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Coronavirus Updates October 2022

Karl_K said:
scheduled for tue for the new pfizer booster shot and a flu shot.
Not sure about the flu shot because I dont want anything in my bad arm. Will see what they say about both in the same arm.
They had a ton of schedule openings for both mon, tue and wed at cvs.
Click to expand...
That was a total bust cvs switched stores on me and I did not notice.
Then they were extremely rude about it.
When I asked if I could get it there they said no the pharmacist is the only one who could do it, he was standing 4 feet away gabbing about non-work stuff with someone inside the pharmacy counter area.
Totally messed up.
What sux, the store closest to us was closed and all the super nice people sent across town to another store.
The next 2 closest stores are all grumpy, rude and not helpful.
 
Today DH is positive as well. Kids still negative. I honestly already feel much better than yesterday. My sinuses have improved a ton and I'm just a bit tired. DH so far just has a sore throat and did not do well on his workout last night.
 
 

FDA Says Young Kids Can Now Get Omicron Boosters Too​

— Pfizer and Moderna's bivalent shots authorized for children starting at ages 5 and 6 years​

by Ingrid Hein, Staff Writer, MedPage Today October 12, 2022

FDA EUA Bivalent COVID-19 vaccine booster shots over a photo of a male physician preparing to vaccinate a young boy.

The FDA expanded the authorizations for the bivalent COVID-19 vaccine boosters to include younger children as well, the agency announced on Wednesday.
Pfizer/BioNTech and Moderna's bivalent mRNA shots, which target the original COVID-19 strain and the BA.4/BA.5 Omicron subvariants, can be administered at least 2 months following completion of a primary series or prior booster vaccination. The updated emergency use authorizations (EUAs) allow for administration in children ages 5 years and up in the case of Pfizer's shot or 6 years and up for Moderna's.
https://www.fda.gov/news-events/pre...nd-pfizer-biontech-bivalent-covid-19-vaccines
Shortly after FDA's announcement, the CDC updated its recommendationsto include the new boosters for kids in this age group, noting that the new boosters will help restore waning vaccine protection and target the "more transmissible and immune-evading" Omicron subvariants.
"Since children have gone back to school in person and people are resuming pre-pandemic behaviors and activities, there is the potential for increased risk of exposure to the virus that causes COVID-19," Peter Marks, MD, PhD, from the FDA's Center for Biologics Evaluation and Research, said in a statement. "While it has largely been the case that COVID-19 tends to be less severe in children than adults, as the various waves of COVID-19 have occurred, more children have gotten sick with the disease and have been hospitalized."
He also noted concerns about long COVID in kids.
"Children may also experience long-term effects, even following initially mild disease," Marks added. "We encourage parents to consider primary vaccination for children and follow-up with an updated booster dose when eligible."
https://www.cdc.gov/media/releases/2022/s1012-COVID-19-Vaccines.html
EUAs previously included monovalent booster vaccines in children. That will now be overwritten, with booster authorization only for bivalent vaccines going forward. For adults, and kids ages 12 and up in the case of Pfizer's shot, the EUA was already amended 6 weeks ago.
To evaluate immune response and safety data of the BA.4/BA.5-targeting bivalent vaccines, the FDA looked at data from trials of bivalent vaccines that contained components of the BA.1 variant in adults. The FDA has also looked at immune response and safety data from clinical studies evaluating booster shots of monovalent mRNA COVID-19 vaccines in pediatric populations.
"These data and real-world experience with the monovalent mRNA COVID-19 vaccines, which have been administered to millions of people, including young children, support the EUA of the bivalent COVID-19 vaccines in younger age groups," the FDA said in its release.
The agency noted that the reported side effects with the bivalent shots have been consistent with those of the monovalent vaccines.
 

More Harm Reduction, Less Abstinence-Only in COVID Messaging, Experts Say​

— "We know that abstinence-only doesn't work in any situation"​

by Joyce Frieden, Washington Editor, MedPage Today October 12, 2022


More attention to harm reduction -- rather than totally abstaining from risky behaviors -- would improve messaging on the COVID-19 pandemic, Amesh Adalja, MD, a senior scholar at the Johns Hopkins Center for Health Security, said Wednesday.

"A lot of COVID-19 was abstinence-only" when it came to behavior, Adalja said during an online briefing sponsored by the Alliance for Health Policy on lessons to be learned from the HIV epidemic. "And it's not surprising that it failed. It's not surprising that most people lied about their activities. Because we know that abstinence-only doesn't work in any situation."



"For so long during the COVID-19 pandemic, that's what the actual official government policy was, even though many of us were saying, 'Harm reduction. Risk calculation. Just give people tools and they'll actually modify their behavior,' and I think that would have avoided some of the politicization that happened," he said. "If we would have had a harm reduction approach rather than the shaming and all of that that went on ... It all [involves] some COVID risk and that was just something that got ignored and hopefully now we're getting to that point."

"Always have the subject matter experts leading this," added Adalja. "When you have politicians involved, it's going to become political, just by definition, because when they view a public health emergency as a way to get a 'one up' on the other party, or they think about the rate of boosters or the low rate of boosters as a win or a loss for them rather than actually thinking about the infectious disease issue."



Both parties are "completely guilty" of politicizing these issues, and "for two different administrations during COVID-19, they don't actually think about what's going on on the ground," he continued. "What's the public health emergency? What do we need to fix here? They think, 'this is going to be good for my polling,' or 'this is my vision.' They shouldn't even be asking polling questions about disease because that's not something that should be in their purview."

Public health agencies, including the CDC, should be somewhat separate from government because "there just needs to be some insulation so that it's not sucked into the vortex of the day-to-day getting a 'one up' on your political opponent," he said.

Caring for HIV patients has become a non-partisan issue, but it didn't start out that way, according to Lindsey Dawson, MPP, associate director of HIV policy at the Kaiser Family Foundation. "HIV is still stigmatized, but there was a time of even deeper stigma. We had a sitting president that didn't mention HIV/AIDS until 1985," she said, referring to former President Reagan. "And that bipartisanship took a lot of coalition-building. It wasn't a given, and advocates made inroads in the agencies. So advocates were deeply involved in evolving policy at the FDA, changing regulatory pathways, and at NIH, having conversations about what clinical trials should look like. And similar conversations were happening on [Capitol] Hill. And so that bipartisanship was fought for."



Dawson said she agreed with Adalja that public health needed to be de-politicized. "We need to have a de-politicized, science-based approach to these conversations with leadership, and that's because the second you say something that is partisan or based in politics, there's going to be fear associated with it. And it's hard to do something when you're coming from a place of fear and threat. But if you're coming from a place of knowledge base and a science base, it might be easier to make political decisions. And I realize that that's easier said than done."

Another thing to consider in terms of distrusting public health messages is the mistrust in the medical community by people of color "based on the harm that has been done" to those communities by medical professionals, said Antoinette Jones, national field organizer for the Positive Women's Network, a group for women diagnosed with HIV. "That feeling is so embedded in the DNA of Black and brown people that it probably would never go away," she said.



"So the way to engage people who are living with HIV is going to look different than people who are not living with HIV, because people who are living with HIV have had more of a hands-on and a witnessing approach to seeing the progression of the HIV virus. So of course they are going to be a lot more trusting and eager to receive the COVID-19 vaccine and even the monkeypox vaccine because we are very, very much closer to science than the rest of our community who is not living with the virus," she continued.

"In order to not see the same things happen that we have seen in an HIV epidemic, we want to definitely do a [harm reduction] approach, but increased hands-on community support is important," Jones said. "Providing resources and education is important, especially when it comes to research and sharing back the research to the community that they have been involved in. And then also access is really important -- making sure that folks are able to get to these testing locations or these vaccine sites in order to increase those numbers ... as well as prevent further cases."



With the development of tools to combat HIV such as pre-exposure prophylaxis (PrEP) and antiretroviral treatment, "I think that HIV kind of became a paradigm for how science can solve a problem, but how it won't go all the way without actual implementation of those tools," Adalja said.

"And I think when you look at COVID, think about the way that the HIV response evolved, the tools that were brought to bear, and how this became a much more manageable infection," he added. "And I think it only happened because there was a concerted effort to actually treat HIV as the big health security risk that it was."
 
 

New Omicron Shots Elicit 'Encouraging Responses' in Humans, Pfizer Says​

— Safety profile similar to that of the original monovalent vaccine​

by Ingrid Hein, Staff Writer, MedPage Today October 13, 2022


A photo of blue rubber gloved hands drawing the Pfizer/BioNTech bivalent vaccine from a vial.

