June 22, 2022

Volume 5 | Issue 9

This week, we are dedicated to good news.  We are not naive - we know that COVID challenges still exist - but we are very happy to report on substantive positive developments.  

• Vaccines for infants, toddlers, and preschoolers!  Vaccines are now available for all Americans over six months of age.  We have previously said that the federal government should not end the State of Emergency until that happened.  

• Long COVID less likely!  Omicron gave us more transmissibility then ever, but at least it has a significantly lower Long COVID rate to date vs. Delta.  (More inside.) 

• COVID mortality levels have decreased into flu range!  Ok - maybe this one doesn't deserve an exclamation point.  But COVID death rates right now are as low as they have been throughout the pandemic. For the first time, they are comparable to those for the flu. (More inside, including graphs.) 

In the interest of balance and not jinxing ourselves, we do have to say that we were equally optimistic a year ago, and we know how that turned out.  BUT, as you will read inside, the US is in a much better place immunologically this year than last. 

June 15, 2022

Volume 5 | Issue 8

A busy COVID news week: 

• Vaccine for grown-ups:   Novavax received an overwhelming yes vote from the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) for a two-dose regimen under an EUA.  This is a more “traditional” vaccine, using protein fragments not mRNA and invoking a somewhat different immune response. The FDA will now assess Novavax's manufacturing and onto the CDC for the final decision before the vaccine is available to the public. 

• Vaccine for little kids:  The FDA published guidance on both Pfizer/BioNTech and Moderna vaccines for five-and-unders, concluding that they were effective in preventing symptomatic infection with minimal side effects. The FDA panel of outside experts just announced their unanimous recommendation for an EUA for both Moderna and Pfizer’s vaccine for younger kids.  (Moderna: 6 months to 5 years / Pfizer: 6 months to 4 years)

• Testing mandates:  The Administration dropped one of the last remaining testing mandates. As of Sunday, there is no need for anyone to test before they board a plane to the US.  

• COVID funding:  Because of the lack of agreement on future COVID funding, the Administration is shifting existing funds out of the buckets it had previously set aside for testing and new vaccine research and putting them into the buckets for treatment and vaccines.  

More inside, including a monkeypox update, self-testing challenges, and persistent COVID (and general health) inequities.

June 8, 2022

Volume 5 | Issue 7

This time last year we hoped and believed that COVID would soon be behind us - vaccines were widely available, home tests had been approved, and physicians had learned how to best treat the most severe case.  But we were wrong then - Delta and Omicron were still in our future.  

Since last June we have made a lot of progress: at least one effective new oral anti-viral; vaccines that continue to protect from serious disease; and severe illness and death remain rare in spite of surging cases driven by the most transmissible variant.  Yet, we have abandoned most pandemic precautions: vaccine and test requirements, and masking in enclosed spaces. Maybe inevitable, there is only so long that anyone can function on high alert. 

We were wrong a year ago - are we right to be more confident now?  It feels like we have entered a new twilight zone where we desperately hope for the best, but have so many unknowns in front of us: 

We have perspective on these and other issues inside the Newsletter.  ​

• What are the odds that Omicron BA.4 / BA.5 drives a new more dangerous surge - more able to evade vaccine and prior infection's antibodies while becoming resistant to novel anti-virals? Will tests work for these new variants?  

• Is there a hidden Omicron-like variant biding its time in an animal or human reservoir ready to burst on the scene in the future (around the end of this year)?

• Is monkeypox the next COVID, or just evidence of our hypersensitivity in the wake of the pandemic?

June 1, 2022

Volume 5 | Issue 6

Our third Pandemic Memorial Day.  We hope that everyone had a relaxing holiday and had time to honor and remember those who made the ultimate sacrifice for the safety of our nation.  

From a COVID perspective, we are tired. But we recognize that our weariness does not matter - we need to move forward with our fight against disease.  

Where are we today in the US?  Spoiler alert - not much good news. 

• Reported cases vs. actual cases:  As we predicted, the US remains above 100,000 in daily reported cases.  See inside for estimates of how many cases actually exist. Bottom line:  We believe that there are as many active cases today as there were during our Omicron Winter. 

• Deaths:  Number of deaths per day is, mercifully, down to an average of 300.  But perhaps most disturbing is that Omicron, perceived as “mild“ compared to Delta, may not be so mild after all.  Massachusetts’ preliminary data shows that Omicron caused more excess deaths than Delta. So, is Omicron inherently less severe, or is there simply more background immunity (both vaccine- and infection-based) now than there was during Delta?

