Issue No. 13

Omicron Emerges, But Delta Still Reigns

The big pandemic news recently has been the emergence of the Omicron, or B.1.1.529, variant. On its own, Delta was doing a great deal of damage, especially in more northern states, but Omicron is clearly more contagious.

As of Dec. 11, Omicron accounted for just 2.9% of infections in the U.S., according to the Centers for Disease Control and Prevention (CDC). One week later – just one week – the proportion jumped to 73%. This CDC bar chart shows the change graphically.

Even before dominance of Omicron, however, Delta, which emerged in the spring and represented nearly 100% of cases by July, had caused U.S. cases to rise 20% over the two weeks ending Dec. 20 to a daily average of 143,000. Hospitalizations have risen 14% and deaths 3% to an average of 1,300.

All these figures are well below records set last January, when daily average cases hit 251,000; hospitalizations, 137,000; and deaths, 3,300. A year ago, no Americans were vaccinated, but this year attitudes and policies have softened and many safeguards have been dropped. Today, there are ominous portents that the weeks ahead will be difficult.

For example, in 2020, U.S. cases began climbing around Oct. 1 as people began moving indoors as the weather cooled. Interior spaces are where COVID spreads. But both October and November 2021 have been warm – the third-warmest autumn in 127 years. Cases started rising slowly in mid-November. So it may be little solace that daily cases on Dec. 20 were one – third below their level of a year earlier.
Particularly alarming is that cases are increasing all over the country. In only 11 states have infections declined over the past two weeks.

Still, the striking geographic distribution of the past month persists, as you can see from this heat map of hospitalizations per 100 beds for the week ended Dec. 17.

The map is taken from the excellent Community Profile Report that is produced weekly by the CDC and the Office of the Assistant HHS Secretary for Preparedness and Response (ASPR). The darkest red indicates that more than 20% of hospital beds are occupied by COVID patients; light green indicates 1% to 3%. With the exception of Utah and Arizona, the reddest parts of the map are in the Northeast and Upper Midwest, the coldest parts of the country in late November and early December.

The top three states for COVID cases per 100,000 population are in New England, and the top 14 states are all north of the Mason-Dixon Line. By contrast, the six states with the fewest cases per 100,000 are all in the South – and, as we have noted before, there is no correlation right now between cases and vaccinations.

For example, in Louisiana, which has the lowest case rate among the states – 11 per 100,000 , compared with a U.S. average of 37 – just 50% of residents are fully vaccinated, compared with the U.S. average of 61%. (“Fully” means two shots of Pfizer-BioNTech or Moderna or one of Johnson & Johnson.) 

Rhode Island and Maine are tied with the highest rates of full vaccination in the U.S., at 75%, but they also rank first and third for the most daily average COVID cases as of Dec. 15. The eight states with the highest COVID infection rates all have vaccination rates at or above the U.S. average.

What does this mean? Certainly, vaccination helps (see the last section of this newsletter), but spending time outdoors appears to be an even more important factor in determining how many people come down with the disease. More focus, it would seem, should be placed at protecting indoor spaces from airborne spread of the SARS-CoV-2 virus.

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Defending Against the Virus in the Interior Spaces Where It Spreads Easiest

Omicron, the 15th letter in the Greek alphabet is racing through America. Open questions are whether it is more virulent than Delta and whether it responds as well to vaccinations. We will get to those issues below, but, first, it’s important to understand that at least one form of mitigation works as well against either variant, or any variant to come.

That defense against COVID-19 involves deploying devices that make interior air clean and safe. The most effective technology is relatively inexpensive and straightforward, but, unfortunately, it is not well understood.

Recognize that virus that causes COVID is relatively easy to deactivate.

The microbiological hierarchy of disinfection, as accepted by the U.S. Environmental Protection Agency and scientific experts, puts “enveloped viruses” like SARS-CoV-2 at the very bottom – that is, most susceptible to disinfection. With the proper technology, it is easier to render harmless the virus that causes COVID-19, with its lipid, or fatty, envelope, than it is to deactivate fungi, bacteria, or non-enveloped viruses such as the highly contagious norovirus that causes vomiting and diarrhea.
Shortly after COVID began to spread, there was widespread interest in ventilation, which generally means the exchange of inside for outside air through an air-conditioning or heating system that is equipped with a filter.

But, as we reported in the last issue of this newsletter experts have come to realize that this technology is insufficient. An article in the October issue of the ASHRAE Journal, a publication of the American Society of Heating, Refrigerating and Air-Conditioning Engineers, acknowledged that HVAC systems are ineffective in fighting pathogens like SARS-CoV-2. mold indoors.

