Coronavirus updates December 2022

[missy]

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Fall bivalent boosters: Science update round 3​

Katelyn Jetelina
4 hours ago

Alright people, the data you’ve been waiting for: the first real-world effectiveness data on the fall COVID-19 (bivalent) booster. Here are the results.

Science until now​

As a reminder, we hoped the fall booster would accomplish three things:

1. Greater protection against infection and transmission, by boosting our first line of defense—neutralizing antibodies;
2. Longer protection against infection and severe disease, even just by a few months; and
3. Broader protection, or the ability to create antibodies that “see” more virus parts and “attach” more strongly compared to the antibodies we have right now.

We have ~9 lab studies showing all three of these things are being accomplished (see my previous updates here and here.)

However, what happens in a lab doesn’t necessarily translate to the real world. This is because the lab is a controlled setting, and the real world interacts with genetics, environment, complex immunity, human behavior, etc. We always need to rely on both for the “true” picture.

Real-world data​

Last Friday, the CDC published the first “real-world” data on effectiveness of bivalent boosters. Their main question: Does the fall booster (with the bivalent Omicron formula) provide additional protection against infection? They compared people who got the fall vaccine (bivalent vaccine) + 1 mRNA vaccine dose of the regular formula, 2 doses, 3 doses, or 4 doses to unvaccinated people.

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Study depiction made by YLE
The scientists used pharmacy data—360,626 tests from September to November 2022—to compare how many people had a positive or negative test.

This is what they found:

• The fall Omicron booster provided additional protection with previous vaccination compared to no vaccination:
  • Among 18-49 year olds, the fall booster was 42% effective against infection
  • 50-64 year olds: 28% effective against infection
  • 65+ year olds: 22% effective against infection
• There was a similar additional benefit of the bivalent vaccine regardless of the number of previous doses received.
• The more time between doses, the more protection.
  • Among those ages 65 and older, for example, effectiveness was 43% if they got their last mRNA dose more than 8 months ago, compared to 28% if they got their last dose 2 months ago.

In all, this study found that fall boosters are helpful against infection.

Real world studies are inherently flawed, especially in places like the U.S. where we don’t have a national health system (nor solid data infrastructure). It’s messy and imperfect but our reality. This study used pharmacy testing data. People who go to a pharmacy to get tested could certainly be different from those that don’t go to pharmacy to get tested (and use at home antigen tests or don’t test at all). But this is the best we have right now.

A few thoughts​

• These results make sense. Several lab studies have shown an increase in neutralizing antibodies after the fall booster. Of our immune tools, neutralizing antibodies act the fastest and stop the virus before it starts replicating in our cells. We had a hunch the vaccines would protect against infection. How long this protection lasts against infection is a key question; we are at the mercy of time.
• Delay in boosting. More time between doses helps prime the immune system. We’ve seen this with other vaccines. In fact, this is why the U.K. officially recommends at least 12 weeks between doses since the beginning of the pandemic. If we get a booster earlier, we won’t “exhaust” or “overwhelm” our immune system, but by delaying we get the biggest bang for our buck. I still stick to my recommendations last month.
• Some may be disappointed in these numbers. Vaccines are not 100% effective against infection. But protection against infection is an added benefit. I’m anxious to see data on the effectiveness against severe disease, which is the primary purpose of vaccines. We don’t have this data yet. It’s coming.
• Vaccination (and previous infection) is not enough. If you do not want to get sick (miss work, possibility of long COVID, etc.), other measures, like masks, are necessary. Yes, still.

Bottom line​

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.



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[missy]

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COVID Omicron Shots Now Authorized for Kids 6 Months and Up​

— Bivalent vaccines will offer better protection in the coming months, says FDA​

by Ingrid Hein, Staff Writer, MedPage Today December 8, 2022

Bivalent COVID-19 vaccines from Pfizer and Moderna are now authorized for use in children as young as 6 months old, the FDA announced on Thursday.
Under an updated emergency use authorization (EUA), Pfizer's updated vaccine is now authorized as the third dose of the primary series for kids ages 6 months to 4 years, following two doses of the monovalent vaccine. Under the terms of the EUA, Pfizer's monovalent vaccine is no longer authorized as a third dose for this age group.

Moderna's bivalent vaccine is now authorized as a booster dose for kids ages 6 months to 5 years, at least 2 months following the two-dose primary series.
The bivalent mRNA vaccines -- which were authorized for older children and adults earlier this year -- target both the ancestral SARS-CoV-2 strain and the Omicron BA.4/5 subvariants, the dominant circulating strains earlier this year.
"Based on available data, the updated, bivalent vaccines are expected to provide increased protection against COVID-19," Peter Marks, MD, PhD, director of FDA's Center for Biologics Evaluation and Research, said in a statement.
The updated EUAs were based in part on immune response data from clinical studies in adults and children who received previous BA.1-targeting bivalent vaccines or additional vaccinations with the companies' monovalent shots. Side effects with the new vaccines are likely to be similar to those experienced after doses of the monovalent vaccines, the agency said.

"Parents and caregivers can be assured that the FDA has taken a great deal of care in our review," said Marks. "We encourage parents of children of any age who are eligible for primary vaccination or a bivalent COVID-19 vaccine booster dose to consider seeking vaccination now as it can potentially help protect them from COVID-19 during a time when cases are increasing."
In its announcement, the FDA noted that children ages 6 months to 4 years who have completed their primary series with the three monovalent doses of Pfizer's vaccine "would still be expected to have protection against the most serious outcomes from the currently circulating Omicron variant," and that data to support a bivalent booster dose in this population are expected early next year.
"More children now have the opportunity to update their protection against COVID-19," said FDA Commissioner Robert Califf, MD, in the agency's press release. "We encourage parents and caregivers of those eligible to consider doing so -- especially as we head into the holidays and winter months where more time will be spent indoors."
Califf added that "as this virus has changed, and immunity from previous COVID-19 vaccination wanes, the more people who keep up to date on COVID-19 vaccinations, the more benefit there will be for individuals, families, and public health by helping prevent severe illnesses, hospitalizations, and deaths."

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[missy]

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Vaccines Are Effective Against Long COVID: Study​

Lisa O'Mary
December 07, 2022


Getting at least one dose of a COVID-19 vaccine decreases the chances of having symptoms beyond 3 weeks or developing long COVID, a new analysis shows.
When compared to people who got no vaccine at all, a single dose of Pfizer, Moderna, AstraZeneca, or the Janssen vaccine was 29% effective at preventing long COVID. The protection was strongest (35% effective) for those who were vaccinated before being infected with the coronavirus. Post-infection vaccination also helped (27% effective).
Since the analysis "showed a significant reduction of post-COVID-19 conditions with the vaccine even after having COVID-19, vaccine should be offered to unvaccinated individuals who have had COVID-19," the authors wrote.

The study was published this week by Cambridge University Press in the journal Antimicrobial Stewardship & Healthcare Epidemiology. Researchers analyzed data for 1.6 million people from 10 studies published from December 2019 to April 2022. The studies they selected evaluated COVID-19 vaccine effectiveness by comparing outcomes for vaccinated and unvaccinated people. Specifically, the researchers looked at how many people had symptoms present 3 or more weeks after having COVID-19.




"The most common symptoms were fatigue or muscle weakness, muscle pain, anxiety, impaired memory, sleep difficulties, and shortness of breath," according to a summary of the analysis.
Up to 23 million people in the United States are believed to have long COVID, according to the US Department of Health and Human Services. Among people who have been infected with COVID-19, the CDC estimates that 13.3% have symptoms for a month or longer, and 2.5% have symptoms for 3 months or longer. Long COVID was included in protections under the Americans With Disabilities Act starting in July 2021.
The study authors cautioned that their findings have limits and said that they could not evaluate the effectiveness of vaccines for long COVID among people with weakened immune systems because of a lack of data. A more standardized definition of long COVID is needed "for research and clinical purposes," they wrote.

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[missy]

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New receptor 'decoy' drug neutralizes COVID-19 virus and its variants
Published December 8, 2022 | Originally published on MedicalXpress Breaking News-and-Events

Scientists at Dana-Farber Cancer Institute have developed a drug that potently neutralizes SARS-CoV-2, the COVID-19 coronavirus, and is equally effective against the Omicron variant and every other tested variant. The drug is designed in such a way that natural selection to maintain infectiousness of the virus should also maintain the drug's activity against future variants.

The investigational drug, described in a report published today in Science Advances, is not an antibody, but a related molecule known as an ACE2 receptor decoy. Unlike antibodies, the ACE2 decoy is far more difficult for the SARS-CoV-2 virus to evade because mutations in the virus that would enable it to avoid the drug would also reduce the virus's ability to infect cells. The Dana-Farber scientists found a way to make this type of drug neutralize coronaviruses more potently in animals infected with COVID-19 and to make it safe to give to patients.

This report comes at a time when antibody drugs used to treat COVID-19 have lost their effectiveness because the viral spike protein has mutated to escape being targeted by the antibodies.

The researchers, led by first author James Torchia, MD, Ph.D., and senior author Gordon Freeman, Ph.D., identified features that make ACE2 decoys especially potent and long-lasting. For example, they found that when they included a piece of the ACE2 protein called the collectrin-like domain, it made the drug stick more tightly to the virus and have a longer life in the body. Their experiments showed that ACE2 decoys have potent activity against the COVID-19 virus because they trigger an irreversible change in the structure of the virus—they "pop" the top off the viral spike protein so it can't bind to the cell-surface ACE2 receptor and infect cells.

The SARS-CoV-2 virus is covered with projections called spike proteins that enable the virus to infect cells. The spike protein binds to the ACE2 receptor on the cell surface and then refolds, driving the spike into the cell, enabling the virus to enter. ACE2 decoys lure the virus to bind to the decoy instead of the cell, "popping" the spike and inactivating the virus before it can enter cells. This explains the drug's surprising potency: not only does it function as a competitive inhibitor, but it permanently inactivates the virus. Since binding to ACE2 is required for infection, variants can change but they must continue to bind to ACE2, making the drug persistently active against all variants.

The researchers say that, in addition to treating antibody-resistant variants of SARS-CoV-2, the drug described in this study could be useful to treat new coronaviruses that might emerge in the future to infect humans. This is because many coronaviruses in nature poised to enter the human population also utilize ACE2 to infect cells.

While the drug, called DF-COV-01, has not yet been tested in humans, manufacturing development is nearly complete and preclinical studies needed for regulatory approval are underway, with the goal of advancing the drug to clinical trials.

The work was performed by a collaborative team including scientists from Dana-Farber Cancer Institute, Massachusetts General Hospital Vaccine and Immunotherapy Center, Boston University Aram V. Chobanian & Edward Avedisian School of Medicine, the National Emerging Infectious Disease Laboratory at Boston University, Colorado State University, and Boston Children's Hospital.

This article was originally published on MedicalXpress Breaking News-and-Events.

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[missy]

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Prone positioning reduces the need for breathing tubes in COVID-19 patients, suggests in-depth analysis
Published December 8, 2022 | Originally published on MedicalXpress Breaking News-and-Events


Patients admitted to the hospital with severe breathing difficulties due to COVID-19 are less likely to need a breathing tube if they lie face down in a prone position, but evidence for its effect on mortality or other outcomes is inconclusive, suggests an in-depth analysis of the latest evidence published by The BMJ today.

Since the 1970s, prone positioning has been standard care for patients with severe acute respiratory distress syndrome, as it encourages a larger part of the lung to expand, so patients can take bigger breaths.

Usually, it is done for critically ill patients who are sedated and intubated (breathing through a tube attached to a mechanical ventilator). But in February, 2020, reports emerged that prone positioning of conscious patients with COVID-19 might also be helpful, and it was widely adopted.

Since then, several studies have examined its effectiveness in conscious patients with COVID-19, but results have been conflicting.

To try and resolve this uncertainty, researchers trawled databases for randomized trials comparing conscious prone positioning to usual care for adult patients with COVID-19 hypoxemic respiratory failure (a serious condition that develops when the lungs can't get enough oxygen into the blood).

They found 17 suitable trials involving 2,931 non-intubated patients who were able to breathe without mechanical assistance and who spent an average of 2.8 hours per day lying prone.

Twelve trials were at low risk of bias, three had some concerns, and two were at high risk, but the researchers were able to allow for that in their analysis.

The main measure of interest was endotracheal intubation (a breathing tube inserted into the windpipe to allow mechanical ventilation). Other (secondary) outcomes included mortality, ventilator-free days, intensive care unit (ICU) and hospital length of stay, change in oxygenation and respiratory rate, and adverse events.

High certainty evidence from a pooled analysis of 14 trials showed that conscious prone positioning reduced the risk of endotracheal intubation compared with usual care (24.2% with conscious prone positioning vs. 29.8% with usual care). On average, conscious prone positioning resulted in 55 fewer intubations per 1,000 patients.

