September 2023 Coronavirus updates

[missy]

"

FDA OKs Updated COVID Shots​

— New single-strain vaccines will exclusively target the XBB.1.5 Omicron subvariant​

by Ian Ingram, Managing Editor, MedPage Today September 11, 2023

The FDA has authorized and approved updated mRNA COVID-19 vaccinesopens in a new tab or window for use in adults and children ages 6 months and up, the agency announced on Monday.
Doing away with any vestige of the original vaccines -- the bivalent shots targeted both BA.4/5 and the wild-type strain -- the new vaccines from Pfizer-BioNTech and Moderna are monovalent products that solely target the XBB.1.5 Omicron subvariant, following recommendations from an FDA advisory panelopens in a new tab or window that convened in June.

The updated vaccines -- approved for people 12 years and up and under emergency authorization for kids 6 months to 11 years of age -- can be used for primary series or booster vaccinations, and with this new action, the previous bivalent shots are no longer authorized for use in the U.S.
While XBB.1.5 now only makes up 3% of U.S. cases, according to CDC's Nowcast trackeropens in a new tab or window, the shots are still expected to offer broad protection against circulating strains. EG.5, dubbed Erisopens in a new tab or window, is currently responsible for the largest share of cases in the nation (22%), followed by FL.1.5.1 (15%) and then mostly a slew of XBB strains.
A particular concern of late has been the BA.2.86 or Pirola strainopens in a new tab or window, which has yet to register on CDC's tracker. Vaccine makers Modernaopens in a new tab or window and Pfizeropens in a new tab or window have assured, however, that their XBB.1.5-adapted products can effectively neutralize the highly mutated variant. The extent of neutralization appears "to be of a similar magnitude to the extent of neutralization observed with prior versions of the vaccines against corresponding prior variants against which they had been developed to provide protection," the FDA stated.

Under the FDA's action, people 5 years and older can receive a single dose of the updated mRNA vaccines at least 2 months since their last dose of any COVID vaccine.
For kids 6 months to 4 years, those who have been previously vaccinated will be eligible for one or two doses of the new products, depending on how many previous doses they have received. Those currently unvaccinated can receive three doses of Pfizer's vaccine or two doses of Moderna's vaccine.
Under the new approval, primary series vaccinations in people 12 years and older for Moderna and Pfizer's products call for a single dose (down from two doses).
"Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death," Peter Marks, MD, PhD, director of the FDA's Center for Biologics Evaluation and Research, said in a statement. "The public can be assured that these updated vaccines have met the agency's rigorous scientific standards for safety, effectiveness, and manufacturing quality. We very much encourage those who are eligible to consider getting vaccinated."

It's widely expected that CDC will recommend the updated boosters for older adults and other vulnerable groups -- such as immunocompromised individuals and those with established medical conditions placing them at high risk for severe outcomes from COVID-19 -- though it's less clear how forceful recommendations will be for younger, healthy populations.
Uptake of the bivalent vaccine, authorized last summer, was limited, with only 17% of the total population opting for a shotopens in a new tab or window to date. That rate reached 43% for adults 65 and over.
Full recommendations for use of the new monovalent vaccines will be made at a meeting of CDC's Advisory Committee on Immunization Practices (ACIP) scheduled for Tuesday, September 12opens in a new tab or window.

"

 

[missy]

"

New COVID Vaccines Force Bivalents Out​

Allison Shelley
September 11, 2023

COVID vaccines will have a new formulation this year, according to a decisionannounced today by the US Food and Drug Administration that will focus efforts on circulating variants. The move pushes last year's bivalent vaccines out of circulation because they will no longer be authorized for use in the United States.
The updated mRNA vaccines for 2023-2024 are being revised to include a single component that corresponds to the Omicron variant XBB.1.5. Like the bivalents offered before, the new monovalents are being manufactured by Moderna and Pfizer.
The new vaccines are approved for use in individuals age 6 months and older. And the new options are being developed using a similar process as previous formulations, according to the FDA.

Targeting Circulating Variants​

In recent studies, regulators point out the extent of neutralization observed by the updated vaccines against currently circulating viral variants causing COVID-19, including EG.5, BA.2.86, appears to be of a similar magnitude to the extent of neutralization observed with previous versions of the vaccines against corresponding prior variants.


"This suggests that the vaccines are a good match for protecting against the currently circulating COVID-19 variants," according to the report.
Hundreds of millions of people in the United States have already received previously approved mRNA COVID vaccines, according to regulators who say the benefit to risk profile is well understood as they move forward with new formulations.

"Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death," Peter Marks, MD, PhD, director of the FDA's Center for Biologics Evaluation and Research, said in a statement. "The public can be assured that these updated vaccines have met the agency's rigorous scientific standards for safety, effectiveness, and manufacturing quality. We very much encourage those who are eligible to consider getting vaccinated."

Timing the Effort​

The US Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices will meet tomorrow to discuss clinical recommendations on who should receive an updated vaccine, as well as further considerations for specific populations such as immunocompromisedand older people.
Manufacturers have publicly announced that updated vaccines will be ready this fall and the FDA says it anticipates the updated vaccines will be available soon.

​

"

 

[ItsMainelyYou]

Great article;

Why scientist Eddie Holmes changed his mind on the origins of COVID-19

The renowned Australian virologist considered the possibility the virus leaked from a Wuhan lab, before changing his mind. He never expected his considerations to be at the centre of an international debate.

www.smh.com.au

Might be deemed too political for some!

It shouldn't be, it's science. I'm glad they were able to put the fearmongering to bed. It takes the last of wind out of the conspiracy disinformation sails.

 

[Gloria27]

early 2021, 95% effective, stops transmission!
summer 2022..... it's not, it doesn't

cause scienc$$$$$!

 

[Brigid]

@ItsMainelyYou I so agree!

 

[missy]

"

Your ACIP cliff notes​

Who is eligible for a Covid-19 vaccine this fall?​

KATELYN JETELINA SEP 12

​

Today ACIP—an external advisory committee to CDC—had a much-anticipated meeting with one goal: determine who is eligible for an updated Covid-19 vaccine this fall in the United States.
This 6-hour meeting was information-packed.
Here are your cliff notes.

Bottom Line Up Front (BLUF)​

Everyone over 6 months is eligible for an updated Covid-19 vaccine this fall. I strongly agree, as the benefits of vaccines outweigh the risks across all age groups.

First up, Novavax.​

Yesterday, the FDA approved mRNA vaccines for this fall, but did not include Novavax. FDA isn’t allowed to comment on why. (My guess is Novavax faced delays in approval for manufacturing—they’ve had trouble with this in the past).
CDC recognized the concern on the ground (for the record, this is a fantastic way to build trust) and clarified today’s recommendation was intentionally designed to be broad enough to cover Novavax when the FDA gives the “okay.”
Novavax stated:

• A fall vaccine is still planned. I’m optimistic.
• A vaccine will be available to those who previously had an mRNA vaccine.

Severe disease for kiddos is similar to flu.​

One of the biggest questions was whether vaccine benefits continue to outweigh the risks for kids. Updated stats were presented:

• More than half of children hospitalized for Covid-19 do not have a co-morbidity.
• Behind adults 75+ years, infants (<6 months) had the highest rate of Covid-19 hospitalization. The burden of severe illness is lowest among children ages 5–17 years compared to other age groups.
• For kids, hospitalization rates were lower or comparable to flu. Once hospitalized, though, more kids went to the ICU for Covid-19 than for flu.
  