In analyzing a restaurant simulation, Zhiqiang Zhai, a professor of Civil, Environmental and Architectural Engineering at the University of Colorado at Boulder and winner of ASHRAE’s Distinguished Science Award, and three colleagues write:
 
It is evident that if purely using the CA [that is, central air-conditioning with filtration], only a small fraction of the particles can be discharged through the ceiling exhausts. Most of the particles are spread out indoors and ultimately deposited on the occupants, tables, ground and walls.
 
The danger to occupants from HEPA [high-efficiency particulate air] filters placed on HVAC systems, write Zhai and his colleagues, is that some pathogens “do not get entrained into the return air vents and may float around in a given space.” In other words, this is not the right solution to contaminated indoor air.
 
Adding eight air purifier units “can clean 28% of the particles.” A table purifier placed in the center of each table in the room – only a few feet away from each occupant -- “can handle almost 80% of the particles, while slightly increasing the deposition on the tables compared to floor units.” But, clearly, sticking an air purifier in front of nearly every person in a room is impractical and expensive.
 
For filters to work, pathogens need to find them. If they have to travel large distances, that connection is elusive. But better answers exist. For example, ActivePure, a Dallas-based company, has developed an Advanced Photocatalysis technology, cleared by the Food & Drug Administration, that is capable of safely suffusing an occupied indoor space with the same oxidative particles found to clean the atmosphere naturally.

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In the C-Suites: ‘If We’re Going to Live With This,
How Do We Live With It Safely?’
 
ActivePure’s chief medical and scientific advisor, Dr. Deborah Birx, who was formerly the White House coronavirus coordinator, recently spoke to an audience assembled at New York’s Hudson Yards by the Building Owners and Managers Association, or BOMA.
 
In an interview with the business news site Bisnow on Dec. 14, Birx assured executives:
 
The workplace in general, because of the modifications that have been done and because of the opportunities that now exist to even improve on those modifications,..is not only fairly safe, but can become increasingly safer.
 
She referred to her own experience – “out and working the entire time, traveling, in states, in airports, in hotels, in meetings, and I haven’t gotten infected. So it’s clear you can mitigate against infection.”
 
Businesses, she said, need “to empower people with the information that they have the confidence about where the virus spreads and how the virus spreads and where it doesn’t spread and what can be done to prevent it."
 
It is “the private sector [that] has to help convey to the American people what a safe environment looks like. I think that’s where the information is going to have to come from," Birx said. "Because the federal messages have been less clear and less leading."
 
The Bisnow article noted that the top 10 office markets in the country hit 40% of pre-coronavirus occupancy in December, the highest figure since the pandemic began. ActivePure’s chief commercial officer, Amy Carenza, also speaking at the BOMA forum, said that the company is working more with office owners as occupancy increases. More corporate executives, she said, now realize that COVID-19 is going to be a presence for years.
 
"What is happening now is that C-suites across America are saying, ‘If we stay home, we’ll be home forever,'" Carenza was quoted in the article as saying. "I think there is a lot of introspection happening across C-suites, but it’s happening from a standpoint of, number one, we’re going to have to learn to live with this, and then, number two, if we’re going to live with this, how do we live with it safely?"

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What We Know and Don’t Know About Omicron

Dr. Tedros Adhanom Ghebreyesus, the director general of the World Health Organization, said in a news briefing on Dec. 14 that “Omicron is spreading at a rate we have not seen with any previous variant.” The W.H.O.’s Africa region, which excludes Egypt and six other nations in the continent’s north and northeast, recorded about 196,000 new cases in the first week of December, nearly double the figure from the week before.
 
Where did Omicron come from? “Viruses like SARS-CoV-2 continuously evolve as changes in the genetic code (genetic mutations) occur during replication of the genome,” says the CDC. These changes produce variants, which have one or more mutations that differentiate them from others. Omicron has 34 “spike protein substitutions,” meaning that it has significant physical differences and probably other characteristics from Delta.

The CDC ranks variants. The lowest level is “Variants Being Monitored.” There are nine of these, from Alpha to Mu, with none posing a threat. The next level is “Variants of Interest,” of which there are currently none. Next is “Variants of Concern.” Here, there are two: Delta and Omicron. The most alarming category, “Variants of High Consequence,” is currently unpopulated. Its characteristics include “a significant reduction in vaccine effectiveness, a disproportionately high number of infections in vaccinated persons, or very low vaccine-induced protection against severe disease.”

Significant research on Omicron, at this early date, is sparse. One of the largest studies, though not peer-reviewed, was released on Dec. 14 by Discovery Health, South Africa’s largest health insurance administrator. It is a real-world analysis of 78,000 positive test results, 19,000 of which were attributed to Omicron infections from Nov. 15 to Dec. 7.

