Coronavirus Updates October 2023

[missy]

"

COVID Vax in Pregnancy Protects Young Infants Against Omicron​

— But only about one-fourth of pregnant women reported getting the vaccine​

by Ian Ingram, Managing Editor, MedPage Today October 2, 2023

Maternal COVID vaccination in pregnancy protected young infants against Omicron-associated hospitalization, but few women actually receive the vaccine during pregnancy, according to new data from the CDC.
At least one maternal vaccine dose had an effectiveness of 54% (95% CI 32-6 against COVID-related hospitalization among infants younger than 3 months of age, and an effectiveness of 35% (95% CI 15-51) for infants younger than 6 months, reported researchers led by Regina Simeone, PhD, of CDC's National Center for Immunization and Respiratory Diseases in Atlanta, in the Morbidity and Mortality Weekly Reportopens in a new tab or window (MMWR).

Newborns are ineligible for COVID vaccination until 6 months of age, but are at high risk for severe outcomes from the virus. In fact, infants younger than 6 months have the highest COVID-associated hospitalization rates outside of seniors.
The case-control study from Simeone and colleagues spanned March 2022 to May 2023 and included 716 hospitalized infants under 6 months of age at 26 hospitals across 20 states in the Overcoming COVID-19 Network. In total, 78% of the 377 infants hospitalized and confirmed to have COVID-19 were babies whose mothers were unvaccinated. Most of the infants hospitalized for COVID-19 were previously healthy (77%), and critical illness occurred in 13%.
"Maternal vaccination, including receipt of a third dose during pregnancy, has been associated with reduced risk for infant hospitalization. Further, maternal vaccination during pregnancy has not been associated with increased risk for adverse pregnancy and infant outcomes," noted Simeone and co-authors.
Their findings were released alongside two other MMWRs showing lower rates of COVID vaccine uptakeopens in a new tab or window during pregnancy compared with other vaccinations recommended by the Advisory Committee on Immunization Practices (ACIP), and provider differencesopens in a new tab or window when it came to recommending the vaccines for this patient population.

Vaccine Uptake in Pregnancy, Hesitancy
A survey study led by Hilda Razzaghi, PhD, of CDC's National Center for Immunization and Respiratory Diseases, found that pregnant women were less likely to get the COVID vaccine during the 2022-2023 flu season compared with other vaccines recommended by ACIP during pregnancy to reduce the risk of pertussisopens in a new tab or window and influenza among women and their infants.
In an online survey conducted this year from March 28 to April 16 among more than 1,800 pregnant women, 27.3% said they received the bivalent COVID booster, as compared with 47.2% for the annual flu shot and 55.4% for the tetanus toxoid, diphtheria toxoid, and acellular pertussis (Tdap) vaccine.
Looking at the COVID shot specifically, women were nine times more likely to receive a bivalent booster if a provider recommended it (63.2% vs 6.8% when a provider did not).
Razzaghi's team also found an increase in flu vaccine hesitancy during pregnancy for the 2022-2023 season (24.7% very hesitant) versus prior seasons (17.2% in 2021-2022 and 17.5% in 2019-2020) and for Tdap vaccination as well (19.8% vs 14.7% and 15.1%, respectively).

In the study, hesitancy for these recommended vaccines was higher in Black versus white women, according to the researchers, who added that prioropens in a new tab or window studiesopens in a new tab or window have shown that pregnant Black women are less likely to receive vaccine recommendations from their provider.
"Maternal vaccination coverage remains suboptimal," Razzaghi and co-authors wrote. "Culturally relevant vaccination recommendations from health care providers are critical to improving vaccination coverage, decreasing persistent disparities in vaccination coverage, combatting increases in vaccine hesitancy observed since the start of the COVID-19 pandemic, and reducing adverse maternal and infant illness and associated complications including death from these three vaccine-preventable diseases."
Provider Influence
Survey data from healthcare providers found that ob/gyns were the most likely to recommend COVID-19 vaccination to their pregnant patients, Mehreen Meghani, MPH, also of the National Center for Immunization and Respiratory Diseases, and colleagues detailed.
Of the 1,538 providers surveyed who cared for pregnant patients, ob/gyns were most likely to recommend the COVID vaccine (94.2%), followed by pediatricians (90.4%) and family practitioners or internists (82.1%), with nurse practitioners (NPs)/physician assistants (PAs) being least likely to recommend it (76.0%).

When asked how important it was for women of reproductive age to stay up to date with COVID vaccination, 80.8% of the ob/gyns said it was very important, as compared with 78.8% of pediatricians, 69.1% of family practitioners or internists, and 55.6% of the NPs/PAs.
"One in five providers felt that it was only somewhat important that women of reproductive age stay up to date with COVID-19 vaccination, despite evidence that these women delay vaccination or remain unvaccinated," the study authors pointed out.
Providers who already offered Tdap and flu-shot vaccinations were more likely to offer or administer COVID shots as well.
These findings came from the Fall 2022 DocStyles survey. Most of the 1,752 responders were family practitioners or internists (57.2%), while pediatricians, ob/gyns, or NPs/PAs each made up 14.3% of the study sample. A majority of the providers were male (55.8%), and more than 60% had practiced for more than 10 years and worked in an outpatient setting.
Most of the providers in the study offered or administered the COVID-19 vaccine (53.5%), the flu shot (80.7%), and Tdap vaccination (71.9%) at their practice, though only 39.7% of ob/gyns offered the COVID vaccine.


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[missy]

From Bloomberg dot com

"
After lackluster vaccine uptake last season — only about 17% of Americans got bivalent boosters last year — Pfizer CFO David Denton said the company would launch ads to encourage people to get updated ones this fall.

“This is exactly the type of messaging that could work,” says Motta.

The company only expects about a quarter of Americans will get the latest shot recently approved to target new variants, even though the Centers for Disease Control and Prevention recommends them for almost everyone 6 months and older. Since the very first Covid shots rolled out in 2021, the jabs have been plagued by vaccine hesitancy. More recently, the ranks of shot dodgers have likely grown due to Covid fatigue.

But research has shown that trusted messengers, including professional athletes like Kelce, can play a significant role in bolstering vaccine uptake.

“People who distrust scientific authorities — a view which, like vaccine skepticism, tends to be more common on political right — tend to be more receptive to non-expert and celebrity sources endorsing vaccine safety and efficacy,” Motta says.

This isn’t the first time the NFL has encouraged fans and players to get vaccinated. The CDC even has a webpage dedicated specifically to the NFL’s Covid efforts.

In the past, drug ads aired during the Super Bowl have historically led to spikes in sales, one study found. Pfizer declined to comment on whether it has looked at the impacts of the new ad campaign on vaccination rates so far.

Football has millions of fans on both sides of the political aisle, making the star power of someone like Kelce especially potent.

Motta says that Kelce’s appearance in the new Pfizer ad not only has the potential to raise awareness about the possibility of booking a “two-in-one” vaccine appointment for flu and Covid, but also to bolster vaccine uptake on the ideological right.



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[missy]

"

Karikó and Weissman’s Nobel Prize​

Your "translated" version of their scientific discovery​

KATELYN JETELINA AND EDWARD NIRENBERG OCT 3

Yesterday, the 2023 Nobel Prize Winners for Physiology or Medicine went to Drew Weissman and Katalin Karikó for their discoveries in the biotechnology behind our Covid-19 mRNA vaccines.
Behind the amazing story of perseverance and collaborative spirit (it’s a fascinating story) is an absolutely revolutionary scientific discovery.
Here is the problem they solved, how we leveraged it for the pandemic, and the far-reaching implications.

​

The problem​

In 1961, we discovered RNA in living things. RNA is a string of letters that gives our cells instructions on how to function.
At first, scientists explored how synthetic messenger RNA (mRNA) could be leveraged in gene therapy. This was attractive because it meant we didn’t actually have to change our DNA. There would be no risk of accidentally introducing mutations that could affect how healthy genes work or, worst case, cause cancer.
But, every time mRNA was introduced to cells for gene replacement, it caused a profound immune response. In other words, our immune system was doing its job: recognizing a foreign agent and trying to get rid of it.
This caused scientists to pivot as there is an obvious application for a situation where you want an immune response: vaccination. In 1993, an mRNA influenza test showed successful induction of anti-influenza T cells in mice. This was incredibly exciting.
But there was a major challenge: the mRNA vaccines activated the immune system too early. This resulted in a mediocre antibody response and diverted T cells from a pathway that supported antibody production.

​

Hou et al., Lipid nanoparticles for mRNA delivery. Nat Rev Mater (2021).

The solution​

Enter Karikó, an RNA biochemist, and Weismann, an immunologist.
Karikó was confident she could fashion a vaccine from mRNA but encountered the same stubborn problem: the mice had trouble coping with the immune response after the mRNA vaccine. The quality of the immune response wasn’t as good as she’d hoped for either. Why did Karikó’s synthetic RNA do this when our cells constantly made mRNA with no such problem? Karikó’s RNA had to differ from the RNA our cells made, but how?
In 2005, Karikó and Weissman found the secret sauce: a group of RNA letter changes (i.e. modifications). A particular modification stood out: the change of U (uridine) to Ψ (pseudouridine, a common modification in our own RNA) prevented the immune system from recognizing the mRNA as foreign. They published these findings in Immunity, one of the top journals in the field of immunology.

​

(Nobel Committee)
As the 2010s progressed, mRNA vaccines trickled into early-phase clinical trials. However, another matter still limited confidence in the approach: mRNA is so fragile that it is very difficult to work with and requires very cold storage conditions.

The pandemic​

Then the pandemic came. While we had a key puzzle piece above, there were also other things that needed to come together:

• Carrier: Needed to find an efficient way to deliver the mRNA to our cells before it degraded (we used fat bubbles, which also had a long history; see timeline above).
• Cell instructions: Needed to stabilize the SARS-CoV-2 spike antigen.
• Storage: Needed to supply special freezers to store the vaccine.

All of these were accomplished; the perfect storm that brought together scientific discovery, extensive investment, and global teamwork.

The implications​

It is not an understatement to say that their discovery totally transformed our approach to vaccines. You would have a hard time naming a virus of public health importance for which an mRNA vaccine isn’t being attempted, but there are uses beyond that:

• Vaccines against tick-borne infections that target proteins in tick saliva.
• Vaccines to stop or reduce autoimmune diseases, like multiple sclerosis.

Bottom line​

Your mRNA Covid-19 vaccine is Nobel Prize-worthy. And an excellent example of our gains from the decades-long road of scientific discovery.