  ​

  Percent of COVID-19- and Influenza-Associated Hospitalizations with ICU Admission among Infants, Children, and Adolescents by Age Group — COVID-NET and FluSurv-NET*, October 2022– April 2023. Source here.
• Covid-19 hospitalization rate is higher than other vaccine-preventable diseases.
  

  ​

  Other pediatric vaccine-preventable diseases: Annual hospitalizations per 100,000 population prior to recommended vaccines compared to COVID-19. Source here.

Myocarditis was not a safety signal last fall.​

After last fall’s updated Covid-19 vaccine, 2 myocarditis cases were verified out of ~650,000 doses. This is a much smaller rate for than the primary series. (We think this is because the increased time interval between doses reduces risk.) However, there is limited data, so this estimate has some uncertainty.

​

Incidence Rates of Verified Myocarditis or Pericarditis in the 0–7 Days After Bivalent Booster in Ages 12–39 years. Source here.
The benefits of a vaccine for severe disease among adolescents outweigh the risks.

​

Estimated COVID-19 hospitalizations prevented vs. potential myocarditis cases for every million mRNA COVID-19 vaccine doses: 12 – 17-year-olds. Source here. Vaccines reduce long Covid.

Long Covid remains a risk.​

Long Covid is a driving factor for many to remain vigilant. I was happy to see CDC presented data on this. One ACIP member noted: “This is the first time we’ve discussed a vaccine preventing acute and chronic health problems.”

• Prevalence has declined (thanks to immunity and virus changes) but remains a risk. Prevalence is highest among young adults.
  

  ​

  Prevalence of ongoing symptoms lasting at least 3 months after COVID-19 by age. Source here.
• Vaccines reduce long Covid, particularly among those who stay up-to-date. This applies to adults and children.

Updated vaccines worked last fall.​

How well? Pretty darn well.

• Emergency department and urgent care visits: 60% effectiveness among kids and adults. (As a comparison, this effectiveness is higher than for the flu vaccine.)
• Hospitalizations: 65% effectiveness, but this waned over time (→ 22% six months later). There is sustained protection against ICU admission.
  • Remember, effectiveness is “relative” to some combination of prior vaccination, prior infection, or both. This means the 65% benefit is above and beyond an individual's underlying immunity.

​

Absolute VE of original monovalent and bivalent booster doses against hospitalization and critical illness among immunocompetent adults aged ≥18 years – September 2022 – August 2023. Source here.

Vaccines are cost-effective for those >65 years old.​

This is the first time the government is not paying for Covid-19 vaccines. Pfzier/Moderna is charging ~$120 per dose and Novavax is ~$75. (I think the cost of these vaccines is absurd given taxpayers funded Operation Warp Speed.)
Nonetheless, is the bang worth the buck? The University of Michigan conducted an analysis and found:

• 65+ years old: Vaccines provide cost-saving in every scenario.
• 18-64 years: There was an average societal cost ($33,000) for every 1,000 quality life-years gained from the vaccine. This decreases if we get a surge of cases or the virus mutates to become more severe. In addition, it’s likely cost-effective among those with risk factors like comorbidities, but data wasn’t presented.

​

Scenario analysis: Probability of hospitalization preliminary estimates. Source here.

• <18 years: Unable to estimate given low numbers and high uncertainty.

Updated vaccine formula remains a good choice.​

Pharma companies showed increased antibodies against currently circulating variants, including the newer BA.2.86.

​

Cross Neutralization Results (Day 29) After XBB.1.5 Vaccine in Adults – Duke Assay. Source: Moderna.

Discussion​

Three noteworthy items were brought up:

1. Access may be challenging because this vaccine is now privatized. For example, pharma requires pediatricians to purchase at least 200 virals. This is a risk to providers and will unintentionally drive inequities.
2. Timing after previous vaccine/infection. This was not covered in presentations, which was incredibly disappointing. During the discussion, committee members asked and CDC’s answer was:
   1. Previous vaccine: Wait at least 2 months.
   2. Previous infection: No specific requirements, but 3 months was suggested.
      (I think this is too short; I’ll pull some evidence for a future YLE post.)
3. Universal vs. targeted. One ACIP member preferred a recommendation for specific groups— like those over 65 years— or words like “should” vs. “may” to communicate urgency. Other members (and I) strongly support universal recommendations because of four reasons:
   1. More lives saved. “Compared with only vaccinating those 65+ years, universal vaccine recommendations projected to prevent about 200,000 more hospitalizations and 15,000 more deaths over the next 2 years.”
   2. Close loopholes for private insurance. They must now cover the vaccine for all.
   3. Promotes equity among those who don’t have a physician.
   4. Increases uptake among *vulnerable* people. It’s less confusing. We’ve already learned this lesson from the flu.

​

ACIP voted (13-1) to recommend Covid-19 vaccines for everyone >6 months old. While the benefit profile differs significantly across age groups and time, risks of vaccination and infection remain outweighed for all ages.

What’s next?​

This goes to the CDC Director for approval. Then, technically, you’ll be able to get a vaccine. However, access may be delayed or challenging, and waiting may make sense for some (more on this later).


"

 

[missy]

"

Should You Get the Flu Shot and COVID Booster at the Same Time?​

— New data shed light​

by Jeremy Faust, MD September 12, 2023

An annual flu shot for all. An annual COVID shotopens in a new tab or window for some. (Or many? Or most? Or all? We don't know just yet.)
That seems to be where we are headed.
While there's a reasonable debate about whether everyone needs an annual COVID booster (rather than only people with increased risks), let's skip that for now. The rest of this article assumes patients who need both shots this fall.

The Big Question: Co-Administration or Not?
One of the most common questions I hear: Is it okay to get both the flu shot and a COVID booster at the same time? The concern is that if both vaccines are given at the same appointment, the body's immune response to one or both might be blunted, leading to lower effectiveness.
Last year, the CDC saidopens in a new tab or window it was fine to get both at once. This was based on research that looked at immune responses when one of the doses in the primary COVID vaccine series and an annual flu shot were given together.
Safety (It's Fine)
The upshot was that doing this -- what we call "co-administration" -- is safe, albeit with the possibility of somewhat higher rates of non-dangerous side effects. What the CDC didn't say -- but I will -- is that side effects might be a bit higher with a co-administration strategy, but in terms of overall hours or days with any side effects (such as body aches, fever, or fatigue), the "twofer" might cause less "momentary misery" for many.

Hypothetically, let's say that the COVID and the flu shot each have a 15% chance of causing 12 hours of side effects, but that when given at the same time, 25% of people have some side effects. If someone receives the COVID shot today and the flu shot 2 weeks later, the odds of side effects from at least one of them is 27.75% (The math: 85% of recipients don't have side effects from the COVID shot. Of that 85%, another 85% will have no side effects from the flu shot 2 weeks later; that means 72.25% won't have any side effects and the remaining 27.75% will. That's higher than the 25% of recipients who had the shots co-administered).
So, in my view, it's probably a wash. That said, there might be a signal suggesting that co-administration recipients have symptoms lasting a bit longer and they may be a bit more intense. But, the differences are not big and some might prefer to have side effects once rather than twice.