However, high certainty evidence from a pooled analysis of 13 trials evaluating mortality did not show a significant difference in mortality between the two groups (15.6% with conscious prone positioning vs. 17.2% with usual care), but the study may have lacked statistical power to detect a difference.

Conscious prone positioning did not significantly affect other secondary outcomes either, including ventilator-free days, and length of stay in the ICU or hospital, based on low- and moderate-certainty evidence.

The researchers acknowledge several limitations, such as lack of individual patient data, differences between the targeted and achieved duration of conscious prone positioning, and variation in the definition and reporting of certain outcomes across studies.

But further sensitivity analysis supported these results, suggesting a high probability of benefit for the endotracheal intubation outcome and a low probability of benefit for mortality.

As such, the researchers conclude, "Conscious prone positioning compared with usual care reduces the risk of endotracheal intubation in adults with hypoxemic respiratory failure due to COVID-19 but probably has little to no effect on mortality or other outcomes."

In a linked editorial, researchers point out that the benefits of prone positioning in patients with COVID-19 may be confined to those with more severe hypoxemia and longer duration of prone positioning, and they say it may be wise to focus efforts on these particular groups.

Several unanswered questions remain, including the ideal daily duration of treatment, the level of hypoxemia that should prompt prone positioning, and how best to improve patient comfort and encourage adherence, they write.

These questions may never be answered definitively in patients with COVID-19, as fortunately, far fewer are experiencing hypoxemic respiratory failure or critical illness, they explain.

"The pandemic should, however, renew interest and encourage further evaluation of conscious prone positioning—an intervention that may benefit a wide range of patients with hypoxemia," they conclude.

This article was originally published on MedicalXpress Breaking News-and-Events.

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[missy]

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Study Comparing Surgical and N95 Masks Sparks Concern​

Kate Johnson




A randomized trial indicating that surgical masks are not inferior to N95 masks in protecting healthcare workers against COVID-19 has sparked international criticism.
The study’s senior author is John Conly, MD, an infectious disease specialist and professor at the Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada, and Alberta Health Services. The findings are not consistent with those of many other studies on this topic.
Commenting about Conly's study on Twitter, Eric Topol, MD, editor-in-chief of Medscape, wrote, “It’s woefully underpowered but ruled out a doubling of hazard for use of medical masks.”
The study, which was partially funded by the World Health Organization (WHO), was published online November 29 in Annals of Internal Medicine.

This is not the first time that Conly, who also advises the WHO, has been the subject of controversy. He previously denied that COVID-19 is airborne — a position that is contradicted by strong evidence. Last year, Conly made headlines with his controversial claim that N95 respirators can cause harms, including oxygen depletion and carbon dioxide retention.
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A detailed examination by the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota, Minneapolis, pointed out numerous scientific flaws in the study, including inconsistent use of both types of masks. The study also examined healthcare workers in four very different countries (Canada, Israel, Egypt, and Pakistan) during different periods of the pandemic, which may have affected the results. Furthermore, the study did not account for vaccination status and lacked a control group. CIDRAP receives funding from 3M, which makes N95 respirators.
In a commentary published alongside the study, Roger Chou, MD, professor of medicine at Oregon Health & Science University in Portland, said that the results were “not definitive,” with “a generous noninferiority threshold” that is actually “consistent with up to a relative 70% increased risk … which may be unacceptable to many health workers.”
Lead study author Mark Loeb, MD, professor of infectious diseases at McMaster University in Hamilton, Ontario, Canada, defended the findings. “The confidence intervals around this, that is, what the possible results could be if the trial was repeated many times, range from −2.5% to 4.9%,” he told Medscape. “This means that the risk of a COVID-19 infection in those using the medical masks could have ranged from anywhere from 2.5% reduction in risk to a 4.9% increase in risk. Readers and policy makers can decide for themselves about this.”

“There is no point continuing to run underpowered, poorly designed studies that are designed to confirm existing biases,” Raina MacIntyre, PhD, professor of global biosecurity and head of the Biosecurity Program at the Kirby Institute, in Sydney, Australia, told Medscape. “The new study in Annals of Internal Medicine is entirely consistent with our finding that to prevent infection, you need an N95, and it needs to be worn throughout the whole shift. A surgical mask and intermittent use of N95 are equally ineffective. This should not surprise anyone, given a surgical mask is not designed as respiratory protection but is designed to prevent splash or spray of liquid on the face. Only a respirator is designed as respiratory protection through both the seal around the face and the filter of the face piece to prevent inhalation of virus laden aerosols, but you need to wear it continually in a high-risk environment like a hospital.”

“It makes zero sense to do a randomized trial on something you can measure directly," Kimberly Prather, PhD, an atmospheric chemist, professor, and director of the NSF Center for Aerosol Impacts on Chemistry of the Environment at the University of California, San Diego, told Medscape. "In fact, many studies have shown aerosols leaking out of surgical masks. Surgical masks are designed to block large spray droplets. Aerosols (0.5 to 3 µm), which have been shown to contain infectious SARS-CoV-2 virus, travel with the air flow, and escape.”



“This study … will be used to justify policies of supplying healthcare workers, and perhaps patients and visitors, too, with inadequate protection,” Trish Greenhalgh, MD, professor of primary care health sciences at the University of Oxford, Oxford, United Kingdom, told Medscape.


“These authors have been pushing back against treating COVID as airborne for 3 years,” David Fisman, MD, an epidemiologist and infectious disease specialist at the University of Toronto's Dalla Lana School of Public Health, Toronto, Ontario, Canada, told Medscape. “So, you’ll see these folks brandishing this very flawed trial to justify continuing the infection control practices that have been so disastrous throughout the pandemic.”

The study was funded by the World Health Organization, the Canadian Institutes of Health Research, and the Juravinski Research Institute. Conly reported receiving grants from the Canadian Institutes for Health Research, Pfizer, and the WHO.

Chou was a coauthor with one of the authors of the Loeb study on a similar subject. He also disclosed being a methodologist for WHO guidelines on infection prevention and control measures for COVID-19.

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[missy]

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The latest​

Three highly contagious respiratory viruses are swarming in the United States, sparking talk of masks again. That’s unlikely to translate into renewed mandates, but health experts are bolstering their recommendations about when to strap on a mask in certain settings, The Washington Post’s Fenit Nirappil and Tara Parker-Pope report.

For much of the past three years, the viral enemy was clear: the coronavirus. Now, there are additional threats — influenza and respiratory syncytial virus, widely known as RSV. “As the country heads into its third pandemic winter, covid-19 cases are on the rise, and the 2022-23 flu season is shaping up to be the worst in a decade— there have already been 4,500 deaths from flu, including 14 children, according to the Centers for Disease Control and Prevention,” Nirappil and Parker-Pope write.

That’s why experts are renewing their advice to wear a high-quality medical mask on public transportation, in airports and on planes, while shopping and in other crowded public spaces.

The nation’s youngest children can now join older children and adults in receiving updated booster shots. On Thursday, the Food and Drug Administration authorized a booster shot of Moderna’s coronavirus vaccine that targets omicron variants.


Children ages 6 months through 5 years old would be eligible for the booster — known as a “bivalent” shot targeting the omicron subvariants BA.4 and BA.5 and the original version of the virus — two months after they had completed Moderna’s two-dose primary series, Laurie McGinley reports. “The agency also cleared an updated shot of the coronavirus vaccine by Pfizer and its German partner BioNTech for children 6 months through 4 years old. That bivalent shot, which also targets omicron, will be substituted for the last shot in the companies’ initial three-dose series. It is not considered a booster shot,” McGinley writes.

Other important news​

A grand jury indicted a Florida state lawmaker for allegedly trying to illicitly obtain more than $150,000 in federal pandemic relief funds, the Justice Department said Wednesday.

China this week moved to ease two key components of its “zero covid” policy by saying frequent coronavirus tests and digital health codes wouldn’t be required for daily life or travel within the country.
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[missy]

From Bloomberg.com

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China’s abrupt reversal on “Covid zero” may trigger a tidal wave of infections in which the country suddenly catches up to the rest of the world in a very bad way. Little time has been spent putting in place the mitigation measures needed to deal with the resulting explosion in cases, which could total 5.6 million a day. The deaths that may result could top 2 million. Currently, more than 6.6 million people worldwide are confirmed to have died from the coronavirus over the past three years, though the actual number is thought to be much higher.

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[missy]

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How can I tell if I had asymptomatic Covid?​

My spouse and I have avoided Covid (we think), by getting vaccinated, boosted and taking care to mask in most public circumstances. With the high percentage of asymptomatic cases, we wonder if there is a way to learn whether we have had Covid? Kelby, San Rafael, California One of the few certainties about Covid-19 is that it impacts different people, well, differently. One person might be hospitalized and another might not show symptoms at all. It’s not always clear why. Researchers are starting to understand that the asymptomatic group is sizeable. A study out this month in the Lancet focused on Covid’s seroprevalence, a measure of how widespread a pathogen is using data from blood samples. Between October 2020 and February 2022, the seroprevalence of the virus was much higher than official CDC case counts, the authors found. “An undercount in cases can happen for several reasons,” says Katrine Wallace, an epidemiologist at the University of Illinois at Chicago. “Increased home testing has led to thousands of cases being diagnosed at home every month, and these cases do not end up in the official statistics. However, people may also have had asymptomatic or very mild Covid cases that were never detected.” This new study may cause people who thought they were among the so-called super-immune to wonder if they actually had asymptomatic infections. A test for antibodies to Covid's nucleocapsid protein can tell them, according to Wallace. There is another test, which detects antibodies to the spike protein of the virus. But it may produce a false positive for people like our reader because vaccines target the same protein. Accessibility to the nucleocapsid test varies by location. As always, the best thing to do is speak to a health-care provider. — Kristen V. Brown "

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For those who wind up in the hospital with Covid, surviving the virus is often just the start.

“Three-quarters of survivors of critical Covid illness develop post-intensive care syndrome — a constellation of brain, lung and other physical problems — within three months of discharge, a study published in May found,” writes Jason Gale. “That rendered some 750,000 post-ICU patients worldwide at risk of cognitive dysfunction in the pandemic’s first year alone.”
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[missy]

From the NYT
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​ Three viruses​

Covid no longer plays the dominant role that it once did in most of our lives. But the risk of Covid — and other viruses — persists. This winter, experts expect cases, hospitalizations and deaths from viral diseases to rise once again.​

The increase may have already begun. Covid cases, hospitalizations and deaths are up over the past two weeks. The upswing resembles the trend we have seen in recent years after Thanksgiving, typically continuing through the holiday season and into the following year. (Check case counts in your area with The Times’s tracker.)​

Flu cases are up, too. The C.D.C. classifies the vast majority of states as having “high” or “very high” activity for the flu and related illnesses. “Hospitalizations for flu continue to be the highest we have seen at this time of year in a decade,” the agency’s director, Rochelle Walensky, said last week.​

Cases and hospitalizations from R.S.V., which typically causes cold-like symptoms but sometimes can be more serious, also spiked earlier this fall. But they seem to have already peaked.​

The infectious disease climate in the U.S. right now is not a picture of Covid’s going away, but of its falling in line alongside other endemic respiratory illnesses in the fall and winter. In some years, Covid could be the worst of the bunch. In others, the flu or R.S.V. could be. “This is the reality that we’ll be living with moving forward,” said Dr. Céline Gounder, a senior fellow at the Kaiser Family Foundation.​

Today’s newsletter will look at this new normal for Covid and other viruses.​

​ A viral season​

By now, the disease trends of the fall and winter may seem familiar: As people gather for the holidays, and generally indoors to avoid the cold, respiratory viruses spread more easily — true for Covid, but also for the flu and R.S.V.​

The biggest risks are for the very old and very young.​

Covid is still a threat, in large part because many people do not have recent immunity from vaccines or infections. But the virus is now largely a disease of older adults, as David Wallace-Wells explained in Times Opinion: Americans 65 and older now account for 90 percent of deaths. (Some younger groups, particularly the immunocompromised, also remain vulnerable.)​

R.S.V. and the flu often afflict an additional population, hitting both the very young and old hardest.​

The flu and R.S.V. have been around for a long time. They were tame in recent years, largely because widespread actions to prevent Covid, such as masking and social distancing, worked against them, too. But because a lot of people have had no recent exposure to the flu or R.S.V., they are also more vulnerable. That has allowed for a comeback by both viruses.​

“The combination of flu and Covid for older people is going to mean a pretty tough winter for hospitals,” Gounder said. “People talk about patients in the hallway — that was not uncommon, actually, before Covid. We’re going to see more of that.”​

​ What to do​

You probably know by now how to reduce your risk of Covid: Get vaccinated and boosted. When the virus is spreading quickly, mask indoors and get tested regularly. If you get sick, isolate to avoid spreading the virus and try to obtain a prescription for Paxlovid to reduce the risk of hospitalization or worse.​

“It’s all the obvious things,” Gounder said. “It’s really a question of whether people want to do them or not.”​

Similar advice applies to the other two viruses, since they spread in similar ways. You can get an annual flu shot along with a Covid booster at your local pharmacy. No vaccine exists for R.S.V., although some are in development.​

The spread of the viruses amounts to a mixed picture. The bad news is that the three pathogens will likely be a regular part of our lives, especially in the fall and winter. The good news is that we are not totally helpless against them.​

​ For more​

Here’s how to spot the flu, particularly serious symptoms, in children. The dog flu is back, too.

