Coronavirus Updates January 2023

[missy]

Happy 2023 all!

Pandemic Curbs Linked to Early Start to Europe's Winter Flu Season​

By Natalie Grover

"
LONDON (Reuters) - Pandemic restrictions that hampered the circulation of viruses other than COVID-19 could be behind the unseasonably early upsurge in respiratory infections in Europe this winter that the festive break could prolong, scientists say.
Apart from COVID-19, regulations to curb movement and social interaction limited the transmission of viruses that typically cause most infections during the colder, winter months, including influenza and RSV (respiratory syncytial virus).
That created a bigger pool of susceptible people, including children born during this time, who had less exposure to these viruses.
RSV usually causes mild, cold-like symptoms, but can result in serious illness in older adults and young infants.

This winter, health officials have warned of what has been dubbed a tripledemic of influenza, RSV and continued COVID-19 cases, adding to the pressure on over-burdened health services.




RSV surveillance data from 15 European countries spanning the pre-COVID years 2010-2011 to 2015-2016 show the median start to the RSV season is early December, and that it peaks around the end of January, the ECDC (European Centre for Disease Prevention and Control) highlighted in a report published this month.
European trends so far suggest that this year RSV cases peaked in late November and are in decline, but there will still be a substantial number of cases in the next four to six weeks, said Agoritsa Baka, the ECDC's expert in emergency preparedness and response.
In Wales, for instance, there were 111.6 confirmed RSV cases per 100,000 in children aged under five in the week ending Nov. 27.

For the 2018-2019 and 2019-2020 season, confirmed cases under the same parameters were below 50. In both those years, even the eventual peaks, which came a few weeks later, were just short of 50.
Meanwhile, COVID cases have risen in recent weeks. In the week ended Dec 18, European cases rose 7% over the week prior, according to ECDC figures.
The flu upsurge began in the second week of November in the European region, an earlier start than the four previous seasons, the agency said.

"The accumulation of more susceptible persons in the last two years, plus the increased mixing of people during the summer months (following the easing of restrictions) have contributed to an earlier start of the outbreaks in the current season 2022-2023," Baka said.

"We do not have any direct reference for this statement," she said, but cited a study published by the U.S. Centers for Disease Control and Prevention that linked sharp declines in influenza circulation in the 2020-2021 season to COVID-19 restrictions in the northern and southern hemispheres.

Peter Openshaw, a respiratory physician and professor at Imperial College London, said it was plausible that limited social mixing in recent years had contributed to a "downward drift" in specific immunity to these viruses at a population level, alongside a decline in general immunological responsiveness in people.

UNKNOWN TERRITORY

With little in the way of direct comparison with the situation this year, it is unclear whether sharp peaks earlier than usual will necessarily lead to a higher total number of cases over the season, compared to pre-pandemic years.




But scientists are concerned that social interaction during the festive season could lead to further increases in respiratory infections, especially as people meet vulnerable elderly relatives.

"If you're sick - don't go to a party. Get tested before you go visit your grandmother. And it would be prudent to wear a mask in crowded places particularly in public transport," ECDC’s Baka said.

As an added complication, viral respiratory infections can predispose patients to bacterial infections, just when some common antibiotics that can treat them are in short supply in Europe.

This has been linked to increased demand given an uptick in severe infections caused by a bacteria called group A Streptococcus, particularly in children under the age of ten.

Supply hiccups attributed to long-standing pricing pressure on the manufacture of generic medicines in the continent that has worsened with the energy crisis have added to the shortage.

(Reporting by Natalie Grover in London; Editing by Matt Scuffham and Barbara Lewis)

"

 

[missy]

"
Scientists find key reason why loss of smell occurs in long COVID-19
Originally published on MedicalXpress Breaking News-and-Events

The reason some people fail to recover their sense of smell after COVID-19 is linked to an ongoing immune assault on olfactory nerve cells and an associated decline in the number of those cells, a team of scientists led by Duke Health report.

The finding, publishing online Dec. 21 in the journal Science Translational Medicine, provides an important insight into a vexing problem that has plagued millions who have not fully recovered their sense of smell after COVID-19.

While focusing on the loss smell, the finding also sheds light on the possible underlying causes of other long COVID-19 symptoms—including generalized fatigue, shortness of breath, and brain fog—that might be triggered by similar biological mechanisms.

"One of the first symptoms that has typically been associated with COVID-19 infection is loss of smell," said senior author Bradley Goldstein, M.D., Ph.D., associate professor in Duke's Department of Head and Neck Surgery and Communication Sciencesand the Department of Neurobiology.

"Fortunately, many people who have an altered sense of smell during the acute phase of viral infection will recover smell within the next one to two weeks, but some do not," Goldstein said. "We need to better understand why this subset of people will go on to have persistent smell loss for months to years after being infected with SARS-CoV2."

In the study, Goldstein and colleagues at Duke, Harvard and the University of California-San Diego analyzed olfactory epithelial samples collected from 24 biopsies, including nine patients suffering from long-term smell loss following COVID-19.

This biopsy-based approach—using sophisticated single-cell analyses in collaboration with Sandeep Datta, M.D., Ph.D., at Harvard University—revealed widespread infiltration of T-cells engaged in an inflammatory response in the olfactory epithelium, the tissue in the nose where smell nerve cells are located. This unique inflammation process persisted despite the absence of detectable SARS-CoV-2 levels.

Additionally, the number of olfactory sensory neurons were diminished, possibly due to damage of the delicate tissue from the ongoing inflammation.

"The findings are striking," Goldstein said. "It's almost resembling a sort of autoimmune-like process in the nose."

Goldstein said learning what sites are damaged and what cell types are involved is a key step toward beginning to design treatments. He said the researchers were encouraged that neurons appeared to maintain some ability to repair even after the long-term immune onslaught.

"We are hopeful that modulating the abnormal immune response or repair processes within the nose of these patients could help to at least partially restore a sense of smell," Goldstein said, noting this work is currently underway in his lab.

He said the findings from this study could also inform additional research into other long-COVID-19 symptoms that might be undergoing similar inflammatory processes.

In addition to Goldstein and Datta, study authors include John B. Finlay, David H. Brann, Ralph Abi-Hachem, David W. Jang, Allison D. Oliva, Tiffany Ko, Rupali Gupta, Sebastian A. Wellford, E. Ashley Moseman, Sophie S. Jang, Carol H. Yan, Hiroaki Matusnami, and Tatsuya Tsukahara.

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

"

 

[missy]

"
First results on the longer-term effects of therapies for the treatment of critically ill patients with COVID-19
Originally published on MedicalXpress Breaking News-and-Events

The world's largest trial into the effect of multiple interventions for critically ill adults with COVID-19 on longer-term outcomes has released results from the 180-day (six month) follow-up of 4,869 critically ill patients.

Published today in the Journal of the American Medical Association (JAMA), the study is part of the ongoing Randomized Embedded Multifactorial Adaptive Platform for Community Acquired Pneumonia (REMAP-CAP) trial and was led by Monash University's Dr. Lisa Higgins from the School of Public Health and Preventive Medicine.

The study found that among critically ill patients with COVID-19 randomized to receive one or more therapeutic interventions, treatment with an IL-6 receptor antagonist (tocilizumab or sarilumab), led to a greater than 99.9% probability of improved 6-month mortality, while antiplatelet agents had a 95% probability of improving 6-month survival.

Moreover, the study also showed that treatments which improve survival, such as interleukin-6 receptor antagonists, do not come at the expense of survival with increased disability or poorer health-related quality of life.

In contrast, longer-term outcomes were not improved with therapeutic anticoagulation, convalescent plasma, or lopinavir-ritonavir, and were worsened with hydroxychloroquine alone or in combination with lopinavir-ritonavir. Corticosteroids did not confer a high probability of improved longer-term survival, although enrolment into this domain was closed early in response to external evidence.

"While we have been treating critically ill patients with COVID-19 for nearly three years, we are still very much in the early stages of understanding the long-term survival, health-related quality of life, and disability among patients with critical illness due to COVID-19," said Dr. Higgins.

"These findings have important clinical and research implications in COVID-19, and in critical care more generally, because they provide evidence that short-term within-hospital treatment effects are sustained longer-term."

The 4,869 critically ill adult patients with COVID-19 were enrolled into the trial between March 9, 2020, and June 22, 2021, from 197 sites in 14 countries. The final 180-day follow-up was completed on March 2, 2022.

As an adaptive platform trial, REMAP CAP continues to evaluate new interventions for the treatment of both COVID-19 and other non-COVID 19 respiratory tract infections.

REMAP-CAP is an Australian-led global adaptive trial investigating multiple treatments for COVID-19 among patients in Intensive Care Units (ICUs). Run by Monash University's Australian and New Zealand Intensive Care Research Centre, the trial mobilized to evaluate specific treatments for COVID-19 patients in ICUs in early March 2020.

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

:

 

[missy]

"

Triple-demic State of Affairs: Jan 5​

KATELYN JETELINA January 5, 2023

Happy New Year! I hope you had a restful holiday. Here is the latest on COVID-19, flu, and RSV in the U.S.

