CORONAVIRUS INFO PROVIDED BY DR. JIM HARRIS – 12/14/2022

FROM THE MARSHALL NEWS MESSENGER:

FROM HOPKINS SUGGESTIONS:

1. EPI UPDATE The WHO COVID-19 Dashboard reports 643 million cumulative cases and 6.62 million deaths worldwide as of December 8. Global weekly incidence remained relatively stable last week, decreasing 1.3% compared to an increase of 16.8% the previous week. A total of 3.04 million cases were confirmed the week of November 28. Weekly incidence fell over the previous week in Africa (-64%)*, South-East Asia (-27%), Western Pacific (-10%), and the Eastern Mediterranean (-4%). The Americas (+14%) and Europe (+4.5%) regions experienced increasing weekly incidence. Global weekly mortality decreased from the previous week, down 17%.

*The WHO dashboard notes that data from the Africa region are incomplete.

UNITED STATES

The US CDC is reporting 98.8 million cumulative cases of COVID-19 and 1.08 million deaths. Incidence for the week ending November 30 remained relatively stable over the previous week, falling to 303,101 cases from 306,856 cases for the week ending November 23. Weekly mortality fell significantly for the week ending November 30, with 1,780 reported deaths compared to 2,634 deaths the week ending November 23. The decline could be a result of delayed reporting due to the US Thanksgiving holiday.

2. MASK USE The US CDC is once again encouraging people to wear masks to help reduce the spread of respiratory illnesses, as hospitalizations rise due to the so-called “tripledemic” of COVID-19, RSV, and flu. The nation appears to be at the start of another COVID-19 wave, with hospitalizations reaching a 3-month high last week. Hospitals are already feeling strain from earlier-than-normal increases in RSV and flu cases and hospitalizations. The US is experiencing the highest levels of hospitalization from flu that it has seen in a decade this early in the season. Experts warn that holiday gatherings present a prime opportunity for respiratory viruses to spread and urge people to take precautions, including mask use, physical distancing, testing, and increased air ventilation. While it is unlikely that widespread mask mandates will return, masking in crowded areas can lower the risk of infection and help decrease the burden on overwhelmed hospitals. 

One more reason to don a mask during the colder months could be to help keep your nose warm. A study published this week in the Journal of Allergy and Clinical Immunology suggests that exposure to cold temperatures hinder immune responses in the upper respiratory tract by killing nearly half of the virus and bacteria-fighting cells in the nostrils, allowing viruses or bacteria to evade this initial immune response. 

3. Authorities are urging indoor masking in major cities as the ‘tripledemic’ rages (NPR) Public health officials are revisiting the topic of indoor masking, as three highly contagious respiratory viruses take hold during the holiday season. Over the past few weeks, a surge in cases of COVID, the flu and respiratory syncytial virus — known as RSV — has been sickening millions of Americans, overwhelming emergency rooms and even causing a cold medicine shortage. The triple threat has been called a “tripledemic” by some health experts. Rochelle Walensky, director of the Centers for Disease Control and Prevention, noted this past week that the simultaneous combination of viruses has been straining healthcare systems across the country.

4. Wrangling Over the International Pandemic Pact Has Begun (Think Global Health) Health officials met this week in Geneva to discuss a rough draft of a pandemic treaty, an international plan to avoid another disaster on the scale of COVID-19. This is the first of many drafts to come, in a process that began with a decision made in December 2021 by the World Health Organization’s (WHO) 194 member states to develop something like a treaty—perhaps an accord, agreement, or other ‘instrument’—to govern the global pandemic response. The project is spearheaded by the WHO and is slated for completion in May 2024.

FROM THE ANNALS OF INTERNAL MEDICINE;

Nirmatrelvir Plus Ritonavir for Early COVID-19 in a Large U.S. Health System

”…In the EPIC-HR (Evaluation of Protease Inhibition for Covid-19 in High-Risk Patients) trial, nirmatrelvir plus ritonavir led to an 89% reduction in hospitalization or death among unvaccinated outpatients with early COVID-19. The clinical impact of nirmatrelvir plus ritonavir among vaccinated populations is uncertain….The overall risk for hospitalization or death was already low (1%) after an outpatient diagnosis of COVID-19, but nirmatrelvir plus ritonavir reduced this risk further.

”(During the study period, 12 541 (28.1%) patients were prescribed nirmatrelvir plus ritonavir, and 32 010 (71.9%) were not. Patients prescribed nirmatrelvir plus ritonavir were more likely to be older, have more comorbidities, and be vaccinated. The composite outcome of hospitalization or death occurred in 69 (0.55%) patients who were prescribed nirmatrelvir plus ritonavir and 310 (0.97%) who were not (adjusted risk ratio, 0.56 [95% CI, 0.42 to 0.75]). Recipients of nirmatrelvir plus ritonavir had lower risk for hospitalization (adjusted risk ratio, 0.60 [CI, 0.44 to 0.81]) and death (adjusted risk ratio, 0.29 [CI, 0.12 to 0.71]).”

FROM BECKERS:

1. Variants: Based on projections for the week ending Dec. 10, the CDC estimates that BQ.1.1 accounts for 36.8 percent of cases and BQ.1 accounts for 31.1 percent of cases nationally. All other lineages are decreasing in proportion this week compared to last week.

2. As of Dec. 7, a total of 1,080,472 COVID-19 deaths have been reported in the United States.

 3. About 64 percent of sites across the country are reporting moderate to high virus levels in wastewater. Of these sites, 38 percent are reporting some of the highest levels for those sites since Dec. 1, 2021.

4. About 27 percent of sites are seeing a decrease in virus levels and about 65 percent are reporting an increase.

FROM A READER WHO HAS LITERALLY TRAVELED THE WORLD:

Newsletter: You’re done with masks? That’s too bad, because COVID isn’t done with us

FROM YOUR LOCAL EPIDEMIOLOGIST:

Will trust in science survive the pandemic?

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AREA COUNTS ARE UP AGAIN:(FROM THE NYT)

FROM THE CDE: DO I NEED ANOTHER BOOSTER:

DO I NEED A BOOSTER CLIC

Then Click the green tab asking “FIND OUT WHEN TO GET A BOOSTER.”

Then you can call your doctor, your pharmacist, or the health department:

MARSHALL/HARRISON COUNTY HEALTH DEPARTMENT

903 938 8338

I just called them and plan to get my 5th Covid vaccination tomorrow from 8-11 or 1-4. They are doing something else today (Thursday). Wear your mask in the building). 