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[missy]

Interesting. And not surprising to me

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Adults who neglect COVID-19 health recommendations may also neglect basic road safety, study finds
Published December 13, 2022 | Originally published on MedicalXpress Breaking News-and-Events

Reasons underlying hesitancy to get vaccinated against COVID-19 may be associated with increased risks of traffic accidents according to a new study in The American Journal of Medicine. Researchers found that adults who neglect these health recommendations may also neglect basic road safety. They recommend that greater awareness might encourage more COVID-19 vaccination.

Motor vehicle traffic crashes are a common cause of sudden death, brain injury, spinal damage, skeletal fractures, chronic pain, and other disabling conditions. Traffic crash risks occur as a complication of several diseases including alcohol misuse, sleep apnea, and diabetes. However, the possible association between vaccine hesitancy and traffic crashes had not been previously studied.

"COVID-19 vaccination is an objective, available, important, authenticated, and timely indicator of human behavior—albeit in a domain separate from motor vehicle traffic," explained lead investigator Donald A. Redelmeier, MD, Evaluative Clinical Sciences, Sunnybrook Research Institute; Department of Medicine, University of Toronto; Institute for Clinical Evaluative Sciences; and Division of General Internal Medicine, Sunnybrook Health Sciences Centre, Toronto, ON, Canada.

"Whether COVID-19 vaccination is associated with increased traffic risks, however, has not previously been tested. Simple immune activation against a coronavirus, for example, has no direct effect on the risk of a motor vehicle crash. Instead, we theorized that adults who neglect health recommendations may also neglect basic road safety guidelines," he continued.

Investigators tested whether COVID-19 vaccination was associated with the risks of a traffic crash in Ontario, which is the most populous part of Canada with over 14,500,000 residents in 2021. The yearly crash risk was 2% for an average adult (minor incidents included), minimum driving age was 16 years, and novice drivers initially received beginner licenses.

The COVID-19 vaccine became available in winter 2020, doses were widely delivered to adults by spring 2021, and uptake had plateaued in summer 2021. Vaccination was free to all, supported by community outreach, accompanied by public campaigns, and connected to a central registration system.

The investigators conducted a population-based longitudinal cohort analysis of adults and determined COVID-19 vaccination status through linkages to individual electronic medical records. Traffic crashes requiring emergency medical care were subsequently identified by multicenter outcome ascertainment of 178 centers in the region over a one-month follow-up interval.

Over 11 million individuals were included, of whom 16% had not received a COVID-19 vaccine. The cohort accounted for 6,682 traffic crashes during follow-up. Unvaccinated individuals accounted for 1,682 traffic crashes (25%), equal to a 72% increased relative risk compared to those vaccinated. The increased risk was more than the risk associated with diabetes and similar to the relative risk associated with sleep apnea.

The increased traffic risks among unvaccinated adults extended to diverse subgroups (older & younger; drivers & pedestrians; rich & poor) and was equal to a 48% increase after adjustment for age, sex, home location, socioeconomic status, and medical diagnoses. The increased traffic risks extended across the entire spectrum of crash severity and appeared similar for Pfizer, Moderna, or other vaccines. The increased risks collectively amounted to 704 extra traffic crashes.

"The study found traffic risks were 50%-70% greater for adults who had not been vaccinated compared to those who had," noted Dr. Redelmeier.

"These data suggest COVID-19 vaccine hesitancy is associated with significant increased risks of a traffic crash, however, this does not mean COVID-19 vaccination directly prevents crashes. Instead, it shows how adults who do not follow public health advice may also neglect the rules of the road. Misunderstandings of everyday risk can cause people to put themselves and others in grave danger."

The authors recommend that individuals who hesitate to take the COVID-19 vaccine reflect on their choices and recognize how such decisions have repercussions in ways they do not imagine.

"We don't want unvaccinated people to feel persecuted and are not suggesting they stop driving; instead, we suggest they drive a bit more carefully. Physicians counseling patients who decline COVID-19 vaccination could consider safety reminders so their patients do not become traffic statistics," Dr. Redelmeier concluded.

This article was originally published on MedicalXpress Breaking News-and-Events.

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[missy]

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Paxlovid effective in reducing COVID-19 hospitalization among vaccinated adults 50 and over
Published December 13, 2022 | Originally published on MedicalXpress Breaking News-and-Events


The antiviral drug nirmatrelvir plus ritonavir (Paxlovid) was granted Emergency Use Authorization for treating COVID-19 in December 2021. In clinical trials, the antiviral was associated with an 88% reduction in hospitalization or death among high-risk, unvaccinated individuals with COVID-19.

However, little was known at the time about whether Paxlovid could significantly benefit vaccinated individuals, or individuals infected with novel variants of SARS-CoV-2 that were not dominant during the drug's clinical trials. By leveraging a large, well-validated, COVID-19 data repository housed within their system, Mass General Brigham researchers confirmed that the drug is associated with a 44% reduction in hospitalization or death in a highly vaccinated population of adults over the age of 50.

The results, now published in Annals of Internal Medicine, suggest that Paxlovid can offer a substantial benefit even to vaccinated patients diagnosed with COVID-19 in the outpatient setting, and can contribute to ongoing efforts to reduce COVID-19 hospitalizations during a projected winter surge.

"When nirmatrelvir plus ritonavir was first becoming available for treating COVID-19, providers and patients asked important questions about who might benefit the most from this intervention, which can pose complications under certain circumstances," said corresponding author Scott Dryden-Peterson, MD, medical director of Mass General Brigham's COVID outpatient therapy.

"The observed rate of hospitalization or death was low (1 percent) among outpatients diagnosed with COVID-19, but we found that Paxlovid was still associated with a proportional reduction of risk for hospitalization of about 50 percent across patient groups with different baseline risk levels."

Dryden-Peterson and team suggest that the lower magnitude of risk reduction seen in this study compared to the clinical trial may be the result of different study contexts, as patients in this study overall had high levels of prior immunity and consequently lower risks of severe disease. However, among the small minority of patients with fewer than three vaccine doses, there was an 81% reduction in hospitalization, a rate comparable to that found in the original trial. Notably, no hospitalizations (69 total) in those treated with Paxlovid were attributed to a "rebound syndrome" that has been described in some patients after their symptoms appear to initially resolve after using the antiviral.

To conduct this study, the researchers emulated a clinical trial of Paxlovid using observational data from nearly 45,000 patients diagnosed with COVID-19 in the outpatient setting from January to July 2022. Of these patients, 28 percent were treated with Paxlovid. The researchers sought to maximize the comparability of the treatment and non-treatment arms of the study, as they would be in a prospective trial, by accounting for a wide variety of factors, including age, comorbidities, vaccination history, race and ethnicity, and neighborhood disadvantage score. This statistical granularity was made possible by using the Mass General Brigham Enclave, a repository that includes carefully validated information on patients who test positive for COVID-19, as well as negative controls.

"Though a prospective, randomized controlled trial is the gold standard for analyzing efficacy of medications, in a pandemic setting, we've been challenged with the need to produce rigorous data to direct clinical care in a much shorter time period," said senior author Ann Woolley, MD, MPH, Associate Clinical Director of Transplant Infectious Diseases at Brigham and Women's Hospital.

"The impetus for this study was in needing to figure out how this therapy fits into Mass General Brigham's response to COVID-19. This study incorporated and built on existing systems and has allowed us to feel, programmatically within the Mass General Brigham system, and clinically within Infectious Diseases, that we were doing the right thing by prescribing Paxlovid to eligible patients."

Using data from the Mass General Brigham Enclave allowed researchers to swiftly evaluate the efficacy of the drug soon after its authorization for use. The results from this study were first available to the public as a pre-print in June 2022 and were incorporated into the U.S. Centers for Disease Control's guidance on treating COVID-19. Other studies have emerged confirming the efficacy of Paxlovid, but this one has the longest study period with a very large reliable, curated dataset.

In the coming months, the authors expect that Paxlovid will be more important in the fight against COVID-19, as there currently are no longer monoclonal antibody therapies that are effective against the circulating strains of the SARS-CoV-2 virus in the U.S. Furthermore, the results from this study are guiding ongoing efforts to direct care to the highest-risk groups.

The researchers found that during this study period, the majority of COVID-19 hospitalizations occurred among patients who were not diagnosed until their admission, highlighting the importance of eliminating barriers toward earlier testing. Among those diagnosed with COVID-19 as outpatients, Black or Latinx patients had much lower rates of Paxlovid prescription, underscoring ongoing disparities in access to and delivery of care.

"These data have been helpful as we prepare for a winter surge," Dryden-Peterson said. "Our findings suggest that Paxlovid can save lives, and it can have a real impact on keeping hospital beds available for the treatment of other conditions. The opportunity to prevent COVID-19 hospitalizations is not there unless people know that they're positive, so we have ongoing efforts to do outreach, make testing available, and communicate to the highest-risk patients that they may benefit from Paxlovid or another antiviral treatment option."

This article was originally published on MedicalXpress Breaking News-and-Events.

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[missy]

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Pfizer-BioNTech COVID vaccine remains effective in preventing hospitalizations, find studies
Published December 14, 2022 | Originally published on MedicalXpress Breaking News-and-Events


Adult hospitalizations from omicron-related SARS-CoV-2 (COVID-19) were less severe than delta and the Pfizer-BioNTech vaccine (also known as Comirnaty and BNT162b2) remains effective in preventing not only hospitalization, but severe patient outcomes associated with COVID-19, two new research studies have found.

The University of Bristol-led research, funded and conducted in collaboration with Pfizer Inc., as part of AvonCAP, is published in The Lancet Regional Health—Europe.

AvonCAP records adults who are admitted to Bristol's two hospital Trusts—North Bristol NHS Trust (NBT) and University Hospitals Bristol and Weston NHS Foundation Trust (UHBW) with possible respiratory infection.

In the first paper "Severity of Omicron (B.1.1.529) and Delta (B.1.617.2) SARS-CoV-2 infection among hospitalized adults: a prospective cohort study in Bristol, United Kingdom," researchers assessed whether delta SARS-CoV-2 infection resulted in worse patient outcomes than omicron SARS-CoV-2 infection in hospitalized patients

The study aimed to provide more detailed data on patient outcomes, such as the need for respiratory support.

The research demonstrated that omicron infection resulted in less serious outcomes than delta in hospitalized patients. Compared to delta, omicron-related SARS-CoV-2 hospitalizations were 58% less likely to need a high level of oxygen support, 67% less likely to need ventilatory support (such as a ventilator) or more critical care, and 16% less likely to have a hospital admission which lasted for more than three days.

Dr. Catherine Hyams, Post-Doctoral Clinical Research Fellow, Principal Investigator for the AvonCAP study and one of the study's lead authors at the University of Bristol, said, "By finding out the reduced requirement of increased oxygen support and total positive pressure support, including non-invasive ventilation, our analysis should contribute to future hospital care and service planning assessments.

"However, the impact of lower severity omicron-related hospitalization must be balanced with increased transmissibility and overall higher numbers of infections with this variant."

The research team suggest there should be ongoing evaluation of the severity of new variants of SARS-CoV-2, along with careful planning of health care resource to avoid health care systems being overwhelmed.

Dr. Leon Danon, Associate Professor in Infectious Disease Modeling and Data Analytics, in the Department of Engineering Mathematics and one of the study's lead authors, added, "These results have been published at a time when China is experiencing a resurgence of COVID-19 and may be useful in helping to understand what is happening there."

The second paper, "Effectiveness of BNT162b2 COVID-19 vaccination in prevention of hospitalizations and severe disease in adults with SARS-CoV-2 Delta (B.1.617.2) and Omicron (B.1.1.529) variant between June 2021 and July 2022: a prospective test negative case-control study," provides the first estimates of two- or three-dose Pfizer-BioNTech COVID vaccine effectiveness against hospital admission for more than three days and against respiratory difficulty requiring oxygen or ventilatory support.