Preliminary results in 80 humans showed that Pfizer/BioNTech's recently authorized Omicron vaccine substantially increased neutralizing antibodies against the BA.4 and BA.5 subvariants, the companies announced.
One week after administration, a single 30-µg booster dose of the bivalent shot produced similar levels of neutralizing antibodies for individuals ages 18 to 55 and those older than 55.
Individuals who received the companies' monovalent vaccine had "more limited increases in the neutralizing antibody response" against the two subvariants, according to the release. Antibody levels were not disclosed in the release.

Pfizer/BioNTech said that early data showed that their bivalent vaccine -- which was designed with components that target BA.4 and BA.5 along with the original strain -- was well tolerated, "indicating a favorable safety profile, similar to that of the original vaccine."
"While we expect more mature immune response data from the clinical trial of our Omicron BA.4/BA.5-adapted bivalent vaccine in the coming weeks, we are pleased to see encouraging responses just one week after vaccination in younger and older adults," said Albert Bourla, PhD, chairman and CEO of Pfizer.
"These early data suggest that our bivalent vaccine is anticipated to provide better protection against currently circulating variants than the original vaccine and potentially help to curb future surges in cases this winter," he added.
BA.4/BA.5-adapted bivalent vaccines from Pfizer/BioNTech and Moderna were authorized by the FDA in August based on immunogenicity data from mouse studies and support from clinical studies testing earlier bivalent vaccines that targeted the original Omicron variant.

"These preliminary findings are consistent with our preclinical data showing a substantial increase in the neutralizing antibody response against the Omicron sublineages BA.4 and BA.5," said Ugur Sahin, MD, CEO and co-founder of BioNTech, in a statement. "The current dominance of BA.4/BA.5 and related sublineages, underscores the importance of our data and science-based approach to develop a vaccine which is adapted to these prevalent strains of the virus and make it available in a timely manner."
The multicenter randomized controlled phase II/III trial has enrolled approximately 900 participants ages 12 and up who have received at least three doses of an authorized COVID-19 vaccine. Participants ages 18 and up were randomized to receive either a 30-µg or 60-µg booster dose of the bivalent vaccine, while those ages 12 to 17 were given a 30-µg booster.
"Among the participants, samples were equally stratified at baseline in each group between those who had a prior or current history of SARS-CoV-2 and those with no prior or current history of SARS-CoV-2," the release noted.
Pfizer/BioNTech said additional findings on responses at 1 month will be released as soon as they are available "to support potential full licensure and global registration" of the bivalent vaccine.
  • author['full_name']
    Ingrid Hein is a staff writer for MedPage Today covering infectious disease. She has been a medical reporter for more than a decade.
 

Do any treatments reduce the risk of infection after you've been exposed to someone with COVID-19?​

Meredith Worthington, Ph.D.

Tod Cooperman, M.D.

Written by Meredith Worthington, Ph.D. — Medically reviewed and edited by Tod Cooperman, M.D.
Latest Update
Paxlovid COVID Rebound?
Last Updated: 10/10/2022

REGEN-COV

Answer:​

There are currently no FDA authorized or approved drugs for post-exposure prevention of COVID-19 due to the Omicron variant. However, there is one monoclonal antibody treatment for pre-exposure prevention of COVID-19 in some people, and there are several drugs authorized to treat COVID-19 if given early to certain patients.

Currently authorized monoclonal antibodies for pre-exposure prevention:​

EVUSHELD (tixagevimab with cilgavimab) is the only product authorized for the pre-exposure prevention of COVID-19 in adults and children 12 and older (weighing at least 88 lbs) who are moderately to severely immune compromised andare unlikely to mount adequate immune response to vaccination, or are not recommended to receive a COVID-19 vaccine due to potential for severe adverse reactions (such as severe allergic reaction).
A study among 5,197 people given EVUSHELD showed that it reduced the risk of symptomatic COVID-19 by 76.7% compared to placebo during a 183-day follow-up period, suggesting that EVUSHELD may protect against COVID-19 for at least 6 months. Eight out of 3,441 people who received EVUSHELD developed symptomatic COVID-19 compared to 17 out of 1,731 people in the placebo group (Levin, N Eng J Med 2022). However, certain SARS-CoV-2 variants may not be neutralized by EVUSHELD, meaning that EVUSHELD may not prevent COVID-19 caused by these variants. Laboratory data shows that the neutralizing activity of EVUSHELD against Omicron BA.4/BA.5 is reduced 33- to 65-fold compared to the original strain, and activity against BA.4.6 is reduced by more than 1000-fold. People living in areas with a high prevalence of these and other Omicron variants who receive EVUSHELD should be aware that they may not be well protected against COVID-19 (EVUSHELD Fact Sheet, last updated 10-2022).
EVUSHELD is administered once as two separate, consecutive shots consisting of 300 mg of tixagevimab and 300 mg of cilgavimab. It is recommended that these shots be repeated every 6 months. Individuals who received an initial dose consisting of only 150 mg each of tixagevimab and cilgavimab within the past 3 months should receive a second dose of 150 mg each of tixagevimab and cilgavimab, and those who received the lower dose more than 3 months prior should receive a second full dose of EVUSHELD. People who received a COVID-19 vaccine can be administered EVUSHELD at least two weeks after vaccination.
The most common side effects of EVUSHELD are headache, fatigue and cough. Injection site pain has also been reported by 2.4% of people who received EVUSHELD in a clinical study, although 2.1% of people who received placebo reported the same side effect (Levin, N Eng J Med 2022). Although less common, a higher percentage of people given EVUSHELD reported heart attack and heart failure compared to placebo, although a clear cause-and-effect relationship has not been established. EVUSHELD should be used with caution in people with significant bleeding disorders.
Be aware that the availability of EVUSHELD is very limited in the U.S., but you can search online for the nearest location.

Currently authorized or approved treatments:​

The following drugs have been granted emergency use authorization for the treatment of mild to moderate COVID-19 (but not severe COVID-19) in adults and, unless otherwise noted below, children 12 and older and weighing at least 88 lbs. (40 kg), who are at high risk for progression to severe COVID-19:
  • Bebtelovimab: On 2/11/22, the FDA authorized bebtelovimab, a monoclonal antibody, for patients for whom other treatment options are not accessible or clinically appropriate. Laboratory data has shown that this antibody therapy remains active against the Omicron variant and the BA.2 subvariant. It should be started within 7 days of symptom onset. Bebtelovimab is not authorized for use in patients hospitalized with COVID-19, or who require oxygen due to COVID-19, as there is concern it could worsen outcomes in these patients. Laboratory research suggests that bebtelovimab has potent neutralizing activity against all Omicron subvariants, including BA.2 (Liu, medRxiv 2022 — preprint).
  • Lagevrio (molnupiravir) is an antiviral drug for the treatment of mild to moderate COVID-19 in adults (but notchildren or adolescents) at high risk for progression to severe disease and for whom other authorized treatments are not accessible or clinically appropriate. It should be started within 5 days of symptom onset.
  • Paxlovid (nirmatrelvir plus ritonavir) is the only antiviral drug that is strongly recommended by the World Health Organization for the treatment of non-severe COVID-19 (see the WHO table of treatment recommendations). It should be started within 5 days of symptom onset.
    In unvaccinated people with COVID-19 who were at high risk for progression but were not hospitalized, giving Paxlovid within 5 days of symptom onset reduced the risk of hospitalization or death by day 28 by 87.8% compared to placebo. Paxlovid was given every 12 hours for 5 days (10 total doses). The most common side effects of treatment were altered taste (dysgeusia), diarrhea, and vomiting (Hammond, N Engl J Med 2022).
    However, based on data from Israel during an Omicron (B.1.1.529) surge, Paxlovid may be much more effective for people 65 and older than for younger people. The data showed that, among people 65 and older and considered to be at risk for severe disease, the rate of hospitalization was 73% lower, and the rate of death was 79% lower, for those who received Paxlovid within about 2 days of testing positive for COVID-19 compared to those who did not receive Paxlovid. The association between Paxlovid treatment and reduced risk of hospitalization was observed for those without prior immunity (85% reduced risk) as well as those with prior immunity from vaccination or previous infection (68% reduced risk). However, among at-risk people 40 to 64 years of age, Paxlovid treatment was not associated with a significant reduction in hospitalization or death (Arbel, N Engl J Med 2022).
    Be aware that Paxlovid should not be used along with drugs or supplements metabolized primarily by the liver enzyme CYP3A4, as Paxlovid may increase plasma concentrations of these drugs. Such agents include colchicine (which is also used in Indian Ayurvedic medicines) and lovastatin (a compound also in red yeast rice supplements). Also, products that are potent activators of CYP3A4 should not be used along with Paxlovid, as these agents can reduce plasma concentrations of Paxlovid and reduce its effectiveness. St. John's wort is an herbal product that can activate CYP3A4, so Paxlovid should not be used with it or immediately after discontinuing it. See the FDA's list of drugs that may interact with Paxlovid. Supplements that inhibit CYP3A4should also not be used with Paxlovid. If you are being started on Paxlovid, tell your healthcare provider if you are taking supplements.
    Also be aware that about 2% of people who complete a 5-day course of Paxlovid experience a recurrence of COVID-19 symptoms and/or test positive for COVID-19 after having tested negative between 2 and 8 days after initial recovery. Reported cases of this "rebound" have all been mild and improved or resolved in about 3 days without additional treatment. The CDC advises that people with COVID-19 rebound should re-isolate for at least 5 days and mask for 10 days from the beginning of the rebound (CDC Health Advisory, 5-24-22; FDA Update, 5-4-22). Interestingly, rebound was also found to occur at about the same rate in people receiving placebo in the Paxlovid clinical trial (who had recovered without Paxlovid). Rebound may be due to a robust immune response to virus that remains in the respiratory tract after treatment after having been mostly cleared from the body, according to results of a small study. However, the researchers noted that additional research is needed to determine if prolonged or additional Paxlovid treatment may be needed by immunocompromised people who may not have adequate immune response to standard Paxlovid dosing (Epling, Clin Infect Dis 2022).
In addition to these authorized treatments, remdesivir (Veklury) is an antiviral drug approved for the treatment of COVID-19 in adults and children 12 and older who are hospitalized with severe COVID-19 or who have mild to moderate COVID-19 but are at high risk for progression to severe disease. It should be initiated as soon as possible after COVID-19 diagnosis.