Effectiveness (It's Good)
The big question for scientists is whether COVID and seasonal flu shots work as well when co-administered. Prior research suggests that immune responses are basically equal -- with either no difference or a small but likely clinically unimportant decrease in antibody levels. But, those studies were done looking at the COVID vaccine primary series, not boosters. These days, virtually all adults getting COVID shots are getting boosters.
Good news, then. A studyopens in a new tab or window released last week in JAMA Network Open shows that recipients who had a seasonal flu shot and a COVID booster (in this case, the bivalent booster) at the same appointment had COVID antibody levels that were not "substantially inferior" to those who got one at a time. Researchers in Israel found that antibody levels were indeed 16% lower in the co-administration recipients, but the margin of error given the sample size rendered this finding not distinguishable from statistical noise. On top of that, both levels are way, way above any reasonable threshold for a "good immune response." So, even if the finding was "statistically real," it probably does not matter in any clinical sense. Either way, the vaccines triggered an ample response in antibodies, both of which would be adequate to stimulate the broad immune repertoire we need to stave off severe disease.

One caveat: we don't know whether co-administration affects the immune response to the flu shot. (This new study only looked at COVID antibodies.) But prior experience tells us that there should not be a problem in that direction either.
Timing (Early Is Not Always Better)
Okay, so you're going to get one or both shots. When should you get them? Increasingly, my colleagues are coming around to the idea that sooner is not better in all cases.
The old idea: You never know when flu or COVID waves will happen. So, the sooner you get a shot, the more days you are protected.
The newer idea: Actually, December to early March is when we expect to see far higher levels of viruses in circulation. Vaccine effectiveness does wane over time, so why waste your best window of protection in September or October when cases are likely to be far lower?

I've always been in the latter camp. I think more experts are leaning in this direction, as long as people don't end up forgetting to get their shots entirely!
Of course, there can be early unexpected peaks of these viruses. Fortunately, very high-risk people can get a COVID booster more often than once. So getting the COVID booster soon (i.e., this month once the new booster becomes available) and in a few months might be a good strategy for people with highly compromised immune systems. Those updated boosters should be rolled out in the coming couple of weeks, so my blanket advice is for people to wait for that. But there are always exceptions that hinge on individual circumstances (which health professionals can sort out with patients).
What About Repeat Dosing of Flu Vaccines for High-Risk Adults?
Can adults who are immunocompromised get two doses of the flu shot, spaced out similarly to how some at-risk patients are approaching COVID boosters? This approach has not been routinely applied to influenza vaccines, and the CDC does not comment on this in its guidanceopens in a new tab or window.

My guess?
More than one dose, given a few months apart, would be useful for at least some people. (Prioropens in a new tab or window studiesopens in a new tab or window did not space the doses enough to address waning; they were designed to see if two shots up front -- spaced just 1 to 2 months apart -- packed a bigger punch.) I believe researchers should re-examine this for people on chemotherapy or other profound immune suppression like those taking anti-rejection medications for organ transplants; some patients in these groups are likely to benefitopens in a new tab or window from more than one dose. This should be studied immediately!
The Bottom-Line (Co-Administration Is Fine, Some Nuance Is Possible)
The CDC is likely going to be pushing co-administration of COVID and flu shots as its primary public health strategy for those who need both. That makes great sense. Any small gain from getting one vaccine at a time would quickly be offset if even a small number of people didn't end up returning for the other shot. Life happens and people get busy -- or sick! So, if there's even a chance that you might not be able to get back for that second appointment, it's best to get both shots at once. But for those who can (and prefer it), it might make sense to space the shots. Higher-risk individuals in particular might choose this approach, especially those with immune systems that aren't quite as strong. In these cases, the possibility of a somewhat better immune response to one-at-a-time vaccine receipt might carry some meaning.


Jeremy Faust, MD,opens in a new tab or window is editor-in-chief of MedPage Today, and an emergency medicine physician at Brigham and Women's Hospital. He is author of the Substack column Inside Medicineopens in a new tab or window, where this postopens in a new tab or window originally appeared.

"

 

[OboeGal]

early 2021, 95% effective, stops transmission!
summer 2022..... it's not, it doesn't

cause scienc$$$$$!

I'm sure this is wasted on you, but for the benefit of folks here who actually ARE interested in the pursuit of truth in science.....in early 2021, the mRNA vaccines WERE 94%-95% effective in preventing infection across the broad population. They were the most effective vaccines that we've ever had, frankly, and that is absolute truth. What changed is not the vaccine or reality; what changed is the virus. It mutated in ways that we couldn't possibly foresee because, you know, it was a FREAKING NOVEL VIRUS! So with mutations affecting the spike protein, the vaccine became less effective in preventing infection. Over time, even with an unusually rapidly-mutating virus, the available mRNA original formula and bivalent boosters performed spectacularly in severely reducing the risk of hospitalization and death, and reduced the risk of infection (and therefore transmission) by around 25%-50%, on average, depending on age and immune status of recipient and time from vaccination. Data just out looking at the performance of the bivalent booster in particular against the Omicron variants that circulated since its release last fall show even better protection against infection than that.

No "lies," no conspiracies, not "all about the money," and anyone who wanted it could get it for free. Everything we were told about the effectiveness of the vaccines, at every point in time, by the medical and research community - not Billy Bob on social media, mind you, who you shouldn't be listening to for medical information anyway - were accurate and truthful at that point in time.

I expect anti-science propaganda on Facebook and such, but it's incredibly disappointing to see it here on Pricescope.

 

[YadaYadaYada]

Further proof you can’t trust Billy Bob, he’s got some issues.

 

[Lookinagain]

I'm sure this is wasted on you, but for the benefit of folks here who actually ARE interested in the pursuit of truth in science.....in early 2021, the mRNA vaccines WERE 94%-95% effective in preventing infection across the broad population. They were the most effective vaccines that we've ever had, frankly, and that is absolute truth. What changed is not the vaccine or reality; what changed is the virus. It mutated in ways that we couldn't possibly foresee because, you know, it was a FREAKING NOVEL VIRUS! So with mutations affecting the spike protein, the vaccine became less effective in preventing infection. Over time, even with an unusually rapidly-mutating virus, the available mRNA original formula and bivalent boosters performed spectacularly in severely reducing the risk of hospitalization and death, and reduced the risk of infection (and therefore transmission) by around 25%-50%, on average, depending on age and immune status of recipient and time from vaccination. Data just out looking at the performance of the bivalent booster in particular against the Omicron variants that circulated since its release last fall show even better protection against infection than that.

No "lies," no conspiracies, not "all about the money," and anyone who wanted it could get it for free. Everything we were told about the effectiveness of the vaccines, at every point in time, by the medical and research community - not Billy Bob on social media, mind you, who you shouldn't be listening to for medical information anyway - were accurate and truthful at that point in time.

I expect anti-science propaganda on Facebook and such, but it's incredibly disappointing to see it here on Pricescope.

You stated this much more succinctly and without any ire than I would have, so thank you.

 

[Brigid]

My husband, my son & I got our 5th vaccination/booster and the Flu vaccine at the same time with no ill-effects.