The study found that a two-dose vaccination with Pfizer-BioNTech provided just 33% protection against COVID-19 infection but 70% protection against hospitalization. “While protection against hospital admission reduced from the highs of 93% in South Africa’s Delta-driven wave, 70% is still regarded as very good protection,” according to a press release by Discovery Health. Protection for those ages 60 to 69 drops to 67% and for those 70 to 79, to 60%.
 
The release quoted the president of the South African Medical Research Council, Glenda Gray, as saying, “We are extremely encouraged by the results of Discovery Health’s analysis…. The Pfizer-BioNTech vaccine provides good protection against severe disease and hospitalization.”

Also, for individuals who were previously infected, “the risk of reinfection with Omicron is significantly higher, relative to other variants.” For Beta, the variant responsible for South Africa’s second wave, the relative reinfection risk is 60%; for Delta, 40%.

The risk of hospitalization for those with COVID infection by Omicron is, however, 29% lower than during South Africa’s first wave early 2020. Furthermore, says the study, “hospitalized adults currently have a lower propensity to be admitted to high-care and intensive-care units, relative to prior waves.”

Children were 51% less likely to test positive for COVID than adults during the Omicron period, and they continue to have a low incidence of severe complications following COVID-19, says the study. But the data indicate that children under age 18 have a 20% higher risk for hospital admission for Omicron than with previous variants.

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Vaccine Efficacy Against Omicron Is Vastly Increased by Boosters

New research on vaccine effectiveness against Omicron has produced some disturbing – and some reassuring -- results.

A study released Dec. 14 by Wilfred F. Garcia-Beltran of Massachusetts General Hospital, Kerri J. St. Denis of the Ragon Institute in Cambridge, Mass., and 15 colleagues examined sera (liquid separated from blood) from 239 individuals who had received a full series of Pfizer BioNTech, Moderna, or Johnson & Johnson vaccines; 71 of them also received boosters. The sera were then tested against the Omicron variant.

The researchers reported, “Remarkably, neutralization of Omicron was undetectable” in most of those who were fully vaccinated but unboosted, even if the vaccinations were completed just three months earlier. But those who were “boosted with mRNA vaccines exhibited potent neutralization of Omicron. ”The researchers also found that Omicron “is more infectious than any other variant tested.” They write:

Taken together, we demonstrate that Omicron drastically escapes vaccine-induced immunity after primary vaccination series with mRNA-1273 (Moderna), BNT162b2 (Pfizer- BioNTech) or Ad26.COV2.S (Johnson & Johnson/Janssen) and exhibits increased infectivity in vitro, raising the potential for increased transmissibility. Of note,…Omicron breakthrough infections may result in attenuated disease severity in vaccinees due to cellular and innate immunity.

However, neutralization remains the leading correlate of protection from infection, and this study demonstrates that receiving a third dose of an mRNA- based vaccine effectively yields a potent cross-neutralizing response against SARS-CoV-2 Omicron, likely through increasing breadth and cross-reactivity of neutralizing antibodies.

Previously, we reported on the waning of vaccine potency, which, after all, is the reason the CDC changed its policy and now says that “Everyone Ages 16 and Older Can Get a Booster Shot.” A large study of 843,000 Israelis who were aged 50 or older found that “participants who received a booster at least 5 months after a second dose of BNT162b2 had 90% lower mortality due to Covid-19 than participants who did not receive a booster.” The study, published Dec. 8 in the New England Journal of Medicine, covered August and September, before the emergence of Omicron.

Boosters work, no doubt, but the U.S. and other countries have had a tough enough time getting their residents to take a single vaccine shot. So far, only 56 million of the 203 million Americans who are fully vaccinated have also had a booster. Will Americans, or others in the world, continue to get booster after booster? And if they don’t, will mutations produce more troubling variants?

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Which Countries Are Most Resilient in the Face of COVID?

The Bloomberg news service has been ranking countries for a year according to their “resilience” to COVID-19. The latest list, published Nov. 30, has the United Arab Emirates (UAE) in first place, followed, in order, by Chile, Finland, Ireland, Spain, Turkey, Canada, Sweden, France, and Denmark. The U.S. ranks 13th of the 53 countries that were rated, with the U.K. 12th, Japan 15th, Italy 27th, Mexico 43rd, and the Philippines last.

Criteria include vaccine doses per 100 population, with Chile leading at 211 (the U.S. is at 138); lockdown severity (less is better); flight capacity; case and death rates; GDP growth forecast; universal health care coverage; and community mobility, with smaller declines being better (the U.S. is down 15%; Chile, just 4%).

What we found significant was how much the ratings change. For example, Germany fell from third in September to 32nd in November. The U.S. rose 13 places from October to November. Japan was second a year ago and 15th in the latest ranking. Chile was in the bottom half of the rankings for 10 months, then soared in October and November. Canada, Denmark and Norway seem to have the best long-term track records, but, clearly, few countries have cracked the code and deal with the pandemic consistently well.