FROM THE NEJM:

Efficacy of Antiviral Agents against Omicron Subvariants BQ.1.1 and XBB

”…Our data suggest that the omicron sublineages BQ.1.1 and XBB have immune-evasion capabilities that are greater than those of earlier omicron variants, including BA.5 and BA.2. The continued evolution of omicron variants reinforces the need for new therapeutic monoclonal antibodies for Covid-19.”

FROM YOUR LOCAL EPIDEMIOLOGIST:

Fall bivalent boosters: Science update round 3

”…We have lab data for fall boosters. We have real world data. And what’s coming in looks good—not perfect, but good. We have lots of reason to believe they will work even better against severe disease, especially among those over 50 years old. Go get your fall booster. We are at the beginning of a wave.”

From last week:” ..There’s a lot we can do: mask, test before seeing loved ones, get that airflow moving, stay home when you’re sick. The least you can do for a healthy season is get a flu and fall COVID-19 booster. If you haven’t gotten one yet, it’s never too late…”

FROM THE NYT:

Reversing ‘zero Covid’

FROM HOPKINS SUGGESTIONS:

1. Models predict massive waves of disease and death if China lifts ‘zero COVID’ policy (Science) Surprised and stung by protests against draconian “zero-COVID” policies, Chinese authorities are gingerly moving to ease the burden of lockdowns, quarantines, and constant testing. But 3 years into the pandemic, China shows no sign of planning a major course change. Mathematical models suggest why: The country is still ill-prepared for living with SARS-CoV-2. Easing restrictions today would likely trigger a massive wave of infections, overwhelm health care facilities, and bring a high death toll.

2. For the uninsured, Covid care has entered a new stage of crisis (New York Times) Difficulty getting care for Covid-19 has become an increasingly common problem for poor, uninsured Americans. After paying about $25 billion to health care providers over the course of the pandemic to reimburse them for vaccinating, testing and treating people without insurance, the federal government is running low on funds for Covid care for the nearly 30 million Americans who are uninsured. The Biden administration is asking Congress to replenish its coffers, but its pleas to lawmakers this year have so far been unsuccessful.

3. A liver drug reduces SARS-CoV-2 entry into cells (Nature) A widely used drug called UDCA reduces SARS-CoV-2 infection in human organoid structures, animals and human organs maintained outside the body. Individuals using UDCA for liver conditions are less likely to develop severe COVID-19 than are people who did not use it. UDCA treatment could help to protect people with suppressed immune systems and offer protection against vaccine-resistant variants. However, this study is not a clinical trial, and our findings must be validated and confirmed in large groups of individuals who are studied over time.

4. Science & Technology

U.S. FDA accepts priority review the Biologics License Applications for Pfizer’s respiratory syncytial virus vaccine (RSV) candidate for the prevention of RSV disease in older adults (Pfizer) Pfizer Inc. announced today that the U.S. FDA accepted a Biologics License Application (BLA) for priority review of its RSV vaccine candidate for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age and older. Priority Review designation by the FDA reduces the standard BLA review period by four months. The Prescription Drug User Fee Act goal date for a decision by the FDA on the vaccine candidate application is in May 2023. 

AND LAST BUT NOT LEASED: 

DO NOT READ THIS JOKE:

Steve lived all his life in the Florida Keys and is on his deathbed and knows the end is near. His nurse, his wife, his daughter and two sons are with him. He asks for two witnesses to be present, and a camcorder be in place to record his last wishes, and when all is ready, he begins to speak:

“My son, Doug, I want you to take the Ocean Reef houses”

“My daughter Kelly, you take the apartments between mile markers 100 and Tavernier.”

“My son, Kevin, I want you to take the offices over in the Marathon Government Center.”

“Cathy, my dear wife, please take all the residential buildings on the bay side on Blackwater Sound.”

The nurse and witnesses are blown away as they did not realize his extensive holdings, and as Steve slips away, the nurse says, “Your husband must have been such a hard-working man to have accumulated all this property.”

The wife replies, “No. He was a hardworking dreamer who had a paper route.”

Remember, next time you hate your life, it’s all about perspective. For, instance, I have a friend who reads 2-3 books a week, works out twice a day, and has people who want to have sex with him all the time, yet complains about how much he hates prison.

Have a Wonderful Holiday Season!

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75688

US, Texas, and East Texas Covid Case Counts are going up again. Here we go again, but we have some immunity, Vaccines available, Flu shots, Masks, and soap. We are also more likely to use more informed and better judgment. 

FROM THE NEW YORK TIMES 1 DEC, 2022

FROM YOUR LOCAL EPIDEMIOLOGIST:

COVID-19 in China and global concern

(J. Harris: Great read regarding China and what likely will happen!)

FROM THE ANNALS OF INTERNAL MEDICINE:

1. Medical Masks Versus N95 Respirators for Preventing COVID-19 Among Health Care Workers (Hopkins summary)

Study on masks vs N95 respirators for health workers spurs concerns (CIDRAP) A study today in the Annals of Internal Medicine suggests that medical masks may offer similar effectiveness as N95 respirators in protecting healthcare workers (HCWs) exposed to COVID-19 patients in certain settings, but experts caution against that interpretation of the results. The World Health Organization (WHO) recommends continuous wear of either medical masks or N95s when caring for COVID-19 patients, while the US Centers for Disease Control and Prevention (CDC) advises using N95s.

2. Outpatient Treatment of Confirmed COVID-19

”…Some antiviral medications and monoclonal antibodies may improve outcomes for outpatients with mild to moderate COVID-19. However, the generalizability of the findings to the currently dominant Omicron variant is limited….”