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[missy]

"

COVID-19 Virus Infects Coronary Vasculature​

Pauline Anderson

TOPLINE:​

A new study finds SARS-CoV-2 directly infects the coronary vasculature and causes plaque inflammation, which could help explain why people with COVID-19 have an increased risk for ischemic cardiovascular complications up to 1 year after infection.

METHODOLOGY:​

• Researchers obtained 27 coronary autopsy specimens from eight patients who died from COVID-19, mean age 70 years and 75% male. All had coronary artery disease and most had cardiovascular risk factors such as hypertension, were overweight or obese, and had hyperlipidemia and type 2 diabetes.
• All but one patient, who was pronounced dead before hospital admission, were hospitalized for an average of 17.6 days.
• To identify SARS-CoV-2 viral RNA (vRNA) in the autoptic coronary vasculature, researchers performed RNA fluorescence in situ hybridization (RNA-FISH) analysis for the vRNA encoding the spike (S) protein; they also probed the antisense strand of the S gene (S antisense), which is only produced during viral replication.

TAKEAWAY:​

• The study found evidence of SARS-CoV-2 replication in all analyzed human autopsy coronaries regardless of their pathological classification, although viral replication was highest in early-stage lesions that progress to more advanced atherosclerotic plaques.
• Findings indicated that more than 79% of macrophages (white blood cells that help remove lipids) and over 90% of foam cells (lipid-laden macrophages that are a hallmark of atherosclerosis at all stages of the disease) are S+, and more than 40% of both cell types are S antisense+, indicating SARS-CoV-2 can infect macrophages at a high rate.
• SARS-CoV-2 induced a strong inflammatory response as evidenced by release of cytokines (including interleukin-1 beta and interluekin-6 that are linked to myocardial infarction) in both macrophages and foam cells, which may contribute to the ischemic cardiovascular complications in patients with COVID-19.

IN PRACTICE:​

"Our data conclusively demonstrate that SARS-CoV-2 is capable of infecting and replicating in macrophages within the coronary vasculature of patients with COVID-19," write the authors, adding that SARS-CoV-2 preferentially replicates in foam cells compared to other macrophages, suggesting these cells "might act as a reservoir of SARS-CoV-2 viral debris in the atherosclerotic plaque."

SOURCE:​

The study was led by Natalia Eberhardt, PhD, postdoctoral fellow, Department of Medicine, Division of Cardiology, New York University, New York City, and colleagues. It was published online September 28 in Nature Cardiovascular Research.

LIMITATIONS:​

Findings are relevant only to the original strains of SARS-CoV-2 that circulated in New York City between May 2020 and May 2021, and are not generalizable to patients younger and healthier than those from whom samples were obtained for the study.
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[missy]

"

New Moderna Vaccine to Work Against Recent COVID Variant​

Jay Croft





Moderna says its COVID-19 vaccine should work against the BA.2.86 variant that has caused worry about a possible surge in cases.
"The company said its shot generated an 8.7-fold increase in neutralizing antibodies in humans against BA.2.86, which is being tracked by the World Health Organization (WHO) and the U.S. Centers for Disease Control and Prevention (CDC)," Reuters reported.
"We think this is news people will want to hear as they prepare to go out and get their fall boosters," Jacqueline Miller, Moderna head of infectious diseases, told the news agency.
The CDC said that the BA.2.86 variant might be more likely to infect people who have already had COVID or previous vaccinations. BA.2.86 is an Omicron variant. It has undergone more mutations than XBB.1.5, which has dominated most of this year and was the intended target of the updated shots.

BA.2.86 does not have a strong presence in the United States yet. However, officials are concerned about its high number of mutations, NBC News reported.




Pfizer told NBC that its updated booster also generated a strong antibody response against Omicron variants, including BA.2.86.
COVID-19 cases and hospitalizations have been increasing in the U.S. due to the rise of several variants.

Experts told Reuters that BA.2.86 probably won't cause a wave of severe disease and death because immunity has been built up around the world through previous infections and mass vaccinations.

Sources:​

Moderna: "Moderna Clinical Trial Data Confirm Its Updated Covid-19 Vaccine Generates Strong Immune Response in Humans Against BA.2.86."
Reuters: "Moderna says updated COVID vaccine is effective against newer variant."

NBC News: "Moderna says new Covid booster works against the highly mutated BA.2.86 variant."
"

 

[missy]

"

COVID Shot While Pregnant Limits Severe Cases in Infants Says CDC​

Lisa O'Mary
October 02, 2023




Getting a COVID-19 vaccine during pregnancy significantly reduces the chance that a baby will be hospitalized for COVID-19, new data shows.
The study from the CDC found that vaccines were 54% effective at protecting infants from COVID-19 hospitalization in the first 3 months of life, and 35% effective at protecting babies from ages 3 months through 5 months old. Infants can be vaccinated against COVID-19 starting at 6 months old.
Infants who were hospitalized with COVID-19 whose mothers were unvaccinated were more likely to need help breathing, compared to infants whose mothers had been vaccinated.
For the study, researchers analyzed data for 716 babies hospitalized between March 2022 and May 2023. Among the babies in the study, 377 were hospitalized with COVID-19. Mothers were considered vaccinated if they'd had at least two COVID vaccines, one of which was given during pregnancy. All other mothers of babies in the study were unvaccinated.

Vaccinated mothers pass antibodies against COVID-19 through the placenta to the fetus. The authors noted that a limitation of the study was that prior infection of mothers was not analyzed, including among unvaccinated mothers. They also said it is possible that "infection-induced antibodies could provide some protection against infant COVID-19–related hospitalization."




"Maternal vaccination during pregnancy provides some protection against COVID-19–related hospitalizations among infants, particularly those aged less than 3 months," the authors wrote. "Expectant mothers should remain current with COVID-19 vaccination to protect themselves and their infants from hospitalization and severe outcomes associated with COVID-19."
Previous research has shown that having COVID-19 during pregnancy increases the risk of preterm birth and stillbirth, and that pregnant people are at an increased risk of experiencing a severe case of the illness.
COVID vaccination rates among pregnant women range from 16% to 27%, according to the CDC. That's in comparison to survey data published this week by the agency that showed 47% of pregnant women reported getting a flu shot during the past flu season. Among women who had a live birth, 54% reported getting the Tdap vaccine, which can protect babies from pertussis (sometimes called "whooping cough").

The professional group for obstetricians and gynecologists "strongly recommends" that all pregnant women get vaccinated for COVID-19 and get the latest booster shot, adding that the vaccines are safe during pregnancy and breastfeeding. The American College of Obstetricians and Gynecologists notes that antibodies from the vaccine are passed from mother to baby through the placenta during pregnancy and may be passed to the baby through breast milk, as well.
Researchers wrote that they were not able to analyze the timing of COVID vaccination during pregnancy, specific brands or formulations of vaccines, nor whether vaccine effectiveness varied against different subvariants of the SARS-CoV-2 virus. They also noted that the results could have been influenced by "maternal characteristics or protective behaviors," and that the impact of breastfeeding, which may transfer antibodies to a baby, also could not be assessed due to incomplete data for some mothers.

Sources​

CDC: "Effectiveness of Maternal mRNA COVID-19 Vaccination During Pregnancy Against COVID-19–Associated Hospitalizations in Infants Aged <6 Months During SARS-CoV-2 Omicron Predominance — 20 States, March 9, 2022–May 31, 2023." "COVID-19 vaccination among pregnant people aged 18-49 years overall, by race and ethnicity, and date reported to CDC - Vaccine Safety Datalink,* United States." "Influenza, Tdap, and COVID-19 Vaccination Coverage and Hesitancy Among Pregnant Women — United States, April 2023."

American College of Obstetricians and Gynecologists: "COVID-19 Vaccines: Answers From Ob-Gyns."
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[Daisys and Diamonds]

New Zealand's Covid-19 response saved 20,000 lives - research

A new report advocates vaccinating at-risk people, improving air quality and some mask-wearing for all respiratory infections.

www.stuff.co.nz

 

[missy]

"

A response to Florida Surgeon General's anti-human remarks​

KATELYN JETELINA AND KRISTEN PANTHAGANI, MD, PHD OCT 6

​

This week the Florida Surgeon General said he is “very uncomfortable recommending the new Covid-19 vaccine to anyone” as it’s “anti-human.” Many of you have sent me this Fox News article that outlines his justifications.

​

He doesn’t have the greatest track record of making evidence-based vaccine recommendations. But as always, each claim should be evaluated individually based on its merit.
Let’s dig in.

Criticism #1: There’s no clinical data for the updated vaccines.​

This fall, we do not have randomized controlled trial data for the updated Covid-19 vaccine. We didn’t have it last fall either. That is true.
But three critical points are missing from his argument:

1. We do have clinical (human) data. Moderna evaluated the human response to the updated vaccine in a lab, and the updated vaccines were found to significantly increase antibodies.
2. The changes from the last vaccine are small, literally the difference of a few amino acids—like a few letter edits on a Word document. We aren’t changing the number of words in the paper (like dosage of RNA), or the platform (like Word to Excel). Because of this, we are confident safety data largely reflects the billions of other mRNA doses already administered.
3. While randomized-controlled trials are the gold-standard evidence, it is not feasible to run them for everything (especially for a mutating virus). Conducting a Phase III effectiveness trial takes time, effort, and resources. The virus has already mutated by the time it’s over, and then we need a new formula. So we have adapted Covid-19 to our flu model. There is also an ethical concern with randomized trials—if we know the vaccine helps, is it ethical to give a placebo randomly to people?

Criticism #2: Side effects ​

Yes, some risks are real. But others are not.
Myocarditis
There was a true and rare safety signal for myocarditis among young males after mRNA vaccines. This has been under intense surveillance and wasdiscussed in length at the latest FDA and CDC meeting.
But, after last fall’s updated Covid-19 vaccine, only 2 myocarditis cases were verified out of ~650,000 doses among young males and females. This is a much smaller rate than with the primary series. It’s about the same rate as background, which means it’s not a safety signal anymore. We think this is because the increased time interval between doses reduces risk. However, there is limited data, so this estimate has some uncertainty.
Although the risk/benefit ratio has changed over time, benefits continue to outweigh risks, even for adolescents.

​

(CDC)
Risk of clotting
Addressing his rumors is an entire post in itself, but here are a few important points that seem to cause repeated confusion:

• The J&J vaccine was associated with a small increased risk of a rare kind of clotting disorder (TTS), not the mRNA vaccine.
• Myocarditis does not mean an increased risk of heart damage from blood clots. Myocarditis is not caused by blood clots. These are separate processes.