How to get medical treatment for COVID-19 quickly:​

It is possible to get treated with antiviral medication for COVID-19 quickly through a streamlined the process called "test to treat," which the U.S. government rolled out on March 8, 2022. This program allows people to get tested at certain pharmacies (such as CVS Minute Clinics, HRSA-supported Health Centers or military Medical Treatment Facilities) and, if positive for COVID-19 and eligible for treatment, receive antiviral treatments (molnupiravir or Paxlovid) at the same location, at no cost. People who test positive for COVID-19 through at-home tests or another testing site can also get antiviral treatments prescribed and filled immediately at test to treat sites, but they will need to show their test results. You can find the nearest test to treat location, as well as the antivirals available there, at https://www.covid.gov/ or by calling 1-800-232-0233. Be aware that not all pharmacies listed are part of the test to treat program and may only be able to fill a prescription (such pharmacies will include the statement, "Talk to your doctor or visit a local community health center to get a prescription before going to this location to get medication."). While the medication is provided at no cost, be aware that sites may charge for services (i.e., the cost of providing testing and treatment) if not covered by insurance.
To help expand access to timely treatment for COVID-19, the FDA authorized pharmacists to prescribe Paxlovid to eligible patients, but with several limitations (FDA New Release, 7-6-22). First, not all pharmacies will offer this service: Community pharmacies that are not participating as a Test-to-Treat site can decide if or how they will offer this service. Second, the patient will need to bring the following information:
  • Health records less than 12 months old that include information (such as laboratory blood work) to allow the pharmacist to assess for kidney or liver problems. If the patient does not have this information, the pharmacist can obtain it through a consult with the patient's doctor.
  • A list of all current medications, including prescription drugs, over-the counter medications and supplements.
Pharmacists may refer a person for further clinical evaluation if the person does not provide enough information to assess kidney and liver function or potential drug interactions, if the person requires a dose adjustment to their current medication to avoid drug interactions, or if Paxlovid is not an appropriate treatment for the individual based on its authorized use.

Drugs no longer used:​

The FDA had authorized two monoclonal antibody combination therapies — REGEN-COV by Regeneron Pharmaceuticals, Inc., which is a combination of casirivimab plus imdevimab, and another monoclonal antibody treatment that is a combination of bamlanivimab plus etesevimab — for post-exposure prophylaxis, i.e., to help prevent infection in people who have been exposed to someone with COVID-19. Both of these monoclonal therapies had previously also been granted emergency use authorization for the treatment of existing mild to moderate COVID-19 infection (i.e., not severe or hospitalized cases or cases requiring oxygen therapy).
However, the FDA revised the emergency use authorization for these monoclonal antibody treatments to limit their use for treatment and post-exposure prophylaxis to only cases in which the COVID-19 patient is likely to have been infected by or exposed to susceptible variants. Since Omicron is now predicted to account for more than 99% of COVID-19 cases in the U.S. and is unlikely to be a susceptible variant, these monoclonal antibody therapies are not authorized for use in any U.S. state, territory or jurisdiction as of 1/24/22. There are no other drugs authorized or approved for post-exposure prevention of Omicron.
Similarly, the monoclonal antibody treatment sotrovimab was previously authorized for the treatment of mild to moderate COVID-19 in adults and children 12 and older who were at high risk for progression to severe disease. However, this was revised by the FDA in February, 2022 to prohibit its use in regions in which COVID-19 infections are likely caused by a variant that is non-susceptible to sotrovimab, such as Omicron BA.2. On April 5, 2022, sotrovimab became no longer authorized for use in any region in the U.S. since the prevalence of the BA.2 variant was estimated to be greater than 50% in all regions (ASPR Important Update, 4-5-22).
 

COVID-19 State of Affairs: Oct 18​

Katelyn Jetelina
Oct 18


SARS-CoV-2 is having a mixed impact across the globe. The WHO is tracking more than 100 subvariants of Omicron, and each country has a different makeup of “subvariant soup,” but two are winning the race: XBB and BQ.1.1. Couple this with changing behaviors and different immune histories (which wave hit and when; booster uptake), and country-to-country comparisons are getting harder than ever.

But I’m up for a challenge. Here is a snapshot of the current landscape, which is changing quickly.

International trends​

In Western Europe, behavior drove the current wave. Thankfully, cases have peaked as it looks like the virus ran out of social networks to follow, but Omicron subvariants (and specifically BQ.1.1) are brewing below the surface. Whether cases continue to descend, plateau, or begin to increase is directly dependent on the number of “susceptible” people the virus can find—the million dollar question.

All eyes are still on Germany, as hospitalizations “for COVID-19” are the highest they have ever been. (Take this with a grain of salt, though, as hospitalizations in Germany have historically been low. So admissions are high, but not outrageous compared to other countries.) The current surge is largely attributed to Oktoberfest as a superspreader event and the fact that Germany’s fall booster rate among 60+ year olds is one of the lowest in Europe thus far.

Image​
(Jean Fisch Twitter)
Also concerning is the quickly rising number of ICU patients in Germany and the fact that 30% of ICU patients are on a ventilator, which is high. In addition, some German hospitals have called for help as a majority of their staff are out sick. In all, excess deaths in Germany are high and increasing.

​
Moving to Southeast Asia, an Omicron subvariant—XBB—is causing a substantial infection wave (as opposed to behavior). Specifically, Singaporeis getting hit hard with a high rate of reinfections due to waning immunity. However, only 15 people total are in the ICU (out of 6 million people). This amazing progress is attributed to:

  1. A highly vaccinated and boosted population, and
  2. A massive BA.2 wave (as opposed to a BA.1 wave, like in the U.S.). This may help as BA.2 is more closely related to XBB than BA.1.
The Singapore Ministry of Health predicts they will peak in mid-November at around 15,000 cases per day—an infection peak much larger than their BA.5 wave but smaller than their first Omicron wave. Their death rate is already far below Germany’s and the U.S.’s, regardless of high case rates. I expect it to remain there.

​
Then there are places like Japan, Australia, and South Korea that have similar growth rates of BQ.1.1 and XBB. These places will be particularly interesting to watch and see which subvariants win the battle. Or, for the first time in this pandemic, we may witness co-circulation—two subvariants of equal strength circulating at the same time. Time will tell.

United States​

It’s incredibly difficult to predict what will happen in the U.S. given that we have such a different immune landscape than other countries. We only have 14.8 million Americans boosted with the fall vaccine—far below what’s needed to divert 100,000 deaths this winter. According to recent models, we are still on track for a fall/winter wave.

​
(Source: JPWeiland)
The CDC now updates COVID-19 data weekly, so we are getting bursts of information rather than a continuous story line. From last Friday’s new data update, Northeast has the highest proportion of BQ.1.1, which jumped from less than 1% to 11% of cases. Increasing subvariants are causing an uptick in wastewater. In fact, the Northeast is experiencing the highest concentration of SARS-CoV-2 in wastewater since last winter.

​
Wastewater trends during pandemic. Yellow=Northeast; Pink= South; Green= West; Purple=Midwest. Source: Biobot Analytics
New York, specifically, has the highest proportion of BQ.1.1—an estimated 25% of cases—in the country. Perhaps more concerning is that it is causing an uptick in hospitalizations. (Keep in mind that reported cases remain flat; these no longer accurately reflect transmission due to at home antigen testing.)