3. Major Update 2: Antibody Response and Risk for Reinfection After SARS-CoV-2 Infection—Final Update of a Living, Rapid Review

”…Evidence for a sustained antibody response to SARS-CoV-2 infection is considerable for both Delta and Omicron variants. Prior infection protected against reinfection with both variants, but, for Omicron, protection was weaker and waned rapidly. This information may have limited clinical applicability as new variants emerge…”

4. Temporal Improvements in COVID-19 Outcomes for Hospitalized Adults: A Post Hoc Observational Study of Remdesivir Group Participants in the Adaptive COVID-19 Treatment Trial (94 hospitals in 10 countries (86% U.S. participants)

FROM HOPKINS SELECTIONS

1. ‘Zombie virus’ resurrected after being frozen for 48,500 years (Independent) Thawing of frozen landscapes has the potentional to unleash infectious “zombie viruses” that have been locked underground for thousands of years, according to new research. One quarter of the Northern hemisphere has permanently frozen ground beneath it, and is facing irreversible thawing due to the climate crisis. This decomposing landscape releases carbon dioxide and methane into the atmosphere, adding more heat to the planet. The new study, led by microbiologist Jean-Marie Alempic from the French National Centre for Scientific Research, looked at samples collected from permafrost in the Russian province of Siberia. From these, scientists were able to awaken 13 new viruses which they labelled “zombie viruses” – including one which remained infectious after more than 48,500 years in deep permafrost. The study, which is yet to be peer-reviewed, noted that there has been limited research into “live” viruses found in permafrost.

2 CDC Awards over $3 billion to bolster public health workforce, infrastructure (The Hill) The U.S. Centers for Disease Control and Prevention (CDC) announced it will award over $3 billion to strengthen the public health workforce and infrastructure of state, local and territorial health departments. The funding is the first-of-its kind, while all U.S. citizens live in a jurisdiction that will receive funds under the new grant. The announcement comes as the United States faces a growing shortage of healthcare workers. The Association of American Medical Colleges estimates that by 2033, the country will have a shortage of up to 124,000 physicians, including both primary care physicians and specialists.

AND LAST BUT NOT LEASED: HOME GROWN GROANERS: 

1. What did one ocean say to the other ocean?

Nothing, it just waved.

2.Did you hear about the fire at the circus?

It was in tents!

3. When does a joke become a ‘dad’ joke?

When it becomes apparent.

NO JOKE: WHY NOT USE PARTS OF GOOD SHEPHERD MARSHALL HOSPITAL 

FOR LONG COVID REHABILITATION???

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75688

HELLO,

EAST TEXAS  area remains Covid quiet. 

HAPPY BIRTHDAY to all of the Norwegians that I know. 

MILTON THE TOMATO decided to head on back to the equator ‘where the weather is cooler.”

FROM BECKERS: GREAT, CONCISE, QUICK COVID SUMMARY IN US:

‘Escape variants’ account for 16% of US COVID-19 cases: 10 updates

FROM THE WASHINGTON POST:

QUESTION: I have had all of the vaccines and boosters — a total of five jabs to date. I’ve had many coronavirus tests, but none positive. Is it possible that I have had asymptomatic covid and didn’t know I had it? — Lynn, Tallahassee, Fla.

ANSWER:” While there is growing research surrounding people who have never contracted the coronavirus, researchers know a majority of Americans have been infected. So if someone has never tested positive for the coronavirus and has never experienced symptoms, there could be two reasons: One, they are among the lucky few who have managed to dodge the virus, or, two, the time when they took the test did not coincide with a peak infection in their body. The latter is especially true if a person has symptoms of a coronavirus infection but tests negative.

…Two tests can detect a coronavirus infection: a polymerase chain reaction (PCR) test and an at-home rapid test. The home test is not as reliable because it can only detect specific proteins from the virus, while PCR tests can identify lower levels of the virus. Neither test can detect a past infection.

…A serology test is the only way to identify if a person’s body has produced antibodies in response to SARS-CoV-2, thus identifying a previous infection.

…But even serology tests are not a guarantee as “antibody levels can decline over time, so a negative [antibody] test is not definitive proof of never having had COVID,” Daniel R. Kuritzkes, chief of the infectious-diseases department at Brigham and Women’s Hospital in Boston, told The Washington Post in an email. “A positive test is definite evidence of past infection; a negative test is less reliable over time…Kuritzkes adds there is not much reason clinically to order the test because antibody levels decay at different rates in different people….” 

FROM YOUR LOCAL EPIDEMIOLOGIST:

ACIP meeting: Updated info on COVID-19, vaccine safety for kids and pregnancy

(J. Harris: Up to date information about Vaccination for youngsters.)

FROM HOPKINS SELECTIONS:

1. UNITED STATES

The US CDC is reporting 96.8 million cumulative cases of COVID-19 and 1.06 million deaths. Daily incidence continues to decline, down to 37,052 new cases per day, the lowest average since mid-April. Average daily mortality also continues to decline, down to 323 deaths per day on October 18.**

2 “ SCRABBLE VARIANTS OR SUBVARIANT SOUP” (CDC)

IMMUNE EVASIVE OMICRON SUBVARIANTS While past surges in COVID-19 cases have been driven largely by single SARS-CoV-2 variants, experts are eyeing a collection of Omicron subvariants that could drive an anticipated wave of infections this fall and winter. In the US, BA.4.6 appeared to be gaining momentum, although BF.7, BQ.1, and BQ.1.1 are showing recent potential growth advantage. The same sublineages are also showing evidence of growth advantage over BA.5 in the United Kingdom. Additional variants, including the recombinant variant XBB, are fueling increases in cases in Southeast Asia and Europe. The US has yet to see a large surge due to these subvariants, with the number of new cases continuing to drop. But public health experts warn data on new cases is unreliable—many are turning to wastewater surveillance to help predict where and when surges may occur—and most expect the downward trend to reverse over the next few weeks. The collection of variants, sometimes referred to as “scrabble variants” or “subvariant soup,” accounts for nearly 1 in 3 new infections reported in the US last week. Globally, detecting these variants and developing accurate assessments of the risk they pose to public health is challenging, as many countries have rolled back their surveillance efforts…

…While available vaccines remain effective in preventing severe illness and death from COVID-19, there are concerns the emerging subvariants will be more immune evasive than previous variants, particularly due to mutations in the receptor binding domain that would prevent antibodies from docking and attacking the virus. AstraZeneca’s EvuSheld, the only monoclonal antibody authorized to prevent SARS-CoV-2 infection, is ineffective against BA.4.6. Other monoclonal antibodies in development already demonstrate vulnerabilities to newly emerging Omicron subvariants. With this new information, the Biden administration is searching for other potential candidates for use among immunocompromised persons…”

FROM THE ATLANTIC:

America Created Its Own Booster Problems

“…And with daily COVID vaccination rates only a notch above their all-time nadir and barriers to inoculation rising, the nation might be bogged down in its booster doldrums for a good while yet—leaving Americans potentially vulnerable to yet another catastrophic surge… The country’s booster problem is the culmination of months of such confusion. It is also an exacerbation of the inequities that plagued the country’s initial immunization efforts. Booster uptake may present its own issues, but those only piled on the problems that vaccination efforts had encountered in all the months before….this messy discourse warped into confusion, consternation, and apathy. “When the scientists don’t agree, what are the rest of us supposed to do?”…Nor have the logistics of booster recommendations been easy to follow. In the past few months, the FDA and the CDC have issued roughly half a dozen shifts in guidance—over not only who should boost, but also when they should boost, how many boosts to get, and whether booster brands should be mixed….The erratic narrative on vaccines writ large also hasn’t done the U.S. booster campaign any favors. When the shots were fresh out of the gate, Americans were set up to believe that they could take an initial course of doses and be done—with COVID vaccines, maybe even with the pandemic itself. But as more data emerged, it became evident that the shots’ protective powers had been oversold. Vaccines operate best in gradations, blunting and truncating the worst symptoms of disease; they never completely obliterate risk. “We failed to communicate that,”….Even if the message on boosters had been clearer from the get-go, that wouldn’t have ensured that people got them. Vaccination rates have tended to track with risk perception,..One fact about boosting hasn’t changed. Asking people to get an additional shot means … asking people to get an additional shot, and that’s become harder than ever. As shot uptake has dropped off, vaccination sites have closed, while community outreach has pulled back….Issues with access, at least, have straightforward (though still difficult-to-implement) solutions. “We need to make the process easier, and more convenient,” Fishman, of UPenn, told me. Reviving and more evenly distributing community vaccination efforts could help. Stand-alone sites could take walk-in appointments; teams of volunteers could bring vials and syringes directly to the places where people live and work. Paid sick leave, subsidized transportation, or even financial incentives for vaccinations could make a big difference too. Perhaps most crucial, additional federal funding to keep vaccines free for everyone would mean shots stay within reach of some of society’s most at-risk members….Clearer policies have a role to play too. Many workplaces, for instance, issued strict requirements for initial doses last year. But booster mandates have been sparser. With eligibility ever-changing, and the possibility of annual shots on the table, that’s logistically understandable, but it sends an implicit message, Lewis told me: “One inference people are making is If boosting was really that important, the government or my boss would be issuing a mandate…”

(J. Harris: Vaccines, masks, hand washing, distance, and go0d sense have clearly worked in controlled environments like smaller universities, the military, and well-managed companies. Personally, I’m about  ”talked out” on the vaccine question. Even some people with good sense won’t take the vaccines. Ok. You probably won’t die this late in the pandemic. But God help you if you wind up with a severe case of Long Covid. Tough luck, Dude. I’ll worry about folks who haven’t had a chance to take the vaccines and myself and my family. In the next few years, the magnitude of and devastation caused by Long Covid will be apparent and will swamp medical resources. )

AND LAST BUT NOT LEASED:

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WE STILL HAVE COVID IN THE AREA:

THERE SEEMS TO BE A CLUSTER OF CASES OF COVID IN  CASS COUNTY. 

FROM HOPKINS,  THE WASHINGTON POST,  AND NATURE COMMUNICATIONS ( three versions in increasing detail):

1. ‘We are in trouble’: Study raises alarm about impacts of long covid (Washington Post) A new long-covid study based on the experiences of nearly 100,000 participants provides powerful evidence that many people do not fully recover months after being infected with the coronavirus. The Scottish study found that between six and 18 months after infection, 1 in 20 people had not recovered and 42 percent reported partial recovery. There were some reassuring aspects to the results: People with asymptomatic infections are unlikely to suffer long-term effects, and vaccination appears to offer some protection from long covid

2.  Outcomes among confirmed cases and a matched comparison group in the Long-COVID in Scotland study

”…Large study provides powerful evidence of long covid’s lasting impact…”

”The Scottish study found that between six and 18 months after infection, 1 in 20 people had not recovered and 42 percent reported partial recovery. There were some reassuring aspects to the results: People with asymptomatic infections are unlikely to suffer long-term effects, and vaccination appears to offer some protection from long covid…“It’s one more well-conducted, population-level study showing that we should be extremely concerned about the current numbers of acute infections,” …We are in trouble….Crucially, this study also identified a sub-cohort of 11 percent who deteriorated over time. This is something seen often in patient groups but has not been discussed enough in the public conversation.”

FROM NEJM LETTER TO EDITOR/STUDY 

Protective Effect of Previous SARS-CoV-2 Infection against Omicron BA.4 and BA.5 Subvariants

(J. Harris: There is some Covid protection from subvariantants if you have had a prior infection with that strain or a similar strain — which makes sense. Vaccinations make more sense to me.)

FROM HOPKINS SELECTIONS:

1. EMERGING SUBVARIANTS The SARS-CoV-2 virus continues to evolve, with multiple emerging sublineages of the Omicron variant of concern (VOC) poised to play a dominant role in the next surge. As noted above, several sublineages are increasing in prevalence in the US as the current dominant strain, BA.5, begins to wane. At this point, it is unclear if the next principal variant would be capable of evading immunity conferred by vaccination, including Omicron-specific booster doses, or prior infection with other variants, but researchers are already working to identify key mutations and project their impact. In contrast to previous surges, the forecasted fall/winter surge may not be driven by a single variant, as was the case with the Delta and Omicron surges in 2021 and earlier in 2022. In fact, WHO officials recently indicated that they are currently monitoring more than 300 Omicron sublineages.

Several of these sublineages are particularly concerning, including BQ.1 and BQ.1.1 that evolved from BA.5 and BA.2.275 and XBB that evolved from BA.2. The BQ.1 and BQ.1.1 sublineages are currently circulating in Europe, which could forecast a fall/winter surge in other Northern Hemisphere countries. All 4 of these sublineages exhibit resistance to existing treatments and vaccines, and the XBB sublineage, in particular, threatens to render existing vaccines ineffective. In addition to the risk of global spread of a vaccine-resistant vaccine, the decline in testing volume worldwide and barriers to including at-home test results in SARS-CoV-2 reporting systems could make surveillance problematic. And the general absence of COVID-19 protective measures (eg, physical distancing, mask use) could facilitate community transmission. Additionally, governments seem to be unwilling to commit additional funding to COVID-19 responses, including research on future vaccines and therapeutics, as evidenced in the US government’s struggle to secure funding for Project COVID Shield, the follow-on to Operation Warp Speed to develop advanced SARS-CoV-2 vaccines. The world is simply in a much different place than it was in 2020 and 2021, which elevates the threat from these emerging sublineages.