 

[missy]

TY @OboeGal I have a certain member blocked and I appreciate you injecting common sense and logic and facts into nonsensical comments


For today's updates
From Bloomberg dot com

"

The ‘Swiss cheese’ model for DIY Covid rules​

My newsroom colleagues have been wondering how we’re supposed to act in this new phase of Covid. Cases are rising but are estimated to be much lower than previous peaks. What does that mean for wearing a mask? Getting boosted? Sending your kid to school? If it feels like the rules are unclear, it’s because they are. Lockdowns and mask mandates — specific guides from government agencies and other officials — are in the past. These measures were once imposed on people, says William Schaffner, an infectious disease specialist at Vanderbilt Medical Center. “But now they’re a matter of your individual decision making.” In other words, updated Covid guidelines are left up to personal responsibility. “Think about who you are, what’s your risk tolerance,” and behave accordingly, Schaffner says. Katrine Wallace, an epidemiologist at the University of Illinois at Chicago, referred to something public health experts use called the “Swiss cheese model,” in which slices, or prevention methods, are layered on top of each other. The holes, or weaknesses, are misaligned. The goal is to create a solid block that, ideally, the virus can’t get through. One person may need more layers than another depending on factors like geography and vulnerability to serious infection. To be sure, some of the basics still apply. The Centers for Disease Control and Prevention website provides a baseline of information with guidance on various topics. Those include what to do if you test positive for Covid, rules for schools and details about long Covid, which hasn’t changed in months. New CDC guidance released on Tuesday recommends updated booster shots for everyone over six months old. But Wallace says there are more steps that require research based on the individual. Some groups are at higher risk for Covid than others, which is also covered on the CDC’s website. The chances of someone getting Covid goes up as cases increase around them, too. Finding local Covid conditions used to be easy, but with the end of widespread testing, robust data reporting on Covid cases was dismantled. That leaves us with spottier data based on wastewater testing, hospitalizations and emergency department visits. Here, the CDC’s website is less useful. Because the agency’s tracker map by county is now based on hospitalizations rather than cases, “pretty much the whole map is green,” Wallace points out. The verdant graphic, which indicates low hospitalization rates, might not be reflective of the actual number of cases in an area. Wallace suggests turning to a local public health department to assess community Covid rates. Schaffner notes that if hospitalizations in an area are rising, you can be sure that Covid is circulating. Armed with this information, you’re ready to add the appropriate layers of protection. Those layers, such as wearing a mask, avoiding crowded indoor places, getting boosted, along with other seasonal jabs and stocking up on FDA authorized home tests, should sound familiar. “If you are a very prevention and health-oriented person, feel free to wear your mask,” Schaffner says. “But nobody’s going to go out there and twist your arm.” — Cailley LaPara

"

 

[missy]

"

Pfizer, Moderna Covid Booster Shots Get Green Light From CDC Panel


CDC panel recommends shot for everyone six months and older
Director Cohen gives final nod, allowing shots to go into arms

September 12, 2023 at 3:59 PM EDT
Updated on September 12, 2023 at 5:54 PM EDT


Covid-19 boosters formulated to protect against newer strains of the virus should become available in the US within days after the Centers for Disease Control and Prevention signed off on their rollout Tuesday.

CDC Director Mandy Cohen endorsed the use of the new shots following recommendation by a panel of vaccine and health experts for the booster shots from Moderna Inc. and from Pfizer Inc. and BioNTech SE. The panel voted 13-1 to recommend its use in those six months and older.

 “CDC recommends everyone 6 months and older get an updated Covid-19 vaccine to protect against the potentially serious outcomes of Covid-19 illness this fall and winter,” the agency said in an emailed statement. “Updated Covid-19 vaccines from Pfizer-BioNTech and Moderna will be available later this week.”

Cohen’s final green light means the shots can be administered across the US. The Food and Drug Administration has already approved them.


Distribution of these boosters could be especially helpful for Pfizer, which has struggled amid a sharp decline in sales of its Covid vaccine and antivirals after a surge during the pandemic. The company is waiting to see how purchases of both products perform this quarter before deciding on cost-cutting measures.


The BA.2.86 strain, known as Pirola, and EG.5 variant, dubbed Eris, are gaining ground. Hospitalizations are also rising for the first time this year, though they are still less frequent than in previous waves.


In June, US health officials told drugmakers to reformulate their boosters in time for the fall season that would protect against another subvariant, the XBB.1.5, that accounted for some 40% of infections at the time. But the new Eris strain has since become the most widely circulating variant, and the highly mutated Pirola is also spreading, raising questions about how effective the new boosters will be.

Moderna said earlier this month that its booster increased antibodies to Pirola almost ninefold in a human clinical trial. Pfizer said its vaccine elicited a “strong neutralizing antibody response” to the same strain in a pre-clinical study. Both companies said trials showed their products also offered some protection against Eris.

Those early findings, and others showing that antibodies from prior infection and vaccination still offer protection against Pirola, are reassuring, the CDC said Friday.

Members of the advisory panel said they endorsed a universal recommendation to allow for broad access to the shot. A couple raised questions about a lack of data on children for this particular booster, while others said the public needs to be informed about the increased risk for certain ages and populations.

Beth Bell, a clinical professor at the School of Public Health at the University of Washington in Seattle, said there needs to be messaging that clarifies that some individuals are at a much higher risk. “A lot of people with underlying medical conditions and who are older, are dying, and they really need to get a booster,” she said.


Pfizer executives participating in Tuesday’s CDC advisory panel said they plan on charging $120 per booster, while Moderna plans to charge $129. A Covid booster by Novavax Inc is currently under review with the FDA for those 12 and up, according to a statement from the company. If it’s approved by FDA it would likely fall under the CDC panel recommendation automatically and not need a separate vote.

"

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[/COLOR]

 

[Gloria27]

I'm sure this is wasted on you, but for the benefit of folks here who actually ARE interested in the pursuit of truth in science.....in early 2021, the mRNA vaccines WERE 94%-95% effective in preventing infection across the broad population. They were the most effective vaccines that we've ever had, frankly, and that is absolute truth. What changed is not the vaccine or reality; what changed is the virus. It mutated in ways that we couldn't possibly foresee because, you know, it was a FREAKING NOVEL VIRUS! So with mutations affecting the spike protein, the vaccine became less effective in preventing infection. Over time, even with an unusually rapidly-mutating virus, the available mRNA original formula and bivalent boosters performed spectacularly in severely reducing the risk of hospitalization and death, and reduced the risk of infection (and therefore transmission) by around 25%-50%, on average, depending on age and immune status of recipient and time from vaccination. Data just out looking at the performance of the bivalent booster in particular against the Omicron variants that circulated since its release last fall show even better protection against infection than that.

No "lies," no conspiracies, not "all about the money," and anyone who wanted it could get it for free. Everything we were told about the effectiveness of the vaccines, at every point in time, by the medical and research community - not Billy Bob on social media, mind you, who you shouldn't be listening to for medical information anyway - were accurate and truthful at that point in time.

I expect anti-science propaganda on Facebook and such, but it's incredibly disappointing to see it here on Pricescope.

Yeah the absolute truth my a....

These companies' research was funded with public money then they patented and sold their vaccines for billions to the goverments of the world (THUS NOT FREE, again paid from public money), the ones that could afford them (not to mention their track record of paying damages from previous bluders, some of them being almost bankrupt priot to the pandemic) Sounds legit!

