Coronavirus Updates July 2022

[missy]

"FDA Calls for Omicron Component in Fall Booster Shots​

— Move follows recommendation from agency's vaccine advisory committee​

by Ian Ingram, Managing Editor, MedPage Today

The FDA on Thursday called on COVID-19 vaccine manufacturers to include components targeting the latest Omicron strains in bivalent booster shots for the fall and winter 2022 season.
"We have advised manufacturers seeking to update their COVID-19 vaccines that they should develop modified vaccines that add an omicron BA.4/5 spike protein component to the current vaccine composition," Peter Marks, MD, PhD, director of FDA's Center for Biologics Evaluation and Research, said in a statement. "As we move into the fall and winter, it is critical that we have safe and effective vaccine boosters that can provide protection against circulating and emerging variants to prevent the most severe consequences of COVID-19."

If all goes according to plan, the modified vaccines could potentially be available in "early to mid-fall," he said.
In his statement, Marks noted that while the initial COVID-19 vaccines have reduced the risks for hospitalization and death, studies have since shown that the effectiveness of both the primary vaccine series and booster doses wane over time. Omicron, in particular, has shown a greater degree of immune escape than prior variants.
The announcement follows Tuesday's meeting of the Vaccines and Related Biological Products Advisory Committee, which overwhelmingly recommended inclusion of components targeting the latest Omicron subvariants (though not all of the outside experts were on board).
Pfizer/BioNTech and Moderna have both already developed bivalent versions of their mRNA vaccines that target the ancestral strain and Omicron BA.1 strain. And while the companies recently announced that these shots can neutralize BA.4 and BA.5, in both cases it was to a lesser extent than against the original Omicron.
"We have advised [the manufacturers] that they should submit these data to the FDA for our evaluation prior to any potential authorization of a modified vaccine containing an omicron BA.4/5 component," said Marks, adding that the companies will also be asked to start clinical trials testing the new component.

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  Ian Ingram is Managing Editor at MedPage Today and helps cover oncology for the site.
  
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[missy]

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Lingering Brain Problems Common After COVID​

— Can new initiative point to long COVID therapies?​

by Judy George, Deputy Managing Editor, MedPage Today

At least one neuropsychiatric symptom has been reported in up to 90% of patients 6 months after COVID-19 hospitalization and in about 25% of non-hospitalized adults with COVID-19, a targeted rapid literature review showed.
Sequelae rates differed depending on the spectrum of post-COVID complications evaluated, the severity, course, and time window from initial infection, and the methodology used to assess symptoms, reported Naomi Simon, MD, MSc, and Jennifer Frontera, MD, both of New York University (NYU) Grossman School of Medicine in New York City.

Commonly reported neuropsychiatric events that occurred 4 or more weeks after acute SARS-CoV-2 infection were cognitive impairment, sleep problems, anxiety, depression, post-traumatic stress disorder (PTSD), fatigue, and headache, Simon and Frontera wrote in a special communication in JAMA Psychiatry.
Diverse reports about symptoms and prevalence rates have made it hard to pinpoint COVID's persistent sequelae, Simon and Frontera noted.
"The current literature describing neuropsychological events following SARS-CoV-2 infection is limited by ascertainment biases, variable definitions of long COVID, conflation of neurological symptoms, signs, and diagnoses, and lack of adequate control populations," Frontera told MedPage Today.
The RECOVER program, an NIH initiative to investigate prolonged health effects of SARS-CoV-2 infection, may help answer important questions, she noted.
"The RECOVER initiative is a multi-centered observational study that incorporates control groups and will allow us to drill down on not only the incidence, risk factors, and outcomes of neuropsychological events post COVID-19, but may also help us to identify therapeutic strategies that can be studied in larger clinical trials," Frontera said.

For their review, Simon and Frontera assessed articles about long COVID or post-acute sequelae of COVID-19 (PASC) published on PubMed and PsycInfo between January 2020 and February 1, 2022. The researchers used the CDC definition of long COVID, which included symptoms that were present 4 weeks or longer from index infection.
Post-infection sequelae rates varied widely across studies. One analysis of people hospitalized with COVID-19 from March to May 2020 showed more than 90% had functional and cognitive problems 6 months later. A 2021 survey of COVID-positive people suggested 25% had lingering cognitive or psychological symptoms that lasted a median of 4 months.
Overall, prevalence rates ranged from 4% to 47% for cognitive abnormalities, 3% to 27% for sleep disturbances, 7% to 46% for anxiety, 3% to 20% for depression, 6% to 43% for PTSD, 5% to 32% for fatigue, and 5% to 12% for headache.
"These rates appear to be higher than rates observed in similar patient populations without COVID-19," Simon and Frontera wrote.
"Among 73,000 non-hospitalized patients 30 days or longer after infection, incident onset of anxiety and fear-related disorders and trauma- and stress-related disorders was significantly greater than among those without COVID-19," Simon and Frontera noted. "However, not all studies have found higher rates of mood and anxiety symptoms after COVID-19 hospitalization than among comparator groups, and substantial variability exists in study methods and quality."

Subjective symptoms, diagnosed syndromes, and objective testing abnormalities were conflated across studies, muddying a solid understanding of long COVID epidemiology, Simon and Frontera observed. Many studies reported cross-sectional data only. Even when associations between SARS-CoV-2 and neuropsychiatric disease seemed plausible, causality was difficult to verify without pathological evidence or robust biomarkers, the researchers pointed out.
What triggered post-COVID neuropsychiatric sequelae also was not clear. Proposed mechanisms included brain injury from acute COVID-19, neurodegeneration from secondary COVID effects, immune dysregulation and chronic inflammation, viral persistence in tissue reservoirs, and reactivation of other latent viruses, Simon and Frontera noted.
"Despite rapidly emerging data, many gaps in knowledge persist related to the variable definitions of PASC, lack of standardized phenotyping or biomarkers, variability in virus genotypes, ascertainment biases, and limited accounting for social determinants of health and pandemic-related stressors," the authors wrote.
RECOVER, which has been criticized for its slow start, includes clinical cohort studies of adults and children, pathology studies, and big data studies based on electronic medical records. The adult clinical cohort study aims to enroll 15,000 COVID patients and 2,680 controls, assuming a long COVID rate of 25%.
To date, RECOVER researchers have enrolled 4,939 adults across 62 sites, 233 children across nine sites, and 28 autopsy participants across three sites, Frontera said.

• 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.
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[missy]

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The latest​

The Supreme Court decided to let New York’s vaccine requirement for health-care workers stand even though it did not allow for a religious exemption. Three justices – Clarence Thomas, Neil M. Gorsuch and Samuel A. Alito Jr. – objected to the court’s decision to refuse to reviewthe state’s vaccine rule, which allowed providers to seek medical exemptions but not religious ones.

Omicron-based booster shots will roll out this fall, following a decision by the Food and Drug Administration to include a component from BA.4 and BA.5, the omicron subvariants gaining ground in the United States. The new boosters will include the original formula based on the virus that spread in early 2020 as well as a formula tailored to the omicron subvariants.

Restaurants were hit hard by the pandemic when indoor dining was strictly limited or banned altogether – but the number that closed because of the strain was far lower than early worst-case scenario estimates. Many hope that the worst is over for the food service industry, now that most pandemic-era restrictions have ended and people are once again dining out.

Other important news​

The Columbus Zoo in Ohio lost Jupiter, a 14-year-old tiger, to covid-19 complications on Wednesday.

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[missy]

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FDA Calls for Omicron Component in Fall Booster Shots​

— Move follows recommendation from agency's vaccine advisory committee​

Omicron-based coronavirus booster shots will roll out this fall

By Carolyn Y. Johnson
Updated June 30, 2022 at 4:32 p.m. EDT|Published June 30, 2022 at 11:13 a.m. EDT

The fall vaccination campaign will use an updated vaccine tailored to fight the omicron subvariants. (Frederic J. Brown/AFP/Getty Images)




This fall, vaccine makers will begin rolling out coronavirus booster vaccines better tailored to fight the current phase of the pandemic.
Two days after outside experts voted in favor of a new vaccine adapted to protect against omicron, the Food and Drug Administration announced that the fall shots would include a component from BA.4 and BA.5, the omicron subvariants gaining ground in the United States.
The change shows the FDA trying to be more nimble in efforts to keep up with a changing virus. The precise formula has not been tested in people yet, but studies showed that vaccines tuned to fight a previous version of omicron modestly increased the short-term immune response in people compared with more shots of the original. The agency will depend in part on that data as it reviews the new vaccines.

