcilvainecompany.com/coronavirus/subscriber/Alerts/2021-01-04/Alert_20210104.html
4. McIlvaine
Coronavirus Market Alert
... Coronavirus
Technology Solutions January 11, 2021 Eliminate
COVID Now with Tight Fitting,
Efficient Masks Details on Mask Options are
Available from Fix the Mask Essential Mask Brace
is ...
Terms matched: 1 - Score: 185 - 11
Jan 2021 - URL:
http://www.mcilvainecompany.com/coronavirus/subscriber/Alerts/2021-01-11/Alert_20210111.html
5. McIlvaine
Coronavirus Market Alert
... Combination
of CATER and Upgraded Disposable Masks Supplied
Initially Lots of Sealing Options Determining
Mask Fit and
the Amount of Unfiltered Air Standard Masks
Result in Twice the Leakage When Worn ...
Terms matched: 1 - Score: 165 - 7
Jan 2021 - URL:
http://www.mcilvainecompany.com/coronavirus/subscriber/Alerts/2021-01-05/Alert_20210105.html
6. McIlvaine
Coronavirus Market Alert
... is
a Life and Death Decision CATER 95 Mask
Suppliers Have a Responsibility to Provide Fit Testing
Advice Hong Kong Masks Performance Evaluated
Ohio is Installing Some Devices Which May Not ...
Terms matched: 1 - Score: 164 - 24
Dec 2020 - URL:
http://www.mcilvainecompany.com/coronavirus/subscriber/Alerts/2020-12-23/Alert_20201223.html
7. Coronavirus
Alerts Table of Contents
... in
Weeks with High Efficiency Masks January 11,
2020 Eliminate COVID Now with Tight Fitting,
Efficient Masks Details on Mask Options are
Available from Fix the Mask Essential Mask ...
Terms matched: 1 - Score: 153 - 13
Jan 2021 - URL:
http://www.mcilvainecompany.com/coronavirus/subscriber/Alerts/TofC.html
8. McIlvaine
Coronavirus Market Alert
... Coronavirus
Technology Solutions October 7, 2020 Efficient
Tight Fitting Masks
are Needed to Beat COVID Supreme Court
Nomination Celebration was a Super Spreader
Event Increase the Effectiveness of Standard ...
Terms matched: 1 - Score: 145 - 7
Oct 2020 - URL:
http://www.mcilvainecompany.com/coronavirus/subscriber/Alerts/2020-10-07/Alert_20201007.html
9. McIlvaine
Coronavirus Market Alert
... Function
of Face Mask Effectiveness Particle Size is
Important but not Completely Quantifiable A
Tight Fit is
Just as Important as Media Filter Efficiency
Determining Mask Fit and
the Amount of ...
Terms matched: 1 - Score: 140 - 4
Dec 2020 - URL:
http://www.mcilvainecompany.com/coronavirus/subscriber/Alerts/2020-12-03-04/Alert_20201203-04.html
10. McIlvaine
Coronavirus Market Alert
... Stepping
on a Foot Sanitizer Mask Choices for the
Pandemic Media Starting to Analyze Mask Fit and
Its Importance ____ Efforts Needed to Reduce
Risk of COVID Evolving to Resist ...
Terms matched: 1 - Score: 136 - 12
Nov 2020 - URL:
http://www.mcilvainecompany.com/coronavirus/subscriber/Alerts/2020-11-12/Alert_20201112.html
Result Pages: 1 2 3 4 5 6 7 8 9 10 11 Next
>>
If
BARDA were to require prototypes to be submitted
for evaluation, how many individual prototype
samples should be evaluated?
Answer: It is one task to evaluate a prototype
from a few samples. It is an entirely different
task to determine the performance of all the
masks being produced. There are a number of
quality control consultants already engaged in
validating masks at manufacturing facilities
around the world.
These companies need to be continually
providing insights on the quality control
challenges.
This is a role undertaken in
Coronavirus Mask Decisions.
What other factors or experiences with
general-use masks do you consider important to
this mask challenge that you want BARDA and
NIOSH to be aware of?
Answer: The challenge to provide tight fitting
efficient masks for everyone extends far beyond
the U.S.
If all Americans were wearing tight
fitting and efficient masks the pandemic would
be temporarily over.
However, flights from overseas would
result in new outbreaks.
Economists have shown that eliminating
the pandemic in Africa and Asia can be justified
just on economic cost.
The CATER Mask can be an elegant solution
in the U.S.
Medical masks with DIY braces may have to
suffice in poor countries but they will be
effective.
CATER masks are already widely used by those
with health problems and for those living in
wild fire areas. The greatest present use is
where ambient air pollution is
high. There will be a continuing need for
this protection.
Also courtesy masks will continue to be
needed.
The average person has two colds per year
each lasting 10-14 days.
PARTNERSHIPS
What
sectors or stakeholders should BARDA engage as
part of these efforts?
Answer:
Engagement should extend to associations,
governments, fiber suppliers, media
manufacturers,
mask manufacturers, antimicrobial
suppliers, quality control consultants,
suppliers of particulate measuring
instrumentation, fit testers, and end user
groups from fitness centers to schools.
Meat processors and other industrial end
users should also be involved.
McIlvaine has identified decision makers
at many of these entities and is conveying their
insights in the Alerts and in periodic webinars.
The next webinar is on January 21 and involves
the broader goal of achieving mask goals
in the short term
If there is an opportunity for sponsorship, is
your organization interested in participating as
a potential sponsor? If yes, what are the
capabilities of your organization in support as
a potential sponsor?
Coronavirus
Mask Decisions covers all masks for
public use.
It is presently a free service with Daily
Alerts, webinars and an intelligence system with
links to relevant papers. It can be accessed at
http://www.mcilvainecompany.com/CATER/subscriber/default.htm
McIlvaine is willing to partner with BARDA in a
range of ways. At a minimum it could include all
data as directed by BARDA in the system.
At a maximum
Coronavirus Mask Decisions
could be become a government owned initiative
with McIlvaine as
sub-contractor as directed.
Would your organization be interested in joining
a list of experts that may provide mentorship to
challenge winners?
Answer: Yes
Would your organization be interested in serving
as a marketing partner and provide marketing and
outreach as part of the challenge competition
including posting on websites, social media, and
other outlets
Answer: Yes
McIlvaine has capabilities well beyond
the those involving
Coronavirus
Mask Decisions. It has databases and reaches
100,000 people around the world
who have air, water, and energy
interests.
A number of contracts have been executed
with U.S. and other governments relative to
environmental issues.
Bob McIlvaine was hired by EPA to testify
before senate sub committees relative to SO2
emissions and solutions.
He was also a director for 25 years of
the Institute of Clean Air Companies
McIlvaine works closely with associations. The
feature article by McIlvaine in the upcoming
issue of International Filtration News is
on masks. This publication is owned by INDA
(association of non-woven manufacturers).
McIlvaine writes feature articles each month for
more than seven publications.
In addition it has more than 50 of its
own publications.