As opposed to more radical antigenic “shifts”—like those observed with the emergence of the Delta variant or the original Omicron variant—the new sublineages of the Omicron variant are exhibiting more subtle antigenic “drift.” This is similar to the evolution observed in annual seasonal influenza epidemics, although on a much shorter timeline. New sublineages appear to be acquiring many of the same mutations, in various combinations, which signals that they may be converging on a common set of traits. Despite the recent pattern, however, it is still possible that the virus could take a more substantial shift, which could result in the emergence of a new major variant with much different characteristics.

2. Rising COVID levels in Europe especially affect seniors (CIDRAP) COVID activity continued to rise in many European countries last week, up 14% compared to the previous week in people ages 65 and older, the European Centre for Disease Prevention and Control (ECDC) said Friday in a regular update. In the United States, COVID indicators continue to fall, with the BA.5 Omicron variant still dominant, but newer subvariants are slowly making more of a mark.  

FROM NYT:

GOOD NYT ARTICLE ON FLU SHOTS AND PRACTICAL INFORMATION

FROM BECKERS:

Paxlovid can interact with heart medications, study suggests

FOR AREA VETERAN from the VA

Dear Veteran,

It’s That Time of Year Again!

The single best way to reduce the risk of seasonal flu and its potentially serious complications is to get the Influenza Vaccination each year.� Good health habits also reduce getting the flu like avoiding people who are sick, covering your cough, and washing your hands often can help stop the spread of germs and prevent respiratory illnesses like flu.

The Overton Brooks Medical Center influenza vaccination opportunity schedule is below.� Quadrivalent Flu shots are free to all enrolled Veterans in these ways:

• During a regular scheduled appointment or any Primary Care as a Flu Walk-In Visit.
• Shreveport Campus Front Circle Drive Thru Flu Clinic on October 8, or October 15, 2022 from 8:00 a.m. to 12 noon.
• To find a community pharmacy to receive a flu vaccine, use the VA Facility Community Partner using your zip code: http://www.va.gov/find-locations/
• Longview, Monroe, and Texarkana Community Based Clinics, Walk-In Flu Clinics are Wednesdays, October 5th thru December 28th from 1:00 p.m. to 3:00 p.m. with no appointment necessary, except November 23rd.
• To find a community pharmacy to receive a flu vaccine, use the VA Facility Community Partner using your zip code: http://www.va.gov/find-locations/�Please make sure the Community Partner is aware you are receiving this through the Community Partnership with VA.
• Moderna Vaccines (1^st dose, 2^nd dose and Bivalent Booster) are available at main campus in Shreveport Drive Thru Flu Clinic.
• Both vaccinations can be received at the same time, per CDC guidance.
• There will be a 15 minute wait after the vaccination.

FROM YOUR LOCAL EPIDEMOLOGIST

Fall boosters, myocarditis, and benefits/risks for young people

Subscribe to Center for Health Security E-Newsletters, Updates, and Alerts

SIGN UP FOR HOPKINS FREE COVID SUBSCRIPTION (click it). 

HARRIS: A great way to keep up with Covid since things have “cooled off” a bit it by subscribing  the free subscription for all of the Hopkins publications. They are free and increasingly readable and useful. They generally have 1-3 short mailouts weekely. Their mail out today, Oct. 13, is wonderful. You can also subscribe. to the past issues. They run a few days behind some of our mailouts, but their information is still timely and trustworthy. I’d subscribe to all of thier offerings. They are free. They are trustworthy and have provided fabulous information.  Alas, they don’t have any jokes. Likely, I will still continue to wart you occasionally.  Good Luck. 

AND LAST BUT NOT LEASED:

Written by Regina Brett, 90 years old, of the Plain Dealer, Cleveland, Ohio :

Be eccentric now. Don’t wait for old age to wear purple.

Life isn’t tied with a bow, but it’s still a “gift.”

All that truly matters in the end is that you loved.

It’s OK to let your children see you cry.

Time heals almost everything. Give time time.

 When it comes to chocolate, resistance is futile

God loves you because of who God is, not because of anything you did or didn’t do.

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FROM YOUR EPIDEMIOLOGIST:

 COVID State of Affairs: Oct 5

”…Here we go again. The start of a new wave. Eyes are on Western Europe, as hospitalizations are uniformly increasing….Interestingly, no new subvariant is driving this wave, as the majority of cases are still the “old” BA.5 subvariant….[BUT]…subvariants are brewing. They only make up a small percentage of cases for now, but they are gaining ground; historically, we feel their impact when they make up ~30-50% of cases. These subvariants will eventually add fuel to the fire…If we combine five of the top new subvariant leaders in the U.S. (referred to as “Pentagon”), it’s clear that case acceleration is brewing below the surface. Given the current growth, we will likely see an impact on national metrics in mid-November….”

(J. Harris:I suggest that you read the whole article referenced above. You might even want to subscribe to her efforts and send her some money. I did, but it looks like I’ll need to send her some more. We are likely to have another bad winter. The most important thing we old folks can do is to stay completely vaccinated, be careful, avoid sick people if possible, and avoid unvaccinated people. Remember, about half the folks with Covid do not know that they have it or just caught it and don’t have symptoms yet. AND, get your FLU SHOT.)

FROM THE LA TIMES:

Coronavirus Today: How COVID lies spread on Facebook

(J. Harris: Wonderful summaries of several papers—READABLE version)

FROM SCIENCE ADVANCES.        Almost unreadable version:

”Losing the battle over best-science guidance early in a crisis: COVID-19 and beyond”

(J. Harris: I have a few readers who have advanced mathematical and statistical skills who can probably understand this article. I simply will have to agree with the conclusions.)

FROM BECKERS: 

CDC revises ‘up to date’ term on COVID-19 vaccination

”…The CDC revised its “up to date” COVID-19 vaccination term Sept. 30 to include the primary series and the recently authorized omicron-targeting booster.”

FROM THE WASHINGTON POST:

Can you get the omicron booster if you have never received the original coronavirus vaccine?

AND LAST BUT NOT LEACHED: 

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FROM THE ATLANTIC:

The Pandemic’s Legacy Is Already Clear

”...In furiously racing to rebuild on this same foundation, America sets itself up to collapse once more…”

”…America’s individualist bent has also shaped its entire health-care system, which ties health to wealth and employment. That system is organized around treating sick people at great and wasteful expense, instead of preventing communities from falling sick in the first place….

