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September 2023 Coronavirus updates

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Don't be surprised if masks come back to hospitals and nursing homes

The case for it, against it, and a big unanswered question​

This will be the first winter with Covid-19 that we’re not in a public health emergency. This leaves a lot of questions open for the front line, like hospitals, health departments, and nursing homes, including: Do we reinstate mandatory masking in hospitals this fall/winter?
The scientific evidence shows a solid case for reinstating masks in hospitals and long-term care facilities. So much so that I think it’s worth pushing through the inertia.
Here’s the data’s story.

Setting the scene​

Before the pandemic, hospitals ran on an average of ~65% occupancy. Wiggle room was built in, but in pre-pandemic times, it wasn’t unusual for hospitals to reach capacity during a bad flu season, especially in pediatric hospitals and ICUs.
The pandemic brought new realities:
  1. We have a new virus in our repertoire of threats.
  2. We have not increased our capacity.
  3. Healthcare workers are burnt out and leaving in droves.
  4. We have learned a ton about viruses, transmission, and available tools to help.

Enter the case for masks​

Masks are one tool that can help keep capacity down and workers and patients healthy.
In-hospital respiratory infections are a problem, particularly for kids. If you go to a hospital, you’re at risk of getting an infection you didn’t have when entering the door. This isn’t new; nosocomial infections, like surgical site infections, ventilator-associated pneumonia, and catheter-associated urinary tract infections, have been a problem for decades.
We also see hospital acquired respiratory illnesses:
  • One study (pre-pandemic) found in-hospital respiratory infections were 5 cases per 10,000 adult admissions; 44 cases per 10,000 pediatric admissions.
    • 13% of people died from in-hospital respiratory infections.
    • 2 of 3 in-hospital respiratory infections occurred during the fall and winter.
  • Another study (during the pandemic) of 288 hospitals found that 4.4% of hospitalizations were due to in-hospital Covid-19 infections.
Community transmission increases hospital transmission. Close quarters, close contact, vulnerable people.
  • One study found a 10% increase in community-onset SARS-CoV-2 infection rate was associated with a 178% increase in the hospital-onset infection rate.
Healthcare workers come to work sick. High workload burden, a sense of personal responsibility, a lack of paid sick time, and perceived expectations. This results in:
  • A significant proportion (15-70%) coming to work sick with flu, for example.
  • A Covid-19 study found 50% presenteeism while sick with symptoms.
Masks work . . . especially in hospitals.
Masks work on individuals. We have limited evidence on whether they work to reduce population-level transmission. But some of the most substantial evidence is in hospitals:
  • A large clinical trial (pre-pandemic) found bacterial and viral infections were significantly lower among healthcare workers who continuously wore an N95 compared to other study groups, like those who wore a surgical mask or no mask at all.
  • One review examined 40 studies on masks in healthcare settings (one randomized controlled trial and 39 observational studies). The majority of studies favored masking vs. not masking in healthcare.
Odds Ratios and 95% confidence intervals of a subset of eligible included studies comparing masked versus unmasked. Source here

What is the case for not making masks mandatory in hospitals?​

There are a few reasons I’ve heard (beyond the normal “masks don’t work” argument):
  1. We didn’t do it in pre-pandemic times.
    1. For the public, this is true. Donning a mask as a personal measure to prevent hospital infections is a new step we’ve taken during the pandemic. This is a highly contagious virus. And we’ve learned leaps and bounds, like the role of asymptomatic disease and viral transmission routes.
    2. For healthcare workers, masks have been a core tool for decades, especially when managing patients with potential respiratory infections. The questions are really when and where? Tossing the mask altogether has never been on the table in high-risk healthcare settings.
  2. Negatively impacts healthcare workers. One study in Singapore found that one-third of nurses said wearing masks negatively affected their work, such as discomfort, frequent adjustment, and inability to concentrate.
  3. Are these infections preventable? Hospital-onset Covid-19 infections occurred at similar rates as other health care–associated infections, like UTIs. A national goal is to reduce these, but this raises a good question about how preventable in-hospital respiratory infections are.
  4. “I thought we were done with mandates!” There is a distinction between public mandates aimed at the population as a whole and a much narrower mandate for specific high-risk settings. If you don’t set foot in a hospital or long-term care facility, most (all?) mask orders won’t impact you.