Overall respiratory health​

It’s still looking rough out there. High numbers of influenza-like illnesses (ILI)—fever, cough and/or sore throat reported at doctors’ offices—are peppered across the U.S.

Respiratory illness season was early and has already reached a high compared to the last decade, but it’s on the descent. It’s too early to celebrate, though, as we may see multiple wave humps as we did in the pre-pandemic years.

​

(Source: CDC)
If we zoom into specific viruses, we see different stories.

RSV​

RSV is nosediving, a welcome development for older adults, parents of kids under 5, and pediatric hospitals.

​

U.S. RSV positivity rates and cases (Source: CDC)
In mid-November 2022, at the peak of RSV, hospitalizations blew pre-pandemic years out of the water. This was mainly driven by admissions among kids under 5 years old, which reached an all time high rate of 70 kids hospitalized per 100,000 infections. (Historically, peaks range from 26-52 kids hospitalized per 100,000 infections).

​

(Source: CDC RSV-NET)

Flu​

Flu continues to follow RSV and is also trending downwards, but certainly not as quickly. All metrics—test positivity rate, positives in nursing homes, hospitalization—are showing reprieve.

As far as cumulative severity, the Northern Hemisphere is largely reflecting patterns of the Southern Hemisphere last summer—flu is back, but not particularly severe. Flu hospitalizations are on track for a mediocre season compared to, for example, the severe 2017-2018 flu season.

​

This doesn’t mean there isn’t any suffering, though. We have already lost 13,000 Americans to the flu—61 of those were children.

Will flu continue to decline? Not necessarily. Countries in the Southern Hemisphere, like South Africa, saw two waves of flu: the first driven by one strain—called influenza A—and the second driven by another strain—influenza B. Currently, influenza A is driving U.S. cases, which means that we, too, may have another wave.

​

South Africa flu specimens, 2022

COVID-19​

Then there’s COVID, the only one of these three viruses trending upwards right now.

I’ll start with the good news: we got through 2022—one full year—without a new variant of concern. In other words, Omicron continued to mutate without a variant coming out from left field. As I’ve written before, this is a welcome development.

The bad news: Omicron subvariants continue to do plenty of damage on their own. This is especially the case when coupled with the holidays (i.e.changing behaviors and social networks) and cooler weather.

Currently the viral culprit is XBB.1.5., which has caught the attention of many. In fact, the WHO is currently conducting a risk assessment, which should be out in a few days.

XBB.1.5 continues to have a viral advantage in the U.S. as it started in the Northeast and is now quickly bleeding into the South and will soon dominate in the Midwest and West. A great visualization below displays the projected spread. A peak is expected in February.





How big or severe will the wave be? It’s hard to predict given such a complex immunity wall in the U.S. and limited knowledge of XBB.1.5, including the inability to rely on trends from other countries, as this is a homegrown problem. (Singapore had a XBB wave, but XBB.1.5. is a 3-generation difference. Also, Singapore has a highly boosted population.)

Regardless, we are already in a wave. For really the first time, reported case numbers have completely decoupled from wastewater, so we can’t rely on this anymore. Wastewater is clearly on the rise.

​

SARS-CoV-2 National Wastewater Trends, over time. Dark blue= wastewater; Light blue/green= Reported cases (Source: Biobot Analytics)
Unfortunately, hospitalizations are increasing too. In the Northeast, hospitalizations among those over 70 years old are reaching very uncomfortable levels. They aren’t close to last winter, yet, but let’s please not make last winter’s disaster our standard of health.

​

Daily new hospital admissions by age in New York. Source: NYT
It’s important to note two positive things regarding severe disease:

1. Hospitalizations are very different today than they used to be. Indicators of severe hospitalization, like ICU use and proportions of dexamethasone administered— the standard of care for COVID-19 pneumonia—are not increasing. This is a good sign that the severity of Omicron with XBB.1.5 mutations may not have changed, but we don’t have hard evidence of this yet.

​

New York Hospitalizations. Source: NYT

1. Vaccines work. People vaccinated with the fall booster have an 18.6 times lower risk of dying from COVID-19 than unvaccinated people right now. The risk of infection is also three times lower. This is even the case for people with weaker immune systems, like those over 80 years old.

​

(CDC)
One of the biggest problems with the newer subvariants is that monoclonal antibodies, including Evusheild, do not work. (Paxlovid still works.) This means that part of the safety net we had for the vulnerable is missing, which is a massive problem. Unfortunately, it looks like this will take months to fix.

Bottom line​

RSV and flu trends are showing welcoming signs, but COVID-19 is now taking over. The impact of XBB.1.5 and the height of the COVID-19 winter wave is unknown, but the vulnerable are already in a tough spot.

There are a lot of sick people out there and still plenty of winter season left. Stay healthy... You know what to do.



"

 

[missy]

"

The latest​ Children who have experienced a rare condition called multisystem inflammatory syndrome (MIS-C) following a coronavirus infection are no more prone to complications from the coronavirus vaccine than other children. A study released this week showed the most common vaccine-related side effects were arm soreness and fatigue in children who were at least 5 years old and had experienced MIS-C. The study’s lead author, Matthew D. Elias, a cardiologist at Children’s Hospital of Philadelphia, said he hopes the research proves reassuring to families with a history of MIS-C — especially those who remain undecided about getting their children vaccinated. ​ ​ ​ ​ “I hope the study has an impact,” Elias told The Washington Post in an interview. “It's always disheartening to see the numbers that show so few children have been vaccinated.” Global demand for coronavirus vaccines has slowed, with steep declines even among nations that have low vaccinations rates. According to Post reporter Adam Taylor, the dismal numbers worry health experts because of the increased risk of new variants emerging in under-vaccinated populations. Pandemic fatigue is among the major culprits fueling the global decline. Covax, a vaccine-sharing initiative backed in part by the World Health Organization, “expects to deliver about 400 million doses around the world in 2023 — less than half of the billion or so annual deliveries it made, mainly to lower-income countries, in 2021 and 2022,” Taylor writes. Other important news:​ Monoclonal antibody drugs could be used to prevent infectious diseases, but the price of these drugs needs to decrease. “The coronavirus pandemic showcased the largely untapped potential for monoclonal antibodies to be leveled against more-commonplace threats such as infectious diseases — if the impetus and money exist,” Washington Post reporter Carolyn Y. Johnson writes. ​ ​ ​ ​ After the winter break, Boston public schools asked students to adopt “temporary masking” from Jan. 4 through Jan. 13. The schools note this is not a mandate and that “no one will be disciplined or sent home if they refuse to wear a mask.” ​ ​

​

Guide to the pandemic​ Track confirmed cases, hospitalizations and deaths in the U.S. and the spread around the world. U.S. vaccine distribution and delivery, tracked by state. ​

"

 

[dk168]

My usual contact at the bench I use in China had Covid recently, allegedly many people went down with it since the country lifted its zero tolerance stance.

Luckily his symptoms were mild and he had recovered from it - he is in his late 20s and in good health.

DK

 

[missy]

"

COVID-19 Research Round-up​

KATELYN JETELINA JAN 10

There are several new scientific developments regarding COVID-19 that might be useful to you for navigating the pandemic. All stem from different COVID-19 “story threads” that I’ve written before. So, here is a quick round-up.

Moderna is doing better​

What we know: Even though Moderna and Pfizer are both mRNA vaccines, they have distinct micro-differences. The impact of those differences on immune defenses has been up for debate.

New info: Another study confirmed that Moderna induced a better first defense (protection against infection). In addition (and for the first time) we see that it also generated a larger T-cell response (i.e. secondary defense) than Pfizer. This likely impacts downstream outcomes, like duration and strength of protection against severe disease.

Why does this matter? Given this study and previous ones, there should be a preferential recommendation for those over age 50 to get Moderna over Pfizer. This is particularly important for older adults, as they have weaker immune systems.

Reinfections and implications for COVID-19 future​

What we know: We have 30+ studies showing that hybrid immunity (vaccination + infection) is strong. However, we don’t know how durable the protection is as Omicron continues to mutate.

New info: A Lancet study assessed the probability of a BA.5 infection (U.S. “summer wave”) after a BA.1 infection (last U.S. “winter” wave). Hybrid immunity was stable up to 35 weeks (8 months). This doesn’t mean reinfections sooner aren’t possible. But, on average, there is a significant pattern.

Why does this matter? The “time” populations are susceptible to COVID-19 will determine the frequency and height of future waves in our “new normal.” This gives hope we’ll eventually see seasonal COVID-19 patterns, like we see with other coronaviruses. This may take a decade, but reprieve is eventually coming.

​

(Bloom Lab)

Vaccines and infections (still) reduce transmission​

What we know: Before Omicron we knew that vaccines reduced transmission. Mis/dis-information has sown doubts.

New info: A new study from Nature examined prison systems to assess transmission networks. A COVID-19 vaccine reduced infectiousness by 22% and prior infection reduced infectiousness by 23%. Hybrid immunity reduced infectiousness by 40%. The least infectious cases were those who had been recently vaccinated.