 UP TO DATE REASONS TO GET VACCINE BOOSTER!

(J. Harris: The numbers in favor of boosters are convincing.)

COVID VACCINE AVAILABLE IN MARSHALL NOW FREE:

We have plenty of Pfizer COVID 19 vaccines (primary and booster) doses available. If you have a business or group that would like us to schedule an onsite vaccine clinic, please let me know.

Jennifer Hancock, RN, BSN  

Executive Director – Marshall-Harrison County Health District

805 Lindsey Drive  |  Marshall |  TX 75670

Tel 903.938-8338  |  Fax 903.938.8330

www.mhchd.org

SHORT VIDEO ANIMATION OF HOW MRNA VACCINE WORKS

(Thank you, Ken Belson, NYT)

FROM HOPKINS SELECTIONS”

1. COVID-19—Clinical Practice

Long COVID Has Forced a Reckoning for One of Medicine’s Most Neglected Diseases (The Atlantic) ME/CFS involves a panoply of debilitating symptoms that affect many organ systems and that get worse with exertion. The Institute of Medicine estimates that it affects 836,000 to 2.5 million people in the U.S. alone, but is so misunderstood and stigmatized that about 90 percent of people who have it have never been diagnosed. At best, most medical professionals know nothing about ME/CFS; at worst, they tell patients that their symptoms are psychosomatic, anxiety-induced, or simply signs of laziness. While ME/CFS patients, their caregivers, and the few doctors who treat them have spent years fighting for medical legitimacy, the coronavirus pandemic has now forced the issue.

2. Public & Global Health:

Five things about covid we still don’t understand at our peril (The Washington Post) Since a new coronavirus launched the global pandemic that has now killed more than 6.5 million people — 16 percent of them in the United States alone ― scientists in record numbers have devoted themselves full time to unraveling its mysteries. In less than three years, researchers have published more than 200,000 studies about the virus and covid-19. That is four times the number of scientific papers written on influenza in the past century and more than 10 times the number written on measles. Still, the virus has kept many of its secrets, from how it mutates so rapidly to why it kills some while leaving others largely unscathed — mysteries that if solved might arm the world’s scientists with new strategies to curb its spread and guard against the next pandemic. Here are some of the most pressing questions they are trying to answer.

3. Moderna seeks FDA nod for Omicron-targeted COVID shot for adolescents, younger kids (Reuters) Moderna Inc said on Friday it has requested U.S. authorization for use of its Omicron-targeting COVID vaccine in adolescents and children. The company is seeking emergency use authorization of its updated vaccine in two age groups – adolescents aged 12 to 17 years and children aged six to 11. The application for the bivalent vaccine for children between the ages of six months and under six years is expected to be completed later this year, the company said in a tweet.

4. (27 Sept): PANDEMIC PREDICTIONS Recent increases in COVID-19 cases in the UK could signal that the US is heading into a fall and winter COVID-19 surge. Historically, the US lags the UK in case trends by about one month, and the UK trend began rising the week of September 17. Some models predict US case trends will continue to decrease into October before beginning to rise, and while current predictions suggest a big increase in infections, the infection-detection rate likely will remain low due to declines in testing. Because the US population has some underlying immunity, and most experts agree the country has the pandemic under control, the death toll is expected to be rather modest….

But this modeling is based on the Omicron BA.5 subvariant, and the emergence of a new variant or subvariant could upend these predictions, particularly if there is a reduction in cross-variant immunity. BA.5 continues to account for the majority of new COVID-19 cases in the US (83.1%), but BA.4.6 (12%) and BF.7 (2.3%), an offspring of BA.5, are beginning to show growth advantage over BA.5. BF.7 has an additional genetic mutation in the spike protein compared with BA.5, which could reduce the efficacy of the monoclonal antibody treatment Evusheld, one of the few remaining therapies effective against BA.4 and BA.5. The mix of variants in the UK appears to be about the same as the US, although epidemiologists are watching to see whether emerging variants such as BQ.1.1 and BA.2.75 grow in proportion.

FROM YOUR LOCAL EPIDEMOLOGIST:

1. BOOSTERS STIMULATE YOUR IMMUNE SYSTEM TO RESIST SOME NEW VARIANTS

”…an updated booster will increase the diversity of our antibodies and that memory will be retained by our immune systems…”

2. mRNA in breastmilk. That’s okay. And more on COVID19 vaccines and pregnancy

(J. Harris: Extensive review of Covid and pregnancy biochemistry/immunology.)

FROM THE NYT

1. In a Game Built on Violence, No Player Is Safe

(A football article written by honorary Marshallite, Ken Belson)

AND LAST BUT NOT LEASED:

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CORONAVIRUS INFO PROVIDED BY DR. JIM HARRIS – 9/23/2022

SO, WE CAN STOP THIS COUNT FOR NOW, AND, HOPEFULLY, FOREVER.

OUR AREA IN TEXAS IS NOW IN  A “LOW DANGER” AREA. I ANTICIPATE THAT MY MAILOUTS WILL BECOME INCREASINGLY INFREQUENT. I KNOW WE ALL HOPE SO. 

STAY WARY. 

FROM BECKERS:

BEST WAY TO TAKE A PILL AND GET QUICK RESULTS

(J. Harris: What a nice study. I never even thought about this. Quick clearance of the medications might really help when taking medicines that “burn” the stomach lining, like aspirin and other nonsteroidal anti-inflammatory drugs — as well as steroids. KEEP RIGHT!)

FROM THE NEJM:

NEW MODERNA VACCINE WORKS WELL AGAINST CURRENT VARIANTS

”The bivalent omicron-containing vaccine mRNA-1273.214 elicited neutralizing antibody responses against omicron that were superior to those with mRNA-1273, without evident safety concerns. ”

FROM MEDICARE:

”…Important: Updated COVID-19 vaccines are now available to provide increased protection against the currently circulating Omicron BA.4 and BA.5 subvariants….

If it has been at least 2 months since you completed your COVID-19 primary series or had your last booster, then you are eligible for an updated vaccine. 

Remember: Medicare covers the COVID-19 vaccine at no cost to you. 