Negative effectiveness
Some real-world, observational studies show that vaccinated people aremore likely to get infected after ~6 months compared to the unvaccinated. This is true.
There’s no immunological evidence to suggest the vaccines are actually harming immunity. So we are left with two hypotheses that have yet to be tested:

1. Bias. For example, vaccinated people may be more likely to be exposed more often (because they feel more protected). Or, those who get vaccinated are more likely to test (and thus, more likely to detect infection).
2. Timing. Even just the timing of when people got vaccinated, when the latest COVID wave went around, and when you assess for vaccine effectiveness can create spurious results if you’re not careful.

​

Spike protein in blood for up to 6 months
He cites a lab study that found protein fragments of the vaccine spike. Thisdoes not mean that the spike protein was circulating in these samples. The immune system processes proteins into fragments naturally, so finding a fragment doesn’t tell you that the spike protein is still intact or being produced. It’s like finding the letter “a” in a document and saying that the document has the word “aardvark” in it.
16% higher risk of serious adverse events in mRNA vaccine recipients
A 2022 study led by UCLA and the University of Maryland was published in Vaccine that analyzed the clinical trial data using different definitions of adverse events. Vaccine is a leading journal in the field, but it is not perfect. This particular study is incredibly messy and should have never been published. For example:

• 16% is not statistically significant— in other words, 16% isn’t any different than 0% increased risk of adverse events after vaccination (risk ratio=1.16; 95 % CI 0.97 to 1.39).
• Authors compared number of adverse events, not the number of patients who suffered. This automatically skews the data because one person often has multiple symptoms (e.g., abdominal pain often accompanies diarrhea.)

Left out​

There are important points completely left out of his argument, which shadow the larger picture too:

• The impact of actually getting infected. The virus continues to be more concerning than the potential for vaccine side effects. The most recent example is an increased risk of cardiovascular disease and stroke due to artery plaque after Covid-19 infections.
• We have other options. His biggest concern seems to be mRNA vaccine biotechnology. We do have another fantastic option that is not mentioned— Novavax—that uses a more traditional vaccine platform.
• Muddling >65 vs. <65 debate. At this point, there’s a legitimate debate about whether vaccines should be approved for everyone or only high-risk. Country-to-country comparisons, for example, have bubbled up. However, lumping everyone together, as this narrative has, is neither conducive to nor helpful in reaching the most at-risk.

Common ground ​

It’s important to acknowledge there are points we agree on:

• Medication (i.e., Paxlovid) is an important tool.
• FDA should push for more evidence. This has been a loud theme from VRBPAC—the external committee to the FDA—throughout the pandemic. Why aren’t we getting T cell data? Why aren’t we getting B cell data? Why can’t we find correlates of protection for antibodies? We should demand data from pharma companies.
• We should always work towards better vaccines. Thanks to the $5 billion Operation Next Gen we are developing next-generation vaccines that prevent transmission (like nasal vaccines) or are variant-proof (like pan-coronavirus vaccines).

Bottom line​

Framing public health as anti-human is an incredibly dangerous game to play.
Health policy decisions need to be grounded in an accumulation of evidence that provides a comprehensive picture of reality. He combines legitimate points with profoundly foolish ones, which muddles the picture, creates a sense of false equivalency, and makes it difficult for the general public to discern the truth.
Keep this in mind when decision-making about Covid-19 vaccines this fall.
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[missy]

Does masking work?

YES


"

What’s the science behind masking?​

Did scientists ever reach a data-supported consensus on how effective masks are against Covid-19? Does effectiveness vary by variant? Anthony, Washington DC Masking is a nuanced topic, informed as much by politics as science. To help sort the facts from the fiction, we turned to Katrine Wallace, an epidemiologist at University of Illinois at Chicago. “Masking is a critical public health tool for preventing the spread of Covid,” Wallace says. Though the mask mandates of peak pandemic have faded, the Centers for Disease Control and Prevention continues to recommend well-fitting masks as a way to help combat Covid. But early in the pandemic, masks and mandates to wear them became a highly polarized topic. “There are many people who are of the opinion that masks do not work, that mask mandates were simply a form of ‘government control,’” Wallace says. “Who can forget the many videos of grown adults throwing tantrums at Walmart greeters who were asking shoppers to don a mask during the height of the pandemic?” Adding to the confusion was a Cochrane review paper published in January 2023. The review examined whether encouraging mask wearing helped to slow the spread of respiratory viruses. The results were inconclusive. Wallace says they were also widely misunderstood. “This review went viral on social media with many people misrepresenting its purpose and conclusions,” she says. People used it to suggest masks themselves were ineffective. “The authors of the review noted many limitations to the available evidence, so the review was not actually able to answer the question of whether the masks themselves reduce the risk of respiratory viruses,” Wallace says. In March, Cochrane published a clarification: “Many commentators have claimed that a recently updated Cochrane Review shows that ‘masks don't work,’ which is an inaccurate and misleading interpretation.” Living with Covid has become just part of living life. It’s easy to let our defenses down in this new normal. But, with more time indoors on the way for the Northern Hemisphere as we enter colder, darker days, cases are likely to rise. And the science still suggests that masks are one of our best defenses against the virus. In February 2022, the CDC published a study that found that consistently wearing a mask in public reduces the risk of Covid between 56% and 83% depending on the quality of the mask worn. (It also found any mask is better than no mask, but that cloth masks have the lowest efficacy.) Data has also shown that masks work best when everyone wears one. “Well-fitting masks are effective when worn consistently and correctly,” Wallace says. That means a proper fit over your nose, mouth and chin to prevent leaks, as well as having multiple layers and a nose wire. “If masks are ill fitting, not worn at all, not worn correctly, or not worn by many people, this obviously affects their efficacy on both individual and population levels,” Wallace says. That makes the question of “do masks work?” a bit tricky to answer. “In a community setting, it is more difficult to nail the exact efficacy down, due to so many people having different masking and general disease prevention behaviors,” Wallace says. — Kristen V. Brown

"

Our own personal experience is also a big yes. My dad had covid and we were with him all day. We were masked and he was not. 13 days later we are covid free still. And I was right up near him much of the day too. So yes, in my personal experience, N95 masks when worn properly do work and keep on working as we were there 8 hours or so

 

[missy]

"

Novavax is here!​

And an updated 2023 vaccine chart.​

KATELYN JETELINA OCT 10 ∙

The world is, once again, seeing the darkest parts of humanity unfold in and around Isreal. Posting about a vaccine felt insensitive without addressing the pain, suffering, and tragedy millions face today. There are massive public health implications of war (malnutrition, clean water, PTSD, bioterrorism risks), and maybe YLE can get there when the time is right. In the meantime, I am grieving with you. Hoping for peace, thinking about those in harm’s way, hoping leaders have wisdom, and hugging my kids extra tight.

Last week, the Novavax Covid-19 vaccine with an updated formula was approved by the FDA. Here are a few quick thoughts.
Also, you’ll find the final version of the vaccine sheet below. I’m stoked that many people, including the CDC, are using it.

What is Novavax?​

Novavax is a small company based in Maryland and has never brought a vaccine to market. This company has a fascinating rollercoaster history; I highly recommend googling over coffee.
Their Covid-19 vaccine contains a coronavirus protein that prompts the immune system. (This differs from Pfizer or Moderna mRNA vaccines, which contain instructions for recognizing the coronavirus.) Scientists combined this protein with an immune-boosting compound derived from the soapbark tree.
This type of vaccine has a much longer track record than the newer approaches. But the innovative aspect is that Novavax found a way to make this vaccine in moth cells (rather than mammal cells). The moth cells become little factories that pump out coronavirus proteins. This allows Novavax to manufacture the vaccine much more quickly than others, which is one reason they can get this to market in 6 months (as opposed to longer).

Who is eligible?​

Anyone 12 years and older. This includes people who previously had a Pfizer or Moderna Covid-19 vaccine.

Where will Novavax be available?​

13,000 stores… eventually. It will take time for distribution, just like the mRNA vaccines. The closest one to me is 75 miles. This will change with time.
Keep an eye out on vaccines.gov. Here is another Novavax finder. (Note: it still has information from the 2022 vaccine rather than the 2023 updated vaccine. I hope this will be updated ASAP.)

Do they work?​

Yes. Most recently, an Italian study of more than 20,000 people showed protection against symptomatic disease was 50% in fully vaccinated people. It did not wane before 4 months.

Is mixing Novavax after an mRNA series better?​

There is some evidence that mixing is immunologically better and some evidence that staying with mRNA is better. It’s a bit hard to know which one is “right” given how little evidence we have at this point. (See a breakdown of the similarities and differences here.)
That said, there are two reasons people may want to go with Novavax:

• Hesitant about mRNA biotechnology, regardless of its long history.
• Side effects. In a randomized clinical trial, Novavax had fewer side effects than mRNA vaccines. This is one major reason why I’m going with Novavax this fall for the first time. (The mRNA vaccines kick my butt. Fingers crossed, this is more forgiving for me).
  

  ​

  Side effects from varying combinations of Covid-19 vaccines. Figure from the Lancet, with YLE annotations. Original source here.

Updated vaccine sheet​

Below is the final version, as we don’t expect updates for fall 2023 options from here on out. Below is an English and Spanish PDF for paid subscribers. Download and share!

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[Karl_K]

I have had a ton of doc appointments lately and I'm almost always the only one wearing a mask other than a couple doctors who put one on before entering because I had one on.
At the lab appointments at one place most of the people drawing blood had one on but at the other no one was wearing them.
I find that not only have I avoided covid but get a lot less colds and avoid the flu.

Later this week I can get my covid booster, I needed some others and cant combine them with the covid one.

 

[Karl_K]

"

​

Updated vaccine sheet​

Below is the final version, as we don’t expect updates for fall 2023 options from here on out. Below is an English and Spanish PDF for paid subscribers. Download and share!

"​

Don't forget to make sure you pneumonia vaccine is up to date. It about killed me twice.
Before the vaccine I got it every couple years and since then I have not had it.

 

[missy]

Don't forget to make sure you pneumonia vaccine is up to date. It about killed me twice.
Before the vaccine I got it every couple years and since then I have not had it.

Wow, I am sorry you went through that Karl!
Yeah I am not yet eligible for the pneumonia vax but for everyone who is I agree with you.
I probably could get eligibility due to two of my underlying conditions though so will look into it. Thank you for the suggestion

 

[missy]

I have had a ton of doc appointments lately and I'm almost always the only one wearing a mask other than a couple doctors who put one on before entering because I had one on.
At the lab appointments at one place most of the people drawing blood had one on but at the other no one was wearing them.
I find that not only have I avoided covid but get a lot less colds and avoid the flu.