​

Why does this matter? On an individual level, vaccines still help in ways other than preventing severe disease. On a policy level, timed vaccination campaigns for a variant of concern may make sense until seasonal patterns arise.

There’s a lot of airplanes with COVID-19​

What we know: Many studies show the possibility of COVID-19 transmission on planes. However, we don’t know how often COVID-19, on average, is present on planes.

New info: A recent analysis found that among wastewater samples taken from 29 flights from June to Deccember 2022, 28 of the planes had COVID-19 samples. Keep in mind this is not necessarily contagious people, but this is still a lot.

Why does it matter? Keep wearing a mask while traveling if you don’t want to get sick. Especially during surges.

Mask mandates in schools work​

What we know: Masks work on an individual level, but the effectiveness of population-level mandates is less understood.

New info: A study from the New England Journal of Medicine compared schools in Massachusetts that kept the mask mandate to schools that removed the mask mandate after the statewide policy was rescinded. Schools that lifted masking had an additional 44.9 COVID-19 cases per 1000 students and staff.

Why does this matter? Mask mandates in large settings, like schools, work. This is important to know now or in future pandemics to keep kids in school.

Novavax​

What we know: Novavax looked good in clinical trials, but we haven’t had great evidence on how well it works against Omicron subvariants and in the “real world”.

New info: The first real-world effectiveness data of Novavax’s COVID-19 vaccine was released in a preprint. It doesn’t look great. Those with a Novavax primary series and/or booster were more likely to get an infection than those with an mRNA vaccine.

Why does this matter? As I’ve written before, Novavax is a great option against severe disease if someone doesn’t have the vaccine. But it’s not the silver bullet we are looking for.

Long COVID-19 plateauing after 3 shots?​

What we know: Vaccines reduce the odds of long COVID, but we don’t know if the risk continues to decline after each shot.

New info: A JAMA study found that the risk of long COVID decreased with vaccination. But after the third shot, protection against long COVID-19 plateaued. More research is needed, as this is surprising.

Why does this matter? Don’t rely solely on vaccines to reduce your changes of long COVID. It helps, but after a while, not by much.

Bottom line​

We are still learning how to live with COVID-19 every day. Yes, science can still help us make better and informed decisions.

You’re now caught up.


"

 

[missy]

"

New Omicron Subvariant Is 'Crazy Infectious,' COVID Expert Warns​

Ralph Ellis
January 10, 2023
The newest subvariant of Omicron, XBB.1.5, is so transmissible that everybody is at risk of catching it, even if they've already been infected and are fully vaccinated, a health expert told USA Today .
"It's crazy infectious," said Paula Cannon, PhD., a virologist at the University of Southern California. "All the things that have protected you for the past couple of years, I don't think are going to protect you against this new crop of variants."
XBB.1.5 is spreading quickly in the United States. It accounted for 27.6% of cases in the country last week, up from about 1% of cases at one point in December, according to the U.S. Centers for Disease Control and Prevention. It's especially prevalent in the Northeast, now accounting for more than 70% of the cases in that region.

It's spreading across the globe, too. Maria Van Kerkhove, PhD., technical lead of the World Health Organization, has called XBB.1.5 is "the most transmissible subvariant that has been detected yet."




Ashish Jha, MD, the White House COVID-19 response coordinator, tweeted a few days ago that the spread of XBB.1.5 is "stunning" but cautioned that it's unclear if the symptoms of infection will be more severe than for previous variants.
"Whether we'll have an XBB.1.5 wave (and if yes, how big) will depend on many factors including immunity of the population, people's actions, etc.," he tweeted.
He urged people to get up to date on their boosters, wear a snug-fitting mask, and avoid crowded indoor spaces. He noted that people who haven't been infected recently or haven't gotten the bivalent booster likely have little protection against infection.

The symptoms for XBB.1.5 appear to be the same as for other versions of COVID-19. However, it's less common for people infected with XBB.1.5 to report losing their sense of taste and smell, USA Today reported.

Sources​

USA Today: "People who haven't had COVID will likely catch XBB.1.5 – and many will get reinfected, experts say"
CDC: COVID Data Tracker

"

 

[missy]

"

COVID-19 vaccines and sudden deaths: Separating fact from fiction​

KATELYN JETELINA AND KRISTEN PANTHAGANI, MD, PHD JAN 17

​ ​ ​ SAVE​ ▷ LISTEN​

Vaccine rumors continue to swirl, and distrust in vaccines remains. The latest onslaught comes from blogs and social media around heart problems and sudden deaths following COVID-19 vaccination, particularly among young adults.
This rumor has been a constant theme since vaccine roll-out, but has recently bubbled to the surface due to a constellation of events: external medical review in Florida on vaccines, videos released (called Died Suddenly), the death of a young prominent soccer reporter, the NFL cardiac arrest incident, the death of Lisa Marie Presley. In fact, every week “sudden deaths” that aren’t remotely related to vaccines go viral.
To be very clear: We have more evidence than for any other vaccine or disease in the history of humans that the benefits of COVID-19 vaccines greatly outweigh the risks.
I partnered with Dr. Kristen Panthagani, physician-scientist and author of You Can Know Things, to tackle this topic. This post is long, but we hope it’s a comprehensive, one stop shop to address the majority of rumors spreading now and in the future.
Here we go.

Deaths by vaccination status: It’s not even close​

Underlying all these rumors is the belief that COVID-19 vaccines are seriously harmful, with some postulating that they are intended to depopulate the planet. If this fanciful rumor had any merit, we would expect those who are vaccinated for COVID to be more likely to die than those who are unvaccinated.
In fact, we see the opposite. The U.K. Health Security Agency recently released data evaluating all deaths (COVID-19, car accidents, strokes, etc.) in the U.K. by vaccination status, after adjusting for age. This is powerful data because it allows us to remove noise from the debate—it doesn’t matter if the death was “with” or “from” COVID or how the person died.
Below is the data visually displayed. And, the story is clear: vaccines save lives. (The impact has changed over time thanks to survivor bias, an increase in vaccination rates, and infection-induced immunity.)

​

What about excess deaths among young adults?​

One of the first rumors that gained a foothold was from an observation by insurance companies: in the third quarter of 2021, deaths increased by 40% in working-aged individuals. Some latched onto this information as evidence that COVID-19 vaccines, which were rolled out earlier that year, were the cause of increased deaths.
This assumption leaves out one key detail — a pandemic. The Delta variant slammed the U.S. during the third quarter of 2021, killing people of all ages.
A new study assessed patterns of excess deaths and COVID-19 specific deaths across time, by state, region, and age. Scientists found that excess deaths increased starting in spring 2020 at the beginning of the pandemic, well before vaccines were introduced into the population. Furthermore, excess deaths tightly mirror COVID deaths, even for working-age adults.

​

(If you’re wondering why there’s a gap between COVID deaths and excess deaths — according to the study’s lead author, Dr. Jeremy Faust, it’s likely “a combination of non-medical deaths like accidental overdose and also, we strongly believe, things like heart attacks that were actually instigated by COVID.”)
The tight link between COVID and excess deaths was seen even in Florida (see red arrow below), which has recently stopped recommending mRNA vaccines for men aged 18-39 based on a deeply flawed analysis.

​

We can also look at specific deaths, like those classified under “diseases of the circulatory system”— which includes things like heart attacks and blood clots in the lung. Circulatory system deaths in 18-39 year-olds were decreasing before the pandemic, but then spiked sharply during the pre-vaccination period. Vaccination roll-outs correlated with a stunning reversal of this trend, as seen in the graph below.

​

Original graph from JM Pienaar here; Annotations by us.

What about young athletes?​

Then there was the tragic injury in the NFL—Hamlin’s heart stopped after a hit to the chest. Within minutes, rumors flooded
an information void to make the conversation about vaccines and death.

In particular, one incorrect statistic was quickly circulated on social media: more athletes died in the last year than have died in the last 38 years.

Where did this statistic come from? After digging, it surfaced that this came from a published letter by Peter McCullough in which he compared sudden cardiac deaths (SCD) in athletes from two data sets from two time periods. This study design can work in epidemiology; however, it has to be done very carefully to make sure we compare apples to apples. McCullough did not do it carefully and compared oranges to apples: compared young vs. old, compared different definitions of SCD, included people who didn’t even die from SCD in the first place, included some people who weren’t athletes, and included some people who didn’t even die.

It was a mess of an analysis. But that didn’t matter because the seed was sown. The rumor filled an information void, and it went viral.

What about blood clots?​

Then there is the Died Suddenly video. This video flashes through dozens of upsetting news headlines and videos of people collapsing to paint an alarming picture of deaths after the COVID-19 vaccine.