FINE A VACCINE SITE NEAR YOU

FROM HOPKINS SUGGESTED ARTICLES: 

AS OF 22 SEPT: UNITED STATES

The US CDC is reporting 95.6 million cumulative cases of COVID-19 and 1,049,101 deaths. Daily incidence continues to decline, down to 55,332 new cases per day. Daily mortality appears to have plateaued, with an average of 356 deaths per day. 

1. Lancet Commission on COVID-19 response: ‘Massive global failure’

Lancet Commission on COVID-19 response: ‘Massive global failure’ (CIDRAP) A stinging new Lancet Commission report on the international COVID-19 pandemic response calls it “a massive global failure on multiple levels” and spares no one the responsibility—including the public—for millions of preventable deaths and a backslide in progress made toward sustainable development goals in many countries.

(J. Harris: This is a readable summary.)

2. Should Your Flu and COVID Shots Go in Different Arms? (The Atlantic) At a press briefing earlier this month, Ashish Jha, the White House’s COVID czar, laid out some pretty lofty expectations for America’s immunity this fall. “Millions” of Americans, he said, would be flocking to pharmacies for the newest version of the COVID vaccine in September and October, at the same appointment where they’d get their yearly flu shot. “It’s actually a good idea,” he told the press. “I really believe this is why God gave us two arms.” That’s how I got immunized last week at my local CVS: COVID shot on the left, flu shot on the right. I spent the next day or so nursing not one but two achy upper arms. Reaching high shelves was hard; putting on deodorant was worse. And it did make me wonder what would have happened if I’d ignored Jha’s teleological advice and gotten both jabs in the same arm.

3. Nation warned to brace for a difficult flu season (The Hill) Health experts are warning the nation to brace for what could be an exceptionally severe flu season this fall and winter, as more people who have not built up immunity over the last few years mix and mingle. There are two big reasons why more people could be vulnerable to the flu this year. The first is that with coronavirus restrictions such as the wearing of masks all but forgotten, people are more likely to come into contact with the flu virus this year than over the last two years. The second reason is that fewer people are likely to be immune from the flu virus this year because fewer people have been getting the flu over the last two years — as the pandemic locked people down and as people worried more about getting COVID-19.

4. Additionally, the WHO last week strongly advised against the use of 2 different antibody therapies—sotrovimab as well as casirivimab-imdevimab—to treat patients with COVID-19 because they have limited clinical activity against currently circulating viral variants. The US FDA previously pulled or limited the use of the drugs, and some experts criticized the WHO for waiting to make the updated recommendation. The WHO expanded its conditional recommendation for the antiviral remdesivir to cover patients with severe COVID-19 and those with non-severe infections but who are at high risk of hospitalization….

Only a handful of COVID-19 therapeutics remain useful against currently circulating SARS-CoV-2 strains. While researchers quickly developed 4 effective treatments for hospitalized COVID-19 patients in the year between January 2020 and February 2021, no new therapies for hospitalized patients have been authorized since February 2021, raising concerns about whether treatment advancements have stalled. 

4. There’s a Shortage of Moderna Covid Boosters in the US (Bloomberg) Some pharmacies are reporting shortages of Moderna Inc.’s new bivalent booster shot for Covid-19 as one factory used in producing the vaccine remains offline following a safety inspection. The US government supply of Moderna’s shot is currently limited, causing appointments for the product to vary across the country, a Walgreens Boots Alliance Inc. pharmacy spokesperson said in an emailed statement. Meanwhile, CVS Health Corp. says some of its drugstores have used all of the updated shots they received from the government, and the company is trying to get more doses. Moderna has been coping without one of its vaccine-manufacturing facilities.

FROM YOUR EPIDEMIOLOGIST:

State of Affairs (Sept 19): COVID19, MPX, Polio, and… Flu

1. SARS-CoV-2 continues to mutate, and there are a few Omicron variants, like BA.2.3 and BJ.1, on the horizon with potentially concerning combinations of mutations. But evidence thus far is extremely limited. Most eyes are on BA.2.75.2, which is a second generation subvariant and has three additional spike protein mutations. Two preprints have shown substantial immune escape, even compared to BA.5. This means it has the potential to cause future waves. The number of BA.2.75.2 cases is still very small across the globe, but counts are doubling every week. If this growth rate continues, BA.2.75.2 may be one that causes the much anticipated winter wave.

2. Flu: Finally, flu. The flu season in Australia wrapped up, and it wasn’t pretty. This is notable because, historically, Southern hemisphere patterns predict what is to come in the Northern hemisphere….U.S. flu activity remains low, as is typical this time of year, but flu season is just around the corner. Given the Southern hemisphere’s warnings, we predict that this activity will change. However, right now, the only predictable thing about viral behavior is that it is unpredictable.

3. The “common” viruses for our kids may be back

(J. Harris: Check this out if you are around kids or grandkids or school kids.)

FROM THE CONVERSATION:

Polio vaccination rates in some areas of the US hover dangerously close to the threshold required for herd immunity – here’s why that matters

”…even today, there are communities in the U.S. that have lower-than-necessary polio vaccination rates. Because many people have not been vaccinated, there is now a real possibility of a resurgence of polio in the U.S….on Sept. 9, 2022, New York declared a state of emergency due to ongoing poliovirus transmission. As of that date, using wastewater surveillance, officials had identified 57 samples of poliovirus in wastewater from four New York counties…As a result of the continued poliovirus detection in wastewater, the Centers for Disease Control and Prevention declared that the U.S. now meets the World Health Organization’s criteria for “a country with circulating vaccine-derived poliovirus.”….There are two key types of polio vaccine in use around the world today. The inactivated poliovirus vaccine is given as a shot, and the oral attenuated (or weakened) poliovirus vaccine is administered as oral drops, sometimes on a sugar cube…

Since 2000, the U.S. has exclusively used the inactivated poliovirus vaccine, which cannot cause disease since it does not contain live virus. But in countries where the poliovirus continues to circulate, such as Pakistan and Afghanistan, the oral attenuated poliovirus vaccine is still used…..In extremely rare cases, the weakened live vaccine used in other countries can mutate back into its virulent form and lead to paralysis. This is how the adult in New York is believed to have come into contact with the virus….For poliovirus, researchers estimate that between five and seven individuals would be infected for each case if those people were susceptible. Based upon these calculations, experts determined that at least 80% of a community or population should be vaccinated against poliovirus to prevent its spread…]]

UT Southwestern opens first academic medical center campus for southern Dallas County

AND LAST BUT NOT LEASED:

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75688

FROM THE MARSHALL NEWS MESSENGER:

LOCAL VACCINE INFORMATION from JENNIFER HANCOCK, RN, BSN

EXECUTIVE DIRECTOR OF MARSHALL-HARRISON COUNTY HEALTH DISTRICT:

”The CDC Advisory Committee on Immunization Practices’ (ACIP) recommends the for use of updated COVID-19 boosters from Pfizer-BioNTech for people ages 12 years and older and from Moderna for people ages 18 years and older.

