January 19, 2022

Volume 4 | Issue 3

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"Let us not go back in anger or forward in fear, but around in awareness".  James Thurber’s words from 70 years ago ring clear today.  We will use them as our new mantra.  In that spirit - we share this information and analysis.  

Cases.  The numbers continue to increase, but the rate of increase seems to be slowing a bit, especially on the East Coast. The Boston wastewater data shows an approximately 55% decline since January 5th.  We saw that type of dramatic decline in South Africa and the UK.  Too early to say whether we have seen the national peak in the US.  

Comparison with Flu.  We continue our work from last week comparing Omicron and the Flu. See inside the Newsletter for details and chart - but the summary is good news.  

• Hospitalization rate: ~3.5% with Omicron but still ~ 2.5x the flu average of 1.5%

• Overall case fatality rate: 0.45% with Omicron, but still ~ 4x the flu average of 0.12%

• Hospital case fatality rate: 9.5% with Omicron is still above the flu average of 8.1%. But this analysis includes both vaccinated and unvaccinated people. Multiple states and cities’ analysis show that hospitalization case fatality rates are 10 to 15x higher for unvaccinated.  That is consistent with the vaccinated having no greater risk of death from Omicron than they do from the flu.

Even with that optimistic data, we can’t forget COVID’s persistent challenges: COVID is far more contagious and far more unpredictable than the flu.  

See inside for more including details on the first antigen test manufacturer contracts for the Biden administration’s initial 500 million free test initiative.

January 12, 2022

Volume 4 | Issue 2

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We are trying not to be dramatic - but hard to stay calm when yesterday at least 760,000 people learned that they have COVID. True, Omicron is less severe on average - but there is no way our health-care system can adequately manage when that many people are getting sick every day. 

So - we dig back into numbers, with the caveat that while we believe that the numbers are directionally correct - there is likely dramatic undercounting in almost every category. 

#1.  Cases. We say at least 760,000 people because we know that a substantial number of people - especially those home testing - are not reporting positive results. (Half of the US does not have a primary-care physician, further complicating reporting.) How much undercounting?  Some say by as much as 60%. Our best guess is 20%. 

#2.  Testing. Almost 2 million tests (virtually all PCR) are reported daily.  We are increasing our unreported test estimate to 5 million tests per day.  Why?  For the last few months, corporate buyers and distributors were purchasing tests in anticipation of back-to-the-workplace testing. Many of those tests are now going directly to employees at home and being used now.  

#3.  Flu comparison. The most common refrain is that now COVID is "just a flu.” Let’s indulge that for a moment. How does COVID compare?  See graph inside Newsletter for details but high-level conclusions are that COVID has: 4x the hospitalizations / 4x the infectiousness and 10x the death rate compared to the 2017 / 18 flu season - one of the worst in recent years.  Too early to have conclusive severity data for Omicron but in New York City, Omicron’s hospitalization rate for the unvaccinated is 11x higher that of the unvaccinated.

Late breaking - a new pre-print from University of California on antigen vs. PCR testing for Omicron and the Biden Administration’s increased support for K-12 schools. Key insights inside Newsletter.  Lastly - the Arizona State University Testing Commons just published its Year in Review 2021.  Presentation attached and will soon be posted at TestingCommons.com.  

January 5, 2022

Volume 4 | Issue 1

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Welcome to 2022 - Pandemic Year 3 - which Time Magazine has dubbed The Year of the Test.  Since Pandemic Year 1 - we have looked at COVID testing related numbers - but then came Omicron, bringing numbers so high as to be almost unbelievable.  However, in the midst of the challenges - there is still good news.  Might Omicron be the beginning of the end?  

The numbers:  

Test Positivity Rate

- 18% nationwide, 33% in New York City, 37% in Arizona and other states 

Cases

-  547,000 average daily case count nationwide for the last seven days  (218% of last winter’s peak)

Hospitalizations

- 101,000 per day (74% of last winter’s peak) 

Deaths 

- 1,200 per day (39% of last winter’s peak) 

Tests 

- 1.7 million tests reported each day, almost all PCR

- 4.0 million tests unreported each day, almost all antigen

Test Capacity 

- 526 million in antigen rapid test capacity by the end of March - not enough and not soon enough but positive momentum (more inside) 

CDC isolation policy 

- Five days in isolation with zero negative tests required and zero differentiation between vaccinated/boosted and un-vaccinated (more inside)

Omicron vs. Delta 

- Omicron 200% more contagious than Delta

- Omicron 60% less likely to cause hospitalization than Delta 

- Omicron 75% less deadly than Delta 

The good news:  

Omicron infects bronchial cells more than lower respiratory tract / lung alveolar cells = more coughs, more airborne transmission, but fewer deaths. Omicron appears to provide some immunity against Delta. Omicron’s death rate for the vaccinated is approaching seasonal flu.  If it continues its current rapid speed of infection, might natural immunity plus vaccine immunity get us to our off-ramp from pandemic and on-ramp to endemic?  