Later this week I can get my covid booster, I needed some others and cant combine them with the covid one.

Same here. No one (and I mean no one but my dh and I) are wearing masks here. Not the doctors, Not the nurses (at hospitals yet). No one is wearing them. But masks can save you from not just getting covid but from getting the flu and other viral borne illnesses

 

[missy]

"

COVID-19 Tied to Autoimmune Disease Risk​

Lucy Hicks
October 06, 2023

TOPLINE:​

Research from Korea provides additional evidence for the connection between COVID-19 and an increased risk for autoimmune conditions post-infection.

METHODOLOGY:​

• In this retrospective study, researchers identified 354,527 individuals diagnosed with COVID-19 via polymerase chain reaction (PCR) testing from October 8, 2020 to December 31, 2021.
• Researchers compared the COVID-19 group to 6,134,940 healthy individuals who had no evidence of COVID-19 to quantify the risk for autoimmune and autoinflammatory connective tissue disorders.
• Patients were followed until diagnosis, death, or end of study period (December 31, 2021).

TAKEAWAY:​

• Risks for alopecia areata, alopecia totalis, antineutrophil cytoplasmic antibody (ANCA)–associated vasculitis, Crohn's disease, and sarcoidosiswere higher in the COVID-19 group.
• Patients with more severe COVID-19 (admitted to the ICU) were at greater risk for many autoimmune conditions, including alopecia totalis, psoriasis, vitiligo, and vasculitis.

IN PRACTICE:​

"Our results emphasize the need to focus on managing not only the acute stages of COVID-19 itself but also autoimmune diseases as complications of COVID-19," the authors write.

SOURCE:​

Sung Ha Lim, MD, of the Yonsei University Wonju College of Medicine in Wonju, Korea, was the first author of the study, published in JAMA Network Open on October 6.

LIMITATIONS:​

The study was retrospective and was comprised almost exclusively of individuals from a single ethnicity. The study could have included individuals with COVID-19 in the control group who did not undergo PCR testing. The analysis did not include detailed information on each patient, including genetic information, that could have contributed to autoimmune disease risk.

"

 

[missy]

"

Pulmonary Embolism During COVID Infection a Deadly Mix​

— 20% of patients with both died during pandemic's first year versus 7% of those with PE alone​

by Elizabeth Short, Staff Writer, MedPage Today October 9, 2023


HONOLULU -- During the first year of the pandemic, patients with pulmonary embolism (PE) had higher in-hospital mortality rates when they also had concomitant COVID-19, according to a nationwide retrospective cohort study.
Using data from the 2020 National Inpatient Sample Database (NIS), 19.8% of patients with both PE and COVID died in the hospital compared with 7.1% of those with PE but without COVID (adjusted OR 3.16, 95% CI 3.07-3.25, P<0.001), reported Rana Prathap Padappayil, MBBS, of Upstate Medical University in Syracuse, New York, during the CHEST annual meetingopens in a new tab or window hosted by the American College of Chest Physicians.

Patients with PE who had COVID were also more likely to require vasopressors (5.31% vs 2.66%; aOR 1.16, 95% CI 1.11-1.22) and extracorporeal membrane oxygenation (0.76% vs 0.30%; aOR 1.62, 95% CI 1.41-1.86), and had longer lengths of stay (7 vs 4 days; P<0.001).
Padappayil noted that acute PE is one of the most common causes of cardiovascular death, with in-hospital mortality rates of around 30%. Studies have shown that COVID is an independent risk factor for developing PE.
Of note, patients with both PE and COVID were less likely to receive certain procedures versus those without COVID, including systemic thrombolysis (2.83% vs 4.71%), catheter-directed thrombolysis (0.13% vs 0.49%), and thrombectomy (0.73% vs 1.94%; all P<0.001).
Because the study data are from 2020 -- the first year of the pandemic -- this may have played a role in the differences among procedure utilization, Padappayil said, noting that a lack of personal protective equipment, a high patient burden, and concerns about evidence likely resulted in patients with both PE and COVID receiving fewer interventions compared with those without COVID.

However, it is unclear if this lack of interventions resulted in higher mortality in patients with PE and COVID, he added.
For this study, the researchers used data from the NIS, which included 425,640 hospitalizations for acute PE (the admitting diagnosis); 11% of these patients also had a COVID-19 infection.
Median patient age was 65, and the majority were women (41.6% with COVID and 50.6% without COVID) and white (53.4% and 70%, respectively); 23% and 19% were African American and 16.4% and 6.7% were Hispanic.
Among the comorbidities present among the patient population were hypertension (62% in both groups), smoking (20% with COVID and 23% without), chronic obstructive pulmonary disease (COPD; 21.6% and 27%, respectively), congestive heart failure (16.5% and 24%), diabetes (13.7% and 10.7%), malignancy (4.1% and 16.6%), and history of venous thromboembolism (4.5% and 9.4%).
Padappayil and team noted that patients with PE and COVID were more likely to be men and non-white, and less likely to have comorbidities, including prior myocardial infarction, diabetes, congestive heart failure, COPD, chronic kidney disease, end-stage renal disease, malignancy, and history of venous thromboembolism.

Limitations to the study included the fact that the NIS database is subject to selection biases and ICD miscoding. In addition, the analysis was limited to in-hospital outcomes, which means the researchers were unable to assess long-term outcomes after discharge.
Padappayil stressed the need for further research using data from the subsequent years of the pandemic. As NIS data become available, his group will look into whether providers have been more willing to use thrombolysis and thrombectomy in patients with both PE and COVID.

• 
  
  Elizabeth Short is a staff writer for MedPage Today. She often covers pulmonology and allergy & immunology. Follow

Disclosures
Padappayil reported no disclosures.
Primary Source
CHEST
Source Reference: opens in a new tab or windowPadappayil RP, et al "Concomitant COVID-19 infection and pulmonary embolism: incidence and in-hospital outcomes in a nationwide cohort" CHEST 2023.

"

 

[Karl_K]

Having had a PE I can tell you there is a ton of variability in how bad they are. Some people can have one and never know it to fall down and die with in a few minutes blockages.
I don't see how to account for that in the study.
A doctor at the walk in clinic sent me home with a panic attack diagnoses and when it got worse later and my leg was acting up, they found I had multiple blood clots in my lungs at the ER.

 

[AdaBeta27]

Too long, can't read it all now. But my sister who's been in neonatal intensive care nursing for 30+ years says they are *definitely* now seeing a lot of very sick babies from covid. And are also seeing a lot of clotting problems in pregnant women and new mothers who've had covid. It's happening to women who had covid before pregnancy, not just during pregnancy. Sis definitely said "clotting issues" and "some very sick babies," also with clotting issues. Microclotting has been linked to long covid. https://www.webmd.com/covid/news/20221207/microclots-may-explain-long-covid-symptoms New imaging has allowed researchers to see microclotting occurring deep in the lungs, and other places. https://www.personneltoday.com/hr/new-scanning-technique-honing-in-on-long-covid-microclots/

 

[missy]

Thank you for sharing @AdaBeta27



”

State of Affairs: Oct 12​

The climate of respiratory health in the United States.​

KATELYN JETELINA OCT 12

It’s heeeere. The official start of the respiratory season kicked off last week.

Here is your first State of Affairs for this fall/winter.

Influenza-like illnesses​

Every Friday, the CDC updates their “influenza-like illness” (ILI) data. This is a database where providers tally patients who presented with ILI—a fever, a cough, and/or sore throat—at their office. So these numbers include everything (flu, RSV, COVID-19, etc.) and are a general indication of the climate of respiratory health in the United States.

ILI is starting to creep up but is still below the “epidemic” level threshold. Last year we were hit early and hard. It will be incredibly interesting to see how this unfolds.

​

(Source CDC; Annotated by KKJ)
Low levels result in a pretty “green” picture of low activity across the United States. We will get to purple here in the next few weeks/months.

​

(CDC)
Here is a deeper dive into the “big three” viruses.

Covid-19: On the decline​

After our summer wave, every Covid-19 metric is declining—wastewater, ED visits, and hospitalizations. This isn’t a surprise; we’ve consistently seen a lull in Covid-19 this time of year. We are exactly overlapping last year’s trends in wastewater.

​

SARS-CoV-2 Wastewater over time. Source Biobot.
Compared to the other big two (RSV and flu), Covid-19 hospitalizationscontinue to take the lead per capita.

​

Hospitalizations per 100,000 over time (Source CDC; Annotated by KKJ)
However, there has been significant decoupling of hospitalization and case numbers due to population-level immunity. Although we continue to see waves of infection, COVID-19-associated hospitalizations remained consistently lower than in previous years. Progress.

​

Covid-19 hospitalizations per 100,000, United States (CDC)
Who is being hospitalized today? According to a new CDC report:

• 2 in 3 are adults over the age of 65 years
• 90% of those hospitalized had multiple comorbidities
• 1 in 4 hospitalized are not up-to-date on Covid-19 vaccine

We are paying close attention to how Omicron continues to change. Below is a beautiful Sankey diagram showing the Omicron family tree. From left to right, it shows the 14 generations of Omicron over time, with the thickness of the line proportional to the number of sequences.

​

Source: UK Health Security Agency
Two specific subvariants will likely drive our expected winter surge:

1. BA.2.86—the highly mutated variant we detected a few weeks ago—is sticking around. It’s now in 24 countries and showing a 30-45% growth advantage. This means it’s not fizzling out; it still has the potential for a wave but not a tsunami. It has already started to mutate, so it will be important to see what incremental changes it makes to increase its capability against our immunity.
2. FLiP mutations—a group of subvariants that have a combination of new mutations called FLip because they involve two L to F amino acid mutations—is gaining ground.

​

Source: JP Weinland

Flu: Very low levels​

Influenza levels are still very low. Last week, 1,040 patients with laboratory-confirmed influenza were admitted to a hospital. This is compared to a typical peak of ~28,000.

​

(CDC)
Interestingly, one specific strain of flu—called Yamagata influenza B—has gone extinct due to Covid-19 measures. This is incredible news because of two things:

1. It wasn’t thought that we could eliminate a flu strain.
2. This strain was notoriously difficult to predict for flu vaccine strain-selection purposes. The WHO has officially recommended not including this strain in future vaccines.