​
DAILY HOSPITALIZATION SUMMARY New York State (Source here)
There is very preliminary data (n=1) showing BQ.1.1’s cellular mechanisms are getting close to Delta in regards to disease severity. We need more data, but not a great thing to see.

Bottom line​

Cross-country comparisons are less straightforward than ever. However, subvariants are growing, and metrics around the globe are starting to reflect it. COVID-19 transmission is rising in the Northeast United States, which means it’s time to start riding the wave. If you were waiting to get your booster shot, now’s the time to schedule an appointment.
 
“

We're not done watching Covid
Here in Germany, it’s a fall of Covid-19 contrasts: conferences, long office days and longer club nights have returned, as has a fresh wave of infections. Everything’s back on in person, and it’s shaping up to be a winter full of viruses, whether flu, Covid or garden-variety cold.

I felt the push-pull last week, when I caught Covid again myself and had to cancel a sit-down with Gavi Chief Executive Officer Seth Berkley. Thankfully Berkley, who helped lead the COVAX effort to bring vaccines to lower-income countries, was kind enough to join me on Zoom – a true Covid throwback moment. He shared his thoughts on the end of the pandemic and what our next public-health challenges will be. Here’s an edited and condensed version of our conversation:

Q: Where do you see us standing with the pandemic, and at what point can we start to talk about a post pandemic world?

A: We have to watch it really carefully. We have all the modern science tools, and we're now watching what the evolution is of a novel virus into the population until it reaches its full ecological niche. We can't write the end of that history and say it's over until we are able to stop the massive changes that are occurring and the waves of disease that we're seeing.

Q: Are there other public health issues on your radar now that you are preparing for or concerned about, maybe something that people aren't paying attention to as much as you think they should?

A: The thing that that's worrying me the most is the Ebola outbreak that's going on in Uganda. We don't have a vaccine for that right now. It goes back to why we need to prepare for vaccines in peacetime that we may need if there's outbreaks, even if they're not the most economically viable.


The Afrigen Biologics & Vaccines Ltd. facility, part of the World Health Organization’s mRNA technology transfer hub in Cape Town. Photographer: Dwayne Senior/Bloomberg
But the other thing I'd say is that the effects of climate are upon us. We're seeing massive flooding, fires, displacement of people. And with that comes disease. Pakistan had some typhoid strains that had resistance to four out of the five known antibiotics. That's why we rolled out the typhoid vaccine first in Pakistan. But with these floods, now we're going to see spread of polio, we're potentially going to see cholera, we're potentially going to see spread of typhoid.

Q: How do the floods in Pakistan make it more likely that polio will spread or that resistant typhoid will spread?

A: These are diseases that are connected with poor water and sanitation. A quarter of Pakistan is underwater, and people have moved to high ground and they're living outside. It's a really dire situation, almost biblical in proportion.

Q: Looking into the Northern Hemisphere, how concerned are you about a winter surge of Covid?

A: We don't yet know if Covid has become fully seasonal in the way other respiratory viruses are. We certainly are seeing an uptick now. I worry about that as it's also started to be a bad flu season, and that also obviously causes morbidity and challenges. The things that people can do to protect themselves against Covid – you know, a little social distancing, wearing masks in crowded places, washing hands – also will protect against flu. Obviously we'd like to see as much of that as possible.

--Naomi Kresge

“
 
Covid is still alive and kicking, as reported by peeps in my various social circles.

A friend's family caught it just a couple of days before her booster appointment!

I am grateful that I am up to date with my vaccination.

DK :))
 
dk168 said:
Covid is still alive and kicking, as reported by peeps in my various social circles.

A friend's family caught it just a couple of days before her booster appointment!

I am grateful that I am up to date with my vaccination.

DK :))
Click to expand...

Best thing you could do.
 
ACIP meeting: Updated info on COVID-19, vaccine safety for kids and pregnancy

Katelyn Jetelina
Oct 21


“
For the past two days, ACIP—the CDC advisory board—met to discuss COVID-19 vaccines among children. Actually, this was one of their three regularly scheduled annual meetings, so they discussed many vaccines. Here are the cliff notes re: the COVID-19 ones as there seems to be a ridiculous amount of misinformation circulating.

Adding COVID-19 to the vaccine schedule

The biggest piece of news was that ACIP voted unanimously to add COVID-19 to the pediatric vaccine schedule. What does this mean? CDC adds the COVID-19 vaccine to the Vaccines for Children program. This means that when the federal government stops purchasing vaccines (funds are all but exhausted), kids without health insurance can still get them for free. This is incredibly important for health equity.

This does not mean the CDC is mandating vaccines for schools (looking at you Tucker Carlson). In fact, the CDC has no say in this. This is done on the state and local level. Some states may decide to mandate the vaccines, but some states will not. (This is why vaccine mandates, overall, are not uniform across the country, as shown in the table below.)


COVID19 hospitalization and myocarditis

The hospitalization rate among children aged 6 months-4 years remains the highest compared to other pediatric age groups. This is likely due to suboptimal vaccination.


COVID-19-associated hospitalizations among children and adolescents ages 6 months – 17 years, COVID-NET March 21, 2020 – October 1, 2022. Source Here.
Because so much was packed into the meeting, there was no formal myocarditis benefit/risk analysis (as I had hoped). But ACIP clearly stated that they regularly conduct this analysis (6 times in total, with the last one on September 1, 2022) and “each time ACIP has determined that the benefits outweigh the risks”. They presented some quick statistics:

No evidence of an increased risk for myocarditis following mRNA vaccination in children ages 6 months–5 years
Risk of myocarditis is rare in adolescent and young adult males within the first week after receiving the mRNA vaccine
The risk of adverse cardiac outcomes were 1.8 – 5.6 times higher after SARS-CoV-2 infection than after mRNA COVID-19 vaccination among males ages 12 – 17 years
Interval of 8 weeks between vaccine doses may further lower myocarditis risk
Pregnancy safety data and effectiveness

ACIP provided an update on the safety of COVID-19 vaccines for pregnancy. This data continues to look solid. At this point, there is literally no question that the vaccines are incredibly safe during pregnancy and incredibly important for the mother and fetus/child. A previous post of mine covered a lot of the specific scientific studies, but this is what the CDC had to update. Here were their takeaways:

COVID infection is not safe in pregnancy. There is some evidence that it increases the risk of miscarriage. Later in pregnancy, it increases the risk of preterm birth, pre-eclampsia and stillbirth.

COVID vaccination is safe in pregnancy. 29 studies in 8 countries and including a total of 334,210 people vaccinated in pregnancy found a decreased risk of stillbirth, and no increased risk of miscarriage, preterm birth, SGA, congenital abnormalities, need for NICU or health problems in babies up to six months old.
The CDC tested for outcomes by vaccine type and timing of vaccination and found no evidence of any differences. In other words, it’s safe if pregnant people get Moderna or Pfizer. It doesn’t matter which one.

For the first time (that I’ve seen), CDC presented the effectiveness of mothers’ vaccines on newborn hospitalizations. Overall, effectiveness of the mother’s vaccination in preventing hospitalization of the child after infection was 80-90% during the Delta wave and 60% during the Omicron waves.

This is fantastic news, especially given infection among children aged 0-5 months is leading to much higher hospitalization rates than the flu (see graph below). Among those hospitalized, only 24% had an underlying health condition.


Cumulative influenza- and COVID-19-associated hospitalization rates per 100,000 among infants 0-5 months, FluSurv-NET and COVID-NET, 2017–2022. Source here.
Also, the rate of deaths from COVID-19 infection is higher in this group. Among infants aged 0-5 months, 265 deaths involving COVID-19 have been reported. We need to get more pregnant people vaccinated.


Cumulative deaths involving COVID-19 in children by age based on death certificate data, National Center for Health Statistics, January 1, 2020–October 1, 2022. Source here.
Other updates

Parents and pediatricians may be interested in some other news that was presented at the ACIP meeting:

Polio vaccines, and specifically the oral vaccines, are being considered in the United States given that our current vaccines do not stop transmission. Nothing was decided, but another vaccine recommendation for everyone may be coming down the pipeline.
RSV vaccines, made by GSK and Pfizer, presented results from their clinical trials. Effectiveness looks nothing short of amazing: 82% efficacy rate for GSK and 86% against severe disease for Pfizer. There may be a rare safety signal of Guillain-Barré syndrome (1 in 15,000 children) for both of them. We really need RSV vaccines.
Bottom line

No surprises from the ACIP meeting. Vaccines are safe. They are effective. Everyone over the age of 5 is now eligible for the fall COVID-19 booster, so get one!