So, let’s raise a swab to 2022.  Stay well or recover quickly -

December 22, 2021

Special Update

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Just when we thought it was safe to go into the water - Omicron came along.  For many reasons, looks like another end-of-year holiday season without free and unfettered fun. And another holiday week that we simply couldn't let pass without at least a brief e-mail only update.

First - let’s talk about Omicron. As you no doubt have heard, the CDC announced that Omicron is responsible for 73% of new cases in the US as of yesterday. To give some perspective: It took 12 weeks for Alpha to become the dominant strain in the US, and it took Delta four weeks. Omicron became the dominant US strain in two weeks flat.  It is “crazy contagious.”  243,619 new cases today alone.  We are hopeful but need more time and experience in the US before pronouncing Omicron as sustainably less severe.   

But amidst the clear challenges, there actually is some real reason for optimism, coming from the FDA and the White House:

--  President Biden announced that the Federal government is purchasing 500 million at-home rapid COVID tests that will be distributed for free to Americans who want them. Great news, but details needed on how and where they will be distributed, how fast, over what time period - and how this volume of tests is being sourced.

--  FDA authorized Pfizer's Paxlovid pill to be taken at home to prevent the worst effects of the virus.

--  FDA announced initial results on antigen testing vs Omicron: "Our RADx partners are currently evaluating the performance of antigen tests with patient samples containing live virus, which is the best way to evaluate true test performance. While the patient samples with live virus were being acquired, initial laboratory studies have been conducted with heat-inactivated samples, and the results have indicated that the antigen tests studied are able to detect omicron."

-- FDA provided draft guidelines for how EUA test holders can transition to full marketing approval. Timing: public comment on these guidelines are open until February 22, 2022.  Four important points from our quick review: 

1.      All issued EUAs will become null and void on a specific date yet to be determined. FDA needs to see a transition plan for either withdrawing from the market or seeking full approval.

2.     FDA will control the date when EUAs will become null and void. This will not be the same date on which HHS declares the Public Health Emergency (PHE) over – manufacturers will have more time beyond that date. 

3.     If a manufacturer plans to withdraw, a transition plan is required. However, a recall of distributed product will not be required.

4.     If a manufacturer submits and FDA accepts receipt, the EUA effectively continues beyond the EUA termination date under the pre-existing EUA until FDA takes final action.

That’s all for now - we will be back on January 5, 2022 - unless we have another big news week - next week. 

A holiday blessing in the time of COVID:  

May your boosters be bold, 

Your masks be meaningful,

Your hands be hygienic, 

And 

Your tests be negative 

December 15, 2021

Volume 3 | Issue 21

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At the end of each year, it is natural to take stock of the past and look to the future.  Here’s our take on 2021 and what we envision for 2022.  

• We are Sad and Grateful:  This week marks 50 million infections and 800,000 deaths in the US alone.  We remember those who have died, those who suffered, and those who are still suffering from COVID.  We also honor all of our essential workers - from those who are delivering direct health care and the science that goes into fighting the virus to those who are providing indirect care - including police, fire, sanitation, our educators  and more - to the many, many people who must show up in person every day to do jobs that many of us have long taken for granted - grocery-store workers, people keeping the supply chain moving, cashiers, restaurant workers, and so many others.  

• We are Disheartened:  Why has COVID become so divisive?  We understand the stress and loss of control, and yet - this virus is the first truly global threat that most of the people alive on this planet have ever faced. How is it possible that we have been unable to gather together against this common enemy? Our actions have allowed it to disproportionately impact some communities, and our lack of willingness to present a unified front has allowed the virus to mutate unchecked. SARS-CoV-2 does not know or care who we are and what we believe. If we continue to debate winners and losers - we will all lose. 

• We are Hopeful:  For the last year, we have advocated and occasionally even pleaded for more focus on testing. We believe that, finally, testing is front and center as part of the fight against COVID.  We see this from the White House, State Houses and houses on Main Street.  Most everyone now accepts that testing can help take back control from the virus.  

• We are hopeful that Omicron is indeed less severe than Delta despite its increased transmission rate and potential challenge to vaccines. We are hopeful that the Pfizer oral treatment is indeed as good as it looks in the trials.

• Like the 1918 pandemic, the second year of COVID was worse than the first. We hope that the third year will see this scourge fade into a disease that no longer threatens our health-care systems or upends our lives. But getting to that point will require more work. In 2022, we look forward to discussing how to wind down COVID into an endemic state and how to wind up preparations for better protection and response against infectious disease in the future. 

See more news, test capacity analysis and commentary inside.