Please call our office at 903-938-8338 to be placed on a list to get the Pfizer COVID 19 booster, we have placed an order and are awaiting shipment (we did pre book weeks ago). You can also go to https://www.vaccines.gov/ to find vaccines in our area.

More information about the new booster can be found at; https://www.cdc.gov/…/2022/s0901-covid-19-booster.html

(J. Harris: Call 903 938-8338 and press 9 when the recording starts and you can schedule a Pfizer vaccine.)

YOUR LOCAL EPIDEMIOLOGIST: 

ONE SHOT PER YEAR? (CLICK)

(J. Harris: Short readable, important, informative, understandable.)

FROM BECKERS:

Travel nurses aren’t returning to their old jobs

FROM HOPKINS:

1. ”For Some Patients, Long Covid Symptoms Mask Something Else (Wired) Long Covid is common—estimates of its prevalence vary widely, but even the most conservative studies imply that millions of people are dealing with long-lasting symptoms of their infections. Hodgkin’s lymphoma, on the other hand, is rare. But with dozens of possible symptoms, long Covid can be easily confused with countless other conditions, including cardiovascular diseases such as hypertension and diabetes, autoimmune diseases like lupus and multiple sclerosis, and cancer. Add the fact that Covid can make preexisting conditions worse, and determining whether or not someone has long Covid becomes a daunting task….”

2. ”How the Pandemic Shortened Life Expectancy in Indigenous Communities (New York Times) In 2020 and 2021, as the coronavirus swept across the United States, life expectancy for Native Americans and Alaska Natives fell by 6 1/2 years — a decline that left the researchers aghast. The comparable figure for all Americans was about 3 years, itself a terrible milestone not seen in nearly a century. What could have left Native Americans and Alaska Natives so vulnerable to the pandemic? There is no simple diagnosis, nor is there an easy fix, experts say. The suffering is inextricably bound to a long history of poverty, inadequate access to health care, poor infrastructure and crowded housing…”

(J. Harris: Genetic studies will be helpful.)

AND LASTLY:

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There is too much information in this mailout, but some really good stuff hit the desk today. Texas is no longer compiling or providing detailed Covid information for daily release. Take your time and just read a couple of articles a day over the long holiday. Have a nice Holiday, perhaps our last bad Covid holiday? 

FROM YOUR EPIDEMIOLOGIST: 

1. ” Cliff notes” ON FALL COVID BOOSTERS

2. Considerations for your fall booster

(J. Harris: Fabulous article, readable. Discussed mix and match and the timing for vaccinations in persons who have had Covid infection.)

THE BEST CDC WEBSITE FOR COVID IN THE FUTURE:

www.cdc.gov/coronavirus/2019-ncov/index.html

(J. Harris: The CDC has done a great job of streamlining its website and eliminating non-pertinent information.)

ROM: THE WASHINGTON POST: 

1. AN INTERESTING OPINION PIECE

Opinion The world might be done with covid, but I’m still keeping my distance

2. ANOTHER VIEW:

“Opinion I’m a doctor. Here’s why my kids won’t wear masks this school year.”

FDA Authorizes Updated Moderna and Pfizer Booster Shots

(J. Harris: Good basic up-to-date Booster information.)

Philanthropist donates $172 million to speed up drug development for the next pandemic

”…Geoffrey Cumming, who made a global fortune in oil and gas, as well as solar power investments and management, is putting up what is purportedly the largest ever gift to medical research in Australia to create the Cumming Global Center for Pandemic Therapeutics. Stunned by the economic and political impact of COVID-19, he “wanted to do something to protect the world in the next pandemic,” says James Angus, a former dean of medicine at the University of Melbourne and a friend of Cumming…”

FROM NEJM:

1. (LETTER) Risk of BA.5 Infection among Persons Exposed to Previous SARS-CoV-2 Variants

”…Overall, we found that breakthrough infections with the BA.5 subvariant were less likely among persons with a previous SARS-CoV-2 infection history in a highly vaccinated population, especially for previous BA.1 or BA.2 infection, than among uninfected persons…”

(J. Harris: From Portugal study of highly vaccinated population. Suggests to me that the new vaccine should be helpful.)

2. Covid-19 Vaccines — Immunity, Variants, Boosters

(J. Harris: The ultimate update at this time. Complex.)

FROM THE AMERICAN MEDICAL ASSOCIATION:

What doctors wish patients knew about the Novavax COVID-19 vaccine

(J. Harris: An alternative to genetically engineered vaccines)

FROM HOPKINS 

1. “…UNITED STATES

The US CDC is reporting 94.3 million cumulative cases of COVID-19 and 1,040,314 deaths. Average daily incidence continues to decline, down from the most recent high of 129,363 new cases per day on July 21 to 88,286 on August 30—the lowest average since May 12. Average daily mortality continues to decline, down to 383 on August 30 from a recent high of 486 on August 12….

Both new hospital admissions and current hospitalizations continue to decline, down 2.9% and 6.3%, respectively, over the past week. Both trends peaked around the last week of July, similar to trends in daily incidence.”

FROM PRECISION VACCINATIONS:

1. Japan Approves and Purchases Antibody Combo for Prevention and Treatment of COVID-19

”…United Kingdom-based AstraZeneca plc announced today that Evusheld, a long-acting antibody combination, has been approved in Japan for both prevention and treatment of symptomatic COVID-19 disease caused by SARS-CoV-2 infection….

The decision by Japan’s Ministry of Health, Labour and Welfare (MHLW) marks the first global marketing approval for Evusheld (tixagevimab and cilgavimab) as a treatment for COVID-19.

2. COVID-19 Pill Vaccine Candidate Posts Positive Phase 2 Study Results

(J. Harris: (An ORAL Covid Vaccine in trials which seems to work even better in previously infected or vaccinated folks.)

AND LAST BUT  NOT LEASED WITH AN EXTRA FOR THE HOLIDAY: 

1. 

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