McIlvaine Coronavirus Market Ale

The U.S. is shaping its mask strategy. In the Alert yesterday we proposed what could be called the “incidentally Humanitarian U.S. Mask Strategy.

It is a two stage program. In the first stage U.S. mask suppliers are encouraged to greatly increase production of effective masks to meet the near term needs. As the need wanes in the U.S. the government would issue coupons to poor countries and allow them to obtain masks from U.S. suppliers.

Why is it in the self-interest of the U.S to pay for masks in poor countries for the next five years?

1. A long term market is created for the mask and media suppliers. They can switch from domestic sales to exports as the domestic market subsides.

2. The improved economies and supply of goods to the U.S and purchase of goods from the U.S. by poorer countries will more than offset any mask subsidies.

3. New variants and even strains of the virus will be prevented from being transmitted from poor to wealthy countries.

4. Wealthy countries need to be prepared for the next pandemic with sufficient supply capacity.

One of the problems in creating a national stockpile of masks for use in a future pandemic is that masks deteriorate over time. A second problem is that it would be prohibitively expensive to invest in idle reserve capacity. 3M thought they had made a sufficient investment but did not conceive of a demand at the current level.

The way to protect the U.S. from future pandemics is create a robust long term mask market including:

· promote the use of masks to protect from air pollution, influenza, wildfires, and other airborne contaminants

The U.S. short term need in mask hours is three times greater than the medical need. So we set up a chart where the present medical demand = 100. The present public demand is set at 300 . total demand is 400.

Present U.S. production for qualified public and medical masks is only slightly above the medical mask production and less than 30% of the total demand.

By the 1^st quarter 2022 production exceeds demand by 5. So a small amount could be exported. By the 4^th quarter 2022 production exceeds demand by 135. So this amount could be exported. It is slightly more than the present U.S. production.

By the end of 2022 U.S production would be close to four times greater than at present. There will be a continuing supply of coupons to poorer countries who will not achieve herd immunity until 2024-2027.

The result will be a very large market for U.S. made masks which will continue for at least the next four to five years.

There are no longer five options for public masks. Inefficient loose fitting cloth masks will quickly be unsalable now that the ASTM standards have been published. This leaves four choices.

McIlvaine has used the N95 as the yardstick by which to measure the others. But there are negatives to the N95 as covered in a JAMA article.

https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2769441

Here are excerpts from the report “Importantly, the effectiveness of any mask also depends heavily on its real-world use; variability in mask filtration during clinical care may fluctuate more by mask adherence and fit than by marginal differences in laboratory-based filtration efficiency. In practicality, when worn properly, N95 masks are suffocating, uncomfortable, and difficult to tolerate for long durations. Best practices for N95 use require intermittent, individualized fit testing and a seal check on donning. Mask fit varies by facial shape and body habitus, and thus, once fit tested, ensuring fidelity to the same manufacturer and size is essential. Filtration efficiency of an N95 mask can also be compromised by even small amounts of facial hair in the area of the seal. Prolonged use of tightly fitting masks may result in facial bruising and abrasions,

“Costs have been a major challenge in procurement of adequate mask supply, with prices increasing in some cases up to 30- to 100-fold.⁷ Outside of pandemic conditions, surgical and N95 masks generally cost approximately $0.08 and $0.50 each, respectively. Standard pricing for KN95 masks, which are generally not sold in the United States, is unavailable, but they have been sold during the crisis from $2 to $4 per mask”.

These masks have been extensively covered in the Alerts. They have all the advantages except availability and cost. It is likely that higher income individuals will choose them despite cost.

These have been covered in a number of Alerts. When you search under the key word “brace” you access 20 articles including

... , Efficient Masks Details on Mask Options are Available from Fix the Mask Essential Mask Brace is Effective and Inexpensive University of Iowa Researchers Find That a DIY Mask Brace is ...

... masks is up to 90 days. A $2 upgraded surgical mask with a brace might have an FFE above 85% . The brace has potentially 1 year of ...

In the February 3 Alert we wrote this about the TMS masks, “The general Consumer Series single-use face masks are designed to provide enhanced coverage with a more comfortable fit. They are wider than the average mask, reducing the gap between the edge of the mask and the ears. The nose bridge is built with higher ductility, allowing it to bend more easily and stay in place without discomfort. The ear loops on their masks are created with a thicker, more comfortable material that has been tested to stretch to two-and-a-half times the original length without losing elasticity.”