FDA advised companies Thursday to create a two-part vaccine for a fall booster campaign. One part of the vaccine will be the original formula, based on the version of the virus that spread globally in early 2020. The other part will be based on the BA.4 and BA.5 omicron subvariants that currently make up half of the strains that are sequenced in the United States.
It is quite possible that BA.4 and BA.5 will be eclipsed by new variants by the fall, but the hope is that a new shot will help broaden immunity, since they are closer to where the virus is today. A scientist from Pfizer showed data to FDA advisers Tuesday that in mice, a vaccine based on those versions of omicron appeared to generate a stronger immune response.
Tracking the coronavirus vaccine
For a year and a half, coronavirus vaccines based on the original version of the virus have provided robust protection, particularly against severe illness. But immunity tapers off over time, and the virus has proved wily, spawning a growing Greek alphabet of new variants that are more contagious and deft at slipping by people’s immune defenses.

“As we move into the fall and winter, it is critical that we have safe and effective vaccine boosters that can provide protection against circulating and emerging variants to prevent the most severe consequences of covid-19,” Peter Marks, director of FDA’s Center for Biologics Evaluation and Research said in a statement.
Some experts have felt anguished that such a consequential decision has to be made based on very limited data. It is possible that the change could provide a detectable increase in people’s protection against severe illness and perhaps also infection, but it is not certain.
“I think the FDA here is making a best guess as to what they think is the right thing to do, and that may turn out to be a good one and it might not,” said John Moore, a professor of microbiology and immunology at Weill Cornell Medicine. “We don’t know and have no real way of knowing.”

The modified vaccine will be used as a booster. People who are still getting their first shots will continue to get the original version of the vaccine.
People who are unvaccinated or unboosted should not put off vaccination in hopes of getting a new shot, particularly given the high levels of transmission, said an FDA official who requested anonymity because they were not authorized to speak. People will still potentially be eligible for the booster in the fall, and all the vaccines are best at protecting against severe illness and hospitalization.
Kathrin Jansen, a Pfizer vaccine scientist, said this week that the vaccine could be delivered in early October.
The federal government announced Thursday that it had agreed to purchase 105 million doses of Pfizer’s rebooted vaccine for $3.2 billion. At $30.50 a dose, that’s a premium over the initial contracts the government made for the original vaccine in 2020, when the vaccines were $19.50 per dose.

Pfizer has said that the price of its vaccine will probably rise after the pandemic, and this may not be the ceiling.
“We expect this is just the second pricing step up between pandemic pricing and future commercial pricing,” SVB Securities Research analysts wrote in a note analyzing the announcement.
Moderna spokeswoman Elise Meyer said that the company would be able to deliver the vaccine in October if data from testing the shots in people is not required before a regulatory decision. An agreement to supply the United States has not yet been announced.

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[missy]

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Nearly 1 in 5 Adults Who Had COVID Have Lingering Symptoms: US Study​

By Reuters Staff


Added to Email Alerts


(Reuters) - Nearly 1 in 5 American adults in a survey who reported having COVID-19 in the past are still having symptoms of long COVID, according to data collected in the first two weeks of June, U.S. health officials said on Wednesday.
Overall, an estimated 1 in 13 adults in the United States have long COVID symptoms lasting for three months or more after first contracting the disease, and which they did not have before the infection, the data suggests.
The data was collected using an online questionnaire from June 1-13 by the U.S. Census Bureau's Household Pulse Survey, and analyzed by the U.S. Centers for Disease Control and Prevention (CDC).
Long COVID symptoms range from fatigue, rapid heartbeat, shortness of breath, cognitive difficulties, chronic pain, sensory abnormalities and muscle weakness. They can be debilitating and last for weeks or months after recovery from the initial infection.

The CDC analysis also found that younger adults were more likely to report persistent symptoms than older adults.

Women were also more likely to report long COVID than men, according to the study, with 9.4% of U.S. adult women reporting long COVID symptoms compared to 5.5% of men.
The survey found nearly 9% of Hispanic adults reported long COVID, higher than non-Hispanic white and Black adults, and more than twice the percentage of non-Hispanic Asian adults.
There were also differences based on U.S states, with the highest percentage of adults reporting long COVID symptoms in Kentucky and Alabama, while Hawaii, Maryland and Virginia had the lowest.

Among the experimental survey's limitations, the CDC cautions in technical notes, is that the percentage of adults who self-report ever having had COVID-19 is lower than estimates based on national seroprevalence studies. The survey also relies on online responses, and had a low (6.2%) response rate.
SOURCE: https://bit.ly/3NdZjyQ Household Pulse Survey Dashboard\
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[missy]

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The hunt for an all-purpose Covid vaccine​

Vaccine makers are racing to keep up with an ever-changing coronavirus. Moderna and Pfizer spent months testing mRNA vaccine boosters targeting the original omicron strain. But last week, after reviewing the data, US regulators instead advised them instead to develop boosters that would target the latest omicron strains, BA.4 and BA.5. By the time those come out this fall, the virus may have moved on to new variants, necessitating yet another round of boosters. So is there a better way? Many researchers think so. They’re working on pan-coronavirus vaccines. The idea is to create a broader-acting shot that could provide long-term protection against a range of future Covid variants. If the more ambitious versions of the concept come to fruition, such vaccines may also provide protection against close cousins of Covid that haven’t yet spilled over into people from bats or other animal hosts. I wrote about this effort for a cover story for Bloomberg Businessweek last December. The bad news is that most of the pan-coronavirus efforts are a few years away from our knowing whether they will work in people. The good news is that pan-coronavirus science is making progress. In the latest findings, published in Science magazine, researchers from the California Institute of Technology and elsewhere report results from an animal study of a vaccine containing portions of spike receptors from eight coronaviruses, including the Covid beta strain as well as various bat and pangolin coronaviruses. The vaccine, developed with technology from the University of Oxford, provided broad protection in monkeys beyond the strains it was targeting. “It is wishful thinking” to imagine that Covid will stop mutating, says Pamela Bjorkman, a structural biologist at the Caltech, who is senior author of the study. “In theory, this vaccine will never have to be updated.” The work “is really compelling evidence that we might be on the right track,” says Regina Dugan, president of Wellcome Leap, a nonprofit that helped fund the research. While the current booster strategy makes sense in the short term, it means “we are one step behind the virus,” says Melanie Saville, executive director of vaccine research for the Coalition for Epidemic Preparedness Innovations. It is spending $200 million over the next several years to fund different vaccines that could provide broader, longer-lasting protection, including the Caltech-Oxford shot. It’s still an open question whether any of the pan-coronavirus vaccines can provide long-lasting protection in people. And even if universal coronavirus shots work, there is the question of whether they can be produced on a mass scale. But given the pace at which Covid is mutating—and the likelihood new coronaviruses will emerge in the future—there is every reason to urgently to try. —Robert Langreth "

 

[missy]

"

BA.4/5 COVID-19 variants now dominant in all US regions​

COVID-19
Lisa Schnirring | News Editor | CIDRAP News
|
Jul 05, 2022

red_sars-cov-2_blue_cells-niaid.jpg​

NIAID
The more transmissible Omicron BA.4 and BA.5 subvariants are now dominant in all parts of the United States, with BA.5 again steadily expanding its scope, the Centers for Disease Control (CDC) said today in its latest weekly estimates.

Cases held steady in lead-up to July 4​

Combined, the two subvariants make up more than 70% of recently sequenced samples, up sharply from 52.3% the previous week.
Of the variants CDC is tracking, BA.5 now makes up 53.6%, and BA.4 makes up 16.5%. The proportion of BA.2.12.1—first detected in New York—continues to decline.
South-central states were the first to see BA.4 and BA.5 become dominant. The two subvariants are more transmissible and have mutations linked to immune escape.
Last week the Food and Drug Administration (FDA) recommended that vaccine companies update their booster shots to include BA.4 and BA.5, which is fueling increased cases in many countries. Hospitalizations are rising as the volume of cases picks up, but so far, there's no sign that illnesses involving the subvariants are more severe.
The updated boosters are expected to be available in early to mid fall, but in recent vaccine advisory group meetings, experts aired concerns about the possibility that more variants will emerge by that time.
Currently, cases in the United States have been holding steady since late May at an elevated level. The 7-day average for daily new cases is 105,745, with daily deaths averaging 389, according to the New York Times tracker. It's unclear how the Fourth of July holiday gatherings will affect COVID-19 spread, but in 2021 a notable Delta variant surge began in July.
Over the holiday weekend, US airports saw their biggest crowds since the pandemic began, with about 2.49 million passengers going through checkpoints, according to the Associated Press.