December 8, 2021

Volume 3 | Issue 20

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Frustrating.  That is the word of the week, the month, the year. 

• Public health professionals are frustrated with the politicization of responses to this worldwide emergency. 

• Anti-vaxxers are frustrated that government or employers are telling them what to do, and the vaccinated are frustrated with the vocal and non-vocal anti-vaxxers wasting what might have been our best chance to eliminate COVID.  

• Test users are frustrated by the lack of broadly accessible and available tests. Testing companies are frustrated with the unpredictability of demand and the need to continue to have the PCR-vs-antigen debate. 

• Everyone is frustrated with masks: 50% say "hell no” while the other 50% are buying N95s and saying “cover your nose too.”

• And the seeming constant uncertainty is certainly frustrating for all of us. 

What to do - clearly no easy answer.  As we approach the end of 2021 and the two-year anniversaries of many COVID milestones, we need to either embrace an integrated approach to testing and surveillance or give up and live with COVID on the virus’s timeline. Yes - harsh language but necessary now. 

Inside the Newsletter: A focus on wastewater as a critical testing tool, the results of the NBA’s extensive player-testing program and a new Omicron sub-variant.

December 1, 2021

Volume 3 | Issue 19

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Hope that everyone had a good holiday weekend with at least some time away from the computer, thinking about something other than COVID - at least until Omicron arrived.  

Today, we are focused on the reality of what we know and what we don’t know about this latest Variant of Concern.

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• It is too early to draw conclusions about its transmissibility or virulence.

• It is too early to draw conclusions about current vaccines’ ability to protect against it.

• Most tests, whether PCR or antigen, should be able to detect it.

We are also focused on what the US needs to do - and has needed to do for some time - regardless of Omicron's or other variant’s presence. The US should conduct more genomic sequencing and report it systematically - both nationally and to the international database of sequences, GISAID.  

November 17, 2021

Volume 3 | Issue 18

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Another Thanksgiving. Most of us thought that this Thanksgiving would be COVID-free and cranberry-heavy. Alas, while cranberry levels may vary, the COVID news definitely continues to be heavy, and comes in several different flavors.

• Let’s start with the Sour - about how successful fake news has been. According to a recent survey by the Kaiser Family Foundation, 78% of American adults say they have heard at least one of eight different false statements about COVID-19, and that they either believe it to be true or are unsure if it is true or false. One-third (32%) of all adults believe or are uncertain about at least four false statements. Equally sad, no news source engenders the trust of more than 50% of these adults. Traditional networks get the highest ratings, at 47%. 

• Bitter News - National case numbers are up again, significantly in 21 states. In 14 states, ICUs are close to capacity again. We are not quite ready to call this the holiday surge, but it will only take two more weeks at these rates to give it that designation.  Europe is clearly already in their fourth surge.      

• Sweet News - Rapid tests have been a little easier to find, and we predict that availability will be up significantly before Christmas.  Also, lots of optimism about the hopefully soon-to-be-authorized COVID treatment pills. So much optimism that the US government has already made plans to purchase 10 million doses from Pfizer, and Pfizer has already made deals to distribute the pill to low- to middle-income countries.  

This week's Newsletter is a cornucopia of important issues - including a shift in the FDA’s approach to EUAs.  See inside!

November 10, 2021

Volume 3 | Issue 17

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The highlight of the week is the news that there are now promising anti-viral pills aimed at preventing serious disease and death from COVID-19.  As you likely know, Merck has filed with the FDA and has already been issued an EUA in the UK. Pfizer has now released results from its trials, as well, and hopes to file within several months.  

The headline of the week is the “The Pandemic is Over.” We wish, wish, wish that were true.  We were also caught up in the excitement: If we could treat COVID quickly and effectively, would that mean the pandemic is done?  Alas - we have a long way to go.  Only one of these drugs has achieved EUA anywhere to date (Merck's, in the UK), and its requested label is only for unvaccinated people either over age 60 or with high risk factors.  Will the unvaccinated even take it, if they were worried about side effects from a fast developed vaccine?  Let’s not declare victory quite yet. 

The testing implication of the week is that these drugs will require a confirmed positive test.  Depending on the label granted on the EUA, it is likely that the drug will need to be given within five days of symptom onset.  Testing is therefore essential for these anti-virals to be used effectively and not wasted. Questions that loom:  Will an antigen self-test be good enough, with their average 98+% specificity?  Will a PCR be required for confirmation?  Will 

Inside the CWT Newsletter we return to questions about COVID in the animal kingdom, genomic sequencing, vaccine or test mandates as well as updated capacity estimates.  

November 3, 2021

Volume 3 | Issue 16

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This week marks El Dia de los Muertos, the Day of the Dead.  While "the theme is death, . . the point is to demonstrate love and respect for deceased family members.” COVID has been especially cruel in this regard - it has prevented so many of us from remembering a loved one in a gathering with family and friends.  