 

[missy]

“​

Considerations for your fall Covid-19 vaccine​

Timing, mixing, and more.​

KATELYN JETELINA SEP 14

Everyone over 6 months is eligible for an updated Covid-19 vaccine this fall. We can leverage scientific data to optimize timing, choice, and, thus, protection.

Here is the lowdown.

How long after infection/vaccination should I wait?​

This is tricky.

We have frustratingly scarce scientific guidance on timing. What we do have tells us this:

• Minimum wait: 2-3 months. A Covid-19 vaccine doesn’t add much benefit within 2-3 months of infection. We don’t have to wait 2-3 months after infection—we won’t “exhaust” or “overwhelm” our immune system. But waiting will ensure we broaden B cells (our second line of defense; our antibody factory that stores some long-term-memory). With an updated vaccine formula, we want our factory updated.
  

  ​

  Figure from Beckner et al., 2022 Cell. Source here.
• Maximum wait 8-12 months: The longer we wait, the more we get out of the vaccine. One study found that waiting 8 months increased neutralizing antibodies 11 times more than waiting 3 months after infection. Another study found a 12-month interval improved vaccine effectiveness against hospitalization.

BUT waiting is a gamble. Even if a vaccine sooner is not as good as it could be, it’s better than waiting too long and catching Covid with limited protection, especially for high-risk people.

SO, this is what I’m suggesting to my family:

• Over 65 or at risk for severe disease: Get vaccine 4 months after infection/previous vaccine. Don’t wait more than 6 months. (Go here to understand why older adults need more urgent protection.)
• Under 65 and not high risk: Wait at least 6 months. Ideally, get vaccinated once a winter wave starts taking off. (Getting it by Halloween is a good bet.) This is what I will be doing with my family. But remember, we have very little/no protection against infection until we do. So, other layers of protection are especially needed.

Do I wait for Novavax?​

There is some evidence that mixing Novavax with mRNA is better and some evidence that staying with mRNA is better. It’s a bit hard to know which one is “right.”

High-risk people: The data pool is so narrow I’m uncomfortable suggesting that high-risk people wait for Novavax; we don’t know if it’s immunologically better. So don’t wait for this option if it’s been >6 months since your last vaccine and/or infection.

Other reasons people may want to wait on Novavax:

• Side effects. The mRNA vaccines are the most reactogenic vaccines we’ve ever had (i.e., a lot of side effects). They kick my butt, so I will be waiting for it.
• Hesitant about mRNA biotechnology.

What about mixing the mRNA vaccines?​

If you’ve only had an entire Moderna series, you may see marginal benefit from getting a Pfizer bivalent booster (and vice versa). But, to be honest, the science is mixed and isn’t very strong. So just get the vaccine that is most easily accessible.

What about mixing with the flu vaccine?​

You can get the flu vaccine (and other routine vaccines) and the Covid-19 vaccine at the same visit. It’s recommended to get them in different arms.

There have been studies on the safety and effectiveness of the co-administration of these two vaccines. In one database, about 454,000 people got the flu and Covid-19 vaccines. Both worked great. The rate of side effects was the same or a little higher among those that co-administered; however, no specific safety concerns were identified.

​

(CDC)

Under 5 years old and not yet vaccinated for Covid-19​

I’m getting a ton of questions from parents whose kids have yet to be vaccinated for Covid-19. First, I’m glad you’re taking this step—it will help protect against severe disease and reduce the duration of illness and transmission.

I agree that guidance is confusing, but I found this CDC slide helpful:

​

(CDC)
Your unvaccinated younger child (<5 years) needs more doses than, for example, an older child because they are more likely to be immune naive (i.e., never have had this virus). Multiple shots the first time ensure the immune system creates a durable memory.

Bottom line​

Fall is here. Our priority is preventing severe disease among high-risk people, and we can be smart about it. But if this feels too much like gymnastics, get your shot before Halloween. It will help you and those around you.

“

 

[dk168]

Still waiting to hear when England will roll out 2023 autumn's Covid vaccination programme for my age group (late 50s).

DK

 

[dk168]

aww you missed me

It didn't occur to you that some people might have more important things to do than to argue with strangers on the internet.


Hateful and abusive? more lies...
you made a direct challenge then you lost your shit when I replied

Blocked from now on. Life is too short for this sh1t!

DK

 

[missy]

"

COVID Hospitalizations Rise for Eighth Week in a Row​

Lisa O'Mary
September 13, 2023




Hospitalizations from COVID-19 rose for an eighth straight week for the period ending Sept. 2, although the increase dipped into single digits for the first time in that stretch. New hospital admissions ticked up 9%, to 18,871 people, the CDC reported in its latest dispatch of virus metrics.
Newly recommended COVID booster shots are expected to be available within days after a flurry of required approvals and recommendations this week from the CDC and the FDA. On Wednesday morning, the Walgreens website advised COVID vaccine seekers to "check back soon for additional details" and stated that existing vaccine appointments would be rescheduled pending arrival of the updated shots. The CVS website's online scheduling tool offered COVID vaccine appointments beginning Saturday, Sept. 16.
An estimated 97% of people in the U.S. ages 16 and older had protective immunity against COVID by the end of 2022, either from infection or vaccination, according to an article summarizing the current state of the pandemic published Tuesday in the Journal of the American Medical Association. Meanwhile, the age-adjusted death rate from COVID dropped from 115.6 per 100,000 people, in 2021, to 61.3 per 100,000 people in 2022, which is a 47% decrease.
But the authors of the article warned that reliance on prior immunity may put people at risk because the protection from a past vaccine or infection decreases over time.

"Among adults who are otherwise healthy ('immunocompetent'), recent estimates of vaccine effectiveness of a bivalent vaccine against hospitalization for COVID-19 were 62% compared with no vaccination in the 2 months after the bivalent dose but decreasing to 24% 4 to 6 months after the bivalent dose," wrote Carlos del Rio, MD, executive associate dean of the Emory School of Medicine in Atlanta, and JAMA Deputy Editor Preeti N. Malani, MD, MSJ.

They also noted that for people ages 65 years and older, the immunity provided by vaccines decreases even faster.

It's unclear what the demand will be for the newly formulated booster, which targets a strain of the virus that was dominant in January called XBB.1.5. The new formulation has been shown to boost antibodies against the virus variants currently causing the most infections.

In their JAMA article, del Rio and Malani said the impact of COVID this season may heavily depend on what people do when they feel sick.

"Regardless of test results, any person with symptoms of a respiratory infection should remain home and avoid going to school or work," they advised. "While COVID-19 is no longer a public health threat, waves of infection will occur for the foreseeable future. How disruptive these are will depend on the behavior of the virus but also, more importantly, on the behavior of humans."

Sources​

CDC: "United States COVID-19 Hospitalizations, Deaths, Emergency Department (ED) Visits, and Test Positivity by Geographic Area, Posted September 11, 2023," "CDC Respiratory Virus Updates, September 12, 2023, 9:00 PM EDT," "Updated COVID-19 Vaccine Recommendations are Now Available, September 12, 2023, 9:00 PM EDT."

Journal of the American Medical Association: "COVID-19 in the Fall of 2023 – Forgotten but Not Gone."