We could write a whole post refuting this video (you can read this one). But a few quick things to take away:

• If you simply Google the sudden death headlines in the video, it’s clear they weren’t from the vaccine. One person died in a car accident. Another died before the COVID-19 vaccines were even available. Another collapsed during a basketball game (before COVID-19 vaccines), but never died.
• The video ultimately alleged mRNA vaccines are killing people via blood clots. As “evidence” it showed images of blood clots being removed from the blood vessels of cadavers. However, it fails to mention that it is totally normal for blood to clot after death.
• The video also showed images of a huge blood clot being surgically removed from a vessel in the lung (a pulmonary embolism), suggesting this clot was caused by a vaccine. However, the footage they used was stolen from a 2019 medical education video—showing not only that this clot was not caused by a COVID vaccine (COVID vaccines didn’t exist in 2019), but also that major blood clots, even in young people, are a well known phenomenon that pre-dated COVID vaccination.

What about all the personal stories of death after vaccination?​

If you have spent much time on the internet, you’ve likely encountered stories of people saying a loved one died or was injured from the vaccine – their father got vaccinated and had a heart attack just a few days later.

As humans, we are wired to find cause and effect in our lived experiences, and the occurrence of a serious health event within days of vaccination appears to be fool-proof evidence of the negative effects of vaccination to many. But as painful as these stories are to hear, and even more so to experience, the reality is even if everyone had gotten a placebo, these stories are statistically bound to happen. Even if everyone had gotten a placebo shot, there still would be deaths after the shot. In order for there to be no deaths after vaccination, that vaccine would have to not only be safe, but actually prevent all deaths, from every cause.

To understand why, here’s a brief explanation of the post hoc fallacy and why it confuses many when it comes to vaccines:

What about the VAERS data rumors?​

Then there are rumors of a possible cover-up after a FOIA (Freedom of Information Act) request from CDC’s VAERS database erroneously claimed clear safety signals for death after vaccinations.

In addition to the important nuances outlined in the video above, it’s important to take VAERS with a grain of salt. VAERS is a type of surveillance called “passive.” It’s run on an honor system that is dependent on people providing accurate data, which people knowingly (or unknowingly) don’t do. Because of this, the CDC has several disclaimers plastered throughout their site: “The reports may contain information that is incomplete, inaccurate, coincidental, or unverifiable.”

VAERS is imperfect, so we also have “active” vaccine safety surveillance called V-Safe. VAERS coupled with V-safe is incredibly powerful. Monitoring systems aren’t perfect, but they are pretty darn good. In fact, they were able to find some rare, but serious, side effects quickly during the vaccine roll-out.

What are the (validated) serious side effects from the COVID-19 vaccines?​

When doctors say the COVID vaccines are “safe,” they don’t mean the risk of side effects is zero (no medical intervention can meet that standard)—they mean the risks of serious side effects are extremely small, and the benefits of the vaccine outweigh those risks.

There are true safety signals that have been legitimately linked to COVID-19 vaccines:

• Serious allergic reactions (called anaphylaxis) occurred in 5 out of 1 million vaccine doses. This is readily treatable, but can be life-threatening if not immediately treated.
• The J&J vaccine (not an mRNA vaccine) was linked with a 4 in 1 million chance of a specific type of serious, sometimes fatal blood clot (thrombosis with thrombocytopenia syndrome). The J&J vaccine was also associated with a small elevation in risk of Guillain-Barre syndrome, a rare autoimmune disease that can occur after both infections and vaccination.
  • Because of these rare risks that are specific to the J&J vaccine, mRNA vaccines are now recommendedinstead of the J&J vaccine.
• Myocarditis (inflammation of the heart) among young males has been linked to the vaccine. About 100 in 1 million doses result in it, particularly after the second shot. Vaccine-induced myocarditis is less severe than myocarditis from the virus itself, which is helpful context.
• Last week, the FDA and CDC announced they are investigating a possible (but not confirmed) link between the Pfizer bivalent booster vaccine and increased risk of stroke in people older than 65 based on results from one of the surveillance databases. So far, at least four other sources of data have shown no link.

Not all of these vaccine-induced events were linked to death, but some were after intense investigations. For example, nine deaths have been causally linked to the clot complications from the J&J vaccine. In 2021, one study reported eight deaths from vaccine-induced myocarditis.

Weigh risk of vaccines with risk of infection​

No one denies COVID-19 vaccines can have rare but severe effects. The question is how severe they are and how often they occur compared to infection.

COVID-19 vaccines have always been safer than infection. One study compared the immediate risks of a COVID-19 vaccine to an infection. With the exception of swollen lymph nodes, infections were far more predictive of heart arrhythmias, heart attacks, myocarditis, and blood clots.

​

Absolute Excess Risk of Various Adverse Events after Vaccination or SARS-CoV-2 Infection. From Barda et al., 2021. New England Journal of Medicine. Source here.
The impact of COVID-19 infection on long-term problems is being uncovered more and more. Unfortunately, we are at the mercy of time for this to play out. But there are already several studies with concerning findings:

• A study in Italy and Spain found excess all-cause mortality related to cardiovascular complications in patients after COVID-19 infection.
• A study in the Lancet found that people infected with SARS-CoV-2 had 3 times the risk of dying over the following year compared with those who remained uninfected. For those aged 60+ years, increased mortality persisted until the end of the first year after infection. It was related to increased risk for heart and/or respiratory causes of death.
• A report from Singapore also found an increase in excess mortality after infection (people with no recent infections had no additional excess deaths). However, it was not linked to cardiovascular events.

Across the globe, COVID-19 vaccines saved more than 20 million lives in the first year.​

​

Figure from Watson et al., (2022) Global impact of the first year of COVID-19 vaccination: a mathematical modelling study. Source here.
In the United States specifically, COVID-19 vaccines prevented 18.5 million additional hospitalizations and 3.2 million additional deaths.

Bottom line​

Safety in vaccines is incredibly important to monitor. Unfortunately, no vaccine is risk free. There are rare vaccine tragedies, and they need to be taken seriously. But do not confound these rare tragedies with thinking they are common occurrences. And certainly don’t forget that COVID-19 vaccines saved millions of lives across the globe and will continue to do so.

"

 

[missy]

"
Research review suggests long COVID may last indefinitely for some people and mimic other ailments
Published January 17, 2023 | Originally published on MedicalXpress Breaking News-and-Events

A small team of researchers, two from the Patient-Led Research Collaborative, the other two from the Scripps Research Translational Institute, has published a Review article in the journal Nature Reviews Microbiology suggesting that long COVID might be a bigger threat than has been realized.

Prior research has shown that some people infected with the SARS-CoV-2 virus develop symptoms beyond the respiratory system. Patients have reported feeling deep fatigue, irregular heartbeat, numbness in extremities and even trouble with organs such as their liver or bladder. Over time, these patients have been diagnosed with long COVID, a mysterious condition without an official diagnostic description.

And while a lot of research has been conducted regarding the respiratory system, including treatments and therapies, and in creating vaccines, little has been done to solve the mystery of long COVID or to treat those who claim to have it. In this new effort, the researchers took a hard look at research by a variety of groups.

The authors on this new effort found evidence in prior reports suggesting that approximately 10% of people infected with COVID-19 develop long COVID and that it is most prevalent in people between the ages of 36 and 50. They also found that people who have mild cases of long COVID will likely recover from it within a year. Unfortunately, for those with more severe symptoms, the outlook is grim. They found few signs that symptoms will ever lessen.

They also found that in many cases, the symptoms of long COVID become nearly indistinguishable from several other conditions, such as chronic fatigue syndrome, mast cell activation syndrome and postural orthostatic tachycardia syndrome. Notably, they point, out, many such symptoms are consistent with autonomic dysfunction.

As one example of the difficulties facing both patients and doctors, the authors found many instances of patients suffering from long COVID who had symptoms identical to postural orthostatic tachycardia syndrome. The findings suggest that these patients will live with their symptoms for the rest of their lives. They conclude by noting that women appear to be more at risk of developing persistent long COVID and face more skepticism from physicians.

© 2023 Science X Network

—Bob Yirka , Medical Xpress

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

"

 

[missy]

"

Is It Time for Yet Another COVID Booster? It's Complicated​

Kathleen Doheny
January 18, 2023

On Twitter, as in real life, it's a question on many minds: When should we think about the next COVID-19 vaccine? Or should we?

For some people who have received a two-dose primary series and all the recommended boosters, that could mean a sixth shot since COVID-19 vaccines became available. But is even that enough (or too much)?

At this point, no one knows for sure, but new guidance may be on the docket.


On Jan. 26, the FDA's Vaccines and Related Biological Products Advisory Committee is meeting. On the agenda is discussion about plans for future vaccinations for COVID-19.The committee, made up of external advisers, evaluates data on vaccines and other products for the agency.




According to the FDA announcement, after the meeting, "the FDA will consider whether to recommend adjustments to the current authorizations and approvals, and the FDA will consider the most efficient and transparent process to use for selection of strains for inclusion in the primary and booster vaccines."

From there, the CDC will take up the issue and decide on recommendations.

The issue is important, as more than 550 Americans a day are still dying from COVID-19, as of the week ending Jan. 13, the CDC reported. That's up from 346 a day for the week ending Dec. 28.


Yet, uptake of the newest vaccine, the bivalent booster, has been slow. As of Jan 11, just 15.9% of the population 5 years and up has gotten it; for those most vulnerable to COVID19 – those 65 and up – the number is just 39%.