How do we acknowledge and honor 5 million people worldwide - including 750,000 in the US - who have lost their lives to COVID? 

We know that fighting COVID is a war - but the challenges are different from those in a “traditional" war.

• In traditional wars - there are safe places where war is not raging.  With COVID - it feels like nowhere is safe.  

• In traditional wars - our most vulnerable populations are spared.  With COVID - they took the brunt of the impact.  

• In traditional wars - we have an enemy that we can see.  With COVID - the enemy is invisible.  

• But like traditional wars - it is not just the soldiers who we lose, but the innocent bystanders. This is so true for COVID. 

Despite this sad milestone, we are seeing signs that a return to “normal” life is coming.  Most importantly, children (ages 5 to 11) can now be vaccinated in the US.  Our largest employers are returning in person, most with some sort of vaccine mandate and / or testing requirement.  Personal events are back with a vengeance - weddings every day, every night, every weekend.   WIth every step forward we are one step closer to taming this scourge. 

So - we ask three things. Honor those we lost as a society - even if you did not personally know someone who died.   Honor the current “combatants” in our war against COVID - our health-care providers of all types - thank them for their service. And honor one another - with kindness and empathy.  We have had enough stress and anger. 

Inside the Newsletter, we have an update on school testing and ask how do we re-position testing as a ticket to freedom, not just a burden. 

October 27, 2021

Volume 3 | Issue 15

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The Optimism:

• Cases continue to decrease (23%) and deaths are down (17%), but still at a sad and staggering 1400 a day 

• Hospitalizations are down to 52,000 - almost 50% lower than just 6 weeks ago

• Pfizer vaccine for 5-11 year olds gets a big thumbs-up from FDA advisory panel  (17 yes, 1 abstention) and the Administration has already set up a distribution plan for kids through pediatricians and others

• Lots of people are getting boosted - 360,000 a day and growing  

• The Administration continues to work to increase access to and supply of rapid OTC antigen tests: 

--> RADx will conduct validation trials for select high-impact / high-capacity rapid antigen test manufacturers and support their EUA application process

--> FDA will streamline the regulatory pathway for manufacturers developing OTC at-home tests, in order to facilitate single-use testing for symptomatic individuals 

--> HHS announced a $562 million investment in 13 companies, with the goal of shoring up test supply chains

The Caution:

• It is getting cold outside and people are moving inside - mostly without masks

• In national surveys - parents are decidedly mixed about getting their young kids vaccinated

• New first vaccine shots have dropped to 230,000 a day 

Lastly, should we worry about post-Delta emerging variants? AY.4.2? Something else? See inside the Newsletter. Hint - we are cautiously optimistic here too, but “absence of evidence is not evidence of absence.”

October 20, 2021

Volume 3 | Issue 14

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Another eventful week:  Vaccine Boosters are in.  Vaccine Mix & Match is in. Vaccine mandates are in. Testing options within Vaccine Mandates may be going out. Rapid tests are still in demand but not yet back in stock. 

Best news - US new cases are down (but deaths still at 1500+ per day). Cases are down in every region around the world except Europe, where UK leads the increase. 

Thanks to those who wrote to say that we should have highlighted the women’s professional sports leagues as well as the men’s. So with congratulations to the Chicago Sky, the new Women’s National Basketball Association champs, we are pleased to profile the women’s pro leagues this week.    

Short intro / long newsletter this week - see inside.

October 13, 2021

Volume 3 | Issue 13

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October is flying by. The headlines are focused on vaccines, particularly on vaccinating those with the highest need - from kids (the hearing on the Pfizer vaccine for 5 - 11 year olds is coming soon) to high-risk populations (who now have access to a booster) to the general public (flu season is approaching) and, of critical importance - pregnant women (recent reports from the UK indicated that in 1 in 5 ICU patients there were unvaccinated pregnant women).

October has also brought a crucial look into early pandemic history - which feels like years and years ago.  It comes in the form of a report from Booz Allen Hamilton, who were commissioned by the FDA (kudos to them) to independently review the FDA’s EUA process. See inside the Newsletter for highlights and our commentary.    

Lastly, October is also a special month for sports fans.  It is a month where every major sport - baseball, football, basketball, hockey - is playing games.  So we decided to share each sport’s COVID-related vaccination and testing policies.  See inside the Newsletter for our first-ever sports story - but we won’t say who we are rooting for in the World Series!

October 6, 2021

Volume 3 | Issue 12

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It has been a good week, with positive developments on many different fronts. 

• Cases: New cases, hospitalizations, and deaths all decreasing in the US.

• Tests:  A new player - ACON labs received an EUA for their OTC antigen test.   Why are we highlighting this one? Two reasons.