"

​

​

 

[missy]

"

This Isn't COVID's Final Act​

— We must keep the virus, and long COVID, center stage​

by Stuart Katz, MD, Alice Perlowski, MD, MA, and Brittany Taylor, MPH September 12, 2023

Katz is a researcher, Perlowski is a cardiologist and long COVID patient, and Taylor is a community engagement leader. All three are involved with the RECOVER long COVID initiative.
This year marks the third year of the COVID-19 pandemic. Over time, as the virus morphed and continued to disrupt our daily lives, people around the world grew tired of COVID restrictions. As a result, we saw mask mandates liftopens in a new tab or window, social distancing practices fade, and vaccination rates declineopens in a new tab or window as more shots became available. Understandably, people were -- and still are -- longing for pre-pandemic normalcy. Nonetheless, a looming reality remains: With hundreds of deathsopens in a new tab or window and thousands of hospitalizationsopens in a new tab or window each week in the U.S. alone, the pandemic is neither over nor behind us.

To date, there have been more than 770 millionopens in a new tab or window cases of COVID-19 worldwide. While ranges vary, approximately 10%opens in a new tab or window of adults in the U.S. who have contracted the virus are currently experiencing long-term symptoms. Persistent fatigue, cognitive issues, shortness of breath, and chest pain often top the list of reported maladies. For some, these symptoms resolve after a few months, but many others report debilitating health issues for years, causing them to seek employment in less demanding jobs or leaveopens in a new tab or window the workforce altogether. Many of those who endure these persistent symptoms -- which we've all come to know as long COVID -- experience disruption in their everyday lives, often reaching beyond the physical realm.
Recent estimates show that the average cost of long COVID care per person is approximately $9,000opens in a new tab or window per year, with families of patients often sharing that financial responsibility. What's more, though long COVID has been recognized as a disabilityopens in a new tab or window, some people have reportedopens in a new tab or window barriers to filing successful insurance claims, adding healthcare costs to an already heavy burden of chronic illness.

Living in a state with one of the highest COVID-19 mortality ratesopens in a new tab or window for Black people at the time, I (Taylor) recall the earlier days of the pandemic in Atlanta. First came the chaos and then came the devastation that seemed to disproportionately impact communities of color. I watched in horror as family, friends, colleagues, and neighbors lost loved ones to a virus we seemed to know little about. While the racial and ethnic disparities of COVID-19 quickly became clear, it was also clear that these disparities were more societal than biological. Atlanta -- the city I love -- went from being a place of rich, Black history, to one ridden with fear and loss. When people began to develop health issues beyond their acute illness, members of our community banded together to find out why.
In 2020, following a growing number of reported health issues several weeks to months after COVID infection, patients drove scientists and policy-makers to fund new research into what patients coined "long COVID." This collective advocacy kindled programs like RECOVERopens in a new tab or window (Researching COVID to Enhance Recovery), a nationwide initiative dedicated to understanding, treating, and preventing long COVID. To date, over 400 researchers, more than 50 patient, caregiver, and community representatives, and over 25,000 study participants have joined the RECOVER effort to help unravel the many mysteries of long COVID. We are three of those people working within the effort -- a patient representative, researcher, and community engagement leader -- and we're here to emphasize why keeping COVID-19 front and center is critical, despite society's desire to put it in our rearview.

So far, insights gained from RECOVER research have:

• Characterized the risk of long COVID for different strains of the SARS-CoV-2 virus
• Explored racial and ethnic disparities seen among long COVID patients
• Identified potential risk factors for the condition, such as sleep apnea, that may help inform future treatment

Some of the patients who called attention to and helped name long COVID were also involved in developing the RECOVER study protocols pushing for representation at the forefront. Thus far, RECOVER observational cohort studies have enrolled people from all 50 states and Puerto Rico with the goal to closely match the diversity of the U.S. population. And our researchers are now analyzing over 50,000 samples of blood, urine, and body tissues, as well as highly detailed imaging and mobile health data to better understand the causes and broad health effects of the elusive condition. In July, RECOVER announced open enrollment for a new arm of the study -- clinical trials -- which will evaluate long COVID treatments through drugs, biologics, medical devices, and other therapies. The viral persistence (RECOVER-VITAL) and cognitive dysfunction (RECOVER-NEURO) trials are the first to launch.

Despite the ongoing research efforts, nearly 7 million deaths worldwide, and the continued devastation COVID inflicts on people across the globe, we must also recognize yet another reality: the evolving virus at the core of the current pandemic has placed us at a crossroads. Many public health emergencies enacted by governments have already or will one day come to an endopens in a new tab or window. At the same time, given the unpredictable nature of viruses -- and current uptick in cases globally -- we must acknowledge the ongoing need to continue surveillance, vaccinationopens in a new tab or window, and research programs to protect the health of communities worldwide and alleviate the suffering of long COVID patients.
Everyday actions can also help. We can be advocates in our own circles by educating those who may not be aware of long COVID's impact. We can remember that COVID safeguards -- such as masking and testing protocols -- don't only protect ourselves, but also others, like the elderly or those susceptible to becoming seriously ill, including those with long COVID. We can trust that good science takes time, and that researchers around the world are simultaneously and collaboratively searching for solutions.

After years of restrictions, many may declare the current phase of the pandemic as COVID's final act. But driven by the pursuit of science, prospect of hope, and the millions still seeking answers, we are committed to keeping the virus center stage.
Stuart Katz, MD,opens in a new tab or window is principal investigator of the RECOVER Clinical Science Core at NYU Langone Health. Alice Perlowski, MD, MA,opens in a new tab or window is founding director and chief medical officer of Blooming Magnolia (a non-profit providing grant support to long COVID patients), a cardiologist, and a patient representative of the RECOVER study. Brittany Taylor, MPH,opens in a new tab or window is a community impact director at the American Heart Association and co-chair of the RECOVER National Community Engagement Group. The views expressed in this article are the authors' alone and should be considered independent of RECOVER and its collaborating institutions.


"

 

[dk168]

Got a text inviting me to book Covid booster this morning, did it straight away for Thursday 21 September 2023, combining it with a trip to the weekly market in town.

DK

 

[Lookinagain]

Got a text inviting me to book Covid booster this morning, did it straight away for Thursday 21 September 2023, combining it with a trip to the weekly market in town.

DK

I have mine scheduled for the same day!

 

[AprilBaby]

Hubs had his Moderna and flu yesterday and got a reaction. Chills, aches, fatigue and headache. He has not had Covid yet. I’m getting mine Sunday. I’m in Portland for two weeks babysitting so I can’t afford to get sick. Flying back to Chicago Saturday. I had my RSV 3 weeks ago.

 

[missy]

From one of our drs newsletters FYI

"
Vaccine Corner

Do you hear that hacking cough in the distance? Flu, Covid, and RSV season is almost here.

Please GET VACCINATED. Don’t fall prey to vaccine fatigue. Vaccines are literal life savers, and the absolute cornerstone of community health. Even if you are not at risk of severe disease or death, getting your Covid and flu shots can prevent you from spreading it to someone else who might die. As George Costanza would say, “We live in a SOCIETY!”





The time to get your new Covid vaccine is right now!

I am seeing a surprising number of patients who have not yet received the Omicron booster—especially kids.


Guys, getting the vaccine for Covid is so important to help minimize the spread and to protect your health. Even if you are not at risk of severe disease and death, remember that this is still a novel, mutating virus, and we have no idea what some of the long-term consequences of illness will be. We are still learning about Long Covid, for which there is no cure and few treatments.