Countries battle rises as a new subvariant emerges​

Globally, countries continue to battle new surges, with cases in Romania nearly doubling over the past week, according to Reuters.
In China, officials have closed schools and businesses in the Shaanxi province city of Xi'an, with a population of about 13 million, for a week after a cluster of cases were detected, according to Agence France-Presse.
Also, cases are rising in the Anhui province city of Suzhou, prompting control measures. And in Shanghai, officials ordered more rounds of mass testing following a cluster of cases linked to a karaoke bar.
In other global developments, virologists are closely watching another Omicron variant called BA.2.75 that appears to be competing with BA.5 in India. So far, BA.2.75 hasn't been designated as a variant of interest or a variant of concern.
Ulrich Elling, PhD, with Australia's Institute of Molecular Biotechnology, said on Twitter that there are few confirmed cases from sequenced samples. Most are from India, but the virus has already been found in Australia, Canada, Germany, New Zealand, and the United Kingdom. He said it's too soon to know if BA.2.75 will take over from BA.2 or make headway on BA.5, but he raised concerns about immune escape, based on mutations.
Last week, Tom Peacock, PhD, a virologist at Imperial College London, urged surveillance experts to keep a close eye on BA.2.75 owing to several spike mutations, its likelihood as a second-generation variant, apparent rapid growth, and wide geographic spread.
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[VRBeauty]

My husband came down with Covid almost exactly a month ago. He was down and out for two days (sleeping all day and feverish) then dealt with lingering fatigue for at least two weeks after that. Yesterday he sought treatment for sinus and congestion issues that seemed to be hanging on from the Covid. The PA told him that lingering, sinus infections were fairly common following a bout with recent strains of Covid. Since the infections also tend to be fairly resistant to antibiotics he was given amoxicillin. Fortunately it seems to be helping. Strep throat seems to be common with the latest Covid strains too.

I escaped the worst of it, but did have to deal with the lingering fatigue.

 

[missy]

My husband came down with Covid almost exactly a month ago. He was down and out for two days (sleeping all day and feverish) then dealt with lingering fatigue for at least two weeks after that. Yesterday he sought treatment for sinus and congestion issues that seemed to be hanging on from the Covid. The PA told him that lingering, sinus infections were fairly common following a bout with recent strains of Covid. Since the infections also tend to be fairly resistant to antibiotics he was given amoxicillin. Fortunately it seems to be helping. Strep throat seems to be common with the latest Covid strains too.

I escaped the worst of it, but did have to deal with the lingering fatigue.

I’m glad you’re doing ok @VRBeauty and hope your husband gets complete relief soon.

 

[diamondringlover]

my 36 year old son had covid in January 2022 (vaxed and boosted a month earlier), he had a mild case of it he was sick for about 3 days with cold symptoms, however 6 months later he is still having issues, he has been diagnosed with long haulers covid, he has fatigue, headaches, head pressure and foggy brain, his GERD is worse he has lost 20 pounds which he couldn't afford to lose he is very fit and thin and to top it all off he just found out he has an irregular heart beat and has to wear a holter monitor for a week to try and figure out what is going on...my heart is literally breaking for him, he just keeps going to doctors so they can rule other things out...this just literally sucks!!!

 

[missy]

“​

CDC estimates 1.6 million hospitalizations and over 200,000 deaths averted through fall 2021​

by Elizabeth Short, Editorial Intern, MedPage Today July 6, 2022

The U.S. COVID-19 vaccination program prevented millions of infections as well as hundreds of thousands of deaths, according to a modeling study.
From December 2020 through September 2021, COVID-19 vaccines were estimated to have prevented about 27 million infections, 1.6 million hospitalizations, and 235,000 deaths among U.S. adults, reported Molly K. Steele, PhD, MSc, MPH, of the CDC, and colleagues.
During the month of September 2021 alone, vaccines were estimated to have prevented 52% of expected infections, 56% of expected hospitalizations, and 58% of expected deaths in adults, the authors noted in JAMA Network Open.

"Vaccination is an effective public health intervention with demonstrable impact, which will be critical in combination with nonpharmaceutical interventions to mitigate the COVID-19 pandemic," they concluded.
Most of the hospitalizations and deaths prevented occurred in adults 65 and older, with 759,000 hospitalizations and 154,000 deaths prevented. The 50-64 age group followed closely behind, with 525,000 hospitalizations and 66,000 deaths prevented.
"This study is among the first, to our knowledge, to present estimates of age group-specific impacts of vaccination among vaccinated persons in the U.S. over time and by HHS region," Steele and team wrote.
"Our estimates, particularly in the early part of 2021, are relatively conservative because most vaccinated individuals during this period were older adults (i.e., older adults were prioritized for vaccination early compared with younger adults); we also included lower VE [vaccine effectiveness] estimates for those 65 years or older," they noted.
"The piecemeal nature of COVID-19 data highlights an urgent need to develop a comprehensive national data collection infrastructure. Nationally representative data on infections, hospitalizations, deaths, and vaccination are needed to prepare for the next pandemic," pointed out Westyn Branch-Elliman, MD, MMSc, of the section of infectious diseases at the VA Boston Healthcare System, and colleagues in an invited commentary.

For this study, a multiplier model was used to extrapolate the number of infections and COVID-associated deaths from data on the number of COVID-associated hospitalizations broken down by state, month, and age group (18-49, 50-64, and 65 and older) from December 2020 through September 2021, factoring in the official start of the U.S. vaccination program on Dec. 12, 2020, as well as subsequent staggered rollouts.
The approximate numbers of those who had completed vaccination were taken from state-reported CDC data, as well as from the Vaccine Administration Management System.
By the end of September 2021, approximately 67% of those 18 and older and 83% of those 65 and older had received either two doses of the Moderna or Pfizer-BioNTech mRNA vaccines, or one dose of the Johnson & Johnson vaccine.

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[missy]

my 36 year old son had covid in January 2022 (vaxed and boosted a month earlier), he had a mild case of it he was sick for about 3 days with cold symptoms, however 6 months later he is still having issues, he has been diagnosed with long haulers covid, he has fatigue, headaches, head pressure and foggy brain, his GERD is worse he has lost 20 pounds which he couldn't afford to lose he is very fit and thin and to top it all off he just found out he has an irregular heart beat and has to wear a holter monitor for a week to try and figure out what is going on...my heart is literally breaking for him, he just keeps going to doctors so they can rule other things out...this just literally sucks!!!

I am so sorry @diamondringlover
I hope he starts feeling better soon and makes a full recovery

 

[dk168]

Covid is alive and well in UK, with cases and hospitalisation going up allegedly due to two new Omicron variants.

A number of peeps in my social circles had been tested positive, some for the first time; all up to date and fully vaccinated. Symptoms reported to be similar to a heavy cold/flu, all fully recovered.

There is a plan for all over 50s to receive a 4th dose later this year in Autumn.

So far only those over 75 and extremely vulnerable have been offered a 4th dose.

Mask wearing is coming back especially in hospitals.

Stay safe everyone!

DK

 

[GliderPoss]

Well….I finally caught Covid. Have managed to dodge it for over 2 years but finally succumbed on Monday. So far moderate symptoms with the worst being epic body aches especially my lower back which is making sleep very difficult.

I’m isolating at home and amazingly my boyfriend managed to avoid it despite us spending weekend together! I’m fully vaccinated so hopefully it will pass quickly

 

[missy]

Hope you feel better soon @GliderPoss

A timely article from the NEJM
Had to remove some of the article because it exceeded the character limit per post. If you are interested in the entire article you can find it at the NEJM

Effects of Previous Infection and Vaccination on Symptomatic Omicron Infections​

"

BACKGROUND​

The protection conferred by natural immunity, vaccination, and both against symptomatic severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection with the BA.1 or BA.2 sublineages of the omicron (B.1.1.529) variant is unclear.

METHODS​

We conducted a national, matched, test-negative, case–control study in Qatar from December 23, 2021, through February 21, 2022, to evaluate the effectiveness of vaccination with BNT162b2 (Pfizer–BioNTech) or mRNA-1273 (Moderna), natural immunity due to previous infection with variants other than omicron, and hybrid immunity (previous infection and vaccination) against symptomatic omicron infection and against severe, critical, or fatal coronavirus disease 2019 (Covid-19).

RESULTS​

The effectiveness of previous infection alone against symptomatic BA.2 infection was 46.1% (95% confidence interval [CI], 39.5 to 51.9). The effectiveness of vaccination with two doses of BNT162b2 and no previous infection was negligible (−1.1%; 95% CI, −7.1 to 4.6), but nearly all persons had received their second dose more than 6 months earlier. The effectiveness of three doses of BNT162b2 and no previous infection was 52.2% (95% CI, 48.1 to 55.9). The effectiveness of previous infection and two doses of BNT162b2 was 55.1% (95% CI, 50.9 to 58.9), and the effectiveness of previous infection and three doses of BNT162b2 was 77.3% (95% CI, 72.4 to 81.4). Previous infection alone, BNT162b2 vaccination alone, and hybrid immunity all showed strong effectiveness (>70%) against severe, critical, or fatal Covid-19 due to BA.2 infection. Similar results were observed in analyses of effectiveness against BA.1 infection and of vaccination with mRNA-1273.