1. Most OTC antigen tests require two tests over 24-48 hours for asymptomatic screening. ACON only requires one test.

2. In an unusual move, the FDA included the company’s manufacturing capacity in their EUA announcement - 100 million tests a month by year end. 

• Late Breaking and Exciting: The White House announced an additional $1billion worth of rapid at-home test purchases and an expansion of the number of pharmacies (to 20,000) that administer free testing. 

• Vaccines: Moderna and J&J have applied for approval (or authorization) for their boosters. FDA's advisory committee will discuss those on Oct. 14 (Moderna) and Oct. 15 (J&J). They'll discuss authorization for use of Pfizer's vaccine in 5- to 11-year-olds on Oct. 26.

• Vaccine Mandates: They are working.  Many are still reluctant - but lots got their shots just ahead of their employers’ deadlines.  

• Therapeutics:  Real progress. Merck’s antiviral pill will now go through FDA review. Data from AstraZeneca’s antiviral injection also looked promising.  

Lastly, the ASU COVIDCommons.com team is proud to announce the TestingCommons.com Q3 2021 Test Review.  Click here for the presentation.  

September 29, 2021

Volume 3 | Issue 11

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For a very long time, COVID testing was all about PCR, the “Gold Standard". When we had to test - we only wanted PCR, even if we had to wait days for the result.

Then antigen tests came along - but faced with widespread skepticism. When antigen tests became available at retail - initial launches were disappointing. Why? Partly because case counts had declined and we all wanted to believe that COVID was behind us, and Americans were not yet ready to embrace testing in their own hands.  Then Delta changed everything - the hope hopes of spring melted into the deep disappointment of summer.  Suddenly antigen tests became the answer.  No longer willing to wait even a day (or two) for PCR test answers - we want our tests now and our answers now.  And now that we want them, there aren't enough to go around.  Manufacturers are changing course, building or rebuilding capabilities. 

What happens next?  Capacity will increase and we believe that self tests are here to stay - for COVID and beyond. When we get COVID under control (and we will), we will still need well-priced self tests, using multiple technologies, for disease diagnosis and surveillance forever.   

For COVID - let’s use whatever tests are available - antigen or PCR. Let’s fall in love with the power that any testing gives us.

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September 22, 2021

Volume 3 | Issue 10

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Sad:  COVID-19 has now surpassed the 1918 pandemic in total deaths in the United States. The US was much smaller back then - so while 675,000 deaths is one in 500 today, it was one in 150 people in 1918. 

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Mad:  We can argue about whether the second and third surges were avoidable, but the fourth was clearly preventable. What we have now, in 2021, was just a fantasy in 1918 - vaccines!  A cure?  No, but the hope is that they will turn this disease from a scourge into something awfully close to the seasonal flu, but only for the vaccinated. Secondly, we are mad about the fact that COVID-19 continues to disproportionately impact communities of color, where the death rate of hospitalized patients is twice as high for Black and Hispanic patients than it is for White patients.  

Hopeful:  Pfizer announced that their vaccine is safe and effective for 5 to 11 year olds. Now it goes through the FDA authorization process. On boosters: J&J announced that their booster raises their vaccine’s effectiveness to the mRNA vaccine level and the FDA just announced guidance for the Pfizer booster. Plus, the Biden administration announced multiple large advance purchase contracts for rapid antigen tests. 

September 15, 2021

Volume 3 | Issue 9

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A big week for testing, from the highest federal level to schools and employers. The rate of new vaccinations has declined, while employer mandates are expanding. It has become crystal clear at the highest echelons that higher levels of testing are required to bridge the remaining gap in our public-health efforts.

Now, we all need to get on board that screening testing is for everyone, not just a punishment for being unvaccinated - we know that Delta’s high transmissibility means it can infect even the fully vaccinated. The importance of this progression in thinking cannot be overstated.  

The results of the third and final Arizona State University COVID Workplace Survey have just been released. Of note:

• 93% of companies are requiring or encouraging vaccinations 

• 70% of companies are testing all or some of their employees 

• Employees are more likely to resign when companies’ COVID mandates are too lax, not too strict: 

• 39% reported resignations because of overly restrictive polices (vaccine / masks / etc) 

• 59% reported resignations because polices were not restrictive enough or lacking 

More details in the Newsletter.

If you have not checked TestingCommons.com lately - there are now more than 2,600 tests on the market or in development around the world. 

September 8, 2021

Volume 3 | Issue 8

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An eventful two weeks - with old patterns morphing into new ones as we go back to work and back to school.  

In so many ways, numbers are so cold. They only tell part of the story - they don’t tell us about the anguish that flares in kitchens and living rooms when a positive test result or a call from a hospital arrives.  But nonetheless, to make the best decisions for the public’s health we have to understand the data.