I understand that some of you are trying to repress the fact that Covid is still a danger, but at least do the bare minimum for protection. Get the vaccine!

If you missed the Bivalent, or Omicron, booster, you do not need it before getting the new one. You can go straight to the latest Covid booster.


Here are a couple of articles that go more in-depth:

https://www.npr.org/sections/health...03134/covid-boosters-updated-vaccines-fda-cdc

https://www.nbcnews.com/health/health-news/fda-clears-new-covid-boosters-5-things-know-rcna102577


Flu shot




This year’s quadrivalent mix has a new addition. See the link for details

https://www.cdc.gov/flu/season/faq-flu-season-2023-2024.htm


RSV

Shots are available only for the over-60 crowd at this time.

RSV vaccines for pregnant women and children are not yet available commercially.

Because the RSV vaccine is so new, some insurers are not covering it yet. Medicare is covering it.


Here are a couple of articles:

https://www.nytimes.com/article/rsv-vaccine.html

https://www.yalemedicine.org/news/should-you-get-the-new-rsv-vaccine


Covid Corner

Have I mentioned yet that you should get the new Covid booster? Because you should.


Also, now that cases are increasing, consider wearing a mask in dense indoor settings, such as the grocery store or concerts or theater or subway. If I am in a controlled location, like my office, where I can ask people if they are feeling ill or have been around anyone who tested positive for Covid in the last 10 days, then I feel comfortable not wearing a mask. It may be awkward to grill your friends before they come over for dinner, but better to be awkward for a couple of minutes than to suffer from the flu or Covid.


I have noticed patients getting pretty casual about Covid: coming out of isolation before the cough or runny nose has resolved, or traveling before Day 5 of isolation, or asking if they still have to isolate at all, or saying that they won’t test when they get symptoms so they don’t have to isolate. I understand that the Covid protocols are a huge pain. I understand that missing 5 days of work or school can feel overwhelming, especially when you do not have much in the way of symptoms. I understand that it’s hard to believe that the exact same virus that causes minimal symptoms in one person can outright kill another person—but it can and it does. Covid is still killing hundreds of people every week.





"

 

[missy]

"

Updated 2023 fall vaccine chart​

Plus a note on insurance and free antigen tests​

KATELYN JETELINA SEP 21

I spied the YLE fall 2023 vaccine chart in the wild! So glad to see it’s getting used. Here’s an update and two random but relevant notes regarding Covid-19 tools.

​

Chicago Department of Health

Chart updates include…​

• Covid-19 vaccine: Eligibility determined. Ideal timing after infection added.
• Flu vaccine: Updated effectiveness to match this year’s strain. (We got great news that the vaccine matches circulating strains well— The Southern Hemisphere reported a 52% effectiveness against hospitalization.)

​

Two random, but relevant notes​

1. Insurance coverage for Covid-19 vaccines. There are many reports that people are being asked to pay for their Covid-19 vaccines. To be clear: no one should be paying for a vaccine.
   1. Private insurance companies are mandated to cover this vaccine with no copay. What has changed since last year? Insurers are no longer required to pay for “out-of-network”. You may need to get your vaccine at your doctor’s office if your pharmacy is not in-network with your insurance plan.
   2. Uninsured or underinsured adults: CVS/Walgreens are required by federal law to cover your vaccine at no cost to you, thanks to the new Bridge Program. This is just for Covid-19, not for RSV, unfortunately.
   3. Uninsured or underinsured kids: Vaccines for Childrencover all kid’s vaccines, not just Covid-19, for those that cannot pay.
2. Free Covid-19 tests are coming back! Starting Monday (Sept 25), households can receive 4 free rapid tests through USPS again. Order here: COVIDtests.gov. Shipments will start Oct. 2.

"

 

[dk168]

5th Covid vaccine received today, Pfizer BioNTech bi-valent one.

The arm is starting to get sore, otherwise all is well.

DK

 

[pearlsngems]

DH and I got our Moderna vaccines yesterday afternoon. We have a little local soreness but no other reaction.
Our daughter is scheduling her vaccine soon, too. She started a new job and only got her new medical insurance card yesterday.

My neighbor who is in her 70s got Covid a few weeks ago and landed in the ER. Her fasting glucose dropped to 35! If her daughter had not been living with her and found her mother barely responsive, she would have died.

 

[Austina]

I’m glad your neighbour will be OK @pearlsngems, that was a close call.

 

[Brigid]

COVID variant update, Australia:-

The 'highly mutated' COVID variant BA.2.86 — known as Pirola — has landed in Australia

A new COVID variant nicknamed "Pirola" has been detected in Australia after sparking a sped-up vaccination program in the United Kingdom.

www.abc.net.au

 

[missy]

"

Long COVID Blood Tests Show Distinct Immune and Hormone Function​

— Algorithm may help predict who gets long COVID​

by Judy George, Deputy Managing Editor, MedPage Today September 25, 2023

Long COVID patients had specific differences in immune and hormone function than other people, blood tests showed.
Compared with matched controls, people with long COVID had marked differences in circulating myeloid and lymphocyte populations, reported Akiko Iwasaki, PhD, of Yale University in New Haven, Connecticut, and co-authors in Natureopens in a new tab or window.
Long COVID patients had exaggerated humoral responses directed against SARS-CoV-2. In addition, their antibody responses were higher against other pathogens that weren't SARS-CoV-2, especially Epstein-Barr virus (EBV).

An algorithm that incorporated blood test and self-reported survey data showed diagnostic potential with an area under the curve (AUC) of 0.94, Iwasaki and co-authors found.
"We found a number of immunological and hormonal factors that collectively are able to distinguish people with versus without long COVID at 94% accuracy," Iwasaki told MedPage Today. "This study speaks to the underlying biological causes of long COVID and provides a basis for future studies that interrogate various therapies that target the root causes of this disease."
"The reduced cortisol levels found in the long COVID patients suggest hypothalamus-pituitary-adrenal imbalance," she pointed out. "The elevated activated B cells and exhausted T cells suggest persistent antigen and potentially persistent virus infection. The EBV reactivation, which was demonstrated by others also, inform about a subset of patients who may benefit from EBV-targeting therapies."
This work is "a crucial first step towards identifying a set of biological differences between people with and without long COVID" and may lead to novel blood biomarkers for an objective diagnosis of long COVID, co-author David Putrino, PhD, of Icahn Mount Sinai in New York City, told MedPage Today.

The study "provides physicians with important insights by highlighting the fact that people with long COVID show measurable signs of hormonal and immunological dysfunction, which should serve as further irrefutable evidence that long COVID is not a functional or psychosomatic diagnosis," Putrino said.
Long COVID symptoms -- ones that lasted more than 3 months after acute infection -- affected 7.5% of U.S. adults according to 2022 CDC dataopens in a new tab or window. By June 2023opens in a new tab or window, that percentage fell to 6%.
Symptoms of long COVID can includeopens in a new tab or window postexertional malaise, fatigue, brain fog, dizziness, gastrointestinal symptoms, palpitations, changes in sexual desire or capacity, loss of or change in smell or taste, thirst, chronic cough, chest pain, and abnormal movements.
In their analysis, Iwasaki and colleagues evaluated data from about 273 people with and without long COVID from Yale and two Mount Sinai locations.
The researchers looked at several groups, including people with no previous SARS-CoV-2 infection, those who had fully recovered after COVID, and those with active long COVID symptoms for 4 months or longer after COVID. The median length of symptoms in the last group was 12 months after acute infection.