RSV: Heating up in the South​

RSV is picking up. National trends are being driven by one region—the South. This typically signals the beginning of RSV season, in which the virus will subsequently spread to the Northeast and West over the next two months.

​

(CDC)

Excess mortality​

After hitting a summer low, excess mortality (red line below) is once again above pre-pandemic normals (double black line).

​

(CDC)

Vaccination​

How we fare in the upcoming season is strongly driven by vaccination uptake. The big question this year is whether Covid-19 coverage will match that of flu.

This is where we are right now:

• Covid-19: Tracking vaccination rates is tricky now that reporting is not mandated. Last week, the CDC estimated 2% of the eligible population (4 million) have had their fall vaccine thus far. This is on par with last fall's uptake.
• RSV: We don’t know about uptake.
• Flu: This data isn’t updated until the end of October. In previous years, ~20% of the population had their flu shot by now.

​

(CDC)

Bottom line​

Things are quiet right now, especially with Covid-19 on the decline. This will change in the weeks to come. Be sure to get your vaccinations before Halloween—a safe goal to hit before things heat up. And once that ILI line hits epidemic levels, I strongly recommend putting that mask back on to avoid all types of viruses.




“

 

[missy]

"
Experts appear to agree that nirmatrelvir-ritonavir (Paxlovid) during the acute infection period may reduce long COVID riskopens in a new tab or window, but it's often not prescribed. (NBC News)

Many community health centers are still anxiously awaiting dosesopens in a new tab or window of the updated COVID shots, but despite the shortages, more than 7 million Americans have received the vaccineopens in a new tab or window. (NBC News, Reuters)

Paxlovid may reduce the chance of long Covid. Why don’t doctors prescribe it more?​

Experts who study and treat long Covid agree that Paxlovid seems to lower the risk of lingering symptoms. Some long Covid patients regret not taking it.

Oct. 12, 2023, 9:21 AM EDT
By Aria Bendix
A consensus has emerged among experts who study and treat long Covid: Paxlovid seems to reduce the risk of lingering symptoms among those eligible to take it.
The idea is intuitive, experts say. Paxlovid prevents the coronavirus from replicating, so researchers think it may also reduce the risk of an infection causing inflammation or organ damage, which in turn can lead to chronic illness.

Clinical observations and a large study published in March support that theory. Among the 282,000 people in the study who were eligible for Paxlovid, the drug was associated with a 26% lower risk of long Covid.
“Research definitely backs up that it helps prevent lingering symptoms — it helps prevent long Covid,” said Ashley Drapeau, director of the Long Covid Clinic at the GW Center for Integrative Medicine.
Some patients who took Paxlovid during their illness also seem to have less severe long Covid symptoms overall than those who did not, according to Drapeau.
But doctors who treat people for active Covid infections say they aren’t widely prescribing Paxlovid, since the medication interacts with several common drugs and is only approved for people vulnerable to severe illness — older adults and people with underlying medical conditions.
Data from the Veterans Affairs St. Louis Health Care System indicates that just 30% of patients who qualify for Paxlovid are being prescribed it, said Dr. Ziyad Al-Aly, the system’s chief of research and development.
Research from Helix, a genomic data company, similarly showed that around one-third of nonhospitalized adults at risk of severe Covid were prescribed an antiviral from February to June.

“It’s really unfortunate that people are not prescribing it enough, especially going into the winter season,” said Al-Aly, who authored the March study.
“It’s kind of like when a vaccine is available and people are not using it,” he added. “It’s really, profoundly sad.”

Some long Covid patients regret not taking Paxlovid​

Reta Greenier, a 61-year-old special education teacher in Saint David, Maine, said she asked her doctor for Paxlovid shortly after testing positive for Covid in August 2022. At the time, she said, she had a cough, a slight fever and fatigue.
“I said, ‘I heard there’s a medicine out there now that you can take that will make this less severe,’” she recalled. “I didn’t know much about long Covid at that point. In fact, I don’t think I knew about it at all.”
But Greenier’s doctor told her he didn’t know enough about Paxlovid to feel comfortable writing her a prescription, she said, despite several factors that made her eligible: her age, weight and a history of asthma. Her doctor did not respond to a request for comment.
Since then, Greenier said, she has had long Covid symptoms including painful constipation and a combination of dizziness and an elevated heart rate that makes her feel like she might pass out. In June, she said, she called her attorney’s office and asked to update her will.
“I thought I was dying,” she said.
Greenier said she can only work part-time now, and wonders whether she would be back full-time if she had taken Paxlovid.
Drapeau said many of her long Covid patients report that they weren’t offered Paxlovid or were told by their health care provider that they didn’t need it.
“Many of my patients come to me and say, ‘If only I had taken the Paxlovid …’” she said.

Why aren’t more people taking Paxlovid?​

Drapeau said doctors probably don’t consider long Covid as a primary risk factor when deciding whether to prescribe Paxlovid.

​

“They’re thinking, ‘How can I prevent this person from being in the hospital?’” she said. “Versus, ‘How can I prevent them having lingering symptoms that are going to cause major debility in their life?’”

Doctors, for their part, cite a few other reasons: Paxlovid interacts negatively with some anti-seizure and heart medications, as well as certain drugs that lower blood pressure or cholesterol. The medication can also have side effects, such as diarrhea, nausea and a metallic taste in the mouth.
Doctors also weigh how severe a person’s symptoms were the last time they got Covid, if this is not their first infection.
“In general, if you had mild symptoms the first time, you’re probably going to have mild symptoms again, and Paxlovid often makes people feel worse,” said Dr. Geoffrey Mount Varner, an emergency room physician in Virginia and Maryland.
To a lesser extent, doctors see Paxlovid’s potential “rebound” effect as a deterrent as well. A small study found that less than 1% of Covid patients saw their symptoms come back one to two weeks after taking Paxlovid. Other research that’s yet to be peer-reviewed found that 6% of a group of 11,300 Covid patients saw symptoms rebound in the month after they took the medication.

But Al-Aly said concerns about rebounds and side effects are overblown.
“You may have malaise again or fever, but it’s all in the acute phase,” he said. “It usually gets better a few days later, and in the long term is inconsequential.”

A potential treatment option for long Covid?​

Paxlovid is taken twice daily, in sets of three pills, for five days. It’s the National Institutes of Health’s preferred treatment for mild to moderate Covid and has been approved since December 2021.
At first, doctors touted Paxlovid as a breakthrough: The drug lowered the risk of severe illness and death from Covid by 89% in a clinical trial, and reduced the risk of hospitalization by 51% in a real-world study.
In the spring and summer of 2022, Paxlovid made up a much larger share of prescriptions filled at pharmacies than it did over the same period this year, according to GoodRx’s prescription tracker. Now, the weekly share of Paxlovid prescriptions is about the same as last October.
Some experts think the drug might even improve symptoms for patients who already struggle with long Covid. As the theory goes, Paxlovid may help clear lingering virus or viral proteins in the body that continuously aggravate the immune system.
But researchers are still evaluating that application of the drug. The NIH’s RECOVER Initiative is giving people Paxlovid for up to 25 days to see if it improves their long Covid symptoms. The first participant in that study was enrolled in July. Studies at the Yale School of Medicine and Karolinska Institutet in Sweden are also investigating Paxlovid as a potential long Covid treatment.
Dr. Benjamin Abramoff, director of the Post-COVID Assessment and Recovery Clinic at Penn Medicine, said he recommends Paxlovid for people with long Covid who get reinfected.
“I’ve had a couple patients report improvement through that process,” he said. “Even if they’re not necessarily high risk, I think there’s a lot of benefit for many of our patients who have significant long Covid symptoms.”
Another unanswered question is whether young, healthy people might benefit from Paxlovid. Though doctors don’t have evidence of that yet, Drapeau said there’s reason to believe the drug could reduce the risk of long Covid even for people without underlying risk factors.
“It makes sense to me that we give it to a wider population,” she said.

"

 

[missy]

"

Intranasal COVID Vaccine Generates Strong Immune Response​

— Plus: Detecting viruses in wastewater and the maternal RSV vaccine for protecting infants​

by Ed Susman, Contributing Writer, MedPage Today October 12, 2023


BOSTON -- Stopping respiratory illnesses before they start through new delivery systems and by such mundane work as analyzing a city's wastewater were among the early highlights at this year's IDWeekopens in a new tab or window meeting.
Intranasal Vaccine Shows Promise
At a press briefing, researchers suggested that those who dislike the idea of having to get poked by needles to prevent infection with SARS-CoV-2 may be able to sniff a vaccine instead.

Johanna Kaufmann, PhD, executive vice president for oncology and immunology at Codagenix, based in Cambridge, Massachusetts, reported that in a phase I study, two doses of a live-attenuated COVID-19 vaccine candidate known as CoviLiv produced a broad humoral and cellular immune response when administered intranasally.
The first-in-human trial was a primary vaccination series study conducted among healthy adults prior to the development of the mRNA vaccines that are now approved for broad public use, Kaufmann noted.
All participants exceeded a twofold increase in spike-specific IgG, with a geometric mean fold rise of 19.5 by day 57. Neutralizing antibodies at this timepoint were induced 2.6-fold with the microneutralization assay and 4.9-fold using the pseudovirus neutralization assays. On day 36 post-vaccination, interferon-gamma response by ELISpot increased 4.5-fold in the two-dose cohort and 2.5-fold in the one-dose cohort.
Kaufmann noted that CoviLiv does not require cold chain storage, making it easier to stockpile in areas that currently lack access to adequate refrigeration for vaccines. Furthermore, intranasal administration provides an alternative to intramuscular vaccines, which experts said could promote greater uptake in areas with lower vaccination rates.

"The study findings provide a glimpse into what could be the next generation of COVID-19 vaccines that provide differentiated protection to more people," she said. "Vaccine administration by nose and easier storage can increase access to vaccinations for underserved areas across the world."
There are currently no intranasal vaccines approved for use against COVID-19.
Wastewater as a Sentinel for Viruses Beyond COVID
Every time you flush the toilet, you are giving scientists clues about what respiratory viruses may be emerging, researchers suggested.
In a Canadian study in the city of Calgary, wastewater-based surveillance was able to accurately predict if the area was primed for outbreaks of seasonal diseases such as influenza A, influenza B, or respiratory syncytial virus (RSV).

"Just one flush can hold a lot of information. Wastewater surveillance equips public health experts, clinicians, policymakers, and the public with community-based, objective data to inform health and safety decisions against the flu and RSV," said Kristine Du, BSc, a lab technician at the Cumming School of Medicine at the University of Calgary. "Knowing what viruses are coming down the pike can help prepare individuals and communities appropriately."