Have a great weekend,
“
 
Coronavirus Updates

Important developments in the pandemic.

By Sabrina Malhi


“ The latest
White people in the United States are now more likely to die from covid-19 than Black people, when adjusting for age, my colleagues Akilah Johnson and Dan Keating report. The shift, which first appeared in October 2021, is a sharp contrast from early in the pandemic when “Black people died at several times the rate of White people.” The exception was when the omicron variant surged.

The reporters analyzed every covid death during the pandemic and found that among White Americans, medical information, vaccine hesitancy and mistrust in the government were among the leading causes of the changing demographics of death.

“Skeptics touted debunked alternatives over proven treatments and prevention. Mask use became a victim of social stigma,” Johnson and Keating write. “Black and White people were about equally reluctant to get the coronavirus vaccine when it first became available, but Black people overcame that hesitancy faster.”

On Tuesday, Fox News contributor Tucker Carlson falsely claimed that the Centers for Disease Control and Prevention would begin mandating coronavirus vaccines for schoolchildren, my colleagues Dan Diamond and Lena H. Sun report.

Carlson tweeted, “The CDC is about to add the Covid vaccine to the childhood immunization schedule, which would make the vax mandatory for kids to attend school.”

The Advisory Committee on Immunization Practices voted unanimously Thursday to update the immunization schedule to include the coronavirus vaccines. But these are recommendations, not mandates, and it's up to states to decide whether they will require it, as the CDC and many public health experts have pointed out.

The recommendation on updating the immunization schedule happens annually and consolidates all of the vaccine guidelines so that clinicians have a one-stop reference.

Other important news
On Wednesday, the Food and Drug Administration granted emergency use authorization for the Novavax coronavirus booster, my colleague Laurie McGinley reports. “The agency said people 18 and older can receive the booster six months after completing their primary series of any coronavirus vaccine authorized in the United States,” McGinley writes.
”
 

Pfizer Expects to Hike US COVID Vaccine Price to $110-$130 Per Dose​

By Michael Erman
October 21, 2022

NEW YORK (Reuters) - Pfizer Inc expects to roughly quadruple the price of its COVID-19 vaccine to about $110 to $130 per dose after the United States government's current purchase program expires, Pfizer executive Angela Lukin said on Thursday.
Lukin said she expects the vaccine - currently provided for free to all by the government - will be made available at no cost to people who have private insurance or government paid insurance.
Reuters earlier on Thursday reported that Wall Street was expecting such price hikes due to weak demand for COVID vaccines, which meant vaccine makers would need to hike prices to meet revenue forecasts for 2023 and beyond.
The U.S. government currently pays around $30 per dose to Pfizer and German partner BioNTech SE. In 2023, the market is expected to move to private insurance after the U.S. public health emergency expires.

"We are confident that the U.S. price point of the COVID-19 vaccine reflects its overall cost effectiveness and ensures the price will not be a barrier for access for patients," Lukin said.




It is not yet clear what kind of access people without health insurance will have to the vaccine.
Pfizer said it expects the COVID-19 market to be about the size of the flu shot market on an annual basis for adults, but that the pediatric market would take longer to build based on shots given so far.
So far the U.S. rollout of updated COVID-19 booster shots which target both the original coronavirus strain and the Omicron strain has lagged last year's rate despite more people being eligible for the shots.

Around 14.8 million people in the U.S. received a booster shot over the first six weeks of the rollout of the new shots. In the first six weeks of the 2021 revaccination campaign, over 22 million people received their third shot even though only older and immunocompromised people were eligible at that point.
Lukin said she does not expect purchasing of the vaccines to transfer to the private sector until the first quarter of 2023 "at the earliest." The move is dependent on the government contracted supply being depleted.
(Reporting by Michael Erman; Writing by Caroline Humer; Editing by Bill Berkrot and Richard Pullin)
 

Updated Moderna Booster Shows Greater Activity Against COVID in Adults​

October 21, 2022




WASHINGTON, DC ― The updated Moderna bivalent COVID-19 vaccine that targets the original virus and the Omicron variant was superior to the original COVID booster in adults aged 18 and older, new results indicate.
The bivalent booster was superior regardless of age and whether a person had previously been infected with SARS-CoV-2.
Additionally, no new safety concerns emerged.

Spyros Chalkias, MD, senior medical director of clinical development at Moderna, presented the data on Thursday at the Infectious Disease Week (IDWeek) 2022 Annual Meeting.




In the phase 2/3 trial, participants sreceived either 50 µg of the bivalent vaccine mRNA-1273.214 (25 µg each of the original Wuhan-Hu-1 and Omicron BA.1 spike mRNAs) or 50 µg of the standard authorized mRNA-1273. The doses were given as second boosters in adults who had previously received a two-dose primary series and a first booster at least 3 months before.
The model-based geometric mean titers (GMTs) ratio of the enhanced booster compared to the standard booster was 1.74 (1.49 − 2.04), meeting the prespecified bar for superiority against Omicron BA.1.
In participants without prior SARS-CoV-2 infection who received updated booster doses and those who received standard boosters, the neutralizing antibody GMTs against Omicron BA.1 were 2372.4 and 1473.5, respectively.

Additionally, the updated booster elicited higher GMTs (727.4) than the standard booster (492.1) against Omicron subvariants BA.4/BA.5. Safety and reactogenicity were similar for both vaccine groups.
"By the end of this year, we expect to also have clinical trial data from our BA.4/BA.5 bivalent booster," Chalkias said.
In the interim, last week, the US Food and Drug Administration granted emergency use authorization for Moderna's BA.4/BA.5 Omicron-targeting bivalent COVID-19 booster vaccine in children and adolescents aged 6 – 17 years.
Also last week, Pfizer/BioNTech issued an announcement that their COVID-19 booster, adapted for the BA.4 and the BA.5 Omicron subvariants, generated a strong immune response and was well tolerated in human tests,

Pfizer/BioNTech said data from roughly 80 adult patients showed that the booster led to a substantial increase in neutralizing antibody levels against the BA.4/BA.5 variants after 1 week.

Separate Study of Causes of Severe Breakthrough Infections in Early Vaccine Formulations​

Though COVID vaccines reduce the incidence of severe outcomes, there are reports of breakthrough infections in persons who received the original vaccines, and some of these have been serious.

In a separate study, also presented Thursday, researchers led by first author Austin D. Vo, BS, with the VA Boston Healthcare System, used data collected from December 15, 2020, through February 28, 2022, in a US veteran population to assess those at highest risk for severe disease despite vaccination.

Results of the large, nationwide retrospective study were simultaneously published Thursday in JAMA Network Open.


The primary outcome was development of severe COVID, defined as a hospitalization within 14 days of a confirmed positive SARS-CoV-2 test, receipt of supplemental oxygen, mechanical ventilation, or death within 28 days.


Among 110,760 participants with severe disease after primary vaccination, 13% (14,690) were hospitalized with severe COVID-19 or died.


The strongest risk factor for severe disease despite vaccination was age, the researchers found.


Presenting author Westyn Branch-Elliman, MD, associate professor of medicine with VA Boston Healthcare System in Massachusetts, said, "We found that age greater than 50 was associated with an adjusted odds ratio of 1.42 for every 5-year increase."





To put that in perspective, she said, "compared to patients who are 45 to 50, those over 80 had an adjusted odds ratio of 16 for hospitalization or death following breakthrough infection."


Priya Nori, MD, an infectious disease specialist at Montefiore Medical Center in New York City, told Medscape Medical News that the evidence that age is a strong risk factor for severe disease ― even after vaccination ― confirms that attention should be focused on those in the highest age groups, particularly those 80 years and older.


Other top risk factors included having immunocompromising conditions; having received cytotoxic chemotherapy within 6 months (adjusted odds ratio [aOR], 2.69; 95% CI, 2.25 – 3.21); having leukemias/lymphomas (aOR, 1.84, 95% CI, 1.59 – 2.14); and having chronic conditions associated with end-organ disease.


"We also found that receipt of an additional booster dose of vaccine was associated with a 50% reduction in adjusted odds of severe disease," noted Branch-Elliman


Nori emphasized that, given these data, emphatic messaging is needed to encourage uptake of the updated Omicron-targeted vaccines for these high-risk age groups.


The study by Chalkias and colleagues was funded by Moderna. Chalkias and several co-authors are employed by Moderna. One co-author has relationships with DLA Piper, LLC/Medtronic, and Gilead Pharmaceuticals, and one has relationships with Celgene/Bristol-Myers Squibb, ChemoCentryx, Gilead, and Kiniksa. Nori has disclosed no relevant financial relationships.


JAMA Netw Open. Published October 20, 2022. Full text


Infectious Disease Week (IDWeek) 2022 Annual Meeting: Abstracts LB750 and 788. Presented October 20, 2022.