Many studies have reported the effectiveness of the COVID-19 mRNA vaccines against hospitalization, but few have assessed the effectiveness against clinically relevant measures of COVID-19 severity. Using detailed clinical data from Bristol's two hospital Trusts—North Bristol NHS Trust (NBT) and University Hospitals Bristol and Weston NHS Foundation Trust (UHBW)—researchers estimate the effectiveness of two- or three-doses of the (original/monovalent) Pfizer-BioNTech vaccine against hospitalization for infection with either delta or omicron SARS-CoV-2 variants.

The study showed that receipt of two-doses of Pfizer-BioNTech vaccine may result in an 83% reduction in the rate of hospitalization due to delta SARS-CoV-2 infection, compared to the unvaccinated. Two doses also prevented severe in-hospital outcomes due to delta SARS-CoV-2 infection, reducing the likelihood of a hospital admission lasting more than three days by 63%. The researchers also found that two doses of this vaccine reduced the risk of a patient needing increased oxygen or ventilatory support by 52% and 59%, respectively.

Receipt of three-doses of Pfizer-BioNTech vaccine was also found to be effective in reducing omicron infection severity, compared to the unvaccinated, including in older adults, reducing the risk of hospitalization for more than three days with omicron SARS-CoV-2 by 56%, and decreasing the risk of needing high-level oxygen or ventilatory support by 42% and 59%, respectively. This is additional evidence that Pfizer-BioNTech vaccine is effective in reducing hospital admissions due to delta and omicron SARS-CoV-2 infection.

Dr. Anastasia Chatzilena, Postdoctoral Research Associate in the Department of Engineering Mathematics, and a lead author of the study, said, "Our research has shown the Pfizer-BioNTech vaccine provides effective protection against hospitalization from delta and omicron infection and has significant benefits in terms of preventing severe disease, including critical care admission and respiratory failure.

"However, the benefit provided by vaccination decreases over time which appears to be more pronounced in older adults, so careful ongoing monitoring of vaccine effectiveness and SARS-CoV-2 disease severity for emerging variants remain important."

This research is part of AvonCAP, an ongoing collaborative surveillance project funded by Pfizer Inc., which records detailed information on every adult patient admitted to Bristol's two large NHS hospital Trusts, NBT and UHBW, with symptoms, signs and/or X-ray evidence of acute disease in the lungs.

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[missy]

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COVID infection, and vaccination, linked to heart condition
Published December 13, 2022 | Originally published on MedicalXpress Breaking News-and-Events


Investigators from the Smidt Heart Institute at Cedars-Sinai validated the link between a debilitating heart condition and COVID-19 and, to a lesser extent, a novel link between the same condition and COVID-19 vaccination.

Their findings, published in the journal Nature Cardiovascular Research, suggest that a small percentage of patients vaccinated against COVID-19 may develop postural orthostatic tachycardia syndrome, or POTS. The investigators also found that those diagnosed with COVID-19 are five times more likely to develop the same cardiac condition after infection than after vaccination, emphasizing the importance of the vaccine.

"The main message here is that while we see a potential link between COVID-19 vaccination and POTS, preventing COVID-19 through vaccination is still the best way to reduce your risk of developing POTS," said Alan C. Kwan, MD, first and corresponding author of the study and a cardiovascular specialist at Cedars-Sinai.

Postural orthostatic tachycardia syndrome is a nervous system-related condition that most commonly affects young women of childbearing age. The most identifiable POTS symptom is a rapid increase in the heartbeat of more than 30 beats per minute, or a heart rate that exceeds 120 beats per minute, within 10 minutes of standing.

Other symptoms include fainting, dizziness and fatigue, although some patients with severe disease may also experience migraine, increased urination, sweaty extremities, anxiety, and tremor.

To validate their findings, study authors used data from 284,592 vaccinated patients treated within the broader Cedars-Sinai Health System between the years 2020 and 2022, as well as 12,460 Cedars-Sinai patients with COVID-19.

"From this analysis, we found that the odds of developing POTS are higher 90 days after vaccine exposure than the 90 days prior to exposure," said Kwan. "We also found that the relative odds of POTS were higher than would be explained by increases in visits to physicians after vaccination or infection."

Kwan emphasizes that despite this finding, the rates of POTS after vaccination were much lower than rates of new POTS diagnosis after COVID-19.

"This knowledge identifies a possible—yet still relatively slim—association between COVID-19 vaccination and POTS," said Kwan.

Many patients—especially those who developed POTS prior to the COVID-19 pandemic—spent years trying to get properly diagnosed. This is because many health care providers are unfamiliar with the disease and its symptoms, which often can be incorrectly attributed to chronic fatigue syndrome or other conditions. However, COVID-19 has expanded the medical field's understanding of POTS.

"In an unexpected but important way, the COVID-19 pandemic brought a great deal of awareness to POTS—both to patients and providers," said Peng-Sheng Chen, MD, an expert on the condition who leads one of only a few POTS specialty clinics in the nation. "Given a broader understanding of the disease, many patients can be diagnosed more quickly permitting earlier interventions that can greatly improve their symptoms."

Many effective interventions involve lifestyle modifications, Chen says, include avoiding triggers such as prolonged standing, extreme heat, extreme cold and alcoholic beverages. Additional recommended measures may include eating a high-sodium diet and wearing abdominal or lower body compression garments. Certain medical therapies can also be considered.

Patients treated for POTS at the Smidt Heart Institute often are encouraged to join the cardiac rehabilitation program, which aims to strengthen the body and heart.

While the Nature Cardiovascular Research study sheds an important light on vaccinations and POTS, researchers say it has its limitations. The hope, however, is this new knowledge will help improve conversations around COVID-19 and vaccines.

"We recognize as clinicians that side effects from vaccines can vary in type and severity, even if still uncommon overall. We hope that clearer data and improved understanding will eventually enhance medical trust and quality of care as well as communications around vaccines," said Kwan. "Ultimately, our goal is to optimize vaccine uptake."

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[missy]

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As COVID Treatments Dwindle, Are New Ones Waiting in the Wings?​

Kathleen Doheny
December 12, 2022


It was the last monoclonal antibody treatment standing. But less than 10 months after the US Food and Drug Administration (FDA) gave bebtelovimabits emergency use authorization (EUA) to fight COVID-19, it earlier this month de-authorized it, just as it had for other monoclonal antibody treatments, and for the same reason: The treatments were outwitted by the viral mutations.

Bebtelovimab couldn't neutralize the Omicron subvariants BQ.1 and BQ.1.1, the cause of nearly 60% of COVID cases nationally as of November 30.

Next on the chopping block, some predict, will be Evusheld, the combination of tixagevimab and cilgavimab given as a preventive monoclonal antibody to people who are immunocompromised and at high risk of contracting COVID and to those who can't take the vaccine. In October, the FDA warned that Evusheld was not neutralizing circulating COVID variants.


As the options for treating and preventing COVID decline, will companies rally quickly to develop new ones, or cut their losses in developing treatments that may only work for a few months, given the speed of viral mutations?





But although monoclonal antibody treatments are off the table, at least for now, antiviral drugs — including Paxlovid — are still very much available, and some say underused.

Others suggest it's time to resurrect interest in convalescent plasma, a treatment used early in the pandemic before drugs or vaccines were here and still authorized for use in those who are immunosuppressed or receiving immunosuppressive treatment.

And on the prevention front, staying up to date with booster vaccines, masking, and taking other precautions should be stressed more, others say, regardless of the number of treatment options, and especially now, as cases rise and people gather for the winter holidays.

"A Major Setback"​

Dr Arturo Casadevall
The bebtelovimab de-authorization was "a major setback," but an understandable one, said Arturo Casadevall, MD, PhD, professor and chair of molecular microbiology and immunology at the Johns Hopkins Bloomberg School of Public Health in Baltimore. "Monoclonal antibodies are great drugs. We are in an unfortunate situation in that they are vulnerable to changes in the virus" and can't offer long-lasting protection.

The bebtelovimab de-authorization was "a major setback," but an understandable one, said Arturo Casadevall, MD, PhD, professor and chair of molecular microbiology and immunology at the Johns Hopkins Bloomberg School of Public Health in Baltimore. "Monoclonal antibodies are great drugs. We are in an unfortunate situation in that they are vulnerable to changes in the virus" and can't offer long-lasting protection.

Supplies of bebtelovimab will be retained, according to the FDA, in case variants susceptible to it return.


"What happened to bebtelovimab is no surprise," agreed Amesh Adalja, MD, senior scholar at Johns Hopkins Center for Health Security. "This is what is going to happen when you are targeting a virus that mutates a lot."


Monoclonal antibodies work by binding to the spike protein on the virus surface to prevent it from entering cells.


However, Adalja doesn't view the disappearance of monoclonal antibody treatments as a major setback. Monoclonal antibodies were not the primary way COVID was treated, he said.


While he does believe it's important that more monoclonal antibody treatments be developed, "I think it's important to remember we still have Paxlovid while everyone is lamenting the loss of bebtelovimab.''

Antivirals: What's Here, What's Coming​

Compared to monoclonal antibodies, "Paxlovid remains a much easier drug to give," Adalja told Medscape Medical News, since it is taken orally, not intravenously.

Dr Amesh Adalja
And it's effective. In a recent study, researchers found that adults diagnosed with COVID given Paxlovid within 5 days of diagnosis had a 51% lower hospitalization rate within the next 30 days then those not given it. Another study shows it could also reduce a person's risk of developing long COVID by 26%.

And it's effective. In a recent study, researchers found that adults diagnosed with COVID given Paxlovid within 5 days of diagnosis had a 51% lower hospitalization rate within the next 30 days then those not given it. Another study shows it could also reduce a person's risk of developing long COVID by 26%.

Paxlovid is underused, Adalja said, partly because the rebound potential got more press than the effectiveness. When a celebrity got rebound from Paxlovid, he said, that would make the news, overshadowing the research on its effectiveness.

Besides Paxlovid, the antivirals remdesivir (Veklury), given intravenously for 3 days, and molnupiravir (Lagevrio), taken orally, are also still available. Antivirals work by targeting specific parts of the virus to prevent it from multiplying.

In the lab, remdesivir, molnupiravir, and another antiviral, nirmatrelvir, all appear to be effective against both BQ.1.1 (a BA.5 subvariant) and XBB (a BA.2 subvariant), both rapidly rising in the US, according to a report last week in the New England Journal of Medicine.

The researchers also tested several monoclonal antibodies and found they did not neutralize either of the subvariants, BQ.1.1 and XBB.

A new oral antiviral, Xocova (ensitrelvir fumaric acid), from Japanese manufacturer Shionogi, got emergency approval in Japan on November 22. It's taken once a day for 5 days. The goal is to expand access to it globally, according to the company.

Pardes Biosciences launched a phase 2 trial in September for its oral antiviral drug (PBI-0451), under study as a treatment and preventive for COVID. It expects data by the first quarter of 2023.

Pfizer, which makes Paxlovid, has partnered with Clear Creek Bio to develop another oral antiviral COVID drug.

Other Approaches​

A receptor protein known as ACE2 (angiotensin-converting enzyme 2) is the main "doorway" that SARS-CoV-2 uses to enter and infect cells.

Dana-Farber Cancer Institute scientists are developing a "decoy" drug that works by mimicking the ACE2 receptor on the surface of cells; when the virus tries to bind to it, the spike protein is destroyed. Human trials have not yet started.


Other researchers are investigating whether an already-approved drug used to treat a liver disease, Actigall (UDCA/ursodeoxycholic acid), could protect against COVID infection by reducing ACE2.


So far, the researchers have found in early research that people taking UDCA for liver conditions were less likely than those not taking the drug to have severe COVID. They also found that UDCA reduced SARS-CoV-2 infection in human lungs maintained outside the body.

Monoclonal Antibody Treatments?​

After the FDA decision to withdraw the bebtelovimab EUA, which Eli Lilly said it agreed with, the company issued a statement, promising it wasn't giving up on monoclonal antibody treatments.


"Lilly will continue to search and evaluate monoclonal antibodies to identify potential candidates for clinical development against new variants," it read in part.


AstraZeneca, which makes Evusheld, is also continuing to work on monoclonal antibody development. According to a spokesperson, "We are also developing a new long-acting antibody combination — AZD5156 — which has been shown in the lab to neutralize emerging new variants and all known variants to date. We are working to accelerate the development of AZD5156 to make it available at the end of 2023."





The AstraZeneca spokesperson said he could share no more information about what the combination would include.

A Convalescent Plasma Comeback?​

Although Paxlovid can help, there are many contraindications to it, such as drug-drug interactions, Casadevall told Medscape Medical News. And now that the monoclonal antibody treatments have been paused, convalescent plasma "is the only antibody-based therapy that is reliably available. Convalescent plasma includes thousands of different antibodies."