COVID Vaccines, 2023 and Beyond​

Meanwhile, infectious disease experts have widely differing views on what the vaccination landscape of 2023 and beyond should look like. Among the areas of disagreement are how effective the bivalent vaccine is, which people most need another shot, and what type of vaccine is best.

Dr Peter Hotez
"I think we probably will need another booster," say
s Peter Hotez, MD, PhD, dean of the National School of Tropical Medicine at Baylor College of Medicine, and co-director of the Center for Vaccine Development at Texas Children's Hospital in Houston. "The question is, what is it going to be? Is it going to be the same bivalent that we just got, or will it be a new bivalent or even a trivalent?"

The trivalent booster, he suggested, might include something more protective against XBB.1.5.
The bivalent booster gives "broadened immunity" that is improved from the original booster shots, says Eric Topol, MD, founder and director of the Scripps Research Translational Institute in La Jolla, CA, and editor-in-chief of Medscape, WebMD's sister site for health professionals.

What I'm asking is, Where is the data that a healthy 12-year-old boy needs a booster to stay out of the hospital?Paul Offit, MD, director of the Vaccine Education Center

In his publication Ground Truths, Topol on Jan. 11 explained how new data caused him to reverse his previously skeptical view of how the FDA authorized the bivalent vaccine in September without data on how it affected humans at the time.

Paul Offit, MD, director of the Vaccine Education Center and a professor of pediatrics at the Children's Hospital of Philadelphia, is a member of the FDA advisory committee for vaccines. He still takes a dimmer view of more bivalent booster vaccines, at least as a blanket recommendation.




While he acknowledges that boosters can help some groups – such as older adults, people with multiple health conditions, and those with compromised immune systems – he opposes a recommendation that's population-wide.


"People who fall into those three groups do benefit," he says, "but the recommendation is everyone over 6 months get the bivalent, and what I'm asking is, 'Where is the data that a healthy 12-year-old boy needs a booster to stay out of the hospital?'"

Evolving Research​

"We are trying to understand how to stay one step ahead rather than several steps behind [the virus]," says Michael Osterholm, PhD, director of the Center for Infectious Disease Research and Policy at the University of Minnesota.

Among the key questions: How well can a vaccine work against a single subvariant, when no one can say for sure what the next predominant subvariant will be?



Much more research has become available recently about the bivalent vaccine and its effectiveness, Osterholm says. "The bivalent vaccine is working as well as we could have expected," he says, especially in high-risk people and in those over age 65. The challenge we have is, what does that mean going forward?"


In his review, Topol concludes: "There is now more than ample, highly consistent evidence via lab studies and clinical outcomes to support the bivalent's benefit over the original booster."


Among other evidence, he looked at eight studies, including four that used a live virus as part of the research. Six of the eight studies showed the bivalent booster is more effective against the BA.5 variant, compared to the original booster shots. Two others showed no real difference.


"The four live virus studies offer consistent evidence of broadened immunity for the BA.5 vaccine that is improved over the original booster shots," Topol wrote. The evidence also found the bivalent antibody response superior against XBB, he wrote.
Topol also cited CDC data that supports the benefits of the bivalent shot on hospitalization in older adults. During November, hospitalization of adults 65 and above was 2.5 times higher for those vaccinated who did not get the booster, compared to those who got the updated bivalent booster.
Boosters do matter, Offit says. "But not for all." In a perspective published Jan. 11 in The New England Journal of Medicine – the same issue that published the two studies finding few differences between the original and bivalent – Offit wrote that boosting is best reserved for vulnerable groups.
Chasing the variants with a bivalent vaccine, he says, "has not panned out. There remains no evidence that a bivalent vaccine is any better than what we had. Please, show me the data that one is better than the other."
Offit believes the goal should not be to prevent all symptomatic infections in healthy, young people by boosting them "with vaccines containing mRNA from strains that might disappear a few months later."




The CDC needs to parse the data by subgroups, Offit says. "The critical question is, 'Who gets hospitalized and who is dying? Who are they?'"
That data should take into account age, ethnicity, vaccine history, and other factors, Offit says, because right now, there is no great data to say, "OK, everyone gets a boost."
Future Vaccine Costs

Another debate – for not only current boosters but future ones, too – centers on cost. Without congressional action to fund more vaccines, vaccine makers have suggested their prices may reach $130 a dose, compared to the average $20-per-dose cost the federal government pays now, according to a Kaiser Family Foundation report.
The government has spent more than $30 billion on COVID-19 vaccines, including the bivalent, to provide them free of charge.
The suggested price increase infuriated many. On Jan. 10, Sen. Bernie Sanders (I-VT), incoming chair of the Senate Committee on Health, Education, Labor and Pensions, sent a letter to Moderna CEO Stéphane Bancel, urging him to reconsider and refrain from any price increase.
"The huge increase in price that you have proposed will have a significantly negative impact on the budgets of Medicaid, Medicare and other government programs that will continue covering the vaccine without cost-sharing for patients."
He pointed out, too, the $19 billion in profits Moderna has made over the past 2 years.
While most people with health insurance would likely still get the vaccines and booster for free, according to the Kaiser analysis, will a higher price discourage people from keeping up with recommended vaccinations, including a possible new booster?
"I think so, yes," Hotez says, noting that vaccine reluctance is high as it is, even with free vaccinations and easy access.
"The government is balking at paying for the boosters," he says. "I think it's very tone deaf from the pharmaceutical companies [to increase the price]. Given all the help they've gotten from the American people, I think they should not be gouging at this point."
He noted that the federal government provided not just money to the companies for the vaccines, but a "glide path" through the FDA for the vaccine approvals.
Are New, Variant-Specific Boosters Coming?
Are Moderna, Pfizer-BioNTech, and others developing more variant-specific vaccines, boosters, or other advances?

Novavax, approved in July 2022 as a primary series and in some cases as a booster, is "also developing an Omicron-containing bivalent vaccine at the direction of public health agencies," says spokesperson Alison Chartan.


Pfizer responded: "When and if we have something to share we will let you know."

Moderna did not respond.

Sources​

Peter Hotez, MD, PhD, dean, National School of Tropical Medicine, Baylor College of Medicine; co-director, Center for Vaccine Development, Texas Children's Hospital, Houston.

Paul Offit, MD, director, Vaccine Education Center and professor of pediatrics, Children's Hospital of Philadelphia.

"

 

[missy]

"
The coming Covid surge

For 1.4 billion Chinese citizens that had the government dictate their movements since the pandemic began, the surge of infections since the end of the Covid Zero policy has forced them to suddenly figure out how to survive on their own. As the Lunar New Year holiday approaches President Xi Jinping asked the public to “make an extra effort to pull through” the virus wave, and state media urged people to “take primary responsibility for their own health.” Rural China is bracing for an onslaught of Covid cases because of the holiday. While China’s propaganda arms have sought to control the narrative by highlighting stories of self-sacrifice, the traumatic experiences risk upending the social contract that underpins the Communist Party’s legitimacy: An acceptance of one-party rule in return for competent governance that keeps people safe and improves their lives. Instead, citizens are now gaining real-world experience in effectively living without the party. — Margaret Sutherlin

"

 

[missy]

"

Real-World Data Support Bivalent COVID-19 Boosters in Older Adults​

— Study from Israel showed high level of protection in people 65 and up​

by Emily Hutto, Associate Video Producer January 19, 2023

Opinion | Real-World Data Support Bivalent COVID-19 Boosters in Older Adults

Study from Israel showed high level of protection in people 65 and up

www.medpagetoday.com

In this video, Jeremy Faust, MD, editor-in-chief of MedPage Today, discusses a new studyopens in a new tab or window from Israel outlining the effectiveness of the bivalent booster in adults ages 65 and up.
The following is a transcript of his remarks:
Hello, I'm Jeremy Faust, medical editor-in-chief of MedPage Today. Thanks for joining us.
Let's talk about the bivalent COVID-19 boosters, which we're just starting to get some readouts in terms of their effectiveness in the real world, because we got to this point pretty much on laboratory data, which is how things went forward with the FDA's authorizationopens in a new tab or window.

Let's start with a clinical study out of Israel, which showed pretty clearly that people who got the bivalent booster had much lower rates of hospitalization than people who didn't. Now, that's not surprising because it wasn't a study of the bivalent booster versus some other kind of booster, like the previous monovalent booster. It was just what we have now, the bivalent booster, which is some Omicron and some Wuhan, against nothing -- against people who didn't get boosted.
And we know for a fact that people who get boosted have a very good short-term response and will mount antibodies and will not get infected, and therefore there will also be fewer other bad outcomes, because if you're not infected, you can't get hospitalized; if you're not infected, you can't die; if you're not infected, you can't get long COVID. So for that short period of time, we know this works -- it works real well.