Marcia Frellick is a freelance journalist based in Chicago. She has previously written for the Chicago Tribune, Science News, and Nurse.com, and was an editor at the Chicago Sun-Times, the Cincinnati Enquirer, and the St. Cloud (Minnesota) Times. Follow her on Twitter at @mfrellick
 

Chinese Capital Steps Up COVID Measures as Cases Quadruple​

Reuters staff
October 20, 2022
logo-reutersprofessional.gif






BEIJING (Reuters) - China's capital, Beijing, has dialled up measures to stop COVID, strengthening public checks and locking down some residential compounds after a quadrupling of its case load in recent weeks, just as a key Communist Party congress entered full swing.
The city of 21 million people on Thursday reported 18 new locally transmitted cases for the previous day, bringing the tally for the past 10 days to 197. That is four times more than the 49 infections detected in the previous 10-day period.
While the number of cases is very small compared with other countries, China's zero-COVID policy has compelled the capital to ratchet up preventive measures, particularly with the Communist Party holding its once-every-five-years congress this week, during which President Xi Jinping is expected to win a precedent-breaking third term as its leader.
Beijing's health authority called for stronger screening of risky individuals and meticulous checks on people entering crowded places including supermarkets and gyms.

Some residential compounds with suspected cases were put under three-day lockdowns that could be extended if new infections emerge.




"Ensure that no one is overlooked," Beijing's health authorities said.
In recent days, China has pledged to stick to its zero-COVID policy despite growing public frustration with it and its toll on the economy, quelling speculation that it would relax the hardline stance soon.
Shanghai, like many other Chinese cities battling sporadic COVID outbreaks, revealed this week that it was planning to build a 3,250-bed quarantine facility on a small island close to the city centre.

In April-May, the city of 25 million people endured a protracted lockdown after detecting hundreds of thousands of cases.
Other major cities including Beijing and Guangzhou have similar quarantine centres with thousands of beds. They also conduct regular public testing campaigns.
(Reporting by Ryan Woo; Editing by Robert Birsel)
 

Ivermectin: Still on a Losing Streak as COVID-19 Treatment​

— ACTIV-6 trial shows no time-to-recovery benefit with anti-parasitic in mild-to-moderate disease​

by Ed Susman, Contributing Writer, MedPage Today October 22, 2022


WASHINGTON -- There were no differences in relief from mild-to-moderate COVID-19 symptoms for patients on ivermectin versus placebo, according to the ongoing ACTIV-6 trial.
Among >1,000 vaccinated and unvaccinated patients, the median time to recovery was 12 days for those in the ivermectin group and 13 days in the placebo group, reported Matthew McCarthy, MD, of Weill Cornell Medicine in New York City, at IDWeek.
As a result, the hazard ratio for improvement in time to recovery was 1.07 (95% credible interval 0.96-1.17, posterior P=0.91), McCarthy and colleagues stated in JAMA, where the results were simultaneously published.

He noted that the current trial was conducted during Delta and Omicron variant surges in the country (June 23, 2021 through Feb. 4, 2022).
McCarthy said during the presentation that treatment with two other repurposed agents -- the antidepressant fluvoxamine (Luvox) and the inhaled steroid fluticasone -- did not offer significantly better outcomes than placebo. "We observed no significant differences in relief of mild-to-moderate symptoms between participants taking ivermectin, fluticasone, or fluvoxamine and participants taking placebo. There was no difference observed in the number of hospitalizations or deaths between patients taking ivermectin, fluticasone, or fluvoxamine and participants taking placebo. There were no safety concerns identified in any arm," he stated.
"These results are consistent with what we have seen in other trials with these agents," said IDWeek session co-moderator Adarsh Bhimraj, MD, of Houston Methodist.
"This is a huge platform trial," he told MedPage Today. "It's strength is in the numbers of patients included, and that it was conducted later in the pandemic which is more relevant to us now, and it is also concordant with other studies."

Bhimraj stated that "there were no surprises with these results of ACTIV-6, which...is good," adding that studies showing which treatments do not work have as much value as those that demonstrate which treatments do work.
He also pointed out that "across all these trials with these different agents, the safety signals are not that bad."
McCarthy's group reported that there were 10 hospitalizations or deaths in the ivermectin group and nine in the placebo group (1.2% vs 1.2%, HR 1.1, 95% CrI 0.4-2.6). The most common serious adverse events were COVID-19 pneumonia with five cases in the ivermectin group and seven in the placebo group, along with venous thromboembolism (one and five cases, respectively). There was one death in the ivermectin group.
For the ivermectin arm of ACTIV-6, 814 people were on ivermectin (400 μ6/kg) and 774 people were on placebo, daily for 3 days. Less than half reported receiving at least two doses of a SARS-CoV-2 vaccine. Median patient age was 48, 57% were women, and about 80% were white. There were 656 patients in the fluticasone arm and 621 on placebo. About a third of the patients had not had any COVID vaccine. Median age was about 46, 63% were women, and about 80% were white. Finally, there were 674 patients on fluvoxamine and 624 patients on placebo. About two-thirds had received at least two doses of the vaccine. They had a median age of 48 years, 58% were women, and about 80% were white.

McCarthy and colleagues acknowledged that "the inclusion criteria allow for a broad study population, this study failed to achieve the level of representation desired for underrepresented populations in terms of racial and ethnic diversity," which was a study limitation.
Still, they concluded that the "findings do not support the use of ivermectin in patients with mild to moderate COVID-19...this study adds to the growing evidence that there is not a clinically relevant treatment effect of ivermectin at this dose and duration."

  • author['full_name']

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

"​

Health officials warn of 'tripledemic'​

By Tisha Lewis
Published October 24, 2022 10:14PM
Health


BETHESDA, Md. (FOX 5 DC) - Health officials are warning people about a potential spike in COVID-19, flu, and respiratory syncytial virus cases. They're calling it a "tripledemic."
The concern is there could be an uptick in cases this season in all three, especially in children.

https://nj.betparx.com/register?bta...L4XZFOUUSUEUNhWGxHgDzdc3wZCCPnFMorsK_-N7OrIZF



The warning comes amid a possible disease outbreak at Stafford High School after nearly half the student body missed class last week.

Since then, the school district says several students tested positive for the flu and more are showing respiratory illness symptoms.


What is RSV? US children's hospitals see rising number of cases

COVID-19 cases have reportedly risen nationwide.

Apparently, in the last two years as everyone masked up, and practiced social distancing, plus distance learning and working from home – the cold and respiratory illnesses declined.

Now, they’re back with a vengeance.

For the most part, the restrictions put in place during COVID, no longer exist.

That means COVID-19 will now coexist with what’s expected to be a robust cold, respiratory illness, and flu season – a tripledemic.

Patty Olinger, the executive director of the Global Biorisk Advisory Council, says parents should protect themselves and their children now before Halloween.

Doctors say they’re seeing cases of the cold and flu and respiratory virus surface earlier this season compared to years past.

"
 

Omicron Outsmarting Immunity; Timing COVID and Flu Shots; Psychedelic Meds​

— Health news and commentary from around the Web gathered by MedPage Today staff​

by Jennifer Henderson, Enterprise & Investigative Writer, MedPage Today October 25, 2022

S
Morning Break over illustration of a syringe, Covid virus, and DNA helix over a photo of green vegetation.

Note that some links may require subscriptions.
Omicron keeps finding new ways to outsmart our immunity. (NPR)
President Biden is set to receive his updated COVID shot today and launch new initiatives, such as free access to Paxlovid in underserved communities. (ABC News)
So, as the U.S. readies for a rough winter of respiratory viruses, this is when to get your COVID and flu shots, according to experts. (STAT)

While economic pressures continue, health insurance inflation is expected to drop sharply. (Wall Street Journal)
During the first year of the pandemic, men died from COVID at a much higher rate than women, according to a new CDC report.
HHS began rolling out a series of ads targeting specific communities with slow uptake of the updated COVID shot. (CNN)
After COVID disrupted measles vaccinations in Africa, cases are surging there. (Reuters)
With nurses stressed out and burned out, that may be putting people's health at risk. (USA Today)
Abortion bans continue to add uncertainty for those seeking fertility treatments. (Healthcare Dive)
Though hospitals reported losing money on Medicare patients, some made millions, according to a report released by the North Carolina state treasurer's office. (Kaiser Health News)
In some statewide midterms, expanding Medicaid is a key issue. (NPR)
Following COVID shutdowns early in the pandemic, autism services for adults in Philadelphia have yet to rebound. (Philadelphia Inquirer)

A psychologist in Illinois was convicted of defrauding Medicare by submitting claims for psychotherapy services he never provided to patients who were deceased, the Department of Justice said.
Creatine won't magically give people abs, but here is what the supplement may do, according to experts. (New York Times)
Here's what a dearth of dead bugs on windshields means. (Washington Post)
Unilever has recalled certain dry shampoos, including Dove and TRESemmé products, due to the potential presence of benzene, a known human carcinogen. (CNN)
With legalization on the horizon, psychedelic therapy companies -- like those behind magic mushrooms -- are scooping up patents that could enhance future profits. (New York Times)
 
missy said:
Let me try to explain this as simply as I can. No attitude from me at all. Just truly want to try to help you understand.