With his colleagues, Casadevall evaluated plasma samples from 740 patients. Some had received booster vaccines and been infected with Omicron, other had received boosters and not been infected, and still others had not been vaccinated and became infected.


In a report (not yet peer-reviewed), they found the plasma from those who had been infected or boosted within the past 6 months neutralized the new Omicron variants BQ.1.1, XBB.1 and BF.7.

A Push for Boosters, Masks​

To get through the coming months, taking precautions like masking and distancing and staying up to date on booster vaccinations, especially for older adults, can make a difference, other experts say.


In a Twitter thread in early December, Peter Hotez, MD, PhD, professor of pediatrics and molecular virology and microbiology at Baylor College of Medicine, Houston, Texas, urged people to take COVID seriously as holiday parties and gatherings occur.


"The single most impactful thing you can do is get your bivalent booster," he tweeted, as well as give your kids the booster, citing preliminary research that the bivalent mRNA booster broadens immunity again the Omicron subvariants.




For seniors, he said, ‘'if you get breakthrough COVID, really important to get Paxlovid." Masks will help not only for COVID but also influenza, respiratory syncytial virus (RSV), and other conditions.


Mitigation measures have largely been abandoned, according to Eric Topol, MD, director of the Scripps Research Translational Institute, La Jolla, California, and editor-in-chief of Medscape. In an op-ed in the Los Angeles Times, and on his Twitter feeds, he reminds people about masking and urges people to get the bivalent booster.




According to the Centers for Disease Control and Prevention, as of December 8, only 13.5% of people age 5 and older have gotten an updated booster, despite research that shows an increase in antibodies to BQ.1.1. Recent research has found that the bivalent booster increases antibodies to BQ.1.1 by up to 10-fold, Topol said.


Adalja is on advisory boards for Shionogi, GSK, and Pardes. Casadevall reports no relevant financial relationships.

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[dk168]

I attended a work function last Thursday, and the younger colleagues who sat opposite and next to me who have not had their 3rd dose let alone the 4th one, both got Covid, and they had caught Covid in the past!

I am still Covid free so far (I had my 4th dose, a bi-valent back in October 2022) and had Covid back in March 2022.

DK

 

[missy]

"

Return of the Mask? COVID, RSV, Flu Renew Calls to Cover Up​

Damian McNamara, MA
December 12, 2022

For those of you anxiously waiting to see if the spread of respiratory illnesses in the United States will be as bad as some experts predict, you might wonder if we're going back to recommendations to wear face masks again.
Actually, health officials have already started. Along with recommending that everyone traveling on planes, trains, buses, and other public transportation wear masks, the CDC also recommends Americans in communities with high COVID-19 numbers again wear a mask indoors in public spaces.
This is welcome news for some people – many of whom say they never stopped wearing masks.

Natalie, a 36-year-old mother of three children who runs a small business in Arizona, is among them.




"I continue to mask because, for me and my family at least, it's a simple measure that helps protect us and others," she says.
She's listened to doctors, epidemiologists, and virologists who say that catching COVID-19 multiple times increases the risk of having long-term health complications. "I don't want that for my family, and I don't want to do that to anyone else, either," she says.


Natalie's positive attitude doesn't mean it will be easy to get everyone back in the mask-wearing habit, many experts say.
"We started to see the unfortunate and expected rise of COVID-19 cases and hospitalizations nationally after the Thanksgiving holiday," CDC Director Rochelle Walensky, MD, said during a media briefing this week. "This rise in cases and hospitalizations is especially worrisome as we move into the winter months when more people are assembling indoors … and as we approach the holiday season where many are gathering with loved ones across multiple generations."
In addition to staying up to date on vaccinations, Walensky said the CDC encourages everyone "to wear a high-quality, well-fitting mask to prevent the spread of respiratory illnesses." This is especially true, she said, for the 5% of the population "currently living in counties with high COVID-19 community levels."

For example, five neighboring counties in New York – Nassau, Suffolk, Queens, Kings (Brooklyn), and Bronx – report enough COVID-19 cases to meet the indoor masking criteria. These high-level areas and others are indicated in orange on the CDC COVID Data Tracker map of the United States.


Priya Nori, MD, an infectious disease specialist in the Bronx, one of the affected counties, says she has been seeing a steady increase in COVID-19 cases in the past couple of months, including after Thanksgiving.


"But there has certainly been a shift in how ill our patients are presenting," says Nori, an associate professor of medicine and orthopedic surgery at the Albert Einstein College of Medicine.


Overall, COVID-19 is less severe, she says, with most patients having upper respiratory illness and not the more concerning lower respiratory tract symptoms. Nor are they seeing patients with a need for oxygen, major blood clots, or strokes.




"This is definitely a different ball game."





Nori adds an important caveat: "We still are very much concerned about the population we consider to be moderately to severely immunocompromised. For those folks, I don't want to share a blanket statement that the illness is very mild."

She emphasizes that masks and other precautions remain essential for the immunocompromised, people over 65, and anyone else at a higher risk for severe outcomes of COVID-19.

The CDC continues to recommend masking for anyone who may be immunocompromised or at increased risk of severe disease, Walensky said.

"So Over Covid"​

"Complacency is our enemy. That is my biggest fear – that people are so desensitized and feeling that it is the norm," New York Gov. Kathy Hochul said during a recent update on winter health preparedness, including COVID-19, the flu, and respiratory syncytial virus (RSV). "Yes, it is become our norm, but it does not have to be the norm that everybody gets sick. That's what we're trying to fight against."

Bruce Farber, MD, chief of public health and epidemiology for Northwell Health in Manhasset, NY – within Nassau County – is likewise concerned. "It appears very unlikely that New Yorkers are going to start wearing masks again unless rates skyrocket," he says.

Nori agrees that complacency remains a challenge. "I don't think that New Yorkers are any different from the rest of Americans or the rest of the world, in that they've had now many multiple waves of COVID go through their communities, they've been ill at least once themselves, and they are pretty experienced at this point with the pandemic."

A potentially high level of "mask fatigue" means people are perhaps less likely to adhere to these community-level recommendations from the CDC, Nori says. People are "just so over COVID."

A Ferocious Start to Flu Season​

"That being said, there are so many good reasons for wearing a mask right now, the least of which is influenza," Nori says. "We skipped multiple flu seasons through the pandemic … and this season is attacking early and intensely."

"In my opinion, especially with the numbers that I'm seeing in terms of positive tests locally, I do feel that flu is really the one to watch for this winter," she says. "Definitely the message is to keep your eye on flu this season because it's coming with ferocity."

Walensky pointed out that flu cases "continue to be the highest we have seen at this time of year in a decade, demonstrating the significantly earlier flu season we are experiencing."

Farber agrees that the flu should be taken seriously. "The flu has the potential to cause over 50,000 deaths this year. It is a very good reason to get vaccinated and to wear masks in crowded areas."

"Not a Forever Situation"​

The flu can lead to severe illness, disability, and death. "For that reason, I advise patients and I advise colleagues that masking continues to be the way to go, especially for the next couple of weeks," Nori says. "If we can remain disciplined about that for the next couple weeks, I think we'll have a much better holiday season and be much better prepared to get through the winter."


"It's not a forever situation," she says. "There will be a day where we can dial this back again."


Masks are "going to be super important to help us get safely through the winter until the spring," Nori says. "And then we can all celebrate if flu and COVID are coming down again at that point, which I think they will."


RSV is also particularly worrisome at the moment. The virus is infecting so many young children that it continues to challenge the capacity of children's hospitals nationwide. It's also infecting many people over age 65 as well. Adding to the concern: There is no approved vaccine against RSV, although several are in development.

What About the Worried Well?​

The CDC recommendations are just that – recommendations. "One need not wait for CDC action in order to put a mask on," Walensky said.





The New York state commissioner of health agrees. "What I want to say is that people should feel free to wear a mask. Everybody can make the decision to wear masks, and I want people to be aware of the settings in which mask wearing would be wise," Mary T. Bassett, MD, said during the governor's news briefing.


She emphasized these are recommendations, not mandates. "We've gone through a period where people are tired of being told what to do, but we in public health are now emphasizing that people can make decisions on their own and make decisions to be protected," Bassett said.


"The people that are testing negative for flu, COVID, and RSV should be very glad, but understand those aren't the only respiratory infections that are out there," Walensky said. "People can still have regular colds."


"But all these things we talked about – masking, washing your hands, covering your cough, and staying home when you're sick – all those things can keep down the spread of all these respiratory infections," and they're important, Walensky said. "You know, it's that time of year."

Sources​

Media briefing, CDC, Dec. 5, 2022.


Rochelle Walensky, MD, director, CDC.


Bruce Farber, MD, chief of public health and epidemiology, Northwell Health, Manhasset, NY.


Priya Nori, MD, infectious disease specialist, Bronx, NY; associate professor of medicine and orthopedic surgery, Albert Einstein College of Medicine.


NYS Update on Winter Health Preparedness


New York Gov. Kathy Hochul.


Mary Bassett, MD, commissioner, New York State Department of Health.

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[missy]

"

Musk, Fauci, trust in science, and how to make it survive​

KATELYN JETELINA DEC 14

​

Trust in public health is eroding, and the implications are far reaching. We, as a field, have to fix this.

Over the weekend​

Any forward-facing scientist can tell you that receiving dangerous messages has been a common occurrence throughout the pandemic. But the hate, resentment, frustration, and anger was crystallized in one instance over the weekend: Elon Musk—the world’s richest man and new owner of Twitter—wrote the post below.

1,176,815Likes177,693Retweets
Five words, that were wrong on so many levels, garnered more than 1.17 million “likes,” 177,000 retweets, and international attention in mass media. Anyone who dared to disagree received a wave of truly grotesque comments. Even Musk noticed as he followed up on his original tweet with: “Truth resonates…”
Of course, the viral reaction is due to many things: social media algorithms, a polarized country, politics, misinformation, disinformation, opinions about Twitter, opinions about Elon. I also think Musk is trying to deflect negative attention from himself. It’s also a reflection of humans’ difficulty coping with randomness—people need someone to blame for the pandemic, the fear they experienced, the people they lost, or the jobs and livelihoods that were changed. The viral reaction was also an indication that people finally felt heard.
But all of the above also overlap with public health. And, their accumulation has been funneled into one sentiment towards our field: distrust.

Change in trust​

Every year, the Pew Research Center conducts a survey with Americans on public confidence in certain groups. Overall, trust in scientists has decreased throughout the pandemic, but ever so slightly. Interestingly it remained higher than public confidence in business officials, the military, public school principals, religious leaders, police officers, and elected officials.
If we compare the responses based on political affiliation, though, the story becomes jarring: confidence in scientists among Republicans dropped significantly. In fact, 1 in 3 Republicans have no confidence at all.

​

Furthermore, declines in trust in science were most pronounced among White adults. Americans with higher levels of education expressed more positive views of scientists than those with lower levels of education.

This is a huge problem, as trust equals lives​

An Oxford report continually assesses country-level factors that most strongly predict COVID-19 deaths. The answer? Not pandemic preparedness. Not government. It was interpersonal trust—a measure of how much people think they can trust another citizen who they don’t already know. In other words, public health worked better in high-trust countries.

​

We cannot have one group trust public health and another not. This is not how viruses work. Infectious diseases violate the assumption of independence—what one person does directly impacts the person next to them. This is unlike cancer or diabetes, for example. Everyone has to be against a virus, or the virus thrives.
Perhaps most concerning is that this isn’t going to be our last pandemic. Since the 1918 flu, we’ve seen diseases emerge faster and faster. Public health also touches on our daily lives beyond infectious diseases: what we eat, social problems, gun violence, and all other acute and chronic medical problems. We need the trust of the community to move the needle for any of these.

What to do?​

As the field of public health copes, self-reflects, and digests the past three years and weighs how to build for a better future, we have to make it our goal, our opportunity, to improve trust. As one scientist said, “You earn public confidence in small drops and you [lose] it in buckets.”
Bottom-up engagement is absolutely necessary. We need to enter conversations with humility. A conversation about false dichotomies (lock down vs. throwing caution to the wind) is necessary. A conversation about disease vs. the needs of a community is necessary. An honest conversation on what we (CDC, state epi, local epi, leaders, communicators) got wrong, got right, and why.
What does this look like? I have a few ideas:

1. Listening sessions. Not hearing and not telling, but listening to people and trusted messengers who are not in “our world.” Bringing them into the solution. It will be painful. It will be time consuming. But it has to be done.
2. A COVID-19 commission that is congressionally mandated, like the 9/11 commission. There is text in the PREVENT Act, but it’s not clear if PREVENT will pass.
3. Preparation for the future. Putting communication at the center of pandemic preparedness. This is still not being done. Building capacity for effective scientific communication needs to be a core of our national strategy. As I’ve written before, a lot needs to be done in this area.

