Coronavirus Technology Solutions
November 18, 2020

COVID is a Lottery Where You Want to Minimize the Number of Tickets

Lonza to Make Moderna Vaccine in the U.S. and Switzerland

EU Approves 4^th Contract with Pfizer

Sonovia Mask Relies on Anti-Microbials Rather than Sub-Micron Filtration

U.S. Death Toll Passes 250,000

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COVID is a Lottery Where You Want to Minimize the Number of Tickets

Covid is a lottery you want to lose. If you live in the U.S. you presently hold about 3% of the winning tickets to win a prize and about 0.5% of the tickets for the grand prize (death). These are not good odds. As a driver or passenger in a country with a 65 mph speed limit you hold 0.5% of the tickets to win the grand prize. But this is over an entire life time and not just six months.

We are willing to take the risks associated with automobiles because of the benefits. If we cut the speed limit back to 55 mph we would increase life expectancy by only a few months. So this is an acceptable risk. Our COVID strategy should be to reduce the number of winning tickets until they are comparable to automobile travel.

 Relative to masks the percent of winning tickets depends on

·         virus load

·         mask performance

·         mask use (in part a function of comfort and attractiveness)

McIlvaine has compared the combination of fit and efficiency to determine mask performance of CATE masks (Comfortable, Attractive, Tight fitting, Efficient) to cloth masks, surgical masks and loose fitting  N95 masks. CATE masks reduce the number of lottery tickets by seven fold vs the others if worn for identical times. If due to comfort and attractiveness CATE masks are used  more frequently this further reduces the number of tickets.

CATE masks can be supplied with various levels of efficiency. Normal leakage is 2% to 8%.  Media efficiency can be 90%, 95% or 99%. So with the highest efficiency and highest leakage you are equivalent to the lowest efficiency and lowest leakage.

Mask use is the other variable. When the virus load is high e.g. equivalent to the risk of traveling routinely at 100 mph everyone will want to wear a mask. But in a situation where the viral load risk is equivalent to traveling at 65 mph many people will discard their masks. If they are wearing comfortable and attractive masks they will be more inclined to wear masks at this risk level.

Mask selection needs to be made on this holistic basis with load, performance and use all considered. It is likely that most people will want multiple mask designs which are appropriate for different levels of risk.  The goal will be to match the mask selection with a risk level equivalent to the 65 mph speed limit.

Lonza to Make Moderna Vaccine in the U.S. and Switzerland

Swiss drug maker Lonza has partnered with Moderna and says it aims to produce 400 million doses of the vaccine annually. The U.S. firm is aiming for 500 million to 1 billion doses in total for 2021. Anyone receiving the vaccine will require two doses, as with Pfizer’s shot, showing how long it could take, with the current manufacturing capacity, to vaccinate internationally.

Lonza will produce ingredients within Moderna’s vaccine, formally called mRNA-1273, in facilities in the U.S. and Switzerland, where it is headquartered. Company Chairman Albert Baehny told CNBC about the “big challenges” facing drug makers like his when it comes to scaling up production.

“We can only produce more than 500 million doses a year if we install additional manufacturing lines, so it is clear that we need additional investments in installation if we want to produce more than 500 million (per year) in the future,” he told CNBC’s “Squawk Box Europe” on Wednesday.

Baehny identified more challenges to vaccine production that the company had had to confront since embarking on its partnership with Moderna.

“There are a few issues, the first is speed. We only started 10, 11 months ago and now we are producing the first commercial batches of the drug substance in North America, and we are planning the first batch of commercial volume in one or two weeks in Switzerland, so the speed has been a challenge.”

“The second challenge is to find the people. For each manufacturing line you need 60-70 educated persons. We’ve installed four manufacturing lines so you have to identify and train these people,” he said.

“Then linked to the speed (issue), you have to have access to the equipment, install the equipment, and then test your manufacturing facility, so (these are) big challenges, resolved, or almost resolved, in less than one year.”

Temperature, and keeping the vaccines cold enough during transportation, is another big challenge.

Pfizer’s vaccine requires a storage temperature of minus 94 degrees Fahrenheit, or -70 degrees Celsius. By comparison, Moderna said on Monday that its vaccine remains stable at 36 to 46 degrees Fahrenheit — the temperature of a standard home or medical refrigerator — for up to 30 days. It can be stored for up to six months at minus 4 degrees Fahrenheit.