1. If everyone got vaccinated the virus would have died out.
2. Because so many did not get vaccinated the virus was able to survive and mutate.
3. Getting vaccinated helps lower the risk of getting Covid and then transferring it to others.

You wrote: "I don't need reasons not to get vaxxed, I need reasons to get vaxxed."
I thought you said you couldn't get vaccinated for medical reasons. But now the truth comes out. No offense to anyone who actually could not get vaccinated for medical reasons. The pandemic lives because of those who selfishly refused to get vaccinated. Not because of those who have a valid medical reason.

Anyway, I do not care why you did not get vaccinated. It is none of my business. You brought it up. I just don't want misinformation being spread. This thread exists to share info and facts.
Click to expand...


Not trying to start anything, just a reminder for next time. The truth comes out indeed.
This quote is from the Coronavirus updates -April's thread.

The blaming, the shaming and the guilt trippin' ....
I was selfish for having medical reasons (that I'm still having and are still ongoing and that I take 2 types of meds daily for and will be getting the 3rd one soon). Not a "valid" medical reason, no...


VERBA VOLANT, SCRIPTA MENENT!

​


P.S.
I would have literally killed my mom if I took the jab then visited her as per advice received, she has severely reduced lung function.
 
Last edited:

​

Neutralization Escape by SARS-CoV-2 Omicron Subvariant BA.4.6​

TO THE EDITOR:​

Figure 1.
nejmc2212117_f1.jpeg
Neutralizing Antibody Responses to Omicron Subvariants.
The B.1.1.529 (omicron) variant of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has splintered into multiple subvariants with increased transmissibility and immune escape.1 At the time of this report, omicron subvariant BA.5 is the dominant global virus and has shown substantial immune escape as compared with previous omicron subvariants.2-5BA.4.6 is a sublineage of BA.4 with two additional mutations in the spike protein (R346T and N658S) (Figure 1A) and has recently increased in prevalence in certain regions currently dominated by BA.5, including in the United States. The ability of BA.4.6 to evade neutralizing antibodies that were induced by infection or vaccination remains to be determined.
We evaluated neutralizing antibody titers against five SARS-CoV-2 strains — WA1/2020 and omicron subvariants BA.1, BA.2, BA.4–BA.5, and BA.4.6 — in 19 participants who had been recently infected with the omicron BA.1 or BA.2 subvariant and in 16 participants who had been vaccinated and boosted with the original mRNA-1273 vaccine (Moderna) (Table S1 in the Supplementary Appendix, available with the full text of this letter at NEJM.org). In the cohort with previous omicron infection, all the participants except for one had been vaccinated; samples were obtained a median of 21 days after diagnosis of omicron infection. In this cohort, the median pseudovirus neutralizing antibody titer was 42,067 against WA1/2020, 6352 against BA.1, 3854 against BA.2, 1673 against BA.4–BA.5, and 630 against BA.4.6 (Figure 1B). The median neutralizing antibody titers against BA.4.6 were lower than the median titers against WA1/2020 by a factor of 67, against BA.1 by a factor of 10, against BA.2 by a factor of 6, and against BA.4–BA.5 by a factor of 2.7.
In the mRNA-1273 vaccine cohort, participants were excluded if they had a known history of SARS-CoV-2 infection or positive results on nucleocapsid serologic analysis or if they had received immunosuppressive medications or other vaccines against SARS-CoV-2. Six months after the initial two mRNA-1273 immunizations, the median neutralizing antibody titer was 951 against WA1/2020, 28 against BA.2, 30 against BA.4–BA.5, and 23 against BA.4.6 (Figure 1C). At a median of 17 days after the first booster dose, the median neutralizing antibody titer was 16,011 against WA1/2020, 802 against BA.2, 449 against BA.4–BA.5, and 225 against BA.4.6. The median neutralizing antibody titer against BA.4.6 was lower than that against WA1/2020 by a factor of 71, against BA.2 by a factor of 4, and against BA.4–BA.5 by a factor of 2.
Our data show that the BA.4.6 omicron subvariant markedly escaped neutralizing antibodies induced by infection or vaccination, with values that were lower than BA.5 titers by a factor of 2 to 2.7, which suggests continued evolution of SARS-CoV-2. These findings provide immunologic context for the increasing prevalence of BA.4.6 in populations in which BA.5 is currently dominant. Moreover, the R346T mutation had also recently been observed in other omicron subvariants, including BA.2.75 and BA.5, which suggests the biologic relevance of this mutation. The potential effect of the emergence of the BA.4.6 subvariant on vaccine boosters containing BA.5 immunogens or on infection with BA.5 remains to be determined.
Nicole P. Hachmann, B.S.
Jessica Miller, B.S.
Ai-ris Y. Collier, M.D.
Dan H. Barouch, M.D., Ph.D.
Beth Israel Deaconess Medical Center, Boston, MA
[email protected]
Supported by a grant (CA260476) from the National Institutes of Health (NIH); by grants (to Dr. Barouch) from the Massachusetts Consortium for Pathogen Readiness, the Ragon Institute, and the Musk Foundation; and by a grant (AI69309, to Dr. Collier) from the NIH.
Disclosure forms provided by the authors are available with the full text of this letter at NEJM.org.
This letter was published on October 19, 2022, at NEJM.org.
 
"

State of Affairs 10/26/22: Triple Threat​

KATELYN JETELINA
​
​
We are seeing an uptick in RSV and the flu in the Northern Hemisphere and particularly in the United States. Given an anticipated uptick in COVID-19, the media is coining this the “triple threat.” Here is the current state of affairs and what it means for you.

Respiratory Syncytial Virus (RSV)​

RSV is a common virus that typically circulates during the fall, winter, and spring. Before the pandemic, everyone could count on being infected at least once before they reached the age of 2. Thereafter, people are typically infected multiple times throughout their lifetime.
Most people recover in a week or two, but it can be serious for two groups:
  • Young children. Before the pandemic, we saw 2,300 per 100,000 children under the age of 1 hospitalized. (In comparison, the estimated hospitalizations rate is 30-40 per 100,000 children for flu and 48 per 100,000 children for COVID-19, pre-vaccine.) RSV is the most common cause of bronchiolitis (inflammation of the small airways in the lung) and pneumonia (infection of the lungs).
  • Older adults. Just like COVID-19, RSV is rough on older adults because their immune systems are weaker and they are more likely to have underlying health conditions, like heart or lung disease. In the U.S. an estimated 177,000 older adults are hospitalized for RSV each year and 14,000 of them die.
Overall, RSV is on the rise. As shown below, the percent positivity rate is above 10-15% in the U.S.—this means RSV is spreading faster than we can test for it and is causing an exponential growth in cases. However, we aren’t at record numbers yet. In fact, we are still below our very unusual 2021 summer surge. Almost all states are showing the same general trend.
​
Respiratory Syncytial Virus (RSV) Trends United States. Source Here.
There is quite a bit of discussion regarding how RSV is transmitted. The standard precaution for healthcare workers is hand washing, hospital gowns, and gloves. (Notice masks are not recommended.) These precautions stemmed from older studies showing the main mode of RSV transmission is primarily through large particles in the eye or nose or directly touching contaminated surfaces. RSV does have small particles that travel far, but this doesn’t seem to be a main mode given this older research.
There is currently no vaccine for RSV. However, last week we received very good news from two manufacturers (GSK and Pfizer) that vaccines in development for adults were highly effective: 82% efficacy rate for GSK and 86% for Pfizer. We can’t expect a vaccine for this season, but maybe next year.

Influenza (Flu)​

The official “flu season” started two weeks ago and case numbers are higher and earlier compared to the past two pandemic years and compared to before the pandemic. (See red triangles in the graph below.)
​
(CDC)
Flu rates are highest among 0-4 year olds, but cases in every age group are increasing. We are seeing regional trends with the flu, as the South has the most activity but East Coast states are starting to increase, too, particularly New York.
​
(CDC)
Flu viruses can be detected up to 5-7 days after becoming sick, but people are most contagious in the first 3-4 days after symptoms begin. Symptoms typically begin about 2 days (but can range from 1-4 days) after flu viruses infect a person’s respiratory tract. Some people can be infected with flu viruses and have no symptoms but still spread the virus.
There is a flu vaccine. We won’t know how well the flu vaccine works until next year (we collect real world data in real time), but lab data is indicating the vaccine is a good match this year. Unfortunately, flu vaccine uptake dropped during the pandemic.