• Treatment (a bright spot): Paxlovid is being used more regularly now, with 300,000 prescriptions per week (compared to ~80,000 per week in April and ~8,000 in February). See inside for our analysis and a discussion of rebound issues. 

• Testing: There is clearly more testing being done at home than ever before. Cases have been increasing and these tests have become widely available, but another reason is the closure of PCR testing centers and the elimination of free testing as part of federal and many state programs.  We continue to estimate usage - now at least six times as many home tests are being used each day vs. lab-based PCR. Good news? Mostly.  But we have lost test result visibility - the primary means to track the epidemic until now.  We must up our game on surveillance (especially wastewater) to compensate. Perhaps obvious, but we cannot stop educating the public on how best to use these tests and what the results mean. 

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More inside including a quick look at Monkeypox as the next pandemic.  Spoiler alert - we don’t think so.   

May 25, 2022

Volume 5 | Issue 5

We must accept so many uncontrollable tragedies in our world -  which makes it impossible to accept those tragedies that are within our control.  Over the last two weeks, we saw violent and vile acts in Buffalo, NY and Uvalde, Texas. It is too easy to explain these away as random acts by deranged individuals. 

We know that we are a Newsletter about COVID Testing - but these events overtake COVID today. We must be proactive to fight where we should have control and impact. Please lobby your friends, enemies, colleagues, elected officials to take this on like the crisis it is - not just gun control, background checks, assault weapons ban, but also funding for comprehensive mental health services and a systematic way to recognize and help resolve anger issues in kids and adults. There is a connection to COVID - the stress the virus is causing breeds frustration and violence, and will continue to get worse as the pandemic drags on. Let’s help improve our collective lives by just fighting against disease but fighting for the changes that make our communities safer.  

On COVID this week - several significant issues, although not specifically testing-focused:  

• The Federal State of Emergency for COVID will be in effect until at least July 16, 2022.  The Biden administration has confirmed that they will give at least 60 days notice before ending it. 

• Debate continues in Congress about whether to fund COVID initiatives going forward, including free vaccinations, treatments and tests.

• Debate continues amongst clinicians and scientists about Paxlovid rebound - why does it happen and is it more prevalent than rebound from untreated COVID?

• The newest large CDC studies on Long COVID show that 20% of those who recover from COVID have at least one lingering symptom. Specifically, "COVID-19 survivors have twice the risk for developing pulmonary embolism or respiratory conditions; one in five COVID-19 survivors aged 18–64 years and one in four survivors aged ≥65 years experienced at least one incident condition that might be attributable to previous COVID-19".

• Late Breaking News:  The Senate HELP Committee released an updated version of the VALID Act. Our analysis next week. 

May 11, 2022

Volume 5 | Issue 4

We were bewildered when our nation saw 100,000 deaths in late spring 2020.  By the end of winter 2021 we were devastated when the deaths rose beyond 500,000.  But we had hope - vaccines were rolling out, cases were going down, and flowers were springing up.  We believed, and we thought we had beat it. Then the big blows came with Delta and Omicron.  Now, near the once-unthinkable milestone of one million - we are resigned. 

A powerful review of the five surges that contributed to this milestone in STAT. 

So where are we now?  In the US, we are most definitely in another surge, though the ultimate size of it has yet to be determined. We expect new reported cases to stay above 100,000 for a few weeks. Yes, hospitalization and death rates are down, but there is a renewed, active debate about whether Omicron is truly less lethal than prior strains as more recent studies attribute Omicron’s apparent mildness wholly to pre-existing immunity (natural infection and vaccination). 

Around the world - mixed results in Europe, with cases in Germany down 30%, France down 56%, but Portugal is up 98%.  Most striking is Asia, where reported cases are way up: Taiwan shows an 800% increase.  Mainland China's lockdowns and zero-COVID policy have become a big question mark as China’s past lockdowns and low vaccination rate has created an Omicron-naive population.  A National Natural Science Foundation of China funded study this week reports a baseline forecast of 1.6 million deaths and the collapse of the healthcare system if the pandemic is uncontrolled.  The study advocates raising vaccination rates and using antivirals broadly as an alternative, but we know from the US experience that achieving the necessary levels of coverage is very hard.  Lockdowns are a lot like tourniquets - they stop the bleeding quickly, but if they are left on too long, they kill the leg and can jeopardize the patient.  