The biggest question remains​

If masks are reinstated, what are the on- and off-ramps, if any? There are a few options:
  1. Keep mandatory masking throughout the year.
  2. Universal masking during a window of time. For example, Marin County has decided to mask in hospitals from November through March after looking at respiratory trends in wastewater data.
  3. Universal masking in high-risk units, like organ transplants and oncology. (Although there are high-risk patients throughout the hospital.)
  4. Require masks based on hospital capacity. But what capacity? This would be confusing to patients going to different hospitals.
Like any policy, where you land on this ultimately comes down to values. (And we know nothing gets people’s blood boiling more than masks.)

Bottom line​

Do not be surprised if hospitals and long-term care facilities return to mandatory masking soon. Some have already announced that they are coming down the pipeline.
Infectious diseases violate the assumption of independence— what we do directly impacts those around us. A low-cost, minimally invasive intervention, like masking, is a great way to start protecting our community’s highest-risk individuals this fall and winter season.


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One hospital here has already implemented a mask requirement.
 
Just saw my new PCP yesterday. I noticed that about 3/4 of the staff was masked, and the sign at the entry specified “masking optional.” If I see my doctor masking, you bet your sweet bippy I’m masking again, too.
 
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Study: Antiviral Med Linked to COVID Mutations That Can Spread​

Ralph Ellis
September 26, 2023




The antiviral COVID medication made by Merck can cause mutations in the coronavirus that occasionally spread to other people, according to a study published in the online journal Nature.
There's no evidence that molnupiravir, sold under the brand name Lagevrio, has caused the creation of more transmissible or severe variants of COVID, the study says, but researchers called for more scrutiny of the drug.
Researchers looked at 15 million COVID genomes and discovered that hallmark mutations linked to molnupiravir increased in 2022, especially in places where the drug was widely used, such as the U.S. and the U.K. Levels of the mutations were also found in populations where the drug was heavily prescribed, such as seniors.
Molnupiravir is an antiviral given to people after they show signs of having COVID-19. It interferes with the COVID-19 virus's ability to make copies of itself, thus stopping the spread of the virus throughout the body and keeping the virus level low.

The study found the virus can sometimes survive molnupiravir, resulting in mutations that have spread to other people.




Theo Sanderson, the lead author on the study and a postdoctoral researcher at the Francis Crick Institute in London, told The Guardian that the implications of the mutations were unclear.
"The signature is very clear, but there aren't any widely circulating variants that have the signature. At the moment there's nothing that's transmitted very widely that's due to molnupiravir," he said.
The study doesn't say people should not use molnupiravir but calls for public health officials to scrutinize it.

"The observation that molnupiravir treatment has left a visible trace in global sequencing databases, including onwards transmission of molnupiravir-derived sequences, will be an important consideration for assessing the effects and evolutionary safety of this drug," the researchers concluded.
When reached for comment, Merck questioned the evidence.
"The authors assume these mutations were associated with viral spread from molnupiravir-treated patients without documented evidence of that transmission. Instead, the authors rely on circumstantial associations between the region from which the sequence was identified and timeframe of sequence collection in countries where molnupiravir is available to draw their conclusions," the company said.
The FDA authorized the use of molnupiravir for the treatment of mild-to-moderate COVID-19 in adults in December 2021. The FDA has also authorized the use of Paxlovid, an antiviral made by Pfizer.

Sources​

Nature: "A molnupiravir-associated mutational signature in global SARS-CoV-2 genomes"

The Guardian: "Use of antiviral may be fueling evolution of Covid, scientists say"

FDA: "Coronavirus (COVID-19) Update: FDA Authorizes Additional Oral Antiviral for Treatment of COVID-19 in Certain Adults"




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WHO 'Concerned' About COVID Increase in Northern Hemisphere​

Stéphanie Lavaud




GENEVA — The increase in cases of COVID-19 in the northern hemisphere is worrying healthcare authorities around the world, who are aware that these countries usually experience a peak in respiratory infections during the winter months.

During a recent press conference, the World Health Organization (WHO) urged nations to closely monitor COVID-19 cases and report the number of hospital admissions caused by the disease over the last few months, especially in Europe.

"The virus is currently reinfecting large numbers of individuals, millions of people, every week," warned Maria Van Kerkhove, MD, PhD, WHO's COVID-19 technical consultant. "We don't have a good idea of the number of infections and reinfections currently happening, because monitoring has been relaxed. But we have some indications of the current trend, in terms of impact."

Around the world, more than 1.4 million new cases of COVID-19 and more than 2300 deaths were reported between July 17 and August 13, 2023, which is an increase of 63% and a reduction of 56%, respectively, compared with the previous 28 days.


Cases on the Rise

Van Kerkhove mentioned the slight increase observed in Europe in recent months. "It's summer in the northern hemisphere, and this is really not what we expect when we talk about respiratory diseases such as the flu, which usually peak during the winter months."