What caught my eye was that, yet again, we've got a large study that really showed that even in a high-risk group -- this is a group of seniors in Israel -- the rate of hospitalization in general was quite low for both groups. So even though the bivalent booster had a great effectiveness in this very short-term period -- to the tune of an 81% reduction in hospitalizations -- the group that didn't get boosted didn't get hospitalized all that often either. It's really close to one in 2,000 people, which is not a great number overall, but is so much better than we've seen in the past.
So, the Israeli data really helps us understand that for 65-years-olds and over, getting a bivalent booster is going to protect against hospitalization. We don't know how long that's going to last, and that's the key. If it turns out that the bivalent booster ends up having a much longer tail of effectiveness than the monovalent did, that'll be good news, but it'll depend upon what variants are circulating and other factors, but we are watching that.

• 
  
  Emily Hutto is an Associate Video Producer & Editor for MedPage Today. She is based in Manhattan.
  
  "

 

[AprilBaby]

I have not kept up with this thread, has almost everyone here had it by now?

 

[Dee*Jay]

I have not kept up with this thread, has almost everyone here had it by now?

To the best of my knowledge I haven't. I had the antibody test (negative), and then we have been tested every single Monday in the office since then by a firm (Radon, I think) contracted by my office. Nada.

 

[missy]

I have not kept up with this thread, has almost everyone here had it by now?

Not yet. Both my dh and I haven’t and as far as I know neither have my parents

 

[missy]

"
The ‘tripledemic’ is upon us. How can clinicians help?
By Naveed Saleh, MD, MS | Fact-checked by Jessica Wrubel | Published January 19, 2023

https://www.mdlinx.com/article/the-and-8216-tripledemic-and-8217-is-upon-us-how-can-clinicians-help/nXSFhiIaQFEEVInTULDZn?show_order=1&article_type=selected&utm_campaign=daily-alert_all-specialties_230121_malert_a90&tag=Morning&ipost_environment=m3usainc&utm_medium=email&utm_source=iPost&iqs=9z2zh41tas0rmo7jjcshaqpa7ugi59fdmmempuqamj0

The winter of 2023 finds the nation in the grips of a ‘tripledemic’—a combination of respiratory syncytial virus, flu, and COVID-19.

The tripledemic is overwhelming hospital EDs and pediatric ICUs, a situation exacerbated by shortages of key medicines including antibiotics, acetaminophen, and ibuprofen.

Physicians should counsel their patients to mask, vaccinate, and take other precautions to mitigate infection risk.

As if the COVID-19 pandemic wasn’t bad enough, experts say winter 2023 finds us in the midst of a “tripledemic.”

What is a tripledemic? While there’s no evidence-based definition, the current use of this term refers to the simultaneous occurrence of respiratory syncytial virus (RSV), flu, and COVID-19.

Clinicians can help patients face this trio of conditions by encouraging them to mask up, get vaccinated, and take other steps to reduce the risk of infection.

Statistical status quo
The emerging tripledemic is reportedly flooding EDs nationwide, with little hope of a reprieve. And while peer-reviewed studies have yet to emerge, some institutions are doing their own research.

Yale Medicine has been documenting this situation in its medical centers.[1] In early December 2022, researchers there found that RSV cases were starting to drop, while flu and COVID-19 cases spiked up. The flu increase was attributed to a lack of immunity to the virus due to the limited exposure that came with COVID-19 precautions.

In an interview with MDLinx, Scott Roberts, MD, an infectious diseases specialist at Yale Medicine, summed up the trend.

“RSV has had a great impact on our pediatric population,” he said. “We have seen this plateau in our region. Flu is at record levels and rising, which is quite concerning. COVID is still quite prevalent in the community, but this varies region to region.”

“In our hospital, flu admissions have eclipsed COVID cases for the first time. We are seeing record levels of flu and RSV cases at the moment. COVID is still circulating, although at levels much less than last winter.”
— Scott Roberts, MD, Yale Medicine
Predates expected surge
Not only is this surge of RSV, COVID-19, and flu occurring at faster rates, but it’s also hitting the nation before the usual seasonal spike, according to an article published by the Boston University (BU) School of Public Health.[2]

RSV cases are as much as 60% higher than their 2021 peak, and inpatient hospitalizations for flu are at the highest levels they’ve been in the past 10 years.

The silver lining may be that RSV cases could be peaking in some parts of the US, including the South, according to the CDC as reported by The Washington Post.[3] RSV, however, is expected to remain a major threat, because there is no vaccine for this virus.

For the week of December 12, 2022, the CDC posted that although the number of COVID-19 cases was higher than it was in October, it had decreased slightly since then.

Focusing on fallout
This situation presents a novel challenge to healthcare systems. Hospitals are designed to reflect “typical need” plus the potential for surges. With an excess surge such as that caused by the tripledemic, there isn’t enough capacity; both EDs and ICUs are quickly filling.

In addition, there’s been a run on antibiotics, which has depleted supplies. Although some of this increased demand can be attributed to legitimate indications for the drug, cases of overprescription may exist.

There are also shortages of ibuprofen and acetaminophen, which bodes poorly for children with aches and fevers. Canada is experiencing similar issues, according to the BU article.

“The greatest danger is straining the healthcare system to the point where limited resources will lead to lesser care for all of us, including those with and without respiratory viruses.”
— Scott Roberts, MD, Yale Medicine
“If beds are full due to flu or RSV patients, there are no beds for heart failure, surgeries, and other conditions that require care,” Dr. Roberts said.

Carefully counsel patients
Physicians need to be especially vigilant in counseling patients.

“Physicians should encourage patients to take precautions, especially over the next few weeks to months while the diseases are circulating at high levels.”
— Scott Roberts, MD, Yale Medicine
“They should get tested if they have symptoms and seek out treatment if they qualify (for flu and COVID-19),” Dr. Roberts advised.

He also suggested “maximizing protection against RSV, COVID, and flu as best as possible. This includes masking for all of them, being up to date on vaccinations for COVID/flu, rapid testing for COVID before gatherings, and handwashing and disinfecting contaminated surfaces for RSV.”

The CDC has recommended masking once again, as 13.7% of communities are exhibiting “high levels” of the COVID-19 virus, according to a report published by The Hill.[4]

Time to mask up again?
A public health threat like this can surely put a crimp on social gatherings. Nevertheless, Dr. Roberts stated that such activities can still be done—carefully.

He stated that get-togethers “can be done safely, but everyone needs to evaluate their risk tolerance. For example, will vulnerable immunocompromised people be at the gathering? Will it only be young healthy college students?”

Physicians may want to recommend to patients that before going to that big party, they should make sure their vaccinations are current, test for COVID-19, and resume wearing masks as they did during the height of the COVID-19 pandemic.
What this means for you

In a healthcare realm already rocked by the COVID-19 pandemic, “new normals” seem to be the norm. While it’s unclear whether the tripledemic will endure in coming years, physicians should continue to counsel their patients on disease precautions and stress masking and vaccination.
"

 

[missy]

"
Israel says has not found a link between Pfizer COVID shot and stroke
Published January 20, 2023 | Originally published on Health News Online Report

Israel has not identified any evidence linking strokes to an updated coronavirus vaccine made by U.S. drugmaker Pfizer and its German partner BioNTech SE, according to a health ministry official.

On Friday, the U.S. Food and Drug Administration (FDA) and the Centres for Disease Control and Prevention said that a safety monitoring system had flagged that the shot could possibly be linked to a type of brain stroke in older adults, according to preliminary data.

"We have not turned up such a finding, even after we went back and rechecked all our data after the FDA announcement," said Salman Zarka, the head of Israel's coronavirus task force said in a video briefing sent to Reuters on Thursday.

Some 389,648 people in Israel have so far taken the shot, which targets the original strain and its BA.4/BA.5 Omicron subvariant.

On Wednesday, the European Union's drug regulator also said it had found no safety signals in the region related to Pfizer's bivalent shot.

Pfizer and BioNTech said in a statement on Friday that they were aware of limited reports of ischemic strokes in people 65 and older following vaccination with their updated shot.

Pfizer further noted that neither the companies nor the CDC and FDA had observed similar findings across other monitoring systems and said there was no evidence to suggest an association with the use of the companies' COVID-19 vaccines.

(Reporting by Maayan Lubell; Editing by Tomasz Janowski)
"

 

[missy]

"

What Older Americans Need to Know About Taking Paxlovid​

Judith Graham
January 19, 2023



A new coronavirus variant is circulating, the most transmissible one yet. Hospitalizations of infected patients are rising. And older adults represent nearly 90% of U.S. deaths from covid-19 in recent months, the largest portion since the start of the pandemic.
What does that mean for people 65 and older catching covid for the first time or those experiencing a repeat infection?
The message from infectious disease experts and geriatricians is clear: Seek treatment with antiviral therapy, which remains effective against new covid variants.

The therapy of first choice, experts said, is Paxlovid, an antiviral treatment for people with mild to moderate covid at high risk of becoming seriously ill from the virus. All adults 65 and up fall in that category. If people can't tolerate the medication — potential complications with other drugs need to be carefully evaluated by a medical provider — two alternatives are available.