At the press briefing, Du said viral signals in Calgary's wastewater correlated with weekly confirmed clinical cases for all three viruses. Influenza A peaked in Calgary's wastewater in November-December 2022; influenza B in February-April 2023; and RSV in November 2022-February 2023.
The data come from weekly collection of 24-hour composite wastewater samples from three treatment plants in Calgary from March 2022 to April 2023. The wastewater values were compared with clinical data reported by Alberta Health Services and reported as total cases and test positivity rates across Calgary and Alberta.
Moving forward, researchers said that onboarding additional respiratory viruses to wastewater surveillance capabilities will help provide a comprehensive assessment of viral respiratory disease activity.
Avoiding Infant Hospitalizations With the Maternal RSV Vaccine
Vaccinating pregnant women with the newly approved RSV vaccineopens in a new tab or window may reduce hospitalizations and the financial resource burden that occurs when children under the age of 1 year are sickened by the infection, researchers suggested.

"The potential benefits of this vaccine underscore how important immunization is for helping prevent serious disease in infants and offering savings to our health system," said Amy W. Law, PharmD, director of global value and evidence at Pfizer, during the press briefing. "These findings provide evidence for expecting families, facing an exciting and changing time in their lives, with an option to offer protection for their child against severe respiratory illness."
Law reported that the vaccine is the first of its kind to produce antibodies in pregnant women to help prevent RSV infection in infants. Approximately 500,000 to 600,000 U.S. infants experience lower respiratory tract disease caused by RSV each year, and it is a leading cause of infant hospitalization.
The CDC's Advisory Committee on Immunization Practices recommended that pregnant womenopens in a new tab or window receive a single dose of Pfizer's prefusion F protein (RSVpreF) vaccine (Abrysvo) at 32 to 36 weeks' gestation to prevent lower respiratory tract RSV infection in infants.

Law said her data are based on a cohort model that depicted clinical outcomes and economic costs of RSV from birth to 1 year of age, lifetime consequences of premature death, and impacts of maternal vaccination among infants. The economic costs are based on cases and corresponding unit costs of direct care, such as hospitalizations, and indirect care, such as time spent caregiving.
The model suggested that a vaccination program for pregnant women with 3.7 million births in the U.S. each year would result in:

• A 50.8% decrease in hospitalizations
• A 31.8% decline in emergency department visits
• A 32.2% decline in outpatient clinic visits
• A decrease of $691.8 million in direct medical costs and $110 million in indirect costs

IDWeek is the joint annual meeting of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, the Pediatric Infectious Diseases Society, and the Society of Infectious Diseases Pharmacists.

• 
  Ed Susman is a freelance medical writer based in Fort Pierce, Florida, USA.
• 
  
• "

 

[missy]

"
Bloomberg dot com

Should I get all my vaccines at once?​

Should you consider having a Covid-19 vaccine, an RSV vaccine and a flu shot? If so, do you have to wait in between? Is this vaccine overload? — Gale, Toronto One trip to the pharmacy for a shot definitely seems easier than three. But before we dive into whether it’s safe to opt for the three-for-one special, let’s talk basics. Last fall, we were hit with a “tripledemic” of influenza, Covid and respiratory syncytial virus — a common ailment that causes cold-like symptoms but can be dangerous for very young or old people. This is the first year we have vaccines for all three diseases, which are great tools for public-health officials to have. “These vaccines reduce the severity of disease and they are excellent at that job,” says Katrine Wallace, an epidemiologist at the University of Illinois at Chicago. “Vaccines may not prevent all infections, but they do prevent hospitalizations and deaths from the infections.” This year’s flu shot is a “quadrivalent” jab that targets strains of seasonal flu. Experts recommend that everyone 6 months and older get it by the end of October. The new Covid shot targets the XBB.1.5 strain of the virus, which is closely related to dominant strains circulating now. Health officials say people older than 6 months should get that one, too. Lastly, there’s the RSV vaccine. It’s available for both people 60 and older and those 32- to 36-weeks pregnant, to protect the child in the early months of life. (An RSV monoclonal antibody shot is also available for babies.) Now, onto the question at hand. The answer is mostly yes, getting at least some of the shots at the same visit is fine. “Co-administration of the flu vaccine and the Covid vaccine is safe and is recommended by the CDC,” says Wallace. “It’s also the easiest way to get up to date on both shots.” You can get a jab in each arm, or the same arm. It doesn’t matter. However, a recent study did find that those who doubled up reported reactions like fatigue, headache and muscle ache more frequently than people who only got the Covid shot. But the reactions were mostly mild and went away quickly. The jury is still out, though, on whether it’s safe to add the RSV shot to the mix. Wallace says she recommends getting the flu and Covid jabs together, then waiting a few weeks for RSV if you’re eligible for it. “Stay up to date! No one wants serious respiratory viruses!” Wallace says. — Kristen V. Brown "

 

[missy]

"

The Case for a Yearly COVID Booster Shot​

— New analysis of Moderna's COVE trial looked at best time for boosters​

by Ed Susman, Contributing Writer, MedPage Today October 17, 2023


BOSTON -- A yearly booster with an mRNA-based COVID vaccine may provide the best protection against catching the pandemic disease, a new analysis of the phase III COVE trial suggested.
"Interestingly, we found that the longer duration between boosting actually provides better protection against COVID-19," Dean Follmann, PhD, of the National Institute of Allergy and Infectious Diseases in Bethesda, Maryland, said here at the IDWeek annual meetingopens in a new tab or window. There was a 24% reduced risk of catching Omicron if the time between the original vaccination and booster was 12.9 months compared with 8.2 months, he reported.

Follmann explained that in the original COVE trialopens in a new tab or window -- the study that led to emergency use authorization of Moderna's mRNA vaccine -- it became apparent that the effectiveness of the vaccine waned after a period of months, and the trial protocol was amended to allow for boosters. However, because the amendment occurred during the trial, participants were given boosters at different times. This gave researchers a chance to employ statistical methods to calculate when the best times for giving boosters would be.
"We knew that the original two-dose regimen of mRNA-1273 was highly efficacious and resulted in an emergency use authorization in December of 2020," Follmann said. "Later data through the blinded phase of that trial showed that this durability worked for months, but since then, we've learned that immunity wanes over time, but if it's boosted or increased with a third dose of mRNA-1273 it shows increases in both binding and neutralization assays. We also know that adults older than 50 are at increased risk of severe COVID-19 outcomes."

He noted that among people age 65 and older, there was an initial vaccine efficacy of 86% against the Omicron strain, which waned to 28% after about 4 months. For people under 65, the initial vaccine efficacy against Omicron was 50%, and that protection waned to around 6% after 4 months, he said.
Annual Booster 'Makes Sense to Me'
Session moderator Rajesh Gandhi, MD, of Massachusetts General Hospital/Harvard Medical School in Boston, called the data "important," and told MedPage Today: "What I am telling colleagues and patients is that an annual COVID-19 vaccine makes sense to me. I will be getting my annual vaccine in the next few weeks."

"People who have not had a vaccine for a year or more would be well served in getting one, particularly if they are at high risk for severe disease," Gandhi continued. "We have seen over and over again during the SARS CoV-2 Omicron era that there is benefit from the vaccine, but it is not an indefinite benefit. I think it shows that you can't rely on a vaccine from a year ago, or especially 2 years ago, to be fully protective today. We probably should be getting an annual COVID-19 vaccine going forward."

Study Details
The analysis assessed protection coverage of the original monovalent mRNA-1273 vaccine, Follmann said. Boosting efficacy was evaluated against Delta and BA.1 Omicron, the strains circulating during the boosting period in the study (September 2021 to April 2022).
For the current analysis, Follmann and colleagues evaluated the effectiveness of the mRNA-1273 50 μg booster -- the so-called third dose of the Moderna vaccine -- in 17,025 adult participants (48% women, more than 77% white) who previously received two doses of 100 µg mRNA-1273 during the randomized placebo-controlled phase or in the open-label phase in 2020-2021. A total of 8,298 participants (mean age 54.5) were in the early-boosted group and 8,727 participants (mean age of 51. were in the late/never-boosted group.

• 
  
  Ed Susman is a freelance medical writer based in Fort Pierce, Florida, USA.

Disclosures
The research was supported in whole or in part with federal funds from the Department of Health and Human Services, the Administration for Strategic Preparedness and Response, and the Biomedical Advanced Research and Development Authority.
Follmann reported having no conflicts of interest to declare; several co-authors are employees of Moderna and may hold stock or stock options; another is a consultant for Moderna; other co-authors reported receiving grants from NIH and/or the National Institute of Allergy and Infectious Diseases during the conduct of the study.
Gandhi reported having no relevant relationships with industry.
Primary Source
IDWeek
Source Reference: opens in a new tab or windowFollmann D, et al "Who to boost when: An analysis of dosing interval and age on COVID-19 outcomes in the COVE trial during the Delta and Omicron waves" IDWeek 2023.
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[missy]

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FDA Authorizes Updated Novavax COVID-19 Vaccine Formulated to Better Protect Against Currently Circulating Variants​

​

For Immediate Release:

October 03, 2023​

​

Today, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) of the Novavax COVID-19 Vaccine, Adjuvanted for use in individuals 12 years of age and older to include the 2023-2024 formula. Individuals 12 years of age and older previously vaccinated with a COVID-19 vaccine (and who have not already been vaccinated with a recently updated mRNA COVID-19 vaccine) are eligible to receive one dose and unvaccinated individuals receive two doses.
The updated vaccine addresses currently circulating variants to provide better protection against serious consequences of COVID-19, including hospitalization and death. Consistent with the totality of the evidence and input from the FDA’s expert advisors, the Novavax COVID-19 Vaccine, Adjuvanted, a monovalent vaccine, has been updated to include the spike protein from the SARS-CoV-2 omicron variant lineage XBB.1.5 (2023-2024 formula).
This authorization follows the FDA’s recent approvals and authorizations of updated mRNA COVID-19 vaccines for 2023-2024 manufactured by ModernaTX Inc. and Pfizer Inc.
“The COVID-19 vaccines have saved countless lives and have prevented serious outcomes of COVID-19 caused by the SARS-CoV-2 virus,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “Today’s authorization provides an additional COVID-19 vaccine option that meets the FDA’s standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization. As we head into the fall season and transition into 2024, we strongly encourage those who are eligible to consider receiving an updated COVID-19 vaccine to provide better protection against currently circulating variants.”
The FDA evaluated manufacturing data to support the change to the 2023-2024 formula of the Novavax COVID-19 Vaccine, Adjuvanted. Additionally, the FDA evaluated non-clinical immune response data suggesting that the vaccine provides protection against the currently circulating COVID-19 variants. The agency also relied on its evaluation of safety and effectiveness data from clinical trials of Novavax COVID-19, Vaccine, Adjuvanted (Original monovalent) and investigational monovalent and bivalent Novavax COVID-19 adjuvanted vaccines, as well as postmarketing data. The data accrued with these Novavax COVID-19 vaccines are relevant to Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) as the vaccines are manufactured using a similar process.
The FDA has determined that the Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) has met the statutory criteria for issuance of an EUA, and that the known and potential benefits of the vaccine outweigh its known and potential risks in individuals 12 years of age and older.
As part of today’s action, the Novavax COVID-19 Vaccine, Adjuvanted (Original monovalent) is no longer authorized for use in the United States.
The FDA granted the emergency use authorization of the Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) to Novavax Inc. of Gaithersburg, Maryland.
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"
On October 3, 2023, the Food and Drug Administration amended the emergency use authorization (EUA) of Novavax COVID-19 Vaccine, Adjuvanted to include the 2023-2024 formula. The Novavax COVID-19 Vaccine, Adjuvanted, a monovalent vaccine, has been updated to include the spike protein from the SARS-CoV-2 Omicron variant lineage XBB.1.5 (2023-2024 formula). The Novavax COVID-19 Vaccine, Adjuvanted (Original monovalent) is no longer authorized for use in the United States.

Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) is authorized for use in individuals 12 years of age and older as follows:

• Individuals previously vaccinated with any COVID-19 vaccine: one dose of Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) is administered at least 2 months after receipt of the last previous dose of an original monovalent (Original) or bivalent (Original and Omicron BA.4/BA.5) COVID-19 vaccine.
• Individuals not previously vaccinated with any COVID-19 vaccine: two doses of Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) are administered three weeks apart.
• Immunocompromised individuals: an additional dose of Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) may be administered at least 2 months following the last dose of a COVID-19 vaccine (2023-2024 Formula). Additional doses of Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) may be administered at the discretion of the healthcare provider, taking into consideration the individual’s clinical circumstances. The timing of the additional doses may be based on the individual’s clinical circumstances.

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[missy]

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Prevalence of Symptoms ≤12 Months After Acute Illness, by COVID-19 Testing Status Among Adults​

United States, December 2020-March 2023​

Juan Carlos C. Montoy, MD, PhD; James Ford, MD; Huihui Yu, PhD; Michael Gottlieb, MD; Dana Morse; Michelle Santangelo, MS; Kelli N. O'Laughlin, MD; Kevin Schaeffer; Pamela Logan, MD; Kristin Rising, MD; Mandy J. Hill, DrPH; Lauren E. Wisk, PhD; Wafah Salah; Ahamed H. Idris, MD; Ryan M. Huebinger, MD; Erica S. Spatz, MD; Robert M. Rodriguez, MD; Robin E. Klabbers, MSc; Kristyn Gatling, MA; Ralph C. Wang, MD; Joann G. Elmore, MD; Samuel A. McDonald, MD; Kari A. Stephens, PhD; Robert A. Weinstein, MD; Arjun K. Venkatesh, MD; Sharon Saydah, PhD

Abstract and Introduction​

Abstract​

To further the understanding of post-COVID conditions, and provide a more nuanced description of symptom progression, resolution, emergence, and reemergence after SARS-CoV-2 infection or COVID-like illness, analysts examined data from the Innovative Support for Patients with SARS-CoV-2 Infections Registry (INSPIRE), a prospective multicenter cohort study. This report includes analysis of data on self-reported symptoms collected from 1,296 adults with COVID-like illness who were tested for SARS-CoV-2 using a Food and Drug Administration–approved polymerase chain reaction or antigen test at the time of enrollment and reported symptoms at 3-month intervals for 12 months. Prevalence of any symptom decreased substantially between baseline and the 3-month follow-up, from 98.4% to 48.2% for persons who received a positive SARS-CoV-2 test results (COVID test–positive participants) and from 88.2% to 36.6% for persons who received negative SARS-CoV-2 test results (COVID test–negative participants). Persistent symptoms decreased through 12 months; no difference between the groups was observed at 12 months (prevalence among COVID test–positive and COVID test–negative participants = 18.3% and 16.1%, respectively; p>0.05). Both groups reported symptoms that emerged or reemerged at 6, 9, and 12 months. Thus, these symptoms are not unique to COVID-19 or to post-COVID conditions. Awareness that symptoms might persist for up to 12 months, and that many symptoms might emerge or reemerge in the year after COVID-like illness, can assist health care providers in understanding the clinical signs and symptoms associated with post-COVID–like conditions.

Introduction​

Post-COVID conditions, or long COVID, comprise a range of symptoms that persist or develop ≥4 weeks after initial SARS-CoV-2 infection, and which are associated with substantial morbidity and reduced quality of life.[1] Estimates of prevalence vary across settings, periods, and patient populations; and many studies lack comparison groups.[2] Symptom trajectory over time using serial measurements has received little attention. Symptoms might either persist or emerge, and previous prevalence estimates typically include both persisting and emerging symptoms, without distinguishing between them.[1,2]

Methods​

Innovative Support for Patients with SARS-CoV-2 Infections Registry (INSPIRE) is a prospective study including eight participating major health care systems,* designed to assess long-term symptoms and outcomes among persons with COVID-like illness at study enrollment who received a positive or negative SARS-CoV-2 test result†,§,¶ (COVID test–positive or COVID test–negative participants, respectively).[2] Participants could report subsequent SARS-CoV-2 positive test results at each follow-up survey. Participants who completed baseline and 3-, 6-, 9-, and 12-month follow-up surveys were included to facilitate distinguishing between emerging and ongoing symptoms. Outcomes included self-reported symptoms across eight symptom categories: 1) head, eyes, ears, nose, and throat (HEENT); 2) constitutional; 3) pulmonary; 4) musculoskeletal; 5) gastrointestinal; 6) cardiovascular; 7) cognitive difficulties; and extreme fatigue (based on fatigue severity scales, which measure the occurrence and severity of eight symptoms associated with postinfectious syndrome; scores range from 10 to 80 and scores ≥25 correspond with previously established threshold for extreme fatigue).**,†† At each period, a participant was defined as having a persistent symptom if he or she had the symptom at that visit and all previous periods. Emerging symptoms were those present at a given time point but not present at the previous time point, including symptoms that resolved and reemerged after an absence.

Analyses included descriptions of the participants' sociodemographic and clinical characteristics; statistical comparisons of the COVID test–positive and COVID test–negative groups were performed using Pearson's chi-square tests. The prevalence of symptom persistence was defined as the proportion of participants with persistent symptoms at each time point; binomial 95% CIs were calculated for each outcome within each group and Pearson's chi-square tests were used to test for differences in proportions. Symptom trajectories were reported as symptom prevalences at each time point, and the proportion of participants with emerging symptoms was also reported. All results are presented by symptom category, stratified by participants' COVID test–positive and COVID test–negative status. Participants who reported a subsequent positive SARS-CoV-2 test result during the follow-up period were excluded from the analysis; as a sensitivity analysis, the same analysis was conducted for the entire cohort. Statistical analyses were performed using SAS software (version 9.4; SAS Institute). This study was approved by the institutional review boards at all eight institutions.§§

Results​

Among 6,075 enrolled participants, 3,726 (61%) completed the 12-month survey, 1,741 (47%) of whom completed all quarterly surveys through 12 months, including 1,288 COVID test–positive and 453 COVID test–negative participants, and are included in this study. Overall, 271 (21%) COVID test–positive participants reported a reinfection and 174 (38%) COVID test–negative participants reported a new infection during the 12-month follow-up period (p<0.01) and were excluded from the main analysis (Supplementary Figure 1, https://stacks.cdc.gov/view/cdc/131538). Approximately two thirds of participants identified as female (842; 67.4%) and 905 (72%) as non-Hispanic White (Table 1). Compared with the COVID test–negative group, a lower percentage of participants in the COVID test–positive group identified as female (65.2% versus 75.2%; p<0.01), and a higher percentage reported being married or living with a partner (60.3% versus 48.9%; p<0.01), and having been hospitalized for acute COVID-like illness (5.6% versus 0.4%; p<0.01). The prevalence of asthma was higher in the COVID test–negative group (18.3% versus 11.6%; p<0.01), as were the prevalences of kidney disease (2.5% versus 0.6%; p<0.01) and other unspecified conditions (20.1% versus 14.5%; p = 0.02).

Symptom prevalence at baseline and persistence through 12 months varied according to symptom category (Table 2). A higher proportion of COVID test–positive participants reported symptoms in each category, except for extreme fatigue, at baseline compared with COVID test–negative participants. Symptom prevalence declined over time within each symptom category: 18.3% of COVID test–positive participants and 16.1% of COVID test–negative participants reported persistent symptoms of any type through 12 months. Symptom persistence through 12 months for a given symptom category ranged from 0.3% (gastrointestinal symptoms) to 5.9% (HEENT symptoms) among COVID test–positive participants and from 1.1% (cardiovascular symptoms or pulmonary symptoms) to 6.8% (extreme fatigue) among COVID test–negative participants. Only the persistence of extreme fatigue was statistically significantly different at 12 months between COVID test–positive participants (3.5%) and COVID test–negative participants (6.8%).

During the follow-up period, the symptom prevalences in each category except for extreme fatigue were similar at each time point for both COVID test–positive and COVID test–negative participants (Figure). Overall, no difference in symptom prevalence between COVID test–positive and COVID test–negative participant groups was observed across the four periods for the nine total symptom categories. Among COVID test–negative participants, prevalence of extreme fatigue was higher at 9 and 12 months compared to the COVID test–positive group. Approximately one half of participants in each group experienced any symptom at 12 months. Emerging symptoms were reported for every symptom category at each follow-up period for both groups. COVID test–negative participants reported higher prevalences of emerging symptoms at 6 and 12 months in each of the symptom categories, except severe fatigue (Table 1). When participants who reported a subsequent positive SARS-CoV-2 test result were included, the observed pattern was similar to that in the primary analysis, with more statistically significant differences in symptom prevalence during the follow-up period (Supplementary Figure 2, https://stacks.cdc.gov/view/cdc/131538) (Supplementary Figure 3, https://stacks.cdc.gov/view/cdc/131538).