CONCLUSIONS​

No discernable differences in protection against symptomatic BA.1 and BA.2 infection were seen with previous infection, vaccination, and hybrid immunity. Vaccination enhanced protection among persons who had had a previous infection. Hybrid immunity resulting from previous infection and recent booster vaccination conferred the strongest protection. (Funded by Weill Cornell Medicine–Qatar and others.)

Qatar endured a wave of the omicron (B.1.1.529) variant of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)1 that started on December 19, 2021, and peaked in mid-January 2022.2-4 The wave was first dominated by the BA.1 subvariant, but within a few days after the onset of the wave, the BA.2 subvariant predominated (Fig. S1 in the Supplementary Appendix, available with the full text of this article at NEJM.org). Although BA.1 and BA.2 remain classified as subvariants of omicron, considerable genetic distance exists between them.5 The protection against these subvariants provided by previous immunity — and whether immunity is induced by previous infection, vaccination, or a hybrid of both — remains to be established.
With the use of data from December 23, 2021, through February 21, 2022, we investigated the protection conferred by previous infection from variants other than omicron, vaccination with two or three doses of the coronavirus disease 2019 (Covid-19) messenger RNA (mRNA) vaccines BNT162b2 (Pfizer–BioNTech)6 or mRNA-1273 (Moderna),7 and hybrid immunity (previous infection and vaccination). Effectiveness against symptomatic BA.1 infection, symptomatic BA.2 infection, and any symptomatic omicron infection was assessed. Protection against any severe (acute-care hospitalization),8 critical (hospitalization in an intensive care unit),8 or fatal9 case of Covid-19 due to BA.1, BA.2, or any omicron infection was also assessed.

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EFFECTIVENESS OF PREVIOUS INFECTION AND BNT162B2 VACCINATION AGAINST BA.1 INFECTION​

Figure 1.

Effectiveness of Previous Infection, Vaccination with BNT162b2, and Hybrid Immunity against Symptomatic Omicron BA.1 and BA.2 Infection and against Severe, Critical, or Fatal Covid-19.Table 2.

Effectiveness of Previous Infection, Vaccination with BNT162b2, and Hybrid Immunity against Symptomatic Omicron Infections and against Severe, Critical, or Fatal Covid-19.​

The effectiveness of previous infection and no vaccination against symptomatic BA.1 infection was 50.2% (95% confidence interval [CI], 38.1 to 59.9) (Figure 1A and Table 2). The median interval between the previous infection and the PCR test used in the study was 324.5 days (range, 91 to 643; interquartile range, 274 to 497).​

The effectiveness of two doses of BNT162b2 and no previous infection was negligible (−4.9%; 95% CI, −16.4 to 5.4). The median interval between the second dose and the PCR test used in the study was 268 days (range, 15 to 394; interquartile range, 211 to 293). The effectiveness of three doses and no previous infection was 59.6% (95% CI, 52.9 to 65.3). The median interval between the third dose and the PCR test used in the study was 42 days (range, 7 to 291; interquartile range, 28 to 62).​

The effectiveness of hybrid immunity (previous infection and two doses of BNT162b2) was 51.7% (95% CI, 43.5 to 58.7), which was similar to the effectiveness of previous infection alone. The effectiveness of previous infection and three doses of BNT162b2 was the highest, at 74.4% (95% CI, 63.4 to 82.2).​

Previous infection, vaccination, and hybrid immunity all showed strong effectiveness (>90%) against severe, critical, or fatal Covid-19 due to BA.1 infection, but some of the 95% confidence intervals were wide because of small case numbers (Figure 1B and Table 2). The severity of BA.1 infections was low, and only 0.3% (95% CI, 0.2 to 0.4) of infections progressed to severe, critical, or fatal Covid-19.​

EFFECTIVENESS OF PREVIOUS INFECTION AND BNT162B2 VACCINATION AGAINST BA.2 INFECTION​

The effectiveness of previous infection and no vaccination against symptomatic BA.2 infection was 46.1% (95% CI, 39.5 to 51.9) (Figure 1C and Table 2). The median interval between the previous infection and the PCR test used in the study was 319 days (range, 90 to 662; interquartile range, 275 to 499).​

The effectiveness of two doses of BNT162b2 and no previous infection was negligible (−1.1%; 95% CI, −7.1 to 4.6). The median interval between the second dose and the PCR test used in the study was 270 days (range, 14 to 399; interquartile range, 213 to 296). The effectiveness of three doses of BNT162b2 and no previous infection was 52.2% (95% CI, 48.1 to 55.9). The median interval between the third dose and the PCR test used in the study was 43 days (range, 7 to 322; interquartile range, 26 to 65).​

The effectiveness of previous infection and two doses of BNT162b2 was 55.1% (95% CI, 50.9 to 58.9), which is similar to the effectiveness of previous infection alone. The effectiveness of previous infection and three doses of BNT162b2 was the highest, at 77.3% (95% CI, 72.4 to 81.4).​

Previous infection, vaccination, and hybrid immunity all showed strong effectiveness (>70%) against severe, critical, or fatal Covid-19 due to BA.2, but some of the 95% confidence intervals were wide because of small case numbers (Figure 1D and Table 2). The severity of BA.2 infections was low, and only 0.3% (95% CI, 0.2 to 0.3) of infections progressed to severe, critical, or fatal Covid-19.​

EFFECTIVENESS OF PREVIOUS INFECTION AND BNT162B2 VACCINATION AGAINST ANY OMICRON INFECTION​

Figure 2.

Effectiveness of Previous Infection, Vaccination with BNT162b2 or mRNA-1273, and Hybrid Immunity against Any Symptomatic Omicron Infection and against Severe, Critical, or Fatal Covid-19.​

The effectiveness of previous infection, BNT162b2 vaccination, and hybrid immunity against any symptomatic omicron infection showed similar patterns to those against BA.1 and BA.2 (Figure 2A and Table 2). The effectiveness against severe, critical, or fatal Covid-19 due to any omicron infection also showed similar patterns to those against these outcomes due to BA.1 and BA.2 (Figure 2B and Table 2).​

Figure 3.

Effectiveness of Previous Infection, Vaccination, and Hybrid Immunity against Any Symptomatic Omicron Infection According to Time since Previous Infection or Vaccination.​

The analysis of the effectiveness of previous infection, two-dose vaccination, and three-dose vaccination as a function of time since the immunologic event (previous infection or vaccination) showed rapidly waning vaccine protection after the second and third doses but slowly waning protection from previous infection (Figure 3). A sensitivity analysis in which previous positive testing included both PCR-positive and rapid antigen–positive results showed similar findings to those of the main analyses, which indicates that exclusion of previous rapid antigen–positive tests may not have biased our estimates (Table S3).​

EFFECTIVENESS OF PREVIOUS INFECTION AND MRNA-1273 VACCINATION AGAINST BA.1, BA.2, AND ANY OMICRON INFECTION​

Figure 4.

Effectiveness of Previous Infection, Vaccination with mRNA-1273, and Hybrid Immunity against Symptomatic Omicron BA.1 and BA.2 Infection and against Severe, Critical, or Fatal Covid-19.​

The effectiveness of previous infection, vaccination, and hybrid immunity in the analysis of mRNA-1273 showed similar patterns to those of the analysis of BNT162b2 (Figure 2 and Figure 4). Additional information is provided in Table S5.​

Discussion​

Previous infection with a variant other than omicron was associated with an approximately 50% reduced risk of infection. No difference in the protection of previous infection against BA.1 and BA.2 was discernable. Two-dose vaccination and no previous infection had negligible effectiveness against BA.1 and BA.2, but most persons received their second dose more than 8 months earlier. These findings are explained by the short-lived protection of primary-series vaccination against omicron infections3,27 and the more durable protection from natural infection,2,28 as confirmed by the additional analysis of protection as a function of time after previous infection or vaccination (Figure 3).​

Booster vaccination was associated with an approximately 60% reduced risk of infection. No difference in the protection of booster vaccination against BA.1 and BA.2 was discernable. However, most persons received their third dose less than 45 days earlier, perhaps explaining the relatively high effectiveness.3​

The protection conferred by hybrid immunity of previous infection and two-dose vaccination was similar to that of previous infection alone, at approximately 50%, which suggests that this protection originated from the previous infection and not from vaccination. This finding is also explained by the short-lived protection of primary-series vaccination against omicron infections.3,27​

However, the highest effectiveness was seen with hybrid immunity from previous infection and recent booster vaccination (approximately 80%). This finding provides evidence for the benefit of vaccination, even for persons with a previous infection. Strikingly, this protection is what one would expect if previous infection and booster vaccination each acted independently. Because previous infection reduced the risk of infection by 50% and booster vaccination reduced it by 60%, the reduction in the risk of infection for both combined, if they acted fully independently, would be 1−(1−0.5)×(1−0.6)=0.8, which is an 80% reduction, just as observed. Although this effect needs to be further investigated, this finding may suggest that the combined effect of these two forms of immunity against omicron infection reflects neither synergy nor redundancy of the individual biologic effects of each.​