These cases are "of concern," she said, especially in countries trying to navigate other problems such as mpox, the plague, earthquakes, heatwaves, and forest fires, where there are fewer beds available for patients with COVID-19.

"We are clearly not in the same epidemic situation as we were a year or two ago," said Van Kerkhove, but the virus is still spreading and killing people.


Government Action Needed

This concern comes as WHO is monitoring several new variants, such as the strain known as BA.2.86. According to WHO, around 10 cases have been detected in Denmark, Israel, the United Kingdom, the United States, and South Africa. It has also been detected in wastewater in Switzerland and Thailand.

"We have only detected a few cases," said Van Kerkhove during the press conference. "We can't determine its spread, because we don't have enough data. We can't predict with certainty what's going to happen with this variant or any other variant. But we are expecting the number of cases to keep going up."

This variant has not been given a name with a Greek letter, a feature reserved for so-called variants "of concern," she clarified.


Just a few days ago, the so-called EG.5 strain had the world's attention.


"While individuals believe the pandemic to be behind us, we are telling governments that they must continue to monitor COVID and remain diligent, as the threat is still there," she concluded.


The Situation in France

In France, between August 14 and August 20, 2023, the slight increase in indicators already observed in recent weeks continued, but these indicators were still at low levels, according to Public Health France. An increase was observed in the number of emergency department admissions for suspected COVID-19 for all age groups (2197 in week 33 vs 1555 in week 32, ie, +41%), but the proportion of hospital admissions after emergency department visits remains stable.


Home visits by doctors from SOS Médecins for suspected COVID-19 have also increased, with 2670 visits taking place in week 33 vs 1888 in week 32 (ie, +41%). However, Public Health France seeks to reassure the public, pointing out "that it is important to note that these numbers remain low, compared with the levels seen during previous waves of the epidemic."


This article was translated from Medscape's French edition.
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Paxlovid Weaker Against Current COVID-19 Variants​

Ralph Ellis
September 22, 2023


A real-world study published in JAMA Open Network found that Pfizer's COVID-19 antiviral Paxlovid is now less effective at preventing hospitalization or death in high-risk patients as compared to earlier studies. But when looking at death alone, the antiviral was still highly effective.
Paxlovid was about 37% effective at preventing death or hospitalization in high-risk patients compared to no treatment. The study also looked at the antiviral Lagevrio, made by Merck, and found it was about 41% effective. In preventing death alone, Paxlovid was about 84% effective compared to no treatment and Lagevrio was about 77% effective, the study said.
The University of North Carolina Gillings School of Global Public Health and the Cleveland Clinic examined electronic health records of 68,867 patients at hospitals in Cleveland and Florida who were diagnosed with COVID from April 1, 2022, to Feb. 20, 2023.

For Paxlovid, the effectiveness against death and hospitalization was lower than the effectiveness rate of about 86% found in clinical trials in 2021, according to Bloomberg.




The difference in effectiveness in the real-world and clinical studies may have occurred because the early studies were conducted with unvaccinated people. Also, the virus has evolved since those first studies, Bloomberg reported.
Researchers said Paxlovid and Lagevrio are recommended for use because they reduce hospitalization and death among high-risk patients who get COVID, even taking recent Omicron subvariants into account.
"These findings suggest that the use of either nirmatrelvir (Paxlovid) or molnupiravir (Lagevrio) is associated with reductions in mortality and hospitalization in patients infected with Omicron, regardless of age, race and ethnicity, virus strain, vaccination status, previous infection status, or coexisting conditions," the study says. "Both drugs can, therefore, be used to treat non-hospitalized patients who are at high risk of progressing to severe COVID-19."

Both drugs should be taken within 5 days of the onset of COVID symptoms.
Sources:
JAMA Network Open: "Nirmatrelvir or Molnupiravir Use and Severe Outcomes From Omicron Infections."
FDA: "FDA Approves First Oral Antiviral for Treatment of COVID-19 in Adults."

Bloomberg: "Paxlovid Is Now Less Effective Against Covid, Study Shows."




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New Data Lowers Estimate of Long COVID's Impact: CDC​

Lisa O'Mary
September 26, 2023


An estimated 18 million adults in the U.S. have had long COVID, and half of them are still dealing with the condition, new national survey data shows.
Results from the CDC’s National Health Interview Survey in 2022 found that 6.9% of adults self-reported they had COVID symptoms for at least 3 months after testing positive or being diagnosed by a doctor as having COVID-19.
The estimate is much lower than previous CDC survey data, which has consistently reported that approximately 14% to 15% of U.S. adults have had long COVID.