I’m sure there are more and even better ways. And I would love to hear your thoughts in the comments. But the fact of the matter is there is no one solution. And this is going to take a whole lot of time.

Bottom line​

We need to understand why five words in a Tweet carry so much weight in public health and threaten our entire profession. Will trust in science survive the pandemic? Maybe. It depends on what we, as a field, do next. If we don’t win hearts and minds, we won’t win against this virus or the next. Trust is key in public health. Our scientific work depends on it. Our health depends on it. Our lives depend on it. Now everyone needs to act like it. That includes, you, Mr. Musk.


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[missy]

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Pfizer-BioNTech COVID vaccine remains effective in preventing hospitalizations, find studies
Published December 14, 2022 | Originally published on MedicalXpress Breaking News-and-Events


Adult hospitalizations from omicron-related SARS-CoV-2 (COVID-19) were less severe than delta and the Pfizer-BioNTech vaccine (also known as Comirnaty and BNT162b2) remains effective in preventing not only hospitalization, but severe patient outcomes associated with COVID-19, two new research studies have found.

The University of Bristol-led research, funded and conducted in collaboration with Pfizer Inc., as part of AvonCAP, is published in The Lancet Regional Health—Europe.

AvonCAP records adults who are admitted to Bristol's two hospital Trusts—North Bristol NHS Trust (NBT) and University Hospitals Bristol and Weston NHS Foundation Trust (UHBW) with possible respiratory infection.

In the first paper "Severity of Omicron (B.1.1.529) and Delta (B.1.617.2) SARS-CoV-2 infection among hospitalized adults: a prospective cohort study in Bristol, United Kingdom," researchers assessed whether delta SARS-CoV-2 infection resulted in worse patient outcomes than omicron SARS-CoV-2 infection in hospitalized patients

The study aimed to provide more detailed data on patient outcomes, such as the need for respiratory support.

The research demonstrated that omicron infection resulted in less serious outcomes than delta in hospitalized patients. Compared to delta, omicron-related SARS-CoV-2 hospitalizations were 58% less likely to need a high level of oxygen support, 67% less likely to need ventilatory support (such as a ventilator) or more critical care, and 16% less likely to have a hospital admission which lasted for more than three days.

Dr. Catherine Hyams, Post-Doctoral Clinical Research Fellow, Principal Investigator for the AvonCAP study and one of the study's lead authors at the University of Bristol, said, "By finding out the reduced requirement of increased oxygen support and total positive pressure support, including non-invasive ventilation, our analysis should contribute to future hospital care and service planning assessments.

"However, the impact of lower severity omicron-related hospitalization must be balanced with increased transmissibility and overall higher numbers of infections with this variant."

The research team suggest there should be ongoing evaluation of the severity of new variants of SARS-CoV-2, along with careful planning of health care resource to avoid health care systems being overwhelmed.

Dr. Leon Danon, Associate Professor in Infectious Disease Modeling and Data Analytics, in the Department of Engineering Mathematics and one of the study's lead authors, added, "These results have been published at a time when China is experiencing a resurgence of COVID-19 and may be useful in helping to understand what is happening there."

The second paper, "Effectiveness of BNT162b2 COVID-19 vaccination in prevention of hospitalizations and severe disease in adults with SARS-CoV-2 Delta (B.1.617.2) and Omicron (B.1.1.529) variant between June 2021 and July 2022: a prospective test negative case-control study," provides the first estimates of two- or three-dose Pfizer-BioNTech COVID vaccine effectiveness against hospital admission for more than three days and against respiratory difficulty requiring oxygen or ventilatory support.

Many studies have reported the effectiveness of the COVID-19 mRNA vaccines against hospitalization, but few have assessed the effectiveness against clinically relevant measures of COVID-19 severity. Using detailed clinical data from Bristol's two hospital Trusts—North Bristol NHS Trust (NBT) and University Hospitals Bristol and Weston NHS Foundation Trust (UHBW)—researchers estimate the effectiveness of two- or three-doses of the (original/monovalent) Pfizer-BioNTech vaccine against hospitalization for infection with either delta or omicron SARS-CoV-2 variants.

The study showed that receipt of two-doses of Pfizer-BioNTech vaccine may result in an 83% reduction in the rate of hospitalization due to delta SARS-CoV-2 infection, compared to the unvaccinated. Two doses also prevented severe in-hospital outcomes due to delta SARS-CoV-2 infection, reducing the likelihood of a hospital admission lasting more than three days by 63%. The researchers also found that two doses of this vaccine reduced the risk of a patient needing increased oxygen or ventilatory support by 52% and 59%, respectively.

Receipt of three-doses of Pfizer-BioNTech vaccine was also found to be effective in reducing omicron infection severity, compared to the unvaccinated, including in older adults, reducing the risk of hospitalization for more than three days with omicron SARS-CoV-2 by 56%, and decreasing the risk of needing high-level oxygen or ventilatory support by 42% and 59%, respectively. This is additional evidence that Pfizer-BioNTech vaccine is effective in reducing hospital admissions due to delta and omicron SARS-CoV-2 infection.

Dr. Anastasia Chatzilena, Postdoctoral Research Associate in the Department of Engineering Mathematics, and a lead author of the study, said, "Our research has shown the Pfizer-BioNTech vaccine provides effective protection against hospitalization from delta and omicron infection and has significant benefits in terms of preventing severe disease, including critical care admission and respiratory failure.

"However, the benefit provided by vaccination decreases over time which appears to be more pronounced in older adults, so careful ongoing monitoring of vaccine effectiveness and SARS-CoV-2 disease severity for emerging variants remain important."

This research is part of AvonCAP, an ongoing collaborative surveillance project funded by Pfizer Inc., which records detailed information on every adult patient admitted to Bristol's two large NHS hospital Trusts, NBT and UHBW, with symptoms, signs and/or X-ray evidence of acute disease in the lungs.

This article was originally published on MedicalXpress Breaking News-and-Events.

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[missy]

"
Reuters Health Information

China Stops Publishing Asymptomatic COVID Cases, Reports No Deaths​

Reuters staff
December 14, 2022




BEIJING (Reuters) -China's National Health Commission (NHC) will as of Wednesday stop reporting new asymptomatic COVID-19 infections, as many people without symptoms no longer participate in testing, making it hard to accurately tally the total count, it said.
The health authority reported 2,291 new symptomatic COVID-19 infections on Dec. 13.
China recorded 7,679 new cases a day earlier – 2,315 symptomatic and 5,364 asymptomatic infections, which China counts separately.
Excluding imported infections, China reported 2,249 new symptomatic local cases. There were a total of 7,451 local cases including asymptomatic infections a day earlier.

There were no new deaths, the same as the previous day, keeping fatalities at 5,235.




As of Dec. 13, mainland China had confirmed 369,918 cases with symptoms.
China's capital, Beijing, reported 476 symptomatic cases, according to the NHC. That compared with 559 symptomatic and 468 asymptomatic cases the previous day, local government data showed.
Some cities reported asymptomatic case counts before the NHC's announcement.

Financial hub Shanghai reported 16 symptomatic cases and 117 asymptomatic cases, compared with 14 symptomatic cases and 115 asymptomatic cases a day before, the local health authority reported.
Guangzhou, a city in the south of nearly 19 million people, reported 533 new locally transmitted symptomatic and 741 asymptomatic cases, compared with 291 symptomatic and 434 asymptomatic cases a day before, local authorities said.
Chongqing reported 179 new symptomatic locally transmitted COVID-19 infections and 1,165 asymptomatic cases, compared with 180 symptomatic and 1,398 asymptomatic cases the previous day, local government authorities said.
(Reporting by Wang Jing and Liz Lee; Editing by Muralikumar Anantharaman and Gerry Doyle)

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China to Roll Out Second COVID Vaccine Booster for High-Risk Groups, Elderly​

Reuters staff
December 14, 2022




BEIJING (Reuters) - China's National Health Commission (NHC) will roll out the second COVID-19 vaccine booster shots for high-risk groups and elderly people over 60 years old, it said in a statement on Wednesday.
The time gap between the first and second booster shots will be six months, NHC said, adding people who can take the second booster shot will include those with severe existing diseases and those with low immunity.
Right before drastically easing its stringent COVID-19 prevention measures earlier this month, China has pushed to speed up vaccinations for those aged above 60 years.
People aged 60 and above who have received two doses inched up from 85.6% in August to 86.4% in November, while the booster rate rose from 67.8% to 68.2% over the same period, according to official data.

It shortened the time gap between basic vaccination and booster shots to three months for the elderly late last month.

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[missy]

"

Fall bivalent boosters: Science update round 4​

KATELYN JETELINA DEC 16

​

We got an early holiday present. One of the last puzzle pieces about the fall booster was released today: data on the effectiveness against severe disease. I also interviewed the CDC Program Lead for more context.

Science until now​

We have ~9 lab studies and 1 real world study showing the fall boosters provide:

1. Greater protection against infection and transmission, by boosting our first line of defense—neutralizing antibodies. (See my previous updates here.)
2. Broader protection, or the ability to create antibodies that “see” more virus parts and “attach” more strongly compared to the antibodies we have right now. (See my previous updates on this here.); and,
3. Longer protection against infection and severe disease, even just by a few months. We are still at the mercy of time for this, but have promising data from the Beta bivalent vaccine clinical trials.

Until now, though, we didn’t know whether they provided additional protection against severe disease and hospitalization. We now have three real world analyses, and things are looking good.

Two new U.S. studies​

Today, the CDC released studies answering the same question from two different perspectives.
The first study leveraged the IVY network—22 hospitals in 18 states. Scientists looked at hospitalizations from September 8 to November 30, 2022 among adults aged 65 years and older. This is what they found:

• Compared to no prior vaccination, effectiveness of the fall booster against hospitalization was 84%.
• Compared to 2+ previous mRNA vaccines, effectiveness was 73%.

The second study leveraged the VISION network—a network of nine hospitals in 11 different states. Scientists assessed emergency room and urgent care visits (a proxy for more severe disease) from September 13 to November 18, 2022. They included patients of all ages, not just over 65 years old. They found:

• Compared to no prior vaccination, effectiveness of the fall booster against emergency room or urgent care visits was 56%.
• Compared to 2+ previous mRNA vaccines, effectiveness was 31-50%.
  • This depended on timing of last dose. If someone got their last mRNA shot 2-4 months ago, for example, effectiveness was 31%. If the last dose was 12+ months ago, effectiveness was 50%.

U.K. analysis​

This data comes on the heels of a report from the U.K. Health Security Agency that ran a similar analysis of their boosters. As a reminder, they used the BA.1 formula only for those over 50 years old, while the U.S. used a BA.5 formula for everyone. They found:

• Effectiveness against hospitalization was 57% compared to those without the Fall booster.

Broader context​

I spoke with Dr. Ruth Link-Gelles a few days ago, as she is the Program Lead of COVID-19 Vaccine Effectiveness at the CDC and Lieutenant Commander in the U.S. Public Health Service. While she worked directly on these studies and probably could repeat the results like the back of her hand, I asked more about the context around these numbers. And, more importantly, how to talk Grandma into getting a vaccine today. Here is what she had to say:

Bottom line​

The fall boosters work. There is now evidence fall boosters broaden protection, help against infection, protect against severe disease, and (we think and hope) provide longer protection. There is one major problem though: more than 150 million people are eligible for a fall booster in the U.S. and have yet to get one.


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[missy]

"

WHO chief hopes COVID will no longer be emergency next year
Updated December 16, 2022 | Originally published on Health News Online Report

World Health Organization chief Tedros Adhanom Ghebreyesus said on Wednesday he is "hopeful" that the COVID-19 pandemic will no longer be considered a global emergency some time next year.

His comments at a briefing with media come as China dismantles its rigid "zero-COVID" policy and allows people to live with the virus, stirring concerns the world's No.2 economy faces a surge in infections.

A WHO body meets every few months to decide whether the new coronavirus, which emerged three years ago in China's Wuhan and has killed more than 6.6 million people, still represents a "public health emergency of international concern" (PHEIC).

The designation is intended to trigger a coordinated international response and could unlock funding to collaborate on sharing vaccines and treatments.

Asked about the conditions needed for the end of the PHEIC, WHO's senior epidemiologist Maria Van Kerkhove said: "There's more work to be done."

"If there are huge chunks of population that have not had vaccinations, the world still has a lot of work to do," said WHO's emergencies director Mike Ryan about the same issue.

(Reporting by Emma Farge in Geneva; Writing by Josephine Mason in London; Editing by Alison Williams and Janet Lawrence)

—Emma Farge

This article was originally published on Health News Online Report.