Even though the five forms of immunity investigated showed large differences in protection against symptomatic infection that ranged from 0 to 80%, they all showed strong protection against Covid-19–related hospitalization and death, at an effectiveness of more than 70%. This suggests that any form of previous immunity, whether induced by previous infection or vaccination, is associated with strong and durable protection against Covid-19–related hospitalization and death. Notably, there was no evidence for a difference in severity between BA.1 and BA.2 infections in the study samples.​

No notable differences were observed between the effects of BNT162b2 and mRNA-1273 vaccination. The results confirmed other findings that we reported recently, including a protection of approximately 50% for previous infection against reinfection with BA.1,2 a protection of approximately 50% for mRNA boosters as compared with primary series,4 and the finding that mRNA vaccines have negligible effectiveness against omicron infection 6 or more months after the second dose.3​

This study has limitations. Ascertainment of BA.1 and BA.2 infections was based on proxy criteria, but this method of ascertainment is well established.24,29,30 Some omicron infections may have been misclassified delta infections, but the incidence of delta was limited during the study period (Section S2). Ascertainment of BA.1 and BA.2 infections was not possible for a minority of infections. However, this may not have biased our results, since both infections with and without BA.1 or BA.2 ascertainment had a similar distribution among exposure categories (Table S6).​

Although matching was performed according to sex, age, and nationality, matching was not possible for other factors, such as coexisting conditions. However, matching according to these factors provided demonstrable control of bias in our earlier studies.11,12,15,21,22 The analysis of effectiveness according to time since the most recent immunologic event is possibly at higher risk than the primary analysis for bias because of confounding, since persons who were vaccinated earliest were more likely to have coexisting conditions or to work in high-risk occupations. Effectiveness was assessed with the use of an observational, test-negative, case–control design rather than a design in which cohorts of individual persons were followed up. However, the cohort study design applied earlier to the same population yielded findings similar to those of the test-negative design.14,15,31Moreover, our recent study of the effectiveness of boosters relative to primary series used a cohort study design and generated results consistent with the results reported here.4​

Nonetheless, one cannot rule out the possibility that in real-world data, bias could arise in unexpected ways or from unknown sources, such as subtle differences or changes in test-seeking behavior. For example, with the large omicron wave, use of rapid antigen testing was expanded to supplement PCR testing in Qatar starting on January 5, 2022, and especially so for some of the routine testing such as post-travel testing. However, rapid antigen testing was broadly implemented and probably did not differentially affect PCR testing to introduce bias, as supported by the sensitivity analysis (Table S3) and the minimal differences between PCR and rapid antigen tests according to exposure category (Table S7). With the small proportion of the population of Qatar being 50 years of age or older,10 our findings may not be generalizable to other countries in which elderly citizens constitute a larger proportion of the population.​

Notwithstanding these limitations, findings were consistent with those of other studies of vaccine effectiveness against omicron infection (BA.1 or BA.2 subvariants were not specified).27,32-36Moreover, with the mass scale of PCR testing in Qatar,12 the likelihood of bias is perhaps minimized. Extensive sensitivity and additional analyses were conducted to investigate effects of potential bias in our earlier studies that used similar methods. These included different adjustments and controls in the analysis and different study inclusion and exclusion criteria to investigate whether effectiveness estimates could have been biased.12,22 These analyses showed consistent findings.2,3,12,17,22​

No notable differences were observed in the effectiveness against BA.1 and BA.2 of previous infection, vaccination, and hybrid immunity. Protection from previous infection with variants other than omicron against reinfection was moderate and durable, but protection of primary-series vaccination against infection was negligible by 6 months after the second dose. Recent booster vaccination had moderate effectiveness, whereas hybrid immunity from previous infection and recent booster vaccination conferred the strongest protection against infection, at approximately 80%. All five forms of immunity were associated with strong and durable protection against Covid-19–related hospitalization and death.​

"

 

[missy]

COVID STATE OF AFFAIRS JULY 7th

COVID State of Affairs: July 7

Driven by Omicron sub-variants, country-level hotspots are now peppered across the globe.

substack.com

“

Driven by Omicron sub-variants, country-level hotspots are now peppered across the globe. Yesterday, the WHO reported cases are on the rise in 110 countries, causing overall global cases to increase by 30% over the past two weeks. Of course, these numbers and country-level comparisons are only as accurate as testing and reporting.


(WHO)
In Europe, BA.4/5 is driving a case surge. Hospitalizations in Portugal finally peaked and are well on their way down. Hospitalizations in other European countries continue to rise, though.


In the U.K., it’s clear that hospitalizations rising are both with and for COVID19. The distribution seems to be stubbornly consistent since a switch during the first Omicron wave last winter, when hospitalizations for COVID19 took the lead.


In India, all eyes are on a new variant: BA.2.75. After first being discovered at the end of May, it quickly took hold and now accounts for 25% of cases, with most samples reported from Maharashtra (Mumbai). There is sparse testing data in India (see the grey bar charts in the figure below), but BA.2.75 appears to be outcompeting BA.5 and BA.2 (with a growth advantage of 17% thus far). This means it has the potential to cause a wave and is important to follow. BA.2.75 cases have been identified in other countries, like Australia, New Zealand, U.K., and Germany, but remain low at this time.


(Mike Honey Twitter)
BA.2.75 carries eight additional mutations on the spike protein compared to BA.2. There are two mutations in particular that are cause for concern: G446S and R493Q. G446S is at one of the most potent sites of escape from antibodies. As the Bloom Lab interestingly pointed out in the figure below, BA.2.75’s impact will be dependent on infection history. Among those with a previous BA.1 infection, the probability of immune escape at spot 446 (and thus infection) is lower than those with a previous BA.2 infection.

Image
Image
(Bloom Lab Twitter)
A few more thoughts on this sub-variant:

Let’s be glad the mutation G446S isn’t on BA.5. If it was, this subvariant could make an even bigger impact. If BA.2.75 does take off, it will be co-circulating with BA.5, so keeping a close eye on recombinants will be important.
This makes the fall booster conversation interesting. Last week, the FDA authorized a BA.4/5 vaccine formula. However, one could make the argument that the original BA.1 vaccine formula would be better with this BA.2.75 news. But, chasing variants is never going to work. Our goal should be broaden protection. An Omicron vaccine will do that, regardless of the sub-variant circulating.
United States

In four short months, four Omicron sub-lineages have come and gone in the U.S. Currently, BA.4/5 made a fast entrance and now accounts for more than 70% of tests. Interestingly, BA.4 stopped (or substantially slowed) growth, so this is really now a story about BA.5. It’s not clear whether BA.5 will result in a wave in the U.S. given our BA.2.12.1 history that other countries did not experience. If we do get a BA.5 wave, it would start about now, so all eyes are on epidemiological trends.


(CDC)
The U.S. holds a steady state of ~100,000 reported cases per day. This equates to about 1M “true” cases per day, using back of the napkin math. (At the height of the first Omicron wave, we experienced ~3.9M true cases per day). The steady state is reflected in national wastewater with plateauing trends across every region.


Regional wastewater trends, past 6 weeks (panel 1) and entire pandemic (panel 2). Purple= Midwest; Orange= Northeast; Pink=South; Green=West. Source: Biobot Analytics
Interestingly, our national test positivity rate (TPR) continues to increase and is at a high rate of 17%. Anecdotally, it feels like more and more people are testing positive, too.


(CDC)
The disagreeing patterns between cases/wastewater and TPR could mean that a wave is about to come (historically, TPR trends upwards first). Or it’s a reflection that cases are just a terrible measure of community transmission. Lack of testing, lack of reporting antigen tests, and biased testing (some groups are more likely to get tested than others) are creating really weird trends in metrics. This begs the question: How do we detect a wave at this point in the pandemic?

Hospitalizations continue to creep up and, on average, 389 Americans are dying each day. Severe disease will continue to occur. As the Kaiser Family Foundation reported, in some states, 3 in 4 people are not up to date on their COVID-19 vaccines (this figure does not include the 4th dose). Also, as we just saw in Portugal, vulnerable groups like the elderly are at risk from high transmission, even if vaccinated. While incredibly tragic, hospitalizations and deaths do remain below any previous peaks, which is progress.


(News nodes)
Bottom line

BA.5 is impacting countries across the globe. It’s story in the U.S. is yet to be determined. It’s important to note, though, that we already have a very high, steady level of transmission. In addition, SARS-CoV-2 continues to mutate so quickly that we start talking about the next variant (BA.2.75) before the current wave peaked.