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Advice to Dentists for Safer Air

“Controlling Pathogens in Your Air” was the title of a thorough article in the trade publication Dentistry Today on Dec. 10. It looked carefully at the dangers of airborne transmission of pathogens, especially SARS-CoV-2, and at the benefits and deficits of different kinds of mitigation.
 
One section of the piece, titled “New Adjunctive Technologies,” discussed devices that “variously offer the capture of micro-organisms and their destruction in the device and/or in the air.” The article urges dentists to ask several questions about these adjunctive devices:
 
First and foremost, do you need one, does it work, and is it safe? Is the device FDA-cleared or being marketed…under the FDA Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers during the COVID-19 public health emergency or neither? Is it CARB-certified (which is needed in California)? Other factors include whether there are independent studies demonstrating efficacy against micro-organisms.
 
Another consideration is the availability of information from studies in healthcare settings supporting efficacy. Does the device operate episodically or continuously, including safely when the room/area is occupied?
 
The piece then looks at specific devices, spending by far the most space on the first, the ActivePure Medical Guardian, which, the article notes, “is cleared by the FDA as a Class II Medical Device and is CARB-certified…. The technology is an advanced form of the one developed and used in the NASA Space Program and included in the Space Foundation Technology Hall of Fame.”
 
The Medical Guardian, says the article, “utilizes a patented process that includes a UV light source in the device and titanium dioxide as a photocatalyst that is used to produce gaseous hydrogen peroxide and other oxidizers. These then exit the device and enter the air. The oxidizers interact with and disrupt bacterial and fungal cell membranes, as well as the outer shell of viruses. This leads to microbial kill.”
 
The piece also notes testing results for the Medical Guardian, including a trial at the University of Texas Medical Branch, using the SARS-CoV-2 virus. “The test protocol was designed to deliver 29 ft per minute of air movement (the lowest setting). Within 3 minutes, a ≥2.87 to ≥3.38 log reduction was found, which equates to a ≥99.87% to ≥99.96% reduction in the concentration of SARS-CoV-2. It was noted that the actual reduction may have been 99.99% or greater since the level of detection was reached.”
 
In a second independent study, “the test micro-organisms were Staphylococcus epidermidis, Erwinia herbicola, RNA MS2 and DNA Phi X174 bacteriophages, Aspergillus niger, andBacillus subtilis. These are proxy/surrogate micro-organisms for known pathogens, among them, respectively, Staphylococcus aureus; Yersinia pestis (black plague); influenza virus and norovirus; HCV, HCB, and HIV; Stachybotrys chartarumand (a toxic black mold); and Bacillus anthracis (anthrax). Three test trials were conducted as well as a control trial. The results showed an overall average net log reduction of 4.8 ±0.74, representing a greater than 99.99% reduction.”

The article concludes by stating that “understanding of airborne transmission has …come into sharper focus, and during COVID-19, a layered approach has been recommended,” including ventilation and newer devices. When dentists are looking at the latter, says the article, “careful review and due diligence are needed to determine…efficacy, safety, and applicability.” Good advice.

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The Characteristics of Breakthrough Infections

The Health System Tracker, a valuable resource devised by Peterson-KFF, published some fascinating data on Dec. 15 about breakthrough infections using a data set of 120,000 COVID-19 admissions between June and September, with Delta dominant.

Among the findings:

• 85% of individuals admitted to hospitals were not fully vaccinated. even though they represented at the time a minority (44%) of the U.S. population. (“Not fully vaccinated” means lacking two shots of Moderna or Pfizer or one shot of J&J; during the period of the study, few if any boosters were available)
• Among adults under 65 who have been hospitalized, 80% of those fully vaccinated and 75% of those unvaccinated or partially vaccinated have at least one of the following co-morbidities: cerebrovascular disease (or stroke), chronic obstructive pulmonary disease (COBD), heart failure, diabetes, obesity, or hypertension. Among adults over 65, the proportions are 90% for those fully vaccinated and 86% for those unvaccinated or partially vaccinated. Very significant is that 47% of those vaccinated and hospitalized in the younger cohort are obese.
• “Adults hospitalized with COVID-19 who were fully vaccinated had shorter average hospital stays than those who were not fully vaccinated within the same age group. For example, among patients over age 65, the median COVID-19 hospital stay was 1.1 days shorter for those who were fully vaccinated (5.6 days) than for those not fully vaccinated (6.7 days).”​

The authors write, “Despite the widespread availability of COVID-19 vaccines, in September, COVID-19 was the second-leading cause of death in the U.S. overall and the first-leading cause of death among people ages 35 to 54.”