We will say it again - testing is the only way to slow these surges. What else is there?  While vaccines remain safe and effective at preventing hospitalization and death, few new folks are lining up.  Masks have become kryptonite.  Ventilation and improved air circulation help, but are expensive and take a long time to implement.  Physical distancing never worked, especially since Alpha. So - we are left with a good defense as the best available offense.  The information that tests provide identify the symptomatic and the asymptomatic and tell us to isolate as need and slow the spread.  

We will taking next week off - see you on May 25th.  Stay safe out there.  

May 4, 2022

Volume 5 | Issue 3

Everything old is new again. This week was all about issues re-emerging.  

• Cases rising again in US: another 50% increase in last two weeks, now above 60,000 cases a day on average.

• Cases rising again in South Africa, but most concerning is that new mutations are arising (BA.4 and BA.5). 

• COVID deaths: COVID was the #3 cause of death again in 2021, as it was in 2020.  (Heart disease was #1 and cancer was #2.)

• Mask recommendations instead of mandates: The CDC reiterates the importance of mask wearing on public transportation.  

• Test to Treat: Anti-viral usage increases still slower then initially expected. Questions about a small number of potential rebound infections. The Biden administration continues to implement its expanded access plan, with 10,000 more sites that will be distributing oral antivirals (mainly pharmacies).

• Test technologies: Despite the perception among many that the pandemic is over, new EUAs and amendments for tests continue to come through. The last few weeks saw two new OTC home antigen tests (total is now 17) and a new saliva-based POC system. TestingCommons.com now listing more than 2800 tests worldwide.  

• Moderna submits application for an EUA for a vaccine for the under-6's.

More on all of this - plus other info - inside the Newsletter. 

April 27, 2022

Volume 5 | Issue 2

Big numbers and big statements this week.

Numbers:

- 75% of kids, 60% of adults, 33% of over-65s have already had COVID

- 53% increase in current cases in the last two weeks and 29% of them are BA.2.12.1

- 10,000 new Test to Treat locations to come

The biggest statement, perhaps, was from Dr. Fauci, saying that the pandemic phase is over. Note he did not say that COVID is gone. As he pointed out, "We're not going to eradicate this virus."  We agree. COVID will become like the flu - a disease that is not always serious but certainly can be, and whose risk we need to manage in an ongoing fashion.   

For better or worse, most of our society seems to have already taken Dr. Fauci's words to heart, and has been behaving for a while now as if the pandemic is over.  But the nagging thought that's still hanging over us is - what's next for SARS-CoV-2? Will there be a continued slow burn or new surge? There is no question that the virus will continue to generate new variants. The key questions are: 

1. Will the new variants be transmissible enough to outcompete current versions of Omicron?  

2. Will the new variants have higher or lower mortality?

Note that #2 is completely independent of #1. We have been lucky because prior infection and/or vaccination have created a background level of immunity that has reduced severity. But we may not be able to rely on that in the future.  All viral evolution happens through drift, (the one to two protein changes per month that we saw in variants before Omicron). But if many small drift steps are hidden from view, perhaps in a single immune compromised individual or an animal host, a radically changed variant shift can appear as if from nowhere - as we got in Omicron. 

Our challenge now is that with most of the 8 billion of us exposed (not to mention further billions of animals capable of reinfecting humans), there is an ever-greater number of evolutionary drifts happening, most of which we will not discover unless a surge emerges. It is still possible that the pandemic phase of COVID may indeed be over - for now. What we don't know - what we've never been able to successfully predict about COVID thus far - is how long "for now" will last.

April 20, 2022

Volume 5 | Issue 1

Well, we had one quiet week. As is standard procedure for this pandemic, our world has changed a lot in seven days:

Masks:

• Masks are off everywhere. Planes, trains, automobiles. (Yes, Uber too.) Businesses small and large. Events large and small.  Even the previously crowned Mask Compliance Capital, San Francisco, reports that only 30% of passengers wore masks in SFO this morning.  

Future of Masks:  

• Late breaking news - DOJ said that they would appeal the decision at the CDC’s request. However, it is hard to imagine that the political will - and more importantly the public will - exists for mask mandates right now.  But it is very important for the future - see inside.  