“

 

[missy]

"

Filling the Gaps​

Covid exposed the vulnerabilities of health systems all over the world, highlighting a need to expand disease surveillance, tackle misinformation and speed up work on vaccines and therapies to fight a slew of both known and unknown pathogens. And while the Oxford-AstraZeneca team, Pfizer and others delivered Covid shots in record time, less affluent regions struggled to gain access as wealthy nations put their own interests first. Production was concentrated in just a handful of countries. Sarah Gilbert is part of a team that’s seeking to fill those gaps and make sure countries are better prepared to deal with the next emergencies. Oxford’s recently minted Pandemic Sciences Institute joins groups such as the Coalition for Epidemic Preparedness Innovations, the World Health Organization’s pandemic intelligence hub and the EU’s Health Emergency Preparedness and Response Authority in a bid to stop outbreaks from exploding into global crises. The institute, which hoped to attract more than £500 million ($597 million) in investment when it was unveiled last year, has so far raised about £100 million. The university aims to build on its Covid vaccine with AstraZeneca, one of the first to cross the finish line, and the Recovery trial that helped identify Covid therapies. “Academic institutions such as Oxford have a lot to contribute in the event of a global public health crisis,” Gilbert tells me. The plan is to move “as fast as possible, but there’s still a way to go to complete our fund-raising,” she says. One priority, she says, is widening vaccine manufacturing capacity globallyand establishing sites that are ready to ramp up swiftly if needed to respond to a new disease. That would minimize delays and help address inequity. But ensuring investments benefit the regions they’re located in and don’t lead to “white elephants” will be crucial, she says. HERA, the new EU organization, also plans to maintain a network of “ever-warm” manufacturing facilities. “During a pandemic, when vaccine production is located in some countries and not others and everyone wants a vaccine, that’s when we see the problems of nationalism,” Gilbert says. “So we have to prepare for that by making sure we have manufacturing on every continent and in every region.” Africa, she says, is especially important. Working with partners, Gilbert and her colleagues are analyzing the pipeline and aiming to spur development of vaccines and medicines in all the major groups of viruses that are known to infect humans. One target is Nipah virus, which has a fatality rate estimated at 40% to 75% and has sparked outbreaks almost annually in parts of Asia. There’s no vaccine currently available. “The nightmare scenario is a disease with the fatality rate of Nipah virus that is also very highly transmissible,” she says. “We need to stop these outbreaks before the virus gets a chance to evolve.” — James Paton "

 

[missy]

"​

Whopping Mortality Benefit in Severe COVID Trial​

— Oral sabizabulin showed 55% reduction in risk for death in hospitalized patients​

by Ian Ingram, Managing Editor, MedPage Today July 7, 2022

Treatment with a novel, oral microtubule disruptor significantly reduced the risk of death in hospitalized COVID-19 patients with severe disease, an interim analysis of a phase III study indicated.
Mortality at 60 days, the international trial's primary endpoint, was more than halved in the group assigned to investigational sabizabulin versus those randomized to placebo (20.2% vs 45.1%, P=0.0042), reported K. Gary Barnette, PhD, of drug developer Veru in Miami.

Patients in the study were at high risk for acute respiratory distress syndrome (ARDS) or death, and this difference represented a 55% relative reduction in the risk for death (relative risk [RR] 0.45, 95% CI 0.27-0.74), according to the findings in NEJM Evidence.
"The reduction in deaths with sabizabulin started within the first week of treatment," the authors noted. "This efficacy was further supported by the consistency of the subgroup analyses of the primary endpoint."
Outcomes in key secondary endpoints landed in sabizabulin's favor as well, with significantly fewer average days spent in the intensive care unit (ICU; 17 vs 31 in the placebo group), on mechanical ventilation (14 vs 29), and in the hospital (26 vs 35).
David Boulware, MD, MPH, of the University of Minnesota in Minneapolis, cautioned on Twitter that the trial had an "unexpectedly high" mortality in the small control group, given that about 90% entered on nasal cannula or high-flow oxygen.

"This level of mortality is significantly higher than expected," he told MedPage Today.
At day 29, the mortality rate was 35.3% in the placebo group. By comparison, mortality rates at similar time points among the control arms of trials involving hospitalized COVID-19 patients have ranged from 7.8% in ACTT-2, 15.2% in ACTT-1, to 25.7% in the control group of the segment of the RECOVERY trial that led to dexamethasone being established as a standard treatment in this setting.
"Sabizabulin is an orally available, novel microtubule disruptor that targets, binds, and crosslinks both the α- and β-tubulin subunits to inhibit polymerization and to induce depolymerization of microtubules in cells," noted Barnette and colleagues.
"Microtubules are intracellular transport structures critical for coronavirus cellular entry, trafficking, replication, and egress as well as for triggering the innate inflammatory response and cytokine storm responsible for ARDS, septic shock, and frequently death," the group added.
A smaller phase II study of sabizabulin in COVID-19 patients at high risk for ARDS supported the drug's efficacy, demonstrating reductions in death and days in the ICU on mechanical ventilation. In early June, Veru submitted an emergency use authorization request to the FDA for use of sabizabulin in this setting.

"By standard FDA metrics, this new medicine has shown superiority over placebo in a randomized trial, thus it should merit an EUA," said Boulware.
The current phase III trial enrolled 204 hospitalized patients with moderate to severe COVID-19 at high risk for ARDS across the U.S. (44%), Brazil (42%), Bulgaria (12%), Colombia, Argentina, and Mexico during the Delta and Omicron waves. Patients needed to have a score of 4-6 on the World Health Organization (WHO) ordinal scale and were randomized 2:1 to either an oral daily 9-mg dose of sabizabulin for 21 days or placebo.
The prespecified interim analysis was conducted after 60 days of follow-up had occurred in the first 150 patients randomized. The trial was halted for efficacy following the interim data, though the study authors noted that the intent-to-treat (ITT) population had a 51.6% relative reduction in all-cause mortality with sabizabulin compared to placebo.
Mean patient age in the interim analysis population was 60 years, just over two-thirds were men, and mean body mass index (BMI) was 32.8. For comorbidities, 60% had hypertension, 63% had respiratory issues, 51% had pneumonia, and 37.3% had diabetes.

A third of the patients had a WHO ordinal scale score of 4 (oxygen by mask or nasal prongs), 60% were on noninvasive ventilation or high-flow oxygen, and 7.3% required mechanical ventilation. Most patients received standard-of-care treatments, including dexamethasone in 83%, remdesivir (Veklury) in 33%, tocilizumab (Actemra) in 10%, and either baricitinib (Olumiant) or tofacitinib (Xeljanz) in 12%.
As noted, subgroup analyses for the primary endpoint -- including age, sex, baseline comorbidities or BMI, whether standard of care was received, and WHO ordinal scale score -- all favored the sabizabulin group.
Barnette's team also looked at geographic location, and patients in the U.S. receiving sabizabulin had a 55.5% relative mortality reduction at 60 days (RR 0.44, 95% CI 0.24-0.81). Of note, vaccination status (45% had received one to three doses) was not included in the subgroup analysis, leaving the question of the drug's efficacy in this large subpopulation somewhat open.
In the ITT population, treatment-emergent adverse events (AEs) were lower in the sabizabulin arm (62% vs 78%), as were serious AEs (29% vs 46%).

• 
  
  Ian Ingram is Managing Editor at MedPage Today and helps cover oncology for the site.
  
  "
  
  

 

[missy]

"

Epidemiology of reinfections​

Katelyn Jetelina Jul 8
Reinfections and infections after vaccination are on the rise. Concurrently, reinfection misinformation is at an all time high. This leaves people with a lot of questions. Here is (hopefully) some clarity and answers for you.

How common are SARS-CoV-2 reinfections?​

Before Omicron, reinfections were rare. In the U.K., reinfections comprised around 1% of cases in April 2021. With the introduction of Omicron, reinfection rates quickly increased to 11% of all infections. Right now, reinfections make up about 25-27% of cases in the U.K. (Remember, U.K. tracks antigen and PCR tests.)

​

Cases by date, UK (Source Here)
Unfortunately, we don’t have a national picture of reinfections in the U.S. Some local jurisdictions closely follow the data. In New York, for example, ~25% of cases this week were reinfections. The rate of first infection is 28 per 100K in NY compared to a reinfection rate of 5 per 100K. Waves are still very much being driven by first infections, but reinfections are on the rise.

How do we get reinfected?​

Our immune system is complex and has multiple defense walls, including antibodies, T-cells, and B-cells. Reinfections can occur for several reasons:

1. The virus mutates to skirt around our first line of defense—called neutralizing antibodies. Omicron keeps mutating to do this better and better. But importantly, Omicron can’t fully escape. This is why immunity can still prevent infection for some.
2. Antibodies wane over time, so our first wall of defense gets shorter and shorter.
3. Some people don’t mount an immune response after a primary, and typically mild, infection.