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[missy]

"

Philadelphia Schools to Require Masks After Winter Break​

Ralph Ellis
December 16, 2022


The Philadelphia School District will require students and staff to wear face masks after returning from the winter break.
District officials said earlier this year that mandatory masking might be required for brief periods if COVID-19 cases spike, The Philadelphia Inquirer reported. Masks were required the first 10 days of the school years but were made optional afterward. Masks will again be mandatory from Jan. 3 to 13, officials said.
"This is a proactive measure to reduce the spread of COVID-19 and other respiratory illnesses in school, reduce absenteeism and prioritize in-person learning after the winter break," Christina Clark, a spokesperson for the School District of Philadelphia, said in a statement, according to the Inquirer.

The school district also announced that free COVID tests will be available at five schools across the city.




Other school districts, colleges, and local governments are considering putting mask mandates back in place as a "tripledemic" of COVID, flu, and RSV puts a strain on hospitals across the country. The threat will probably increase as people gather in groups during the holidays, health officials warn.
Officials in New York City and Los Angeles County said last week that masking was recommended in indoor spaces, and the Los Angeles County Health Department director said masking may be required if case counts grow and hospitals become more strained in coming weeks.
The CDC recommends people wear masks on public transportation and in indoor public settings in areas with "high" COVID community levels.


Sources:

The Philadelphia Inquirer: "Philadelphia schools will require masking for 10 days after winter break."

Los Angeles County Department of Public Health: "With LA County in High Community Level for COVID-19, Public Health Asks Residents to Mask, Get Boosted - 3,756 New Positive Cases and 17 New Deaths Due to COVID-19 in Los Angeles County."

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[missy]

Not technically Covid related but super interesting so including for anyone who might be interested

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4 Things to Know About Moderna's mRNA Cancer Vaccine​

Patricia McKnight
December 16, 2022




A cancer vaccine based on the messenger RNA (mRNA) technology, provided alongside the checkpoint inhibitor pembrolizumab (Keytruda), has shown encouraging results in an open label phase 2b clinical trial. The trial found that the combination regimen reduced the risk of cancer recurrence or death among melanoma patients by 44% compared with pembrolizumab alone, according to the vaccine's manufacturer Moderna.
Here are four things to know about the mRNA-4157/V940 cancer vaccine and what the company has in store for upcoming clinical trials.

1. The mRNA vaccine is personalized​

Moderna's mRNA vaccine is personalized for each patient. The vaccine is designed to prime the immune system in a way that allows a patient to generate a tailored antitumor response specific to their tumor mutations.

To identify a patient's specific mutations, researchers sequence DNA from the patient's normal tissue as well as DNA from the tumor. Results are compared to identify a set of mutations unique to the patient's cancer. Researchers then develop a single synthetic mRNA coding for up to 34 neoantigens, designed based on the tumor's specific mutational signature. The aim is for mRNA-4157/V940 to help the patient's immune system identify and attack the tumor cells only.

2. Development, distribution happens quickly​

The process of personalizing the vaccine happens over several weeks, according to Moderna's Head of Development for Oncology Kyle Holen.



By itself, "the RNA sequencing takes only 2 hours to develop, which is just mind-boggling that it can happen so quickly," Holen said. "It's important to do this quickly because patients with cancer don't have much time to wait."

After acquiring samples from patients, sequencing, running the algorithm to identify specific mutations, manufacturing the RNA, and delivering the vaccine to patients take about 6 weeks in total.

3. Adverse events higher in the experimental arm​

Serious treatment-related events occurred in 14.4% of patients who received the combination of mRNA-4157/V940 and pembrolizumab vs 10% receiving pembrolizumab monotherapy. The adverse events observed were consistent with those seen in phase 1 of the trial, and Moderna did not report any events in the phase 2b trial.

4. Moderna's plans to expand beyond melanoma​

Moderna is still developing a phase 3 clinical trial for mRNA-4157/V940, which the company hopes to launch sometime in 2023, Holen said during a press conference. Moderna also plans to expand its personalized mRNA vaccine approach beyond melanoma to other tumor types but has not begun that expansion yet.


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[missy]

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Potential new treatment for 'brain fog' in long COVID patients
Updated December 16, 2022 | Originally published on MedicalXpress Breaking News-and-Events

Individuals with long COVID, sometimes referred to as "long-haulers," experience symptoms that may persist for weeks, months, or even years after their acute viral infection. While symptoms vary widely, a common complaint among patients is "brain fog"—a colloquial term for significant, persistent cognitive deficits, with consistent impairment of executive functioning and working memory.

Long-haulers may experience a lack of mental clarity, poor focus and concentration, memory problems, difficulty with multi-tasking, and more. Brain fog can be debilitating, but there currently are no treatment options that are approved for the condition.

While the number of patients they studied is too small for their results to be definitive, Yale researchers, using their extensive experience with two existing medications, have published initial evidence that those drugs, given together, can mitigate or even eliminate brain fog.

Guanfacine, developed in the lab of Amy Arnsten, Ph.D., Albert E. Kent Professor of Neuroscience and professor of psychology, was approved by the Food and Drug Administration (FDA) for the treatment of ADHD in 2009, but clinicians have also used it extensively off-label for other prefrontal cortical disorders such as traumatic brain injury (TBI) and PTSD.

Now, Arnsten has joined forces with Arman Fesharaki-Zadeh, MD, Ph.D., assistant professor of psychiatry and of neurology, who has been treating long COVID patients with a combination of guanfacine and N-acetylcysteine (NAC), an anti-oxidant also used for the treatment of TBI.

The combined therapy, they found, was successful in relieving brain fog for their small cohort of patients. And while larger, placebo-controlled clinical trials will be needed to establish these drugs as a bona fide treatment for post-COVID-19 neurocognitive deficits, they say patients can obtain them now if their doctors wish to prescribe them.

"There's a paucity of treatment out there for long COVID brain fog, so when I kept seeing the benefits of this treatment in patients, I felt a sense of urgency to disseminate this information," says Fesharaki-Zadeh. "You don't need to wait to be part of a research trial. You can ask your physician—these drugs are affordable and widely available." Because they are FDA-approved and have been used for years, their safety for patients is established.

The researchers published their case study in Neuroimmunology Reports on November 25.

Focus on a brain area with unique properties

Executive functioning, working memory, and attention regulation are carried out by a recently evolved area in brain called the prefrontal cortex. Neural circuits in this region are "remarkably vulnerable" to inflammation and stress, says Arnsten, who has spent decades studying the circuits behind cognition.

"The circuits that generate higher cognitive function have very special molecular needs because they're having to create neural activity without any sensory stimulation—abstract thoughts and memories, for example," she says. "The neurons have to generate and sustain their own activity." Arnsten says inflammatory factors can interfere with these molecular needs and inhibit the circuits' ability to function. Hence, brain fog.

Guanfacine, one of the two drugs tested in this trial, is designed to strengthen prefrontal cortex connections and protect against inflammation and stress. While originally developed to treat ADHD, it is being used to treat other conditions associated with prefrontal cortex dysfunction, and studies show that the drug is effective in restoring executive functioning and memory. NAC, the second medication, is a robust antioxidant and anti-inflammatory agent that can also be used to treat this neural region.

Fesharaki-Zadeh is a clinical neuroscientist with special interests in traumatic brain injury and PTSD who has been treating his patients successfully with a combination of guanfacine and NAC for years. After encountering his first long COVID patient in June 2020, he became interested in using this regimen to treat the post-COVID brain fog.

"I had the idea of approaching the treatment from two different perspectives—modifying the pro-inflammatory, pro-oxidation pathway with NAC, and treating the post-COVID neurocognitive sequelae impacting executive functioning with guanfacine," he says. "We wanted to attack this using a multi-model approach that took advantage of the synergistic relationship between NAC and guanfacine."

Guanfacine and NAC relieve long COVID brain fog

Faced with his first long COVID case, Fesharaki-Zadeh recognized the overlap between the brain fog his patient was facing and symptoms in his post-concussive patients. So he started with NAC, which is commonly used to treat symptoms following concussions, and noticed partial benefits in energy and memory. Encouraged, he tried adding in guanfacine and saw even more improvement.

Since then, Fesharaki-Zadeh has treated 12 patients experiencing post-COVID brain fog with this regimen. He instructed patients to take 1 mg of guanfacine at bedtime, and if well-tolerated, to increase the dosage to 2 mg after one month. Patients also took 600 mg of NAC once a day.

Eight patients reported substantial benefits, including improved memory, organizational skills, and ability to multi-task. For some, the brain fog completely resolved, and they were able to resume their normal activities. Two patients were unavailable for follow up, and the other two discontinued the medication due to side effects including low blood pressure and dry mouth. Since then, the researchers have modified the regimen from an immediate-release form of guanfacine to an extended-release form, which reduces the risk of side effects.

One patient in the cohort was a nurse who had become so debilitated that she had to significantly reduce her hours at work. Although she found relief with the treatment, she had to briefly stop due to dizzy episodes, and her cognitive deficits returned. When she resumed treatment, her brain fog once again lifted. She has not experienced any dizziness since.

"This was not a placebo-controlled trial, but anecdotes like this make one more confident that the relief is really due to the drug and not the placebo effect," says Arnsten.

"She needed to greatly reduce her working hours at a time when she was needed most," says Fesharaki-Zadeh. "Treating her condition not only helps her, but also all of us."

Hope for long COVID patients and beyond

As one patient after another began reporting relief, Fesharaki-Zadeh grew excited. For most of his patients, this was the first time a treatment was successful in alleviating their brain fog.

"I was just struck by these younger folks who are being devastated by this disease that was continuing to persist," he says. "As a physician, in the beginning, I felt powerless. We feel urgency to get this case report out so that more patients could be treated."

The researchers hope that their case study will lead to the funding of placebo-controlled clinical trials involving a larger cohort of patients undergoing this treatment. But long-haulers who are debilitated by their symptoms need treatment now. Fortunately, the researchers say, they can ask their physicians for a prescription for guanfacine, and NAC is available over the counter.

"If patients have a physician who can read our paper, we're hoping that they can access help right now," says Arnsten.

The researchers also hope that this regimen can be helpful in other groups of patients. long-COVID is not the only post-viral syndrome to cause brain fog—patients with conditions including post-Lyme and myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), for example, can also experience debilitating cognitive deficits.

Indeed, Fesharaki-Zadeh has already seen promising results while treating one post-Lyme patient. Furthermore, the treatment may be beneficial in other inflammatory conditions. He has also seen cognitive benefits in one of his multiple sclerosis (MS) patients who was struggling with cognitive and memory deficits.

"I just feel so grateful for my collaboration with Amy Arnsten and that my understanding of traumatic brain injury could be helpful," says Fesharaki-Zadeh. "Our success was a combination of having the right knowledge at the right place and time while working with the right people."

This article was originally published on MedicalXpress Breaking News-and-Events.


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[missy]

"

The whole world is now living with Covid​

Covid finally cracked China. With that, 2022 became the year Covid won. While most of the world never tried to eliminate the virus, or quickly abandoned any hope of success, a handful of places across Asia and Australia showed it could be done, at least initially. China used strict measures to keep Covid largely at bay even as others like Singapore and New Zealand capitulated months ago to the contagious omicron variant. The last holdout in a world rife with coronavirus, China has now thrown in the towel and is letting it rip through its 1.4 billion people. The government largely dismantled its Covid Zero regime in early December and the virus quickly spread. In Beijing, infections inundated the city of nearly 22 million, leveling households and offices in a matter of days. People lined up at hospitals for seven hours in freezing weather to see a doctor, at-home tests and fever-reducing medicines were sold out, and food delivery took hours – if it arrived at all. Students stopped showing up for online classes as they fell ill, and workers called in sick. A cyclist rides along a near empty road in Beijing. Bloomberg The abrupt about-face in the capital, arguably China’s most protected city, caught everyone by surprise. Though endowed with the best medical resources in the country, hospitals are struggling to handle surging demand. Many doctors and nurses, some suffering from Covid, have been asked to keep working as long as they can. For days after China did away with the majority of its internal curbs, Beijing was almost a ghost town. Its notoriously congested roads were free flowing. Shops and restaurants were mostly empty. People were either nursing Covid or sheltering at home. It’s hard to know how many were infected, as the city’s official tally dried up along with its vast network of testing booths. The scene in Beijing is a disturbing omen for the rest of the country, which has fewer resources to deal with the coming Covid onslaught. Infections are on the rise everywhere, and a massive migration by millions of people for Chinese New Year in late January could turbocharge its spread. While omicron appears to do less harm than some earlier variants, it remains deadly. Independent research groups estimate it will eventually kill 1 million to 2 million people in China, though questions are already rising about the toll. After more than a month of surging cases, fewer than a dozen deaths have been officially reported, defying the experience of other, more highly-vaccinated places. The result is rising suspicion that the true scale of fatalities are being hidden. Police and security guards are stationed outside a Beijing crematoriumreportedly designated to handle Covid fatalities after workers told foreign media that they were overwhelmed with bodies. Funeral parlors in some parts of northern China are running out of refrigerator space for corpses, according to social media posts. The damage will also spread to the economy, slowing the country’s factories and its growth. Political leaders have issued a spate of policy directives for rural areas and small towns to prepare. But after focusing like a laser-beam on preventing Covid for the past three years, it’s unclear if the last-minute cramming will help. China, like the rest of the world, now must contain the damage. — Michelle Fay Cortez "

 

[missy]

"

Uncovering the relationship between fatty liver disease and COVID-19
Updated December 20, 2022 | Originally published on MedicalXpress Breaking News-and-Events


Dr. Jawaher Alharthi, from the Westmead Institute and medical research, University of Sydney, Australia, and her colleagues have discovered how COVID-19 increases the risk of fatty liver disease and how the latter is increasing the severity of COVID-19, aiding the development of potential treatments for these patients.