• What do we think?  We have said that dropping mask mandates would have to come soon, but if we had a magic wand we would have waited until a vaccine was available for under-5-year-olds. 

• What really scares us?  The next infectious disease.  Will Americans respect public health authorities and wear masks to help prevent another pandemic? Maybe only if the death rate is scary high - we shudder to think. We have truly entered the era of individual health: You have to protect your own health and not rely on those around you to help. 

Cases and Variants:  

• The downturn is now turning back into an upturn.  Reported cases are up 47%, but thankfully, hospitalizations and deaths are still down 13% and 6%, respectively.  Lab-based PCR tests are up 13%, but we don’t have good reporting for at-home testing. More on this gap inside the Newsletter.  BA2 now accounts for 75% of US cases - but the real concern is BA.2.12.1, at 18%. This new sub-variant is even more transmissible than BA.2

New Technologies:

• COVID breath-based test granted an EUA.  More on how this technology works inside.

April 13, 2022

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COVID Quiet.  We don’t want to jinx it, but we love the sound of it.  Everything is relative - we know that cases are up (8%), but hospitalizations, ICU patients, and deaths continue to decline reassuringly in the US.  European cases seem to have peaked.  China is still increasing, but at less than 2 per 100,000 people.  We are hopeful that these trends reinforce the fact that while COVID will not go away, it will (soon, we hope) be manageable without debilitating impact on the US health care system.   

Some highlights and lowlights from the past week:

- The US Public Health Emergency has been extended until July 15th.  We know that some are calling for the PHE to be over, but we have two caveats about this:   #1 - All Americans must have access to vaccination, so before we can lift the emergency order we need a vaccine authorized for those under age 5.  #2 - Make sure the federal and state governments - as well as private businesses - clearly understand and articulate the likely consequences of dropping the emergency order.  We know that there will be surprising (some good / some bad) consequences - but let's try to at least go in with our eyes and minds wide open.    

- Variants:  BA.2 is now accounting for 86% of US cases and is the dominant variant worldwide. But most of the variant vibe this week was about the potential of XE - a so-called hybrid or recombinant variant.  First reported in the UK and then Japan, XE appears to be a mix of BA.1 and BA.2, and is thus another sub-variant of Omicron.  WHO has not given XE its own letter - and it is not clear that it deserves one - but it clearly needs to be monitored. (Speaking of WHO monitoring, they are also watching BA.4 and BA.5.)  

- Precautions: Amidst most locales dropping COVID precautions, Philadelphia announced that they will be reimposing the indoor mask mandate - after a 60% increase in cases in ten days.  Businesses can opt out if they require proof of vaccination. Much too early to tell if this is the beginning of a trend. Philly has a sad history with infectious disease - in 1918 - they led the country in deaths.  

- Tests: Two more antigen OTC home tests were granted EUAs - Xiamen Boson Biotech and OSANG. 

In appreciation of getting some COVID Quiet and the dual Easter and Passover holidays this weekend (love it when they coincide in modern day) - we will only have this email and no attached CTN Newsletter this week.  Stay safe, everyone. 

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April 6, 2022

Volume 4 | Issue 14

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Science has been in the spotlight for the last two pandemic years. Those in science fields know that the scientific method is intricately disciplined, and the analysis carried out is rigorous. However, it rarely gives single final answers to highly complex questions. At some point in the investigation, we have to gather all the evidence - pro and con - to construct the best available answer.  In reality, all these apparently concrete answers are subject to revision as new facts emerge. Nothing is absolutely 100%. Science has made extraordinary strides in addressing the COVID pandemic, but has been frequently accused of either being too certain or too vague - often both at once. The bad news is that this process has allowed the tailoring of data to fit various people's own hypotheses, however accurate or ludicrous.  

The good news is that 1000 times more scientists have been drawn into building the most integrated body of knowledge about a disease that has ever been assembled - the integration of genomics, immunology, virology, diagnostics and data science. We should applaud the scientists who have ignored the threats to speak out about what should be done. This is, in our view, the single biggest achievement of the past two years, and it should be the foundation of future preparedness.

Why are we thinking about science today?  This week was a big one for science - not all directly related to COVID. Twenty one years ago, the first ‘complete' draft of the human genome was decoded, and excited headlines ensued. The inside-baseball story, though, is that it was “only” 92% complete.  Now, with improved technology and thousands of hours of work, a broad scientific team have now published a truly complete human genome, adding 200 million more base pairs and 1,956 new genes to our collective knowledge.  