So unfortunately, with more transmission, a rapidly evolving virus, and a virus that recently mutated to become less severe, we can expect SARS-CoV-2 reinfections.

Who is at most risk for a reinfection?​

Thanks to U.K. surveillance data, we know people are more likely to be reinfected if they:

• are unvaccinated
• had a “milder” primary infection with a lower viral load
• did not report symptoms with their first infection
• are younger (although reinfections are rising for all age groups, as seen below)

​

Are reinfections common with other diseases?​

Immunity from some viruses and vaccines, like measles, can last decades. However, just like SARS-CoV-2, other respiratory viruses mutate more quickly and antibodies wane, so reinfections are more common. This happens with the flu, RSV, and other coronaviruses. During a regular flu season, for example, 1 in 5 people are reinfected. While children and adults can be reinfected with RSV, reinfection is associated with milder disease.

How quickly can someone be reinfected?​

An early 2021 study found that people have great protection from SARS-CoV-2 in the first 90 days after infection. In fact, the CDC still uses the 90-day window to exclude counting new positives as reinfections. However, reinfections do occur earlier. A study in Denmark found that while pre-Omicron reinfections were rare (593 out of 4.4 million people), many occurred within 60 days of infection. Two additional studies (here, here) confirmed reinfections occurred as early as 20 days after infection during the first Omicron wave (reinfections remained rare; 1,739 out of 1.8 million people).
A reinfection can, theoretically, occur as soon as the virus has cleared, but clearance varies for individuals. The virus can linger far beyond the infectious period. This means you can test positive on a PCR test weeks after initial infection, but this is a reflection of the initial infection rather than a new infection. Testing positive on an antigen test a few weeks after initial infection, though, is reflective of a new infection (assuming it’s not a Paxlovid rebound).
One could theoretically get reinfected week after week or month after month, but this would be incredibly rare because it assumes no immune response after each subsequent infection. In fact, I’m unaware of a single instance of rapid reinfection described. The cadence of reinfection going forward (every 6 months? every year?) is not clear, as we are at the mercy of time, viral evolution, and booster roll-outs.

How severe are reinfections?​

Even if our first layer of defense is down (causing reinfections), our secondary line of defense kicks in preventing severe disease. This is displayed nicely in the figure below (ignore the x-axis, as this was made for other respiratory viruses).

​

Siggins et al (2021) Durability of Immunity to SARS-CoV-2 and Other Respiratory Viruses. Trends in Microbiology. Source here.
We continue to see this phenomenon at the population and individual level:

• Population level: Population patterns show severe disease getting more and more rare with each subsequent wave. Disease is milder for Omicron than Delta, but not enough to explain this pattern. Our immunity wall is building up, causing welcoming patterns, like decreases in deaths in South Africa shown in the graph below.

​

• Individual level: We see lower severity of disease with reinfections. Before Delta, a study in Qatar found reinfections had 90% lower odds of resulting in hospitalization or death than primary infections. Another study in the U.K. found reinfections were associated with a 61% lower risk of death than primary infections. Those who were vaccinated had lower risk of severe reinfection compared to those who were unvaccinated. In 2021, the U.K. found that viral load was significantly reduced after reinfections compared to primary infections, and thus protects against severe disease.
  

  ​

  More recently, a Danish pre-print study evaluated reinfections after 1.8 million Delta and BA.1 infections. No reinfection resulted in hospitalization or death. Even more recently, a pre-print from Qatar found effectiveness against severe reinfection remained incredibly high (97%) through June 5, 2022. (It’s important to recognize this study population was very young and very healthy.)

What about the Veteran’s Affairs (VA) reinfection study?​

A few weeks ago, a now infamous VA pre-print was released comparing the risk of poor outcomes (e.g. death, health problems) among those with reinfections to those with primary infections. The viral pre-print sent shockwaves through media, as the study was widely misinterpreted to say the health risks from reinfections are worse than risks from primary infections. This is not what the study showed.
The authors did not compare reinfections to the same person’s primary infection. Instead they compared people with reinfections to a separate cohort of people with primary infections (see figure below). Because of this, the only thing we can conclude is that being infected again is worse than not being infected again, which is expected.

​

(Figure by Prof. Michael S Fuhrer)
It’s also important to recognize that this sample was high risk: The average person in the study was 62 years old, 25% were smokers, 80-90% were unvaccinated, 30-40% had diabetes, and 19-26% had heart disease. Similarly, among those reinfected, 20% were hospitalized during the first infection. Among those who had three infections, 8.3% were immunocompromised (compared to 1.1% of first infections).
It’s imperative to assess severity of reinfection among high-risk groups. And, clearly, there are vulnerable pockets of people that will get severe reinfections. But, assuming reinfections are more severe than primary infections for everyone is incorrect.

If I had a fever for first infection (moderate disease), will my response be milder with reinfection?​

This isn’t very clear. A Danish pre-print evaluated BA.2 reinfections after BA.1 infections. The rate of mild symptoms was higher but the rate of moderate symptoms (defined as flu-like symptoms) was lower. This was a very small sample size (33 people), so more evidence is needed.

​

Stegger et al (preprint) Occurrence and significance of Omicron BA.1 infection followed by BA.2 reinfection. Source Here

What about long COVID after reinfection?​

We desperately need more research on long COVID, and we need to sufficiently recognize it as a risk of infection. I couldn’t find much on the risk of long COVID due to reinfections. We can hypothesize lower risk given lower viral load, but this is an educated guess and we don’t know how long COVID occurs or how to treat it.

Bottom line​

There are myriad reasons we need to do our best to reduce SARS-CoV-2 transmission and prevent infection. Wearing masks, staying up to date with vaccines, and improved ventilation will help. And, ideally, reinfections would not occur. But we are well past the point of zero COVID, and reinfections can be expected, just like with other respiratory viruses. Vaccine and infection-induced immunity is clearly reducing severity of reinfection. Unfortunately, protection from severe reinfection isn’t guaranteed for high-risk groups.



"

 

[missy]

“

The latest​

Florida and other Republican-led states are trying to use federal covid aid to finance tax cuts. The $1.9 trillion coronavirus relief package was meant to help states fight the pandemic, shore up local economies and prepare for a potential recession. Congress explicitly told states not to use the funds to subsidize tax cuts or make up for reductions in tax revenue, because once the federal funds dried up there would be budget shortfalls with no easy fix. States have challenged that rule in court – and most of them have won.

A luxury nursing home in West Palm Beach, Fla., that diverted the first available coronavirus vaccines away from vulnerable people to wealthy donors in December 2020 agreed to pay $1.75 million to settle legal claims against it. “Do not be weak be strong you have the opportunity to take advantage of everyone who needs the shot and figure out what they have and what we can go after,” the nursing home’s CEO wrote in a text to the fundraising team, according to the Justice Department. The company, MorseLife Health System, denied the allegations levelled by the Justice Department, but agreed to settle “to avoid the expense and distraction of protracted litigation.”

Since June 18, about 267,180 children younger than 5 have received their first coronavirus shot, according to newly published data from the Centers for Disease Control and Prevention. That is a tiny fraction of the nearly 19 million kids in that age group who are newly eligible to receive the vaccine.

Other important news​

New York Mets pitcher Chris Bassitt said he regrets telling the team he tested positive for coronavirus – and probably would not tell them again in the future.


“

 

[missy]

"

Can I catch Covid outside?​

Is it still very uncommon to get Covid from outdoor events? — Davey, Brooklyn, New York This summer — our third in the pandemic — has seemed to defy the received wisdom about Covid’s spread. In the past, we’ve all breathed a sigh of relief at the prospect of finally socializing in the safety of the great outdoors during warm weather. Indoors means more chance of breathing in virus-laden particles from the air. Outside there is less risk, so ipso facto summer means less virus risk. Those are just the rules. And yet, this summer, many places around the world have seen cases rise. Here in New York, the city health department is once again asking us to mask up amid rising cases. Europe is also at the center of a resurgence, the WHO says. So what gives? Part of the shift, says Katrine Wallace, an epidemiologist at the University of Illinois at Chicago, is due to the power of new Covid variants to spread. “The newer omicron sub-lineages BA.4 and BA.5 are currently together accounting for 70% of all new Covid-19 infections,” she says. “These variants are rapidly gaining ground because they are far more transmissible than any of their Covid-19 variant predecessors.” This in turn has led to a surge in US cases, where the seven-day average of daily infections stands at about 100,000, up from about 30,000 in April and 20,000 this time last year. As those numbers rise, so do hospitalizations. “All things being equal (size of gathering, activity, group of people, etc.), it is safer to have an event take place outdoors versus indoors, but the risk of transmission is still not zero,” Wallace says. And the more crowded the event, the greater the risk. A patio lunch with a few friends is far lower-risk than a place where people are packed in tight. “‘Crowded’ is a a matter of judgement, but in my view, if you are within 12 or 18 inches of others — especially if you are having conversations or everyone is shouting to be heard — that’s crowded,” says Jessica Justman, an infectious diseases specialist and epidemiologist at the Columbia University Irving Medical Center. Being outside, Wallace points out, only helps improve one of the variables for Covid risk: ventilation. Masks, vaccination, social distancing, testing and hand washing all play a role, too. No one measure is 100% effective. And the more virus there is, the more precautions you need. “Unfortunately, the more transmissible a virus is inside, the more transmissible it will also be outside,” says Wallace. “But if you limit the size of gatherings and take sensible precautions, outdoor events can be a safer way to socialize this summer.” — Kristen V. Brown "