Comfort and attractiveness are independent variables but efficiency of virus removal is a combination of media capture and limitation of in leakage. Furthermore this in leakage is a function of the way the mask is worn and by whom.

Many cloth masks have fitted filter efficiency (FFE) ratings which are below 20%. A poorly fitted N95 might have an FFE below 70%. A loose fitting surgical mask could have an FFE below 60%. A poorly fitting CATER mask can have an FFE below 70%.

The big difference between the four options is the in leakage and not the filter media penetration. In the case of particulate media capture the differences are all within a 10% range. The in leakage can be a difference of 40%. So the choice of mask types is highly dependent on the fit.

The ASTM standards have now been published and are likely to completely change the way masks are selected. the fact that a label with the following information on it will be displayed with each mask is very powerful. In the example a mask with 60% filtration efficiency is labeled both to show that it meets the standard but also how it is better than the minimum. The example of sunscreen has been used to illustrate the advantage of showing higher performance.

There is also a graphic option which shows the range and the performance of the specific mask.

In order for manufacturers and brands to say their face mask meets ASTM’s standard, they have to prove it. Here’s how it works: Brands and mask makers are required to test their face coverings in accredited labs. The tests certify that the masks adhere to ASTM’s guidelines.

Manufacturers also have to complete a conformity assessment indicating that face coverings labelled as ASTM-compliant have met all of the requirements of the standard, including design criteria, performance criteria, test methods, labelling and user information.

One area which needs industry input is fit or in leakage. Here is what is in the standard relative to fitness.

“Design criteria include setting minimum areas of face coverage over the wearer’s nose and mouth, prohibiting open vents or valves, requiring a means for retaining the barrier face covering on the wearer’s head, and providing a representation of product sizing. Manufacturers are further required to perform a design analysis for assessing leakage of exhaled air from the barrier face covering. Manufacturers are permitted to conduct quantitative testing as specified in this standard to supplement the design analysis.

NOTE 3—The principal performance criteria for barrier face covering determined by testing are sub-micron particle filtration efficiency and airflow resistance. Quantitative leakage assessment testing is optional for information purposes and is not required. This testing is not likely to be representative of outward leakage from the barrier face covering and should not be claimed to represent the amount of source control offered by the face covering. Bacterial filtration efficiency testing is also optional and not required. It is significantly different than sub-micron filtration efficiency, and the results of BFE testing cannot be interchanged or directly compared. The scope of this standard does not include accessories to barrier face coverings.

4.1.3 Sub-micron particulate filtration efficiency and airflow resistance do not account for the leakage of air around the perimeter of the barrier face covering. A leakage assessment using a design analysis of the product is required to assess the ability of the barrier face covering design to provide appropriate coverage for a range of wearer faces of different dimensions. The design analysis can be conducted by the manufacturer in a number of different ways. The standard also permits the supplemental use of quantitative information obtained from a modified form of Test Method F3407 using test subjects. This test yields a reportable ratio of outside particulate concentration to the concentration of particles in the wearer’s breathing zone. Thus, a leakage ratio of 1.0 indicates the outside and inside environments are equal and that particulates flow through gaps in the barrier face covering (in addition to any particulates that pass through the filtration materials of the mask).

Fit (leakage) is a complex subject and involves facial features and wearing habits as well as quantitative tests. It is asking too much of a standard to rate fit in the same way it does particulate efficiency.

The ASTM standards provide a measurement structure and while not providing a fit (leakage) standard they do indicate the importance of a good fit. It is then up to experts to make comparative leakage assessments. They in turn need to communicate these findings to the media.

Let’s use the example of sunscreen and compare it to masks as rated by Consumers Reports.

For sunscreen “Consumer Reports uses a testing protocol that is modeled on the one the Food and Drug Administration (FDA) requires sunscreen manufacturers to use. But as is the case with other products we test that have government or industry standards, we use those standards as benchmarks and develop our own methodology to identify differences in performance and give consumers a comparative evaluation.

We test only sunscreens with a listed SPF of at least 30 and are water-resistant (for 40 or 80 minutes, the two time periods the FDA permits water-resistance claims for). We buy the sunscreens for our tests off the shelf, the way consumers would and use three samples, preferably with different lot numbers, of each product.