The launch of the Human Genome Project in 1990 was hugely controversial. Was it too expensive? Impractical? A blackhole for resources needed elsewhere in fields from HIV to cancer? After all, PCR had only been invented five years earlier and was just beginning to be widely available. But it is these two scientific efforts that permitted the full sequence of SARS-CoV-2 to be completed, the first diagnostic for COVID to be available and the first mRNA vaccine research to be started within five weeks of the first case. 

On the COVID front itself: 

• Congress still debating money for treatment, tests, and vaccines. See inside for details and our commentary (but you probably can guess what we're saying!). 

• A bright spot - the use of funding for already-allocated K-12 school testing has been extended through July 2023.

• Cases are down nationally. Several states are seeing upticks, but the numbers are so small, we certainly would not call it a surge. 

• Hospitalizations and deaths are also down nationally - fingers crossed here. 

• Globally, cases and deaths are down almost 30% in the last two weeks. Nation by nation it is a mixed bag: Western Europe is showing signs of having peaked, but China and Southeast Asia are in a growing crisis.

See inside for more.  

March 30, 2022

Volume 4 | Issue 13

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100 days. It's been 100 days since we reached the point that every US state had recorded at least one Omicron case.  Just 100 days - It feels like we have been to hell and back since then. The pandemic created a new phenomenon - COVID time - where single days felt like either a week or 15 minutes and and we now date everything as either Before, During or After the Pandemic.  

While some news makes us hope we might be looking toward a future that, while still including COVID, won't be an endless crisis - other news gives us pause. Here are the current highlights: 

• The US data dashboards look the way we want them to look on a national level: Cases, deaths, and hospitalizations are down, and tests are up. But given that 13 states have cases trending up, and three (AR, CT, NY) are up more than 20% in two weeks, we worry. Thanks a lot, BA.2.

• The FDA authorized a second booster (fourth shot) for those over 50. Justification came in part from Israel, where a second booster was authorized for over-60s and showed 71% lower mortality vs. a single booster.

• The global data is decidedly mixed. 22+ countries are showing an uptick in cases.  Most visible is China, where rolling quarantines are being implemented as well as new mandatory booster campaigns.  A few, like South Africa, are lifting restrictions and heralding a post-pandemic era.

• Late-breaking news - the CDC announced that it has eliminated its COVID risk-scaling system for cruise ships. Anchors aweigh!  (Or sail at your own risk!)

More inside on BA.2 vs. BA.1, the imbalanced impact of in-home tests, lessons learned about the communication of science to broad audiences and Good News about kids’ immunity. 

March 23, 2022

Volume 4 | Issue 12

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It’s hard to catch a break right now.  We had three happy weeks of watching COVID cases and restrictions drop but then - Wham!   Over the last week - story after story about a potential new surge of BA.2 in the US. 

The logic is seemingly strong - a). BA.2 has become 35% (per CDC data) of US cases in 4 weeks. b). BA.2 is 50% more contagious than BA.1. c). Cases are starting to rise in a few US large cities  d). BA.2 dominates Europe's fast-growing case count, and the US has typically been just a few weeks behind Europe.  e). Nearly all COVID mitigations have been dropped.  

What is the alternative view? a). BA.2 is actually only marginally more contagious than BA.1 and is no more virulent.  b). Case numbers appear to be peaking in Europe (although not in Asia, where they have been living in almost full lockdown).  c). The current season / weather is in our favor - everyone is desperate to get outside, and each week gets warmer and warmer. And, most importantly:  d). Given the significant Omicron surge in the US - mostly BA.1 - we have substantial natural immunity in addition to our vaccine-based protection. We have higher immunity than those societies that have been locked down in small or large ways during Omicron.

So - where are we?  We are cautiously optimistic about the short term (next 8-16 weeks) in the US.  Even if we see more cases, we are hopeful that it won't come with an increase in hospitalizations or deaths.  Are we concerned?  We're more worried about the potential arrival of a completely new variant - not an Omicron sibling - especially if it arrives in the fall or winter when we are inside and fully back to workplaces and schools.  Either way - we think it is critical to create a proactive and realistic plan for the future. As we've said before, "hoping it goes away" is not a strategy.

See inside Newsletter for more about planning for the safer future.  