“Those are standard conditions in the pharmaceutical industry,” Baehny said. “So I don’t see many problems for the distribution, for the shipping and for the storage of Moderna’s vaccine,” he said.

Lonza Biologics in Portsmouth NH has ramped up its production of the vaccine in anticipation of final approval for worldwide distribution.

"The Lonza Portsmouth site commenced production in July and began large-scale production at the end of September,” Lonza spokesman Glenn Myers said Monday.

“We can't say how much vaccine has been produced; however, our goal is to produce drug substance from our Portsmouth manufacturing suites for 100 million doses per year,” he added.

Lonza is also bulking up its workforce. “We have scaled up our production workforce with 70 dedicated employees with a plan to scale to 100 employees as quickly as possible," said Myers.

Lonza CEO Pierre-Alain Ruffieux offered his congratulations on Moderna’s phase 3 clinical trial data of its vaccine, called mRNA-1273.We are proud to support Moderna in the production of mRNA-1273. Our collaboration will allow for the manufacture of material equivalent to 400 million doses per year from Lonza’s facilities. Large-scale production began at our Portsmouth, U.S., site at the end of September and we are on track to begin production at our Visp, Switzerland, site before the end of the year,” Ruffieux said.

“With positive interim results from both Moderna’s and Pfizer’s mRNA vaccine candidates, we are witnessing a major step forward in the evolution of vaccine technology, with the potential to change the way we manage infection and disease in the future,” he added.

EU Approves 4^th Contract with Pfizer

The European Commission approved a fourth contract with pharmaceutical companies BioNTech and Pfizer, which provides for the initial purchase of 200 million doses on behalf of all EU Member States, plus an option to request up to a further 100 million doses, to be supplied once a vaccine has proven to be safe and effective against COVID-19. Member States can decide to donate the vaccine to lower and middle-income countries or to re-direct it to other European countries.

Today's contract with the BioNTech-Pfizer alliance builds upon the broad portfolio of vaccines to be produced in Europe, including the already signed a contracts with AstraZeneca, Sanofi-GSK and Janssen Pharmaceutica NV, and the concluded successful exploratory talks with CureVac and Moderna. This diversified vaccines portfolio will ensure Europe is well prepared for vaccination, once the vaccines have been proven to be safe and effective.

President of the European Commission, Ursula von der Leyen, said:  “In the wake of Monday's promising announcement by BioNTech and Pfizer on the prospects for their vaccine, I'm very happy to announce today's agreement with the European company BioNTech and Pfizer to purchase 300 million doses of the vaccine. With this fourth contract we are now consolidating an extremely solid vaccine candidate portfolio, most of them in advanced trials phase. Once authorized, they will be quickly deployed and bring us closer to a sustainable solution of the pandemic.”

Stella Kyriakides, Commissioner for Health and Food Safety, said: “A safe and effective vaccine is the only lasting exit strategy from the pandemic, and is at the centre of our European Vaccine Strategy. Today's agreement follows the encouraging first indications from the clinical trial results and is further evidence of our commitment to putting more Europe in the area of health. It is a very telling example of what the EU can achieve when working together, as a Union, and a case in point of what a future European Health Union will be able to deliver.”

BioNTech is a German company working with US-based Pfizer to develop a new vaccine based on messenger RNA (mRNA). mRNA plays a fundamental role in  biology, transferring instructions from DNA to cells' protein making machinery. In an mRNA vaccine, these instructions make harmless fragments of the virus which the human body uses to build an immune response to prevent or fight disease.

The Commission has taken a decision to support this vaccine based on a sound scientific assessment, the technology used, the companies' experience in vaccine development and their production capacity to supply the whole of the EU.

Vaccine doses for Europe will be produced in BioNTech’s German manufacturing sites, as well as in Pfizer’s manufacturing site in Belgium. If the BNT162b2 vaccine candidate receives approval from the European Medicines Agency (EMA), then doses will be ordered by the EU Member States who have elected to receive the vaccine as part of this agreement.

Pfizer’s manufacturing plant in Portage played a big role in the development of the vaccine but so far production is being limited to the Belgian site. Pfizer is headquartered in Manhattan. The company went through several hands going back to its roots as the Upjohn Company in Kalamazoo. The company reached a massive $2 billion deal with the U.S. government earlier this year, along with its joint venture partner in the vaccine, BioNTech. Pfizer is planning to produce as many as 100 million doses of the vaccine this year. Next year – that skyrockets to 1.3 billion doses. It is a two-dose vaccine. That makes production, distribution, and keeping track of jabs all the more important.