• Cases: Now averaging 150,000 per day.

• Tests: Now averaging 1.5 million a day.  But these reported tests dramatically underestimate the number of actual tests completed, as they do not include the vast majority of antigen tests - both at home and in point-of-care systems that do not automatically get reported to state or federal health authorities. More on this in the coming weeks - but our best estimate is that those uncounted tests number 800,000 a day, bringing the total to 2.2 million.  And it is not enough.  

• Deaths: Now averaging 1,500 per day - up 91% in just these last two weeks. And it is far too many.  

More inside, including information on Mu vs. Delta, vaccinated vs. unvaccinated viral load, Pfizer vs. Moderna, and early K-12 data.

August 25, 2021

Volume 3 | Issue 7

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Good: 

- The FDA fully approved the Pfizer/BNT vaccine. No new data - but we know that it will motivate at least some vaccine-hesitant people to get vaccinated and many companies / government institutions to issue vaccine mandates.  

- Willingness to test is way up, with more than 1 million tests per day reported. Positive rate is now 13.6% nationally.  Please note that this vastly underestimates the numbers of home / OTC tests - the majority of which are rapid antigen tests. 

Bad:  

- With test willingness up, test availability is down.

- Deaths in the US have averaged over 1,000 for the last seven days.

- Delta and its sub-group, AY3, account for virtually 100% of all infections. The average person with Delta infects 7 other people.

Ugly: 

- Vaccinated people can clearly spread disease - regardless of whether they have symptoms.

- Israel is seeing their own surge despite the fact the over-80% vaccination rate country-wide.

- Kids’ “invisible immunity shield” to COVID has disappeared with the Delta variant (if it ever really existed - it may have been a figment of under-testing and asymptomatic infection all along) 

August 18, 2021

Volume 3 | Issue 6

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Where are we? 

• If we are pessimistic - Cases continue to climb; 140,000 a day average, deaths now over 650 per day, and in the last week 18% of new cases were in children. 

• If we are optimistic - The UK reopened and dropped virtually all restrictions in mid July at the height of their Delta surge, when there were 47,000 infections a day. One month later, new infections have dropped to an average of 29,000 a day. The UK is ahead of the US - 61% in the UK are fully vaxxed, and 71% have had one dose. In the US, 51% are fully vaxxed, and 61% have had one dose. 

• In the US, there is good news on testing. Reported tests are over 1 million a day compared to 1.4 million a day during the last surge, but actual tests are much higher, as most of the home / OTC tests as well as point-of-care and surveillance tests are not included in state-reported numbers. We expect testing numbers to continue to increase with more symptomatic people and more testing mandates. 

• Net net, we are realistic - and focus on what we can do to shorten whatever this Delta surge has in store for us. The most important issues today are getting kids back to school and adults back to the workplace.  More schools and businesses are now mandating vaccines, masks, and testing - regardless of vaccine status. 

August 11, 2021

Volume 3 | Issue 5

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Another tough week. Delta is now part of the lexicon for everyone from ages 6 to 96. Many will even start to learn the Greek alphabet, as Eta, Iota, Kappa, and Lambda have been classified as Variants of Interest by the WHO. Current focus (as we hypothesized six weeks ago) that the next Variant of Concern may be Lambda. (Epsilon is no longer considered a Variant of Interest).  

Looking for any good news, at least for those who are vaccinated: From the Kaiser Family Foundation database for the 25 US states that are tracking vaccination status of new COVID cases, only 0.01 to 0.54% of those vaccinated will have a breakthrough case, and data from COVID tracker shows that vaccinated folks remain about 25 times less likely to experience severe disease. And while (depressingly) folks with breakthrough Delta cases do carry about the same amount of virus as unvaccinated folks, they do so for a much shorter time than the unvaccinated. Even with Delta, the vaccines are still overwhelmingly doing the job they were meant to do.

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To participate in the Arizona State University Employer Survey on COVID issues in the workplace - please go to https://chs.asu.edu/diagnostics-commons/workplace-commons

August 4, 2021

Volume 3 | Issue 4

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Another tough week. 150,000 new cases today - 92,000 average over the last week - 35% of the January high.  Testing up 40% for two reasons - rise in symptomatic people and the “Vaccinate or Test" mandates are starting to take shape.  Hospitalizations up another 90% this week - now at 33% of the January high. Deaths, at 371 daily average are far too many but, thankfully, are only 9% of the January high. Virtually all hospitalizations and deaths are the unvaccinated - but - sadly - we now understand that vaccination is not a free pass. 

Schools have started to reopen, especially in the west. No official numbers yet, but informal reports indicate that interest and implementation in testing is up.  Businesses continue to reopen in person (some big tech as exceptions) with vaccine mandates. 