"There's lots of evidence that Paxlovid can reduce the risk of catastrophic events that can follow infection with covid in older individuals," said Dr. Harlan Krumholz, a professor of medicine at Yale University.
Meanwhile, develop a plan for what you'll do if you get covid. Where will you seek care? What if you can't get in quickly to see your doctor, a common problem? You need to act fast since Paxlovid must be started no later than five days after the onset of symptoms. Will you need to adjust your medication regimen to guard against potentially dangerous drug interactions?
"The time to be figuring all this out is before you get covid," said Dr. Allison Weinmann, an infectious-disease expert at Henry Ford Hospital in Detroit.

Being prepared proved essential when I caught covid in mid-December and went to urgent care for a prescription. Because I'm 67, with blood cancer and autoimmune illness, I'm at elevated risk of getting severely ill from the virus. But I take a blood thinner that can have life-threatening interactions with Paxlovid.
Fortunately, the urgent care center could see my electronic medical record, and a physician's note there said it was safe for me to stop the blood thinner and get the treatment. (I'd consulted with my oncologist in advance.) So, I walked away with a Paxlovid prescription, and within a day my headaches and chills had disappeared.

Just before getting covid, I'd read an important study of nearly 45,000 patients 50 and older treated for covid between January and July 2022 at Mass General Brigham, a large Massachusetts health system. Twenty-eight percent of the patients were prescribed Paxlovid, which had received an emergency use authorization for mild to moderate covid from the FDA in December 2021; 72% were not. All were outpatients.

Unlike in other studies, most of the patients in this one had been vaccinated. Still, Paxlovid conferred a notable advantage: Those who took it were 44% less likely to be hospitalized with severe covid-related illnesses or die. Among those who'd gotten fewer than three vaccine doses, those risks were reduced by 81%.

A few months earlier, a study out of Israel had confirmed the efficacy of Paxlovid — the brand name for a combination of nirmatrelvir and ritonavir — in seniors infected with covid's omicron strain, which arose in late 2021. (The original study establishing Paxlovid's effectiveness had been conducted while the delta strain was prevalent and included only unvaccinated patients.) In patients 65 and older, most of whom had been vaccinated or previously had covid, hospitalizations were reduced by 73% and deaths by 79%.

Still, several factors have obstructed Paxlovid's use among older adults, including doctors' concerns about drug interactions and patients' concerns about possible "rebound" infections and side effects.

Dr. Christina Mangurian, vice dean for faculty and academic affairs at the University of California-San Francisco School of Medicine, encountered several of these issues when both her parents caught covid in July, an episode she chronicled in a recent JAMA article.

First, her father, 84, was told in a virtual medical appointment by a doctor he didn't know that he couldn't take Paxlovid because he's on a blood thinner — a decision later reversed by his primary care physician. Then, her mother, 78, was told, in a separate virtual appointment, to take an antibiotic, steroids, and over-the-counter medications instead of Paxlovid. Once again, her primary care doctor intervened and offered a prescription.


In both cases, Mangurian said, the doctors her parents first saw appeared to misunderstand who should get Paxlovid, and under what conditions. "This points to a major deficit in terms of how information about this therapy is being disseminated to front-line medical providers," she told me in a phone conversation.


Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, agrees. "Every day, I hear from people who are misinformed by their physicians or call-in nurse lines. Generally, they're being told you can't get Paxlovid until you're seriously ill — which is just the opposite of what's recommended. Why are we not doing more to educate the medical community?"

The potential for drug interactions with Paxlovid is a significant concern, especially in older patients with multiple medical conditions. More than 120 medications have been flagged for interactions, and each case needs to be evaluated, taking into account an individual's conditions, as well as kidney and liver function.

The good news, experts say, is that most potential interactions can be managed, either by temporarily stopping a medication while taking Paxlovid or reducing the dose.

"It takes a little extra work, but there are resources and systems in place that can help practitioners figure out what they should do," said Brian Isetts, a professor at the University of Minnesota College of Pharmacy.

In nursing homes, patients and families should ask to speak to consultant pharmacists if they're told antiviral therapy isn't recommended, Isetts suggested.

About 10% of patients can't take Paxlovid because of potential drug interactions, according to Dr. Scott Dryden-Peterson, medical director of covid outpatient therapy for Mass General Brigham. For them, Veklury (remdesivir), an antiviral infusion therapy delivered on three consecutive days, is a good option, although sometimes difficult to arrange. Also, Lagevrio (molnupiravir), another antiviral pill, can help shorten the duration of symptoms.

Many older adults fear that after taking Paxlovid they'll get a rebound infection — a sudden resurgence of symptoms after the virus seems to have run its course. But in the vast majority of cases "rebound is very mild and symptoms — usually runny nose, nasal congestion, and sore throat — go away in a few days," said Dr. Rajesh Gandhi, an infectious-disease physician and professor of medicine at Harvard Medical School.

Gandhi and other physicians I spoke with said the risk of not treating covid in older adults is far greater than the risk of rebound illness.

Side effects from Paxlovid include a metallic taste in the mouth, diarrhea, nausea, and muscle aches, among others, but serious complications are uncommon. "Consistently, people are tolerating the drug really well," said Dr. Caroline Harada, associate professor of geriatrics at the University of Alabama-Birmingham Heersink School of Medicine, "and feeling better very quickly."


"

 

[missy]

"

Annual COVID-19 booster? FDA cliff notes​

KATELYN JETELINA JAN 27

A consequential meeting took place at the FDA today. Their external scientific committee—called VRBPAC—met to discuss the national plan for COVID-19 boosters going forward. They essentially needed to answer one question: Do we simplify the COVID-19 vaccine approach in the U.S. and, if so, how?

Here are your cliff notes.

The challenge​

No one has a crystal ball for SARS-CoV-2's future, but it will be with us for a long time. So we need to figure out how to mount a proactive, sustainable approach given the rapidly changing landscape.

Some things are helping us right now:

• COVID-19 may be finding a more predictable path. (We’ve had Omicron for more than a year.)
• A majority of people have been exposed to the virus. Hybrid immunity is robust.

But some things are working against us:

• mRNA vaccines are not perfect.
• People aren’t getting vaccinated, even if the updated vaccines are working.
• ~4 million babies per year will be immune naïve.
• Different populations have different risks;
• COVID-19 is mutating four times faster than the flu.
• The U.S. is moving towards privatizing vaccines.

Presentations galore​

The amount of information and data packed into this 8-hour meeting was both overwhelming and not very helpful. (See more below.) I won’t go over every detail, but here are some important tidbits.

Who is most at risk?

The CDC presented data that is not surprising: most hospitalizations and deaths occur among older adults. Interestingly, children under 6 months are being hospitalized at about the same rates as those aged 50-64 years. This highlights the importance of maternal vaccination during pregnancy.

​

Slide from CDC
How well are the bivalent vaccines working against severe disease?

The bivalent vaccines are working well. Adults who received a bivalent booster had 3 times lower risk of hospitalization and 2 times lower risk of dying compared to those who were vaccinated but did not get the bivalent booster. Both were more effective than no vaccination.

​

Slide from CDC
There is a problem with this data though: people who got the bivalent vaccine are likely very different, in environment and behaviors (like masking), from people who didn’t get the bivalent vaccine. So, we don’t know if this difference in outcomes results from the vaccine, per se.

Moderna surprised us today with new data, though: a randomized trial in the U.K. They randomly gave people the original vaccine or the bivalent vaccine (BA.1 formula) as a booster. The bivalent vaccine did better. This really put the debate to rest.

​

Slide from Moderna
Even though the advantage is small, this data solidified the idea that an updated vaccines “anchors” our response to better respond to the circulating virus. This complements the B-cell data we’ve seen so far, too. (Note: Even Dr. Offit, who’s been critical of the bivalent vaccine, praised the study).

Stroke safety signal?

A highly anticipated analysis on the stroke safety signal after the Pfizer bivalent booster was presented. Some details:

• Only one safety monitoring system found a signal. The other U.S. safety monitoring systems did not.
• 130 people over the age of 65 had a stroke after the Pfizer bivalent vaccine (while 92 events were expected). Among 22 cases investigated thus far (among all 130), three people died. One has been linked to the vaccine.
• The safety signal attenuated last week.
• Concurrent flu vaccination did not explain this safety signal.
• Various countries in Europe, and Israel, have not seen increased risk in their surveillance systems. (This is incredibly reassuring).

Their bottom line message: everyone who is eligible still needs to get vaccinated.

What about Novavax?

I was excited to see Novavax data. It’s clear this is a solid vaccine.

And their presentation was much more useful than Moderna’s or Pfizer’s. To demonstrate, they included data on mixing Novavax with mRNA vaccines. It looks like no matter how you mix the two, the combinations work about the same way. At least in the short term. I’m very curious to see how this looks in the long term.

​

Slide from Novavax
The big bummer is they need 6 months to make an updated vaccine. This isn’t ideal given how quickly the virus mutates.

What about next generation vaccines?

There are clearly limitations to the vaccines. We can do better. An NIH presenter said they are focusing on new vaccines that are:

• Variant proof;
• Longer lasting; and/or
• Have enhanced ability to block infection/transmission.