Sonovia Mask Relies on Anti-Microbials Rather than Sub-Micron Filtration

The SonoMask is made of a fabric impregnation of zinc oxide nano particles, which has proven to have a strong anti-viral effect in laboratory testing. The fabric has also been tested to successfully last throughout 55 wash-cycles, with a filtration rate of 5μm, in accordance with WHO guidelines. Tests by Taryag Laboratories showed more than 98% efficiency on 5 micron particles.  It should be noted that N95 masks are tested using 0.1 micron particles with efficiency rating being based on 0.3 micron particles. So the efficiency test method is not comparable. It claims high overall protection but this must be based on anti-microbial features rather than particle removal.

The Wall St. Journal wrote in May “Sonovia had been working toward selling machines and chemicals used to add antibacterial and antiviral properties to fabric, and it began manufacturing masks using the technology two months ago, said Liat Goldhammer, the company’s chief technology officer. The fabric used in the masks has been tested successfully on other coronaviruses, and Sonovia is awaiting the results of recent tests on the novel coronavirus. They have sold thousands of masks to consumers in the U.S. and have also donated thousands to hospitals in South Africa, Israel and Germany.

The sono-chemical coating methodology was developed in 2013 at the  Bar Ilan University in Israel. Sonovia’s team, which includes Chemistry Nobel Prize Winner Prof. Sidney Altman, and has used the company’s proprietary formula to significantly decrease the transmission and impact of hospital acquired infections globally.

The question is what impact the anti-viral nano particles have on small virus particles which pass through the mask. It would seem that there would be no contact or if there were contact it would be so brief as to not be meaningful. On the other hand the material could be effective on viruses captured by the mask. This could reduce surface transmission from the mask. 

Here is the comparison with other masks prepared by Sonovia.

Besides the efficiency concern another area of investigation is health impacts related to nanoparticles.  One researcher believes that this is an area where more study is needed.

U.S. Death Toll Passes 250,000

The United States passed a grim milestone on Wednesday, hitting 250,000 coronavirus-related deaths, with the number expected to keep climbing steeply as infections surge nationwide.

Experts predict that the country could soon be reporting 2,000 deaths a day or more, matching or exceeding the spring peak, and that 100,000 to 200,000 more Americans could die in the coming months.

Just how bad it gets will depend on a variety of factors, including how well preventive measures are followed and when a vaccine is introduced.

“It all depends on what we do and how we address this outbreak,” said Jeffrey Shaman, a Columbia University professor of environmental health sciences who has modeled the spread of the disease. “That is going to determine how much it runs through us.”

Back in March, when the virus was still relatively new and limited mainly to a few significant pockets like New York, Dr. Anthony S. Fauci, the top infectious disease expert in the country, predicted that it might kill up to 240,000 Americans.

It has now passed that mark, with no end in sight.

Since the very beginning, preventive measures like wearing masks have been caught up in a political divide, and that remains the case today, as the Trump administration resists beginning a transition of power to President-elect Joseph R. Biden Jr. and cooperating on a pandemic strategy.

New vaccines may begin to have an impact next year, experts said, and for now, developments in treating the disease as well as a younger population getting infected mean that far fewer people who are admitted to hospitals are dying. Infections are also being diagnosed earlier, which helps combat it.

The deadliest day of the pandemic in the United States was April 15, when the reported daily toll hit 2,752.

There is always a lag in deaths, compared with the rate of infection and hospitalizations, and with the latter measure now hitting records every day — 76,830 Americans were hospitalized on Tuesday, according to the Covid Tracking Project — the death toll is certain to go on rising.

Covid-19 deaths have continued their bleak march with little respite throughout the year.

By March 24, a little over a month into the pandemic, 50,000 people had died. That number doubled to 100,000 by May 27 and added another 50,000 within two months, by July 29. Two months later, on Sept. 22, the total reached 200,000.

Toward the end of the summer, the number of cases being reported daily in the United States eased, after a brief spike in July. But they have been soaring again since the beginning of November.

On Sept. 22, there had been somewhat more than 6.9 million total cases in the United States, according to a New York Times database. As of today, there have been more than 11.5 million.

The combination of the onset of winter, fatigue with preventive measures, holiday travel and gatherings as well as the patchwork of responses across all 50 states is expected to drive that number still higher.

“We have a lot of people who have not been infected with this yet,” said Dr. Shaman. “If you get complacent, the virus does not care. It is just going to come back.”