July 28, 2021

Volume 3 | Issue 3

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Delta continues to drive US case numbers up to 108,000 today. We saw 63,000 cases/day on average over the last week - compare that to 12,000/day on average one month ago. Test positivity rate is very high at 10%, with a slight increase in testing.  Hospitalizations are up 70%, with 97% of those in hospital unvaccinated. The only good news is that deaths are only up 6%.

• Vaccine mandates are taking hold, with the Veterans Administration, California, and New York issuing them for public workers and front-line healthcare workers. 

• 58 healthcare organizations, including the nation’s largest, issued a joint statement urging vaccination mandates.

• As strong as the mRNA vaccines are - and they are strong - breakthrough cases are rising, and some of the vaccinated folks who are infected can carry enough virus to infect others. As a result, the CDC issued a new indoor mask guidance for everyone in areas of high or substantial transmission.  

• All of this is causing increased interest in school testing. So does testing work in schools?  Just-published data from the UK compared the efficacy of quarantine vs. daily testing for close contacts.  More inside the Newsletter, but bottom line - students in the testing Intervention Group lost 40% fewer school days, and COVID-related staff absence dropped by 60% in comparison with the Quarantine Group without an elevated number of outbreaks.

July 21, 2021

Volume 3 | Issue 2

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It is the beginning of the fourth surge in the US and the concurrent rise of the Delta variant. But we're now facing yet another obstacle: test hesitancy combined with vaccine hesitancy.   

We do have some good news on vaccines: numbers are stable and up a little - at least not declining. Courts are ruling that employers and universities can maintain vaccine mandates.  

But tests are down, down, down. Even Amazon, just as they're launching a DTC COVID mail-in test, has made the decision to STOP regularly testing their own warehouse employees. Not good.  See Newsletter for more commentary. 

July 14, 2021

Volume 3 | Issue 1

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Variants 

While Delta is now the cause of the majority of US cases, we are already starting to think about the next worrisome variant.  Not enough is known about it yet, but concern is rising about Lambda (aka C37), already prevalent in South America. 

The antigen vs. PCR debate continues 

Another study shows serial antigen / rapid tests' equivalence to PCR; see inside for more details.  

June 23, 2021

Volume 2 | Issue 15

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A relatively slow week of new COVID testing-related news, with one big exception. The VALID Act was re-introduced. VALID is the Verifying Accurate and Leading-edge IVCT Development Act  VALID re-ignites the debate as to when and who could and should regulate diagnostic tests.  More inside the Newsletter. 

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For those who may have missed the TestingCommons.com Pandemic Review, the presentation is available here. In summary: there are now at least 2,418 COVID tests authorized or in development globally. More than half are available commercially in different parts of the world, and the remainder represent the next generation of COVID tests for this pandemic and maybe the groundwork for the next viral threat.

June 16, 2021

Volume 2 | Issue 14

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The news this week was all about debates on topics like:

• Which test type is best (PCR vs. Antigen)

• How to validate Antigen tests (PCR standard vs. independent standard)

• Where to test (local testing centers vs. at home)

• Where COVID-19 originated (from the wild vs. from the lab)

• When COVID-19 came to the US (2019 vs. 2020)

June 9, 2021

Volume 2 | Issue 13

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• The short, medium and long term future of COVID testing. Current testing numbers are down but the big question is what will happen in the fall with schools and businesses mostly back in-person?

• The impact of Variants of Concern.  The WHO introduced a new naming convention using the Greek Alphabet and not the countries of initial identification. The big question is the uncertainty around B.1.617.2 (now VOC Delta) - will it cause a new surge and exploit the unvaccinated? 

• School testing. The focus moves to summer camps and other programs.  We take a deeper look at the youngest learners with an update on a new testing program in pre-schools and childcare.  The big question in the education arena  is how many colleges will require vaccination? 

May 26, 2021

Volume 2 | Issue 12

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• Testing Updates: We lowered our capacity projections to reflect reduced demand, decreased interest in building new capacity as well as fewer than expected new EUAs. But innovation continues with a new technology debut in Singapore. K-12 testing scales down for spring but readies for summer and fall. Late breaking: DoD announces Coordination Hub winners - see inside. 

• COVID’s Origin: Recent analysis reveals a potential role of the Wuhan Institute of Virology and the origin of COVID. More to come as additional information emerges.

• Just in: President Biden set a 90 day deadline for a full accounting on this issue. 

• Man's Best Friend: More developments on a canine coronavirus (see inside to see what all the barking is about!)

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May 19, 2021

Volume 2 | Issue 11

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Best news: All 50 states are reporting a decrease of COVID cases.  

Biggest news: The CDC issued new and mostly relaxed guidelines on the use of masks and testing for vaccinated individuals.   

Sad news: The pandemic rages on in India with only moderate improvements in the availability of critical necessary supplies.  