March 16, 2022

Volume 4 | Issue 11

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There are no perfect solutions or analyses. This is certainly true in the intersection of COVID, public health, government policy, and individual behavior.  This week marks the two-year anniversary of the declaration of the pandemic by WHO, and of lockdowns in both the US and - to varying degrees - around the world.  We are still learning about the relative effectiveness of the various different approaches to COVID, but a few things have become clear: 

1. COVID deaths have been underestimated. Lancet just published the most comprehensive meta study to date, looking at excess deaths from 2020 and 2021, in 74 countries, compared to 11 years of historical data.  The conclusion: Total deaths as a result of COVID were 18.2 million - more than three times the official reported death toll of 6 million. 

2. Countries that had very strict or mandatory lockdowns - from China to Australia - had lower death rates than countries that did not. 

3. Countries that began with strict COVID rules and are now opening up without adequate vaccination levels are experiencing significant COVID spikes. Probably not a surprise, as the “downside” of fewer cases in the past is a lower level of natural immunity now. China is seeing cases approach a level not seen since early 2020; New Zealand is having its first surge ever; and Australia is seeing a major double peak surge in cases. However, spikes in Omicron cases need not cause equivalent spikes in deaths, as South Korea, is currently demonstrating, with its 86% vaccination rate.

4. Public policy is a critical factor in determining case and death rates, but individual behavior - especially compliance with public health guidance - is equally critical.  

We have had two years of hard-won experience. Let us honor those who fell to this disease - and those whose lives have been upended by it - by learning from what we've seen. The true tragedy would be to ignore the lessons that COVID-19 has taught us. We all want a better future - let's use what we now know to make that happen.

See inside for more on the WHO’s statement on testing, school masking data and Good News about the Flu.  

March 9, 2022

Volume 4 | Issue 10

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Milestones and anniversaries - so important, yet arbitrary in so many ways.   Why do we celebrate just the “round” numbers?   Maybe it is because it is too hard to celebrate the bad news too frequently, and there is not enough time to celebrate the good news too often.  

We bring this up today because several milestones and anniversaries are coming into view this month.  

Globally, we surpassed 6 million reported deaths this week. The United States, with 4.25% of the world’s population, now accounts for 16% of COVID deaths. At 960,000 recorded deaths as of today, we know that we will be acknowledging the sad one-million-death milestone shortly.  We also know that there is substantial undercounting - the number is likely higher in many countries outside of the US  - but our disproportionate share of tragedy is clear.   

So where does that leave us? How do we best go forward? Amidst the good news of our lower case numbers, we celebrate our renewed ability to see people in 3D regularly now. But we must still carefully and objectively look both backward and forward, to ensure that we understand the lessons we need to learn. Change often comes out of crisis. Let’s use this crisis well.  (See inside Newsletter for more on this.) 

To that end, this week a group of 53 scientists, clinicians, and policy people published Getting to and Sustaining the Next Normal: A Roadmap for Living with COVID, a comprehensive and often critical look at what our government has done and should do moving forward to deal with COVID - and equally importantly, avoid or at least be prepared for the next pandemic.  They warn against “premature triumphalism.”   We agree with most of their recommendations, especially around the critical need to prepare for a future that includes more infectious disease.  We also believe that we all need at least some time to celebrate some level of “victory". Then we'll take another deep breath and acknowledge that we may have more challenges ahead of us. 

March 2, 2022

Volume 4 | Issue 9

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President Biden’s State of the Union address last night included a strong COVID focus - all about taking back control from the virus. Going forward - we need to Protect (with vaccines, tests), Prepare (to respond to new variants), and Prevent (shutdowns of schools or businesses). 

The headlines today were about the Administration's new Test to Treat program - the perfect companion to Test to Play and Test to Stay.  See inside Newsletter for more details and updated forecasts of test capacity as we move (hopefully sustainably) into the next phase of the pandemic.  

All that being said, COVID clearly was not the most consequential part of the week. War rages in Ukraine. We feel the same sort of helplessness that we felt two years ago at the beginning of the pandemic. Our thoughts are with the Ukrainian people as they bravely fight. 

February 23, 2022

Volume 4 | Issue 8

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It has been a long week during which COVID was replaced - appropriately - in the headlines by the terrible Russia / Ukraine situation.  So this week, both our email and Newsletter will be short.  

On the COVID testing front - it was a quiet week, in a good way.  Tests seem to be available online and in retail stores across the country - accessible to most Americans. 