COVID-19​

Then there is COVID-19, which is calming down in Europe, even in Germany. We are also getting good news from Singapore, where the Omicron subvariant XBB took hold and caused an infection wave. Thankfully their XBB infection wave was smaller than the BA.5 wave. (We expected the opposite.)
​
In the U.S., wastewater is stalling, while the Omicron subvariants, and particularly BQ.1.1, take hold. BQ.1.1 has now grown to 16% of reported cases. We typically see a variant’s impact at around 50%, so we still have some time.
​
SARS-CoV-2 wastewater trends during pandemic. Source: Biobot Analytics
However, hospitalizations have started to rise for those over the age of 65, which is not a welcoming trend given that subvariants have yet to take over.
​
COVID19 daily admissions per 100K, by age group (NYT)

What does this all mean?​

It’s becoming a petri dish out there. The triple threat specifically, though, isn’t in full throttle yet. This is clearly displayed in Chicago’s weekly surveillance report below where some viruses are rising but not all.
​
Respiratory Virus Laboratory Surveillance in Chicago
Will a triple threat come? This is one of the biggest debates among epidemiologists— the concept of whether we are witnessing virus-virus interaction. We know very little about how well viruses co-circulate with each other. For example, is flu spiking early because COVID-19 isn’t spiking yet? Maybe. Could RSV spike, then decline, then COVID-19 take over, then decline, then flu spike, and then decline? Maybe. Or, could they all spike at the same time? Maybe. We just don’t know what will happen, but a resurgence is expected.
This winter also depends on the strength of our healthcare system. The combination of our usual viruses co-circulating with COVID-19, burnt out healthcare workers, understaffed hospitals (in 2021, over 330,000 workersleft healthcare), and staff being out for illnesses themselves, does not paint a pretty picture.

Bottom line​

Lots of viruses are spreading right now and it’s a bit earlier than normal. We don’t have a triple threat yet, but I don’t think we want to see one, as I’m concerned for our healthcare systems. Do your part by getting vaccinated, staying at home while you’re sick, and other measures like washing hands, wearing a mask, and getting that airflow moving.

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The Updated COVID Boosters Could Have Been Better
— From design to implementation, our bivalent shots missed the mark

by John P. Moore, PhD, and Céline Gounder, MD, ScM
October 26, 2022

In August, the FDA authorized updated COVID-19 vaccine boosters containing an equal mix of the ancestral vaccine and a component tailored against the Omicron BA.4/5 subvariants. It rejected the idea of yet another booster of the original vaccine -- which the U.S. has in abundant supply -- or authorizing a monovalent Omicron-only booster. In our view, this decision was not clear cut and may have been the wrong one.


European countries made different choices based on similar information, opting instead for a bivalent vaccine containing an equal mix of the ancestral vaccine and one designed against the Omicron BA.1 subvariant. Meanwhile, the World Health Organization's Strategic Advisory Group of Experts on Immunization (SAGE) committee recently noted that "...currently available data are not sufficient to support the issuance of any preferential recommendation for bivalent variant-containing vaccine boosters over ancestral-virus-only boosters....The bulk of the benefit is from the provision of a booster dose, irrespective of whether it is a monovalent or bivalent vaccine."

Why are there such different perspectives? Let's look at what the immunology tells us.

When a dose of a BA.4/5-specific vaccine booster is given, most of the resulting increase in antibody production is derived from memory B-cells primed by the ancestral vaccine. Only a small fraction of the antibodies recognize new binding sites unique to BA.4/5. Furthermore, because the bivalent boosters are a 50-50 blend of the ancestral and BA.4/5 vaccines, only a half-dose of Omicron-specific vaccine is being administered. These points are why we and colleagues have argued that the updated boosters may be at best minimally better at eliciting neutralizing antibodies against BA.4/5 compared to the original vaccines. Two preprints released this week show that this is indeed the case. And at least one study provides clinical data showing that the updated COVID-19 booster probably won't protect any better against Omicron infections than the original vaccine. It's important that people recognize these limitations and do not increase their exposure to the virus after being boosted.

A reasonable counter-argument was that we do need to keep up with the times and develop vaccines to better protect against the Omicron subvariants. Yet, administering a monovalent, and hence a full dose, of a BA.4/5 vaccine may have better achieved this goal. The available data suggest that monovalent Omicron vaccines elicit a stronger antibody response to Omicron subvariants than do bivalent formulations.

Medical News from Around the Web
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In moving ahead with the bivalent formula, the FDA may have wanted to hedge its bets against the possible re-emergence of a pre-Omicron or Delta-like variant this winter, a scenario that, while unlikely, is not impossible. At the same time, the U.S. was well prepared for that outcome, because we have enormous supplies of the ancestral COVID-19 vaccines, until they expire. These vaccines can now only be used for initial vaccinations, not boosters, at a time when very few Americans are lining up to get their initial COVID-19 vaccine series.


The FDA and CDC didn't assess an approach that could have considered vaccination against the Omicron variants as if they were entirely new viruses. We know that two full doses of the ancestral vaccines were needed to induce strong antibody responses. The same immunology considerations could have been applied to eliciting antibodies against the sites that are unique to the Omicron variants -- here, the science suggests two full-doses of an Omicron-specific monovalent vaccine would be much more effective than the single half-dose that's in the bivalent booster. This might have been a good option for vulnerable populations in need of the strongest practically achievable protection.

In rolling out boosters, the FDA and the CDC should also apply the lessons learned in properly spacing vaccine doses, as this is important for optimal benefit. The CDC advises that a booster can be given "within 2 months" of infection or vaccination. However, a 4- to 6-month interval would be substantially better if the goal is to maximize antibody production. Boosting too soon after the previous dose (or infection) likely won't work as well as waiting a few more months. One reason is the presence of pre-existing antibodies in the blood, which can form complexes with the spike proteins produced by the vaccine and thus impair how the immune system responds to the vaccine. The levels of those anti-spike antibodies are high for a month or two after vaccination or infection, but fall steadily over the next few months. Furthermore, boosting too soon abrogates B-cell responses to vaccination.


As we've heard over and over again, vaccines on shelves don't prevent COVID-19 -- vaccinations in arms do. One obvious factor driving poor booster uptake is that many aren't even aware that updated bivalent boosters exist. A recent Kaiser Family Foundation (KFF) survey shows that over half of adults in the U.S. have heard only "a little" (31%) or "nothing at all" (20%) about them. Another potential factor in the low uptake of the bivalent boosters could be the FDA's decision to authorize it without having human safety data in hand, only mouse studies. As scientists and healthcare professionals with vaccine experience, we have no concerns about the safety of the bivalent vaccine. It's still the same vaccine, just with a tweak. To us, it's akin to having a car resprayed in a different color. We would not require a full safety evaluation before driving it. However, the public is very fickle about mRNA vaccine safety because of the vicious lies circulated by vaccine skeptics. Authorizing a new vaccine based on only mouse data was asking for trouble. A significant fraction of the public (18%) is now in "wait and see mode," perhaps a reflection of a lack of trust in the safety of the bivalent boosters. This outcome was all too predictable. The FDA and CDC should have seen it coming. At the very least, the messaging could have been better. Furthermore, the FDA de-authorization for the standard booster eliminated an option for people who trusted that one but may be antsy about the safety of new bivalent versions.

The people at greatest risk for severe and fatal outcomes are those who haven't yet gotten vaccinated against COVID-19. According to KFF polling, this group has proven very resistant to change, although some are now slowly coming around. Unfortunately, the FDA did not authorize the bivalent vaccines for use as a primary series or to boost a previously infected but never vaccinated person. An updated primary series based on the bivalent vaccine might provide better protection as well. The bivalent vaccine would essentially initiate two different primary series responses -- one against ancestral viruses and one against Omicron subvariants.

There remain many uncertainties about how best to design and implement COVID-19 vaccines in the face of what seems to be an ever-evolving virus. The pandemic, in one form or another, will be with us for many years yet. To respond as effectively as possible, we must continue to study different vaccine designs in carefully designed clinical trials. We must fully factor in the outstanding improvements to the knowledge of viral immunology that have emerged in the past 2 years. Forewarned is forearmed.

John P. Moore, PhD, is a professor of microbiology and immunology at Weill Cornell Medicine in New York City. Céline Gounder, MD, ScM, is an internist, infectious disease specialist, and epidemiologist; a senior fellow and editor-at-large for public health at the Kaiser Family Foundation and Kaiser Health News; and host of the "American Diagnosis" and "Epidemic" podcasts.

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