This will take time, though, without an Operation Warp Speed 2.0-level investment or global collaboration. In addition, unlike the first generation mRNA vaccines, we don’t have decades of groundwork. We are really starting from scratch, and it will take time to understand what works and why.

So what is the FDA actually proposing?​

They want to replicate the flu vaccine model, but faster:

• Flu: Scientists at the WHO meet twice a year. For the Northern Hemisphere, strain decision is in February for a fall vaccine roll-out.
• COVID-19: FDA proposes scientists meet in June for strain selection for a annual September vaccine roll-out. This timeline is possible for mRNA vaccines; not for Novavax. So I’m not sure what FDA is going to do about that.

The scientific committee had a lot of questions after this proposal:

Just annually?

The FDA defended a fall only campaign in three ways:

1. Winter is when the stress on hospital systems will be greatest, thanks to other respiratory viruses.
2. The FDA thinks it’s already seeing seasonal patterns. (I disagree, although we agree this will eventually happen.)
3. Once a year eases implementation and decreases confusion for the public, which may help increase vaccine uptake.

Some voting members said it may be annual for now, but not later. Or maybe we won’t even need an annual. We really have no idea.

Nonetheless, it’s clear the FDA thinks the primary objective for vaccines is to do what’s good for the population, which may be different from what’s good for the individual (like getting a booster before a surge).

What about the rest of the world?

The WHO provides universal, annual recommendations for the flu vaccine. However, many are concerned the U.S. is going to dictate what is best because this is where pharma is located. The rest of the world won’t have a choice? It’s not clear how FDA’s plan will be harmonized with the rest of the world.

Why include the original Wuhan strain?

In other words, do we still need to include the original formula or do we just use the updated Omicron formula? One theoretical concern is imprinting. (I’ve written about imprinting before; see more here.) The FDA said this decision will be made at the next meeting.

Elephants in the room that weren’t addressed​

I was disappointed this meeting didn’t address practical implications. Maybe this is because VRBPAC is punting policy to ACIP. (VRBPAC/FDA’s primary job is to discuss the effectiveness and safety of vaccines. This is different from ACIP, whose job it is to determine policy.)

Some important unanswered questions:

1. Who gets an updated vaccine? When? And what dosage? There was an over 1.5 hour presentation on vaccine safety, which mostly focused on the new stroke signal. Myocarditis was brought up, but quickly glossed over. We have yet to see a benefit/risk analysis for bivalent vaccines by age. This is desperately needed for the court of public opinion, where questions remain, particularly for younger folks.
2. If the vaccine is updated once a year, could people get the “older” vaccine more than once a year? For example, could older adults get a booster before a new surge?
3. What is the game plan if a random variant of concern comes up? How do we determine when to do this? SARS-CoV-2 is not the flu.
4. Why isn’t the FDA pushing pharma to do more? A common theme throughout the pandemic FDA meetings is that “it’s too hard to measure anything other than antibodies” and “we don’t have the data needed to make a decision.” The FDA could require sponsors to do detailed investigations, e.g. assessing lymph nodes, bone marrow, and breakthroughs. This would help us understand immunity better, so we can make better recommendations. It’s not clear why they aren’t pushing for this.

Bottom line​

It sounds like in the future we will get updated COVID-19 vaccines. Maybe yearly? Maybe a booster for some people (like older adults) but not others? There are still a lot of unanswered questions. If we use the flu model for SARS-CoV-2, it’s a giant leap of faith with no contingency plan. We will need a bunch of luck that it will work. Time will tell.


"

 

[missy]

"

Updated covid vaccines prevented illness from latest variants - CDC
Published January 26, 2023 | Originally published on Health News Online Report

The updated COVID-19 boosters from Pfizer Inc/BioNTech SE and Moderna helped prevent symptomatic infections against the new XBB-related subvariants, offering new evidence of how the vaccines perform against these fast-spreading strains, U.S. officials said on Wednesday.

"Today we have additional evidence to show that these updated vaccines are protecting people against the latest COVID-19 variants," Dr. Brendan Jackson, head of the U.S. Centers for Disease Control and Prevention's COVID-19 response, told reporters in a briefing.

Released last fall, the updated boosters target the BA.4 and BA.5 Omicron variants of the SARS-CoV-2 virus, which are no longer dominant. The now-dominant XBB-related subvariants are derived from the BA.2 version of Omicron.

Lab studies had suggested that vaccine protection was lower against the XBB variants compared with prior variants, raising questions about how well the vaccines worked against these rising strains of the virus, Jackson said.

For the study, researchers reviewed COVID-19 cases from Dec. 1 through Jan. 13, a period in which U.S. circulation of XBB and XBB.1.5 increased. It showed that the updated vaccine helped prevent illness in roughly half of the people who had previously received two to four doses of the original COVID-19 vaccine, CDC said.

The CDC said the updated vaccine worked similarly against BA.5-related infections and XBB/XBB.1.5-related infections. It was 52% effective at preventing infections against BA.5 and 48% against XBB/XBB.1.5 among those aged 18-49. Effectiveness fell to 37% against BA.5 and 43% against XBB/XBB.1.5 among those aged 65 years and older.

Although not reflected in the study, Jackson said data to be released later on Wednesday shows the updated vaccine reduced the risk of death from COVID-19 by more than twofold compared with vaccinated people who had not received the updated booster. The updated shot also reduced the risk of death from COVID-19 by nearly 13-fold in people who are unvaccinated.

Study author Ruth Link-Gelles of the CDC said overall, the vaccines cut the risk of symptomatic infection by about half on a population, but individuals see a different benefit based on their risk factors.

Link-Gelles said the estimates are for symptomatic infection, which CDC defined as one or more symptom of COVID-19. Given the findings, the CDC urged people to stay up to date on their recommended COVID-19 vaccines.

XBB.1.5 was estimated to make up nearly half of U.S. cases in the week ended Jan. 21, government data showed.

The CDC analysis comes ahead of a meeting on Thursday at which outside experts to the U.S. Food and Drug Administration are expected to discuss whether and how the United States should offer the COVID vaccine as an annual shot.

(Reporting by Raghav Mahobe in Bengaluru and Julie Steenhuysen in ChicagoEditing by Caroline Humer and Matthew Lewis)

—Julie Steenhuysen and Raghav Mahobe

This article was originally published on Health News Online Report.

"

 

[Gloria27]

How much are those Pfizer stocks worth nowdays?

 

[lulu_ma]

My three kids got it two weeks ago for the first time.

My17 yo was the most rundown. My 8 yo barely had any symptoms. I thought I was out of the danger zone. Then a couple of days ago, I partially lost my sense of smell and taste.

Sure enough, I am positive. Congestion is my only symptom.

ETA:
All the kids are boosted. My DH and I got the bivalent. Up until two weeks ago, my sister is the only one in our initial pod that got it. She caught it a year ago.

 

[MamaBee]

@AprilBaby My husband, son who lives with us, and I still didn't get it..Neither did my middle son and daughter-in-law. Their son, who was four at that time, did get it. He wasn’t vaccinated yet..My son isolated with him but didn’t get it. My older son, who lives by himself, got it..My 97 year old mother who IIves in a nursing home didn’t get it either.

 

[MamaBee]

My three kids got it two weeks ago for the first time.

My17 yo was the most rundown. My 8 yo barely had any symptoms. I thought I was out of the danger zone. Then a couple of days ago, I partially lost my sense of smell and taste.

Sure enough, I am positive. Congestion is my only symptom.

I hope you feel better soon @lulu_ma..

 

[lulu_ma]

I hope you feel better soon @lulu_ma..

Thanks @MamaBee. Quarantining stinks, but the symptoms are mild-so I should not complain!

 

[Diamond Girl 21]

My three kids got it two weeks ago for the first time.

My17 yo was the most rundown. My 8 yo barely had any symptoms. I thought I was out of the danger zone. Then a couple of days ago, I partially lost my sense of smell and taste.

Sure enough, I am positive. Congestion is my only symptom.

ETA:
All the kids are boosted. My DH and I got the bivalent. Up until two weeks ago, my sister is the only one in our initial pod that got it. She caught it a year ago.

Wishing you and your family a speedy recovery.

 

[missy]

Sending healing vibes your and your family’s way @lulu_ma and (((hugs)))

 

[lulu_ma]

Wishing you and your family a speedy recovery.

Thanks @Diamond Girl 21 and @missy .

My kids are cleared to be back at school (they only had to quarantine for 5 days and then were able to attend school masked). I'm the only I am the only one stuck

 

[MamaBee]

Thanks @MamaBee. Quarantining stinks, but the symptoms are mild-so I should not complain!

I’m so glad your symptoms are mild. I just got off the phone with a friend who had it over Christmas. Her son and family had it but didn’t know it. They all started vomiting..within two days of each other. They thought it was food poisoning because she made ribs..One by one they started vomiting. Ten of them! They all tested..but only two tested positive but they all had the same thing. The doctor said the new variants sometimes escapes the test. Her husband couldn’t even get out of bed. The son and daughter-in-law said their stomachs weren’t quite right before they arrived..but they thought it was one of those 24 hour things. Obviously they brought Covid with them..