Metabolic dysfunction associated fatty liver disease (MAFLD) affects one-in-four adults and nearly one-in-10 children worldwide. Globally, MAFLD is the most frequent kind of chronic liver disease.

Liver disease is a silent killer. Most people don't know they have a liver problem until it's advanced and they develop liver scarring, liver cirrhosis and, in severe cases, liver failure and deadly cancer. Its complications, however, are not limited to liver disease. It is strongly associated with several other cardiometabolic diseases such as Type 2 diabetes and cardiovascular diseases.

In response to COVID-19, the host (humans) mounts an immune response whose delicate balance determines the course of illness.

Severe COVID-19 is associated with exacerbated immune and hyperinflammatory responses and inflammatory macrophages can induce a cytokine storm leading to tissue damage.

A new study by researchers at the Westmead institute for medical research, University of Sydney, have discovered how COVID-19 increases the risk of fatty liver disease and how is the latter increasing the severity of COVID-19, aiding the development of potential treatments for these patients.

Dr. Jawaher Alharthi, the first author of this work said, "The relationship between fatty liver disease and COVID-19 considered a bit of a mystery, as we do not know how and why both diseases increases the risk of each other. Our research team led by professor Mohammed Eslam conducted a large and detailed genetic and molecular study and identified that gene called MBOAT7 associated with the severity of both MAFLD and COVID-19."

"This gene, plays an important role in the regulation of immune and inflammatory responses upon COVID-19. A disruption in the activity of the MBOAT7 gene could increase the chances of increase cytokines production and tissues damage and liver disease," Dr. Alharthi said.

The epigenome is a set of markers that determines not just gene expression, but genes themselves and influenced by environment, diet, and hormones.

"Interestingly, we also identified that disruption of MBOAT7 may 'preprogram' the cell epigenome and prime it to respond severely to even a weak stimulation upon COVID-19 that ultimately increases tissue damage."

The findings are published in the journal Nature Communications.

This article was originally published on MedicalXpress Breaking News-and-Events.

More Nonalcoholic Fatty Liver Disease (NAFLD) News

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Study: First-degree relatives of patients with NAFLD are at risk of liver disease
Nov 2, 2022
Multiomics study of nonalcoholic fatty liver disease
Oct 25, 2022
New hope for treatment of nonalcoholic fatty liver disease?
Dec 9, 2020

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Real-world data study confirms bivalent mRNA booster vaccines associated with greater short-term protection
Published December 20, 2022 | Originally published on MedicalXpress Breaking News-and-Events

One of the first real-world data studies comparing the new bivalent mRNA COVID-19 booster vaccines with the original monovalent vaccines reports the bivalent conveyed greater short-term protection against symptomatic COVID-19 infection in adults.

The multi-state study from the Centers for Disease Control and Prevention's VISION Network found that the bivalent booster dose provides greater short-term protection against symptomatic COVID-19 infections which generate emergency department and urgent care visits or hospitalization, compared to prior receipt of two, three or even four doses of first-generation vaccines without a bivalent booster vaccine.

How well the bivalent shots protect against COVID-19-associated medical visits had previously been largely unknown.

"This study clearly shows the benefit conveyed by a bivalent booster vaccine—lowering the risk that you will have to go to the E.D. or be hospitalized due to COVID," said study co-author Shaun Grannis, M.D., M.S., vice president for data and analytics at Regenstrief Institute and Regenstrief Professor of Medical Informatics at Indiana University School of Medicine.

The study found that from mid-September to mid-November 2022, adults who had received bivalent COVID-19 booster vaccines made 57 percent fewer COVID-19 related emergency department or urgent care visits compared to adults without prior vaccination and 51 percent fewer visits compared to adults who first had received monovalent vaccines.

Bivalent booster vaccine effectiveness against hospitalization was also significant—61 percent compared to adults without prior vaccination and 44 percent compared to adults who were vaccinated with first generation vaccines.

Among adults who had completed a primary vaccine series or one or more monovalent boosters, greater time since the most recent dose was associated with greater relative protection following the bivalent booster vaccine.

Data from immunocompromised individuals were not included in this study of the effectiveness of bivalent mRNA vaccines.

The authors conclude, "These findings support efforts to improve coverage with bivalent vaccines, although optimal timing for receipt of bivalent vaccine booster doses needs to be established. All eligible persons should stay up to date with recommended COVID-19 vaccination, including receiving a bivalent booster dose. In addition, persons should consider taking other precautions to avoid respiratory illness this winter season, including masking in public indoor spaces, especially in areas where COVID-19 community levels are high, to protect themselves and others and reduce strain on the health care system during an ongoing surge in multiple respiratory viruses."

"Early Estimates of Bivalent mRNA Vaccine Effectiveness in Preventing COVID-19–Associated Emergency Department or Urgent Care Encounters and Hospitalizations Among Immunocompetent Adults—VISION Network, Nine States, September–November 2022," is published in the CDC's Morbidity and Mortality Weekly Report.

This article was originally published on MedicalXpress Breaking News-and-Events.

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Could Vaccines Provide Better Immunity Than COVID Infection?​

F. Perry Wilson, MD, MSCE
December 20, 2022


Welcome to Impact Factor, your weekly dose of commentary on a new medical study. I'm Dr F. Perry Wilson of the Yale School of Medicine.

An interesting paper started making the rounds last week, one with a conclusion that was compelling in its simplicity and appealed to some preexisting beliefs: Vaccination against COVID provides more protection than being infected by COVID.

At first, you hear that and you're like, of course vaccination is better than infection. Infection makes you really sick and can kill you, and vaccination doesn't.

But that's not what the study was saying. It was saying that vaccination was better than infection even among those who recovered from their COVID infection. And that, if true, would be really important, but also really surprising.


What made COVID so dangerous initially was that it was a novel human pathogen — something none of our immune systems had encountered before. There are essentially two ways to educate your immune system about SARS-CoV-2: Get infected by it or expose your immune system to a vaccine. And, pretty clearly, the vaccine is better from a risk-benefit profile.





But what if you've already been infected? What if you, fortunately, made it through that initial infection? Are you as protected as you would have been had you been vaccinated? More protected? There's certainly an argument for the latter. After all, real COVID infections expose your immune systems to way more antigens than the vaccine — and likely in higher doses as well.

But to date we don't have a great head-to-head study on this topic. Until now.

I'm talking about this study "SARS-CoV-2 Infection, Hospitalization, and Death in Vaccinated and Infected Individuals by Age Groups in Indiana, 2021-2022," appearing in the American Journal of Public Health.


Researchers leveraged the fact that Indiana has a remarkably detailed accounting of patients infected with COVID and vaccinated against COVID to create a unique cohort study. Here's how it worked.

They identified people from the state who were infected with COVID and who had not been vaccinated, and people who had been but had never been infected. They then searched for matches between the groups. For each vaccinated person, they found a person who had been infected at around the same time, who had the same age, sex, race, zip code, and number of preexisting conditions. Thirty days after the event, vaccination or infection, the clock started ticking. The idea here is that, by 30 days later, immunity from that exposure has built up.

In total, they were able to create 267,847 matched pairs.


The analysis was fairly straightforward: You have a person who was vaccinated and a similar person who was infected at the same time. What would happen going forward?


The results are pretty interesting.


The vaccinated people were more likely to become infected in the next 6 months than the previously infected people — about two times as likely, actually.

But in terms of the other outcomes — emergency room visits, hospitalizations, and death — the vaccinated people did better.

In other words, given the choice between infection and vaccination, it's pretty clear that you'd choose vaccination.

But let's be a bit careful here. Obviously, people who choose to get vaccinated are different from those who don't, and in ways that aren't captured by matching for age, race, sex, and zip code. People who get vaccinated might be healthier in many other ways; they might have been more careful about masking or washing their hands. The authors argue that this isn't a huge problem. After all, the infection rate was higher in the vaccinated group, but I'm not sure I buy it. Comparing initial infections and recurrent infections is pretty much apples and oranges.

The other question I have is one of biologic plausibility. Sure, vaccination is the safer way to educate your immune system, but assuming you survive your infection, you'd think the overall effects would be pretty similar. Multiple rounds of vaccination may have additive effects, but this analysis was conditioned on the first vaccine dose. One explanation could be that COVID infection hurts you in long-term ways, such that even if you survive the initial infection, your subsequent risk of bad events is higher.

There's a potentially bigger issue with this analysis as well. In the methods section, the authors write, "Matched pairs were censored when an infected participant received a vaccination or a vaccine recipient became infected."

At first, this might make sense. If a previously infected person is vaccinated, we are no longer seeing the "benefit" of prior infection alone. But the problem arises in the opposite case. Censoring a matched pair when the vaccinated member of the pair gets COVID means that you can never observe things like death from COVID in that individual; all events have to happen before infection. I suppose there is an argument that this is fair, since the infected person in the pair, by design, had survived their COVID infection for at least 30 days. But I am concerned that this would bias the results in favor of vaccination.

Of course, even if you believe the analysis, it isn't entirely relevant to the current status of COVID. Few of us are in the position that the study creates, never having been infected and deciding whether to obtain immunity through a vaccine or "naturally." Nowadays, the more relevant clinical question is whether those who have been previously infected, but not yet vaccinated, would do better in the long term if they bit the bullet and got the vaccine. When that study gets published, we'll cover it here.

For Medscape, I'm Perry Wilson.

F. Perry Wilson, MD, MSCE, is an associate professor of medicine and director of Yale's Clinical and Translational Research Accelerator. His science communication work can be found in the Huffington Post, on NPR, and here on Medscape.

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The latest​

1. Health officials are reluctant to bring back mask mandates, despite the rising number of coronavirus infections and other respiratory infections, such as flu and RSV.

Masking is one of the top infection-prevention methods, according to the Centers for Disease Control and Prevention, but the politicization of masks has led Americans to the current “to-mask” or “not-to-mask” crossroads.

Washington Post reporters delve into the multifaceted reasonsbehind the apprehension about mandating masks again, finding that some people don’t feel compelled to wear masks without an official mandate. Others believe masking requirements should be implemented as cases begin to rise.

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Are you still masking this winter? Please send me an email if you are, and tell me why or why not.

2. The federal government is increasing the availability of Tamiflu through the Strategic National Stockpile to states and territories requesting the flu medication.

There is no nationwide shortage of the antiviral treatment, but the Biden administration wants to prepare for localized shortages to “address any strain to health care systems created by the confluence of COVID-19, flu, and RSV — including a specific focus on expanding access to medicines under high demand,” according to an HHS news release.

HHS Secretary Xavier Becerra sent a letter to governors this month assuring them that the administration is ready to help their states with resources and supplies.

On Thursday, HHS said it has “been closely tracking the increased demand of certain medicines due in part to multiple illnesses circulating this winter season.”

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The flu season arrived earlier than usual this year. So far, there have been 12,000 deaths from the illness, and about 156 million doses of the flu vaccine have been distributed in the United States, according to the CDC.

Other important news​

Loss of smell was one of the lesser reported side effects of a coronavirus infection when the pandemic started. But as the virus made its way through the population, anosmia — the medical name for the condition — became an ongoing symptom that affected some patients for months even after other, more common symptoms subsided. The cause has puzzled scientists, but a small study offers insight and suggests that damage to the cells in the nasal cavity could be the culprit.

The Centers for Disease Control and Prevention issued an advisoryThursday to doctors and public health officials about an increased risk of invasive group A streptococcal disease (iGAS) in children. “While the overall number of cases has remained relatively low and iGAS infections are rare in children, the CDC said it would be investigating reports of increased cases in states,” Washington Post reporter Adela Suliman writes.

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