Each sunscreen is rated on three criteria: SPF, variation from SPF, and UVA protection. In addition, CR's trained sensory panel evaluates the scent and skin feel of the products.”

Can CR do the same type of evaluation on mask fit? CR is already anticipating the ASTM standards and has zeroed in on the importance of fitness.

CR advises “ASTM International, an organization that facilitates the creation of standards for a wide variety of products, is working on developing a standard for the design, performance, and labeling requirements for face coverings. But until that standard is released, a few tips can help you figure out how to make sure you’re adequately protected.

“Wear the most protective mask you possibly can, every single day,” says James Dickerson, the chief scientific officer at Consumer Reports. “Don’t skimp.”

“The right fit can go a very long way even with just a simple cloth mask,” says Monica Gandhi (who participated in the last McIlvaine mask webinar). A mask should have a sturdy nose wire, to help the mask fit the natural contours of your face.”

“But there are other tweaks you can make to improve the effectiveness, adds Philip Clapp, Ph.D., a post-doctoral researcher at the Center for Environmental Medicine, Asthma, and Lung Biology at the University of North Carolina at Chapel Hill and co-author of the December JAMA study.

“For instance, his study found that simple steps like tightening ear loops (either by tying them or fastening them with a claw-type hair clip placed behind the head) and tucking in side pleats significantly improved a surgical mask’s filtration rates. “Anyone can do that in 15 seconds, and it doubles its efficiency,” he explains.

“The new study from the CDC reinforced Clapp's findings. It found that a surgical mask with knotted ear loops that’s tucked in on the sides to create a tighter fit reduced exposure for the wearer by 64.5 percent if a simulated cougher was unmasked, and by 95.9 percent if both the cougher and the receiver were wearing these modified, snugly fitted surgical masks.

“To make sure your mask is snug enough, Clapp advises that you try this simple self-test: Cup your hands around your mask and see if you can feel the places where air is escaping. “You also don’t want to see gaps around your nose, the sides of your cheeks, or under your chin,” he says. If you do, you'll want to tighten up”.

“Ultimately you want all the air you inhale and all the air that you exhale to go through some sort of filtration device,” says Dickerson. “If it doesn’t—if it goes out the sides or through a vent—then you might as well not be wearing a mask.”

So we have to give Consumer Reports lots of credit for being current on both the ASTM standards and the need for ratings which are inclusive of all the important parameters.

So the industry has its work cut out for it. It has the ASTM standards as a measurement structure. It now needs to help experts and media such as Consumers Reports rate masks holistically and fairly. One of the tools will be this CTS publication

When will the pandemic end? It’s the question hanging over just about everything since Covid-19 took over the world last year. The answer can be measured in vaccinations.

Bloomberg has built the biggest database of Covid-19 shots given around the world, with more than 119 million doses administered worldwide. U.S. science officials such as Anthony Fauci have suggested it will take 70% to 85% coverage of the population for things to return to normal. Bloomberg’s Vaccine Tracker shows that some countries are making far more rapid progress than others, using 75% coverage with a two-dose vaccine as a target.

Israel, the country with the highest vaccination rate in the world, is headed for 75% coverage in just two months. The U.S. will get there just in time to ring in the 2022 New Year (though North Dakota could get there six months sooner than Texas). With vaccinations happening more rapidly in richer Western countries than the rest of the globe, it will take the world as a whole seven years at the current pace.

Bloomberg’s calculator provides a snapshot in time, designed to put today’s vaccination rates into perspective. It uses the most recent rolling average of vaccinations, which means that as vaccination numbers pick up, the time needed to hit the 75% threshold will fall.

The calculations will be volatile, especially in the early days of the rollout, and the numbers can be distorted by temporary disruptions.

For example, New York’s target date was briefly pushed out to 17 months this week after a winter blizzard prevented some from getting vaccinated (it’s now back down to 13 months). Likewise, Canada’s vaccination rate dropped by half in recent weeks following reports of delayed vaccine shipments. Based on Canada’s latest rate of inoculations it would take more than 10 years to reach 75% coverage. That might serve as a wake-up call to Canadian politicians and health officials, but it doesn’t mean the country is doomed to a decade of social distancing. Canada has contracts to buy more vaccine doses per person than any other country, and its vaccination rates are expected to climb.