On the COVID vaccine front - Continued interest among pharma companies in creating new vaccines; continued data showing vaccines' effectiveness against Long COVID. 

On the COVID precautions front - Mask mandates have been dropped in 49 states (all but Hawaii).  Proof-of-vaccination requirements for public venues have been dropped virtually everywhere.

All good news and we don’t want to be party poopers, but before we celebrate that "only” 125,000 people were diagnosed with COVID today, we remind ourselves that on June 23, 2021 - eight months ago - 11,000 people were diagnosed. We all really believed it was over then, but Delta and Omicron were still to come. So, let’s enjoy the moment and cross our fingers that we have crossed the rubicon. Let’s also be aware that we may need to ramp back up in the future.

February 16, 2022

Volume 4 | Issue 7

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The headlines this week continue to be about ramping down mask mandates, postponing vaccine mandates, decreasing testing rates, and even the CDC lowering the risk rating for taking a cruise. 

Despite the deep divisions in this country and so many others, there seems to be a steadily forming consensus that society needs to move forward and out of the pandemic. The good news: We're all psychologically ready to move to a post-COVID world as these latest Omicron waves are ebbing. The bad news: We still have 10,000 reported deaths a day worldwide (of which the US is 22%). Denmark, the proclaimed poster child of dramatic ramp-down, has seen an increase of cases - and, more importantly, deaths - since their complete removal of all COVID restrictions.  Hong Kong and other Asian cities are seeing major surges.  But to be fair, no one was surprised.  For most, it is now about living amidst COVID, not aggressively avoiding it.  

Our deep hope is that we learn from this - as individuals, as leaders and as communities. So, today, we begin a new feature:  “Applying the Lessons of the Pandemic: Testing Edition.” (Last month, we added “The Good News is…”  feature.) As the Weekly TESTING newsletter - we will emphasize (beg if necessary!) that we continue testing and making testing increasingly accessible and affordable. We need testing to detect and squash hotspots before they spread. We need testing to best utilize emerging therapies. If we are to live with this virus and its progeny - let’s at least know when we are sick and protect ourselves and others.  

See inside the Newsletter for more about continued investment in some cool new test technologies, COVID testing at the Super Bowl, and lastly, The Good News is … about vaccines for pregnant women.

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February 9, 2022

Volume 4 | Issue 6

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New perspective on the numbers and COVID protocols this week.  All signs are good for the US and some other countries to look towards the end of the acute phase of the pandemic. As we have written and many have said - coronavirus with one variant or another will be with us for a long time, if not forever.  

But let’s share why we are cautiously optimistic:  

#1 There is mounting evidence that Omicron is substantially less severe than Delta. A new review of 1.5 million positive Omicron cases in the UK (37% of all UK Omicron) shows the strong reduction in risk of hospital admission and death by vaccination status across age groups. Omicron hospital admissions were 59% lower and deaths 69% lower than Delta. (Vaccines are still the most effective measure: A three-dose mRNA vaccine regimen is equally effective against either variant compared to no vaccination (hospital admission: Delta 83% lower; Omicron 81%. Death: Delta and Omicron both 87% lower). Prior infection alone provided about half the protection of vaccination.) 

#2 The WHO noted that the broad spread of Omicron “offers plausible hope for stabilization and normalization.” They note that the immunity that comes with recovery from Omicron will help countries live with COVID - but cautions that immunity will likely wane, and new variants may not be as mild.  

#3 Millions of doses of Paxlovid are being ordered by countries around the world. Great news given the strong efficacy. 

#4. Denmark has dramatically and confidently lowered its COVID restriction - not because COVID cases are way down (they are flat and still relatively high per capita), but because the infections that are occurring do not disrupt society and have not overwhelmed hospitals.   

#5. Dr Fauci said so! In an interview with Financial Times, Fauci said, "As we get out of the full-blown pandemic phase of COVID-19, which we are certainly heading out of, these decisions will increasingly be made on a local level rather than centrally decided or mandated. There will also be more people making their own decisions on how they want to deal with the virus.”

All that said, we are acutely aware that we have been here before.  In June 2021, cases were down to 10,000 a day nationwide, and Delta looked less severe than previous mutations. Today we celebrate "only" 250,000 cases a day. Deaths are up today because of the sheer number of cases, but we expect that to decrease soon.  We agree with Fauci that the next phase will be more about individual health than public health. 