News to watch: Taiwan saw an extraordinary increase in cases after 253 days without a single case. 

Surprising news: Nine members of the NY Yankees organization tested positive after vaccination. 

Late breaking news:  Today the FDA (CDR) issued a safety communication that antibody tests “should not be used to evaluate immunity or protection from COVID-19 at any time, and especially after the person received a COVID-19 vaccination.” 

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May 12, 2021

Volume 2 | Issue 10

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This week was full of news: 

• Good news - The US COVID death rate has fallen to 600 a day and new cases to 38,000 a day.  For comparison, the death rate is still almost double the death rate from the flu for the worst flu season in recent history.  

• Great news - The Pfizer / BioNTech vaccine is now FDA authorized for 12 to 15 year olds. With CDC’s expected authorization tomorrow - vaccinations are 

• Bad news - The WHO has designated a fourth variant of concern, B.1.617, which appears to be highly transmissible and the dominant variant in India and rapidly rising in 40 other countries. 

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May 5, 2021

Volume 2 | Issue 9

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A relatively quiet week for COVID related issues in the US, therefore a good week to step back and provide some commentary on where we are in the US compared to the rest of the world and opine on what the near term future might hold. 

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April 28, 2021

Volume 2 | Issue 8

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This week’s newsletter is being sent now to align with the release of the Keeping Workers Well Employer Survey from Arizona State University which, with support from The Rockefeller Foundation, examines how employers are coping with the pandemic and their plans for the future. The Report, Back to the Workplace: Are we there yet? Key Insights from Employers One Year Into the Pandemic contains 

responses from 1,339 employers, 75% of which have more than 250 employees.  

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April 21, 2021

Volume 2 | Issue 7

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We're monitoring new variants and their impact on diagnostics, while also tracking a fun 4/20 themed update. 

April 14, 2021

Volume 2 | Issue 6

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A deep dive into increasing diagnostics company acquisitions by strategics. 

April 7, 2021

Volume 2 | Issue 5

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A special edition Q1 Roundup summarizes all the EUAs and EUA Amendments in Q1 and key takeaways. We also update capacity numbers to reflect recent EUAs and manufacturing updates.

March 31, 2021

Volume 2 | Issue 4

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The Rockefeller Foundation and Health Catalysts Group release the K-12 National Testing Action Program: Connecting Schools with the Nation's Leading Testing Companies to Safely Reopen, enabled by the Biden administration's $10 billion allocation to school COVID-19 testing. 

March 24, 2021

Volume 2 | Issue 3

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FDA marks some firsts with the first EUA for a COVID screening device which identifies infection through certain biomarkers and the first COVID diagnostic to receive full marketing authorization rather than an EUA. We also examine why there are so many damaging variants emerging. 

March 17, 2021

Volume 2 | Issue 2

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Capacity projections are significantly reduced to reflect reduction in demand, however we also discuss the "wild cards" that could impact capacity and the new federal investment in school testing.  

March 10, 2021

Volume 2 | Issue 1

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With increased FDA focus on home tests and home test collection kits, we explain what these different types of tests are and how many of each are on the market. 

March 3, 2021

Volume 1 | Issue 10

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Small update to capacity numbers this week, while novel strains continue to dominate the research and policy conversation and the Biden administration expands insurance coverage of COVID-19 tests. 

February 24, 2021

Volume 1 | Issue 9

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An update to capacity numbers reflects EUA's that failed to materialize in February. We also track a new FDA policy on test and variants and new investments in testing infrastructure from the Biden Administration.

February 17, 2021

Volume 1 | Issue 8

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Our commentary on CDC's new school reopening guidance and other new and noteworthy topics. ​

February 9, 2021

Volume 1 | Issue 7

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Will current vaccines will protect against emerging coronavirus strains? The good, the bad, and what we're watching. 

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February 2, 2021

Volume 1 | Issue 6

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All signs point to increased investment in at-home tests, while school reopening efforts face local resistance. 

January 26, 2021

Volume 1 | Issue 5

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Joe Biden is sworn in as President and takes immediate actions to address the pandemic. we also highlight new insights on asymptomatic COVID-19. 

January 19, 2021

Volume 1 | Issue 4

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New data emerges on variants spreading in the U.S. while central lab antigen tests show promise. 

January 12, 2021

Volume 1 | Issue 3 

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Massachusetts announces program to offer weekly, free pooled testing to all K-12 schools. Meanwhile, more field studies emerge measuring test quality.

January 5, 2021

Volume 1 | Issue 2

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New studies add detail on the real world performance of antigen tests. 

December 29, 2020

Volume 1 | Issue 1

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Tracking a big week in rapid antigen tests, with new EUAs for Abbott Binax At-Home, Ellume, and Quidel QuickVue.