Participants completed questionnaires about symptoms, medical history, and health-related quality of life, and provided blood samples. Most acute infections in the long COVID group occurred early in 2020, when parental SARS-CoV-2 strains drove most new cases.
Long COVID participants had a mean age of 46 and convalescent controls had a mean age of 38, but the two groups did not differ in sex or hospitalization for acute COVID. The aggregated medical history of the two groups did not differ in baseline prevalence of anxiety or depression.
Fatigue (87%), brain fog (78%), memory difficulty (62%), and confusion (55%) were the most common self-reported symptoms in the long COVID group. Postural orthostatic tachycardia syndrome (POTS) also was prevalent; 38% of people with long COVID in the study had formal diagnostic testing and clinical evaluation. Half of participants with long COVID reported negative effects on employment status.
Serum cortisol was the most significant predictor of long COVID status. Other biomarkers indicated abnormal T cell activity and reactivation of multiple latent viruses, including EBV and other herpesviruses.

The findings on EBV, herpesviruses, and low cortisol are especially important, observed Ziyad Al-Aly, MD, of Washington University in St. Louis and chief of research and development at the VA St. Louis Healthcare System, who wasn't involved with the research.
"They may help inform treatment trials," he told MedPage Today. "For example, whether treating EBV or cortisol replacement would ameliorate symptoms and improve outcomes would need to be considered in the light of these findings."
People with long COVID often are told the disease is "all in your head," Al-Aly noted.
"This study provides objective evidence of significant differences in the immune profiles of people with long COVID versus matched controls." he said. "I hope this puts the 'it's all in your head' idea to rest."

• Judy George covers neurology and neuroscience news for MedPage Today, writing about brain aging, Alzheimer’s, dementia, MS, rare diseases, epilepsy, autism, headache, stroke, Parkinson’s, ALS, concussion, CTE, sleep, pain, and more. Follow

Disclosures
This work was supported by the National Institute of Allergy and Infectious Diseases, FDA Office of Women's Health Research Centers of Excellence in Regulatory Science and Innovation, Emergent Ventures at the Mercatus Center, the Howard Hughes Medical Institute Collaborative COVID-19 Initiative, and the Howard Hughes Medical Institute.
Researchers reported relationships with UnitedHealth, Element Science, Identifeye, F-Prime, Refactor Health, Hugo Health, CMS, FDA, Johnson & Johnson, Google, Pfizer, Thyron, Boehringer Ingelheim, Pliant, AstraZeneca, RoBar, Veracyte, Galapagos, FibroGen, BMS, RIGImmune, Xanadu Bio, PanV, Paratus Sciences, InvisiShield Technologies, Roche, and Seranova Bio, and are inventors of a patent describing REAP technology.
Primary Source
Nature
Source Reference: opens in a new tab or windowKlein J, et al "Distinguishing features of long COVID identified through immune profiling" Nature 2023; DOI: 10.1038/s41586-023-06651-y.

"

 

[missy]

"
Insurance Coverage of Updated COVID-19 Vaccines: A Cheat Sheet

Published: Sep 22, 2023


On September 11, 2023, the FDA approved and authorized updated COVID-19 vaccines from Pfizer and Moderna. The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) recommended them for everyone from the ages of 6 months and older on September 12 and the CDC Director adopted this recommendation on the same day. This marks the first time that COVID-19 vaccines will be commercialized – that is, transitioned to the commercial market for their manufacturing, procurement and pricing. Up until this point, the federal government had purchased all COVID-19 vaccines and provided them free of charge to anyone, regardless of insurance coverage or ability to pay. The commercial price being charged by Pfizer and Moderna is $115 to $128 per dose, respectively, about 3-4 times higher than the price paid for by the federal government. In addition to the cost of the vaccine, there may be a cost associated with administering the vaccine and/or the cost of a provider visit.

With commercialization, the way in which vaccines are paid for and whether they are covered by insurance will now be dictated by insurance market rules and regulations. Because of the Affordable Care Act and laws passed during the COVID-19 pandemic, COVID-19 vaccines will continue to be free of charge to virtually everyone with private and public insurance coverage, although uninsured adults will have no guarantee of free vaccines. This cheat sheet provides details on coverage rules by insurance type and for people who are uninsured.




LEGAL BASIS

Private:

ACA: Requires private insurers to cover any ACIP recommended vaccine once the CDC Director adopts recommendation no later than one year later.

CARES Act: Expedited coverage requirement to 15 business days for COVID-19 vaccines

DOL FAQs: The 15-day requirement was already satisfied 15 days after first COVID-19 vaccine recommended in December 2020. As of January 5, 2021, any COVID-19 vaccine that is approved or authorized by the FDA must be covered immediately.

Medicaid:

ARPA: Requires no cost-sharing through September 2024

IRA: Requires Medicaid coverage of ACIP-recommended vaccines for adults with no cost sharing permanently.

Medicaid covers ACIP-recommended vaccines for children at no cost through the Vaccines for Children Program.

Medicare:

CARES Act: Requires no cost-sharing

Uninsured Adults:

There is no federal guarantee of free recommended vaccines for adults. Section 317 of the Public Health Services Act created a discretionary program that provides some limited support for recommended vaccines. The Biden administration has proposed creating a mandatory Vaccines for Adults Program, modeled on the Vaccines for Children Program

Uninsured Children:
Section 1928 of the Social Security Act created the VFC program. Vaccines are automatically included in program if recommended by ACIP and included on the CDC’s vaccine schedule. COVID-19 vaccines were added to the vaccine schedule on October 19, 2022.



SOURCES

Affordable Care Act, March 23, 2010, Section 300gg–13: https://t.co/Q5ySrwDFSB

Coverage of Certain Preventive Services Under the Affordable Care Act, Federal Register, Vol. 80, No. 134, July 14, 2015: https://www.govinfo.gov/content/pkg/FR-2015-07-14/pdf/2015-17076.pdf

CARES Act, March 27, 2030, Section 3203 and Section 3713: https://www.congress.gov/116/plaws/publ136/PLAW-116publ136.pdf

Department of Labor FAQ, October 4, 2021: https://www.dol.gov/sites/dolgov/fi...tivities/resource-center/faqs/aca-part-50.pdf

Department of Labor FAQ, March 29, 2023: https://www.dol.gov/sites/dolgov/fi...tivities/resource-center/faqs/aca-part-58.pdf

ARPA, March 11, 2021, Section 9811: https://www.govinfo.gov/content/pkg/PLAW-117publ2/pdf/PLAW-117publ2.pdf

Vaccines for Children Program: https://www.cdc.gov/vaccines/programs/vfc/index.html

HHS Bridge Access Program: https://www.cdc.gov/media/releases/2023/p0914-uninsured-vaccination.html and KFF, https://www.kff.org/policy-watch/covid-19-vaccine-access-for-uninsured-adults-this-fall/.

Vaccines for Adults Program proposal: https://www.cdc.gov/budget/documents/fy2024/FY-2024-CDC-congressional-justification.pdf#page=79
"