Lest we get too giddy - let’s remember the lessons of last year - don’t stop testing.  If nothing else, we need to see testing continue to be available in order for Paxlovid and other drugs in the future to be used effectively. 

Let’s Test to Treat, Test to Stay, and Test to Protect. 

. 

February 2, 2022

Volume 4 | Issue 5

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Today is Groundhog Day and a numerical alliterative - 2.2.22. It certainly feels like we have been here before. 

Week after week we wonder - will there be enough information to fill another Newsletter? You'll have to look inside to find out. But here are some hints:  

- Update on the Biden Billion (Hint: 550 million)

- How likely is it for a very close contact to get COVID? (Hint: 50/50)

- Do at-home antigen tests work against Omicron? (Hint: Yes)

- Are there any at-home molecular tests? (Hint: Also Yes) 

- Our own recommendations on exiting isolation after a COVID positive test (Hint: Different from the CDC)

- AND our new feature, “The Good News Is . . . ”

Oh, and did we mention - today is Groundhog Day. It certainly feels like we've been here before.

January 26, 2022

Volume 4 | Issue 4

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We stepped back to “take at a look at our lives” and “look out at how the time has past” in the two years since the first US COVID case and focus on three questions we heard a lot this week.  

#1 Should we worry about the “new" BA.2 version of Omicron?

Definitely not yet.  A new BA.2 Omicron version has been detected worldwide, most prominently in India and Denmark, where BA.2 is now dominant. There are 10 mutations in the spike protein that differ between Omicron BA.2 and BA.1, but 9 are far away from the critical regions (receptor binding and cleavage domains) essential to both Omicron’s enhanced transmissibility and immune escape.  The most notable difference relevant to testing is the absence of the S gene dropout / target failure, so this “lemonade out of lemons” shortcut cannot be used in place of more expensive sequencing to distinguish Omicron BA.2 from Delta.  Any change anywhere in a protein can have impact elsewhere, but given our current state of knowledge, fingers crossed that BA.2 harbors no new clinical surprises – only time will tell for sure.   

#2 Are more kids getting COVID now?  

Definitely yes - but only a few become very sick. There are about 75 million “children” in the US (~23% of the US population) and last week, 1.15 million kids were diagnosed with COVID (25.5% of all cases). That is four times the previous highest week ever, which happened in last year’s fall surge.  States vary widely in who is counted as a child: Florida and Utah end “childhood" at 14 years; all other states do so between 17 and 20 years. The CDC has more granular data by age, but their statistics lag up to six weeks, so cannot be used to assess the impact of Omicron just yet.  
 

On the good-news side, despite more COVID cases  in children, there is no evidence of any increase of severity.  Child mortality is steady at 0.01% of child cases, and that has persisted since October 2020 (before then it was higher, not lower, with 43 states reporting).  Based on the 24 (mostly smaller) states that do report child hospitalization, 0.7% of child cases are being hospitalized currently, which is lower than the 0.85% of kids’ cases hospitalized in 2021.  We are hopeful that the data will show the same shortening length of stay for children as is being seen for adults, for whom median length of stay has declined to 2-3 days with Omicron from the 7-10 days of Delta.

#3 Is COVID over when it becomes endemic? 

Definitely no. Moving from pandemic to endemic has been our stated goal for some time now. Maybe we need to get a refresher on what endemic means. Better than a pandemic - yes - but not a panacea. Endemic merely means the virus becomes a steady, regular, ever-present part of our daily world. The virus does not go away and may still remain as deadly as it is today - although, as we noted last week, Omicron now has essentially equivalent mortality to the flu for the vaccinated.  As Dr. Fauci said, endemic means COVID “is not disruptive” - unless of course you get sick. Endemic does mean that there are fewer surprises and healthcare professionals know how to manage the disease.  Endemic does mean that there will be outbreaks - but likely smaller than ones during the pandemic phase. Great piece by Aris Katzourakis in Nature about endemicity with a warning that endemic does not mean necessarily benign, as we all hope. 

Conclusion for today?  We are cautiously optimistic about Omicron’s downward case trends (down 14%), providing we continue to test, isolate, and protect ourselves and the vulnerable.  Deaths continue to rise (up 35%) and are likely to stay high for 2-3 weeks.  

Inside the Newsletter - see more about the First 500 Tests, and the continued debate about PCR and antigen test technologies. 

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.

. 

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.