The CDC also newly reported that 1.3% of U.S. children have had long COVID, and 0.5% of children having symptoms lasting at least 3 months at the time of the survey in 2022.




The agency lists 19 possible long COVID symptoms, including fatigue, shortness of breath, a pounding heart, brain fog, and changes in smell or taste, as well as symptoms worsening with physical or mental effort.
The 2022 survey results were analyzed by demographic factors such as income, gender, age, and race or ethnicity to see if groups of people are affected differently by long COVID.
Wealthy people were the least likely to report having long COVID, while people whose family incomes were well below the federal poverty level were the most likely to have long COVID. Women were more likely than men to ever have long COVID or currently have the condition. People ages 35 to 49 years old were most likely to report having the condition.

When the researchers looked at how long COVID affected people based on race or ethnicity, the data showed:
  • 8.3% of Hispanic people reported ever having long COVID, and 3.4% were currently affected.
  • 7.1% of White people reported ever having long COVID, and 3.7% were currently affected.
  • 5.4% of Black people reported ever having long COVID, and 2.4% were currently affected.
  • 2.6% of Asian people reported ever having long COVID, and 1.1% were currently affected.
This past summer, the U.S. Department of Health and Human Services announced the launch of federally funded clinical trials to study long COVID symptoms, treatments, and prevention.
Sources:

CDC: “Long COVID in Adults: United States, 2022,” “National Center for Health Statistics Long COVID Household Pulse Survey,” “Long COVID in Children: United States, 2022,” “Long COVID or Post-COVID Conditions.”

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Vaccine rollout is a mess today, but wasn't during the pandemic.

“Gen. Perna is no longer in charge”​

The fall Covid-19 vaccine rollout is a mess right now. Nursing homes are still waiting for vaccines. People are being turned away at appointments. Some are being asked to pay.
This is due to a massive shift: vaccines are now commercialized. In other words, the government is no longer responsible for purchasing or distributing Covid-19 vaccines.
More specifically, one person is no longer in charge: General Gus Perna— a four-star general and Chief Operations Officer of Operation Warp Speed.
Many, including me, underappreciated the gargantuan task of promptly, equitably, and smoothly getting Covid-19 vaccines to 330 million people, especially during an emergency. We just arrived at a clinic, and Covid-19 vaccines were magically there.
I attended a summit last week where General Perna shared his story of tackling this massive challenge. It was fantastic—apolitical, funny, honest, inspiring, sober. I bugged and begged the sponsor—Palantir—to get ahold of the recording for you. And I was successful! (Thanks Palantir.)

Watch it. Listen to it. You won’t be disappointed. It gave me a whole new appreciation for this effort, especially right now when it’s hard to find a vaccine. It shows the power of public-private partnerships. And, if anything, it shows how many people were working behind the scenes during the emergency, ultimately saving
3.2 million lives
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Gen. Perna at the Software for Government Summit September 2023


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Study: Unexpected Vaginal Bleeding Rises After COVID Vaccination​

Jay Croft
September 27, 2023




Non-menstruating women were more likely to experience unexpected vaginal bleeding after receiving COVID-19 vaccinations, according to a new study.
Researchers suggested it could have been connected to the SARS-CoV-2 spike protein in the vaccines. The study was published in Science Advances.
After vaccinations became widely available, many women reported heavier menstrual bleeding than normal. Researchers at the Norwegian Institute of Public Health in Oslo examined the data, particularly among women who do not have periods, such as those who have been through menopause or are taking contraceptives.
The researchers used an ongoing population health survey called the Norwegian Mother, Father, and Child Cohort Study, Nature reported. They examined more than 21,000 responses from postmenopausal, perimenopausal and non-menstruating premenopausal women. Some were on long-term hormonal contraceptives.

They learned that 252 postmenopausal women, 1,008 perimenopausal women and 924 premenopausal women reported having unexpected vaginal bleeding.




About half said the bleeding occurred within four weeks of the first or second shot or both. The risk of bleeding was up 3 to 5 times for premenopausal and perimenopausal women, and 2 to 3 times for postmenopausal women, the researchers found.
Postmenopausal bleeding is usually serious and can be a sign of cancer, Nature wrote. "Knowing a patient's vaccination status could put their bleeding incidence into context," said Kate Clancy, a biological anthropologist at the University of Illinois Urbana-Champaign.

Sources​

Science Advances: "Unexpected vaginal bleeding and COVID-19 vaccination in nonmenstruating women"

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