(Enlarge Image)
Figure.
Self-reported prevalence of emerging and reemerging symptoms,*,†,§ by symptom category during 12 months¶ among adults with an acute COVID-like illness with no evidence of new or reinfection by SARS-CoV-2 test result status** — Innovative Support for Patients with SARS-CoV-2 Infections Registry, United States, December 2020–March 2023
Abbreviation: HEENT = head, ears, eyes, nose, and throat.
*Symptom categories were any symptom (one or more symptoms), HEENT (headache, runny nose, loss of smell, loss of taste, sore throat, and loss of hair), constitutional (tired, chills, feeling hot, fever, and shakes), pulmonary (cough, shortness of breath, and wheezing), musculoskeletal (aches and joint pains), gastrointestinal (diarrhea, nausea or vomiting, and abdominal pain), cardiovascular (chest pain and palpitations), cognitive difficulties (forgetfulness/memory problems, difficulty thinking, or difficulty concentrating), and extreme fatigue (fatigue severity score ≥25).
†Emerging symptoms were symptoms present at a given time point but not at the previous time point, including symptoms that resolved and reemerged after an absence.
§https://www.cdc.gov/me-cfs/pdfs/wichita-data-access/symptom-inventory-doc.pdf
¶Point prevalence at each time point is presented for the COVID test result–positive and COVID test result–negative groups for each symptom category.
**Without evidence of reinfection.

Discussion​

In this prospective, multicenter study of 1,296 persons with acute COVID-like illness, approximately 16% of participants reported persistent symptoms 12 months after their illness, irrespective of their SARS-CoV-2 test result status at baseline. A higher proportion of COVID test–positive than COVID test–negative participants reported symptoms in each symptom category at baseline. The prevalence of symptoms declined substantially in both groups from baseline to the 3-month follow-up assessment and continued to gradually decrease at the 6-, 9-, and 12-month follow-up assessments; persistence of any symptom prevalence at 12 months was not statistically significantly different between the COVID test–positive (18.3%) and COVID test–negative (16.1%) participant groups.

These findings expand the understanding of post-COVID conditions. Previous studies have reported symptom prevalence estimates across varied, nonstandardized periods or at a single point in time, resulting in challenges comparing studies and difficulty distinguishing among the presence of reported persistent symptoms at the time of COVID-19 diagnosis, those that resolved and then reemerged, and those that emerged after initial recovery.[3–9] Few previous longitudinal studies have compared symptoms in COVID test–positive participants with those in persons with a COVID-like illness and who received negative SARS-CoV-2 test results. By conducting serial measurements of emerging and ongoing symptoms, this study was able to ascertain that participants who were symptomatic at a given time point included participants with ongoing symptoms as well as those with emerging symptoms (i.e., symptoms that were not present 3 months earlier). The inclusion of participants with COVID-like illness and negative test results guides discussions on characterizing symptoms associated with post-COVID conditions.[10] This differentiation adds nuance and clarity to the natural history of post-COVID conditions and characterizes the fluctuating nature of symptoms over time and recognizes that these symptoms are not unique to COVID-19 or to post-COVID conditions. Many participants experienced new symptoms ≥6 months after the acute illness, suggesting that the prevalence of emerging symptoms in the months after acute COVID-like illness might be considerable. Cognitive difficulties and extreme fatigue were two common symptoms that emerged after 6 months and are often reported to occur with post-COVID conditions.[1,3,6,9]Differentiating between symptoms that resolve and emerge over time helps to characterize post-COVID conditions and suggests that measurements at single time points underestimate or mischaracterize the true effects of disease.

Limitations​

The findings in this report are subject to at least four limitations. First, among the COVID test–negative group, no information on any other condition that might have caused the reported acute symptoms is available. Second, although the number of participants who subsequently reported a positive SARS-CoV-2 test result was higher in the COVID test–negative than in the COVID test–positive group, the rate of nonresponse to the question about having a subsequent SARS-CoV-2 test result was relatively higher in the COVID test–negative group. Testing was not systematically performed and participants with a subsequent SARS-CoV-2 infection might have not tested or might have received a false-negative test result. However, analysis including participants who reported subsequent positive test results did not differ substantially; thus, the results are not likely driven by subsequent SARS-CoV-2 infections. Infection with any other pathogen or the occurrence of other medical problems might have been experienced by persons in either group and could account for some reported symptoms. Third, the survey did not include all possible symptoms; therefore, other symptoms might not have been captured. Finally, this study did not report symptom severity or impact on daily activities, thus the functional significance of these findings could not be assessed.

Implications for Public Health Practice​

Given the findings that approximately 16% of persons who have had an acute COVID-like illness might experience persistent symptoms through 12 months, post-COVID–like conditions could represent a substantial impact on health and the health care system. This report highlights the patterns of symptoms after acute COVID-like illness by providing estimates of symptom prevalence for both ongoing and emerging symptoms. Improved understanding of the persistent and fluctuating nature of symptoms could guide clinical care and public health response to post-COVID–like conditions.

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[missy]

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Pfizer to Price COVID Treatment Paxlovid at $1390 Per Course​

By Michael Erman
October 19, 2023

(Reuters) - Pfizer on Wednesday said it will set the U.S. price for its COVID-19 antiviral treatment Paxlovid at nearly $1,400 per five-day course when it moves to commercial sales after government stocks run out, more than double what the government currently pays for it.
The new list price, which does not include rebates and other discounts to insurers and pharmacy benefit managers, is $1,390 per course, Pfizer said in an emailed statement. The U.S. government paid around $530 per course for Paxlovid it has made available to Americans at no cost.
Paxlovid, the most commonly prescribed at home treatment for COVID-19 in the U.S., will remain available for free to patients there until the end of the year, Pfizer said.
Under an agreement with the government, the drug will also stay free of charge for patients insured under the Medicare and Medicaid programs through the end of 2024, and to uninsured and underinsured patients through 2028.


In Pfizer's clinical trial, Paxlovid was shown to reduce hospitalizations and death by around 90% for unvaccinated people at risk for serious disease. In another trial, Pfizer was not able to show benefit for those considered at standard risk, including vaccinated patients.




Influential U.S. drug pricing watchdog the Institute for Clinical and Economic Review (ICER) said last year that its suggested price range for Paxlovid based on the benefits and value to patients was between $563 to $906 per course.
The United States purchased around 24 million courses of the oral two-drug treatment from Pfizer, and still had a large supply, but arranged to return 7.9 million courses last week. The company also slashed its full-year revenue forecast due to lower-than-expected sales of its COVID-19 products.
Under that deal, a credit for the returned Paxlovid doses will pay for the supply to Medicare, Medicaid, underinsured and uninsured patients.

Demand for the drug has fallen since last year. In 2022, patients were given around 7 million courses of the drug, according to U.S. government data. Through Oct. 1, around 3.4 million courses had been administered in 2023.
The new list price was first reported by the Wall Street Journal.
(Reporting by Michael Erman in Maplewood, N.J.; Editing by Bill Berkrot)


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I will add what my pulmonologist at Columbia Presbyterian told me. She is heavily involved in research and is well known in the field of pulmonology. She said in their patients they are seeing 60% rebound with Paxlovid and according to her it is worse than the actual disease at this point in time. This is what she told me just a few weeks ago. FYI

 

[missy]

Novavax

Is the Novavax COVID Vaccine Better Than mRNA Vaccines? What We Know So Far

Novavax’s protein-based vaccine is the latest FDA-authorized COVID booster available this fall. Here’s what you should know

www.scientificamerican.com

 

[missy]

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Fall 2023 vaccine coverage and reaching "passive positives"​

Our piece in Scientific American​

KATELYN JETELINA OCT 24

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We are approaching the end of October, and at least 10 million Americans have gotten the Fall 2023 Covid-19 vaccine. This amounts to ~3% of the eligible population (only 7% of nursing home residents). This is severely trailing typical flu vaccine coverage, just like last fall.

​

For those interested in nuance: Is this year trailing last year’s Covid-19 coverage too? Well, yes, as seen in the line above. But, we are comparing apples to oranges. The end of the public health emergency meant that states were no longer required to report vaccine uptake to the CDC, but some are still reporting. So, the 2023 numbers are the bare minimum. Models considering differential reporting show Covid-19 coverage is about the same as last year.

This is nothing to brag about.

Five reasons​

Covid-19 is more transmissible, more severe, has more long-term implications, and is more unpredictable than the flu. So, why is coverage so much lower than flu?

1. Covid-19 circulates year-round, while flu circulates seasonally. This means that ~15% of the population was infected with Covid-19 this summer and do not need the fall vaccine.
2. Debate on eligibility. There is a debate about whether those under 65 “need” a Covid-19 vaccine. Many physicians I highly regard (but disagree with) are on the fence about recommending it for everyone. We don’t have this with flu.
3. Lack of access. The choppy rollout this fall is well documented. Even with distribution smoothed out, there is a lack of access. For some local health clinics, the vaccine costs more than they can afford or willing to financially risk. This is causing grave inequities. The closest place for my youngest is 50 miles away.
4. Fatigue. We have been hammered to get Covid-19 vaccines for the past three years. People are just… tired… of hearing about it.
5. Lack of resources. There is now zero federal money for a Covid-19 vaccine campaign for education and outreach. Health departments are on their own, too. (The panic and neglect cycle is too real in public health.)

So what should we do?​

All of us—friends, family, neighbors, schools, pharmacies, doctor offices, health departments, employers—need to be laser-focused on “passive positives.”
This approach works with organ donations. We should do it with vaccines. And it’s beyond time we leverage behavioral science to get vaccinations in arms as much as we do bench science to get vaccines in vials.
In a Scientific American piece last week, I partnered with two leading psychologists on the what, how, and why behind passive positives. Check it out HERE.

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Bottom line​

Increasing trust, access, and coverage of vaccines will take an all-hands-on-deck approach. We are exhausted, but it’s worth the push—fewer lives will be lost, fewer work and school days will be missed, and our quality of life will improve.
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[Karl_K]

Had my booster yesterday and after near zero reactions to the others its kickin my rear this time.
Chills, body ache and just general blah zero energy.
Pfizer booster and all my others were Pfizer also.

 

[missy]

Had my booster yesterday and after near zero reactions to the others its kickin my rear this time.
Chills, body ache and just general blah zero energy.
Pfizer booster and all my others were Pfizer also.

Hi Karl! That actually could be a good sign because it means your body is building up a defense against the virus should you get infected. So take heart. And I hope you are feeling much better today!