 

[missy]

"

​

​ ​ ​ Important developments in the pandemic.​

​ By Katie Shepherd with Fenit Nirappil ​ ​ The latest​ The newest omicron offshoot, BA.5, is sweeping across the United States. But spotty testing and data collection has significantly hampered the nation’s ability to accurately track the number of new cases. Some epidemiologists think there could be as many as 1 million new cases a day, and one expert called BA.5 “the worst version of the virus that we’ve seen.” The latest subvariant is taking over quickly because it can easily dodge immunity from prior infections and vaccines, increasing the risk of reinfection. That same variant is gaining ground in China, raising fears that cities will have to reenter lockdown not long after strict restrictions were lifted after the nation’s last major wave of cases. Shanghai residents only weeks ago emerged from a two-month lockdown that kept most people isolated inside their homes. The BA.5 variant has been detected in the city, and Shanghai officials have begun testing residents and locking down high- and medium-risk streets. Did the coronavirus disrupt your Fourth of July weekend or other recent travel plans? Share your experience with The Post.​ Other important news​ A businessman who fraudulently spent $1.6 million of federal coronavirus aid on a mansion with its own movie theater was sentenced to two years and nine months in prison. Senate Majority Leader Charles E. Schumer (D-N.Y.), who is fully vaccinated and twice boosted, tested positive for coronavirus this weekend. "​

 

[missy]

Each COVID-19 Reinfection Increases
Health Risks​

Damian McNamara
July 07, 2022

"
People who get reinfected with the virus that causes COVID-19 have more health risks with each round of reinfection, a large national database study reveals.

Researchers saw worse health effects during active infection, but some symptoms lasted as long as 6 months, suggesting a direct link between reinfection and long COVID.

"Reinfection adds or contributes additional health risks. It is not totally benign, and people should try to avoid getting reinfected," says lead study author Ziyad Al-Aly, MD.


The risks remained whether or not people were fully vaccinated. In some cases, people might have been infected earlier with the Delta strain and now be exposed to Omicron or its subvariant, BA.5, which may be better at evading vaccine protection, he says.


"It is also possible that the first infection may have weakened some organ systems and made people more vulnerable to health risks when they get a second or a third infection," adds Al-Aly, a clinical epidemiologist at Washington University and chief of research and development at the VA St. Louis Health Care System. "There are a lot of variables at play, but it is clear that reinfections contribute additional risks and they should be avoided."

Al-Aly and his colleagues compared 257,427 people with a first infection with the virus that causes COVID-19 to a group of 38,926 people who had a second or later infection, and then to 5.4 million people who never were infected. The information for the study came from veterans in a Department of Veterans Affairs health care database.

The results were published online June 17 as a pre-print study, which means it has not yet been peer-reviewed, a key step to help evaluate and validate clinical research. The study is under review by the journal Nature Portfolio.

Experts Weigh In​

Three COVID-19 experts who were not involved in the research raised a couple of caveats, including how a study of veterans might or might not apply to the general population.

"It's the first study to characterize the risks of reinfection," says Eric Topol, MD.

He points out that a second infection, compared to a first, was associated with twice the rate of people dying from any cause, as well as twice the risk of heart or lung problems.


The extra risks grew larger with each infection as well, says Topol, executive vice president of Scripps Research and editor-in-chief for Medscape, WebMD's sister site for health care professionals.


"Obviously these findings are worrisome since reinfection was quite rare before the Omicron wave hit, at 1% or less through the Delta variant wave. But now reinfections have become much more common," he says.

Higher Risks, Especially for Some​

The study was "well done," says Ali Mokdad, PhD, when asked to comment. Al-Aly and colleagues "have access to a good data, and they have done several studies."


He says the extra risks are more likely among the elderly, the immunocompromised, and people with other medical conditions.


"It makes sense, and let me explain why,” Mokdad says. “When you have somebody who got COVID-19 the first time and was impacted by it, maybe someone who was older or who had a chronic condition, the next hit would also cause more damage."


"That's why you would expect some people would be more likely to have a harder second infection," says Mokdad, an adjunct professor of epidemiology and professor of health metrics sciences at the University of Washington in Seattle.


"The best thing for you and for the general public — healthy or not, chronic condition or not — is not to get infected," he says. "Go get your vaccines and your boosters, and wear a mask when you're in a place that is crowded and you cannot keep a safe distance."

Veterans' Risk Factors Different?​

"When you look at that study, the big caveat is that veterans don't resemble the general population," says Amesh Adalja, MD, a senior scholar at the Johns Hopkins Center for Health Security at the Bloomberg School of Public Health in Baltimore.


"I don't think you can generalize [the study] to everybody, but really for people that have risk factors for severe disease," he says, because veterans tend to be older and have more health conditions.


He says a lot of people who get reinfected are testing positive at home. As a result, their cases don't make it into research. In contrast, the veterans in the study were "people who for whatever reason wanted to get a formal test."


As the virus has mutated away from the vaccines, the shots can still protect against severe illness, hospitalization, and death, but they are less able to protect against infection, Adalja says. "That's also the case with prior immunity. If you were someone infected with BA.1 or Delta, for example, your ability to fend off the new variants, BA.4 and BA.5, may not be very high."


The study shows why "it's important to stay up to date with your vaccines," he says, "and why we need to get better vaccines that are targeted to variants that are currently circulating."


Despite these caveats, Adalja says, the researchers used "a robust database" and a large study population, which "gives all of us confidence in the strength of the finding."

Looking at Longer-Term Effects​

Whether reinfection contributes to increased risk of long COVID was unknown, so researcher Al-Aly and colleagues followed the veterans over 6 months. They compared people who had one, two, three, or more infections to the non-infected group.


Among those with reinfection, about 13% had two infections, 0.76% had three infections, and .08%, or 246, people had four or more infections.


Compared to veterans with a first coronavirus infection, those who got a reinfection had more than double the risk of dying from any cause.


Even though "the mechanisms underpinning the increased risks of death and adverse health outcomes in reinfection are not completely clear," the authors say, "the findings highlight the consequences of reinfection and emphasize the importance of preventing re-infection SARS-CoV-2," the virus that causes COVID-19.


Asked about the next step in their research, Al-Aly said, "BA.5 seems to be the main challenge looming ahead, and we are focused on trying to better understand it."


Sources:


Research Square: “Outcomes of SARS-CoV-2 Reinfection.”


Eric Topol, MD, executive vice president, Scripps Research; editor-in-chief, Medscape.


Ali Mokdad, PhD, adjunct professor of epidemiology and professor of health metrics sciences, University of Washington, Seattle.


Amesh Adalja, MD, senior scholar, Johns Hopkins Center for Health Security, Bloomberg School of Public Health, Baltimore.


Damian McNamara is a staff journalist based in Miami. He covers a wide range of medical specialties, including infectious diseases, gastroenterology, and neurology. Follow Damian on Twitter: @MedReporter.

"

 

[missy]

"

Goodbye Shanghai: After 16 Years, COVID Curbs Send American Family Packing​

By Casey Hall
July 08, 2022




SHANGHAI (Reuters) - American Heather Kaye and her family, including cat Mochi, are part of a wave of residents departing Shanghai, leaving behind their homes and memories, driven out by two years of strict COVID-19 curbs, including a crushing two-month lockdown.
Heather and husband George arrived in Shanghai from New York in 2006 for a one-year adventure, but 16 years later their two-bedroom apartment in Shanghai’s historic former French Concession is the only home their children have ever known.
So while repatriating to the United States is technically a homecoming for Heather and George, leaving Shanghai means leaving home for daughters Charlotte, 14, and Matilda, 12.
Heather spent the month of June readying for a return to the United States. Her husband left weeks earlier with their family dog to help prepare for their new life in Washington D.C.

"I haven't had the luxury to really grieve a lot of what I'm leaving behind because I need to get two kids and a cat out of here … so it's been really focused on that logistics," she told Reuters from her flat which had just been emptied out by movers.

The Kaye family are part of an exodus of both foreigners and locals from Shanghai as China's most cosmopolitan city tries to find its footing and return to normal life after a strict city lockdown aimed at stamping out the infectious Omicron variant.
While some opted to leave in the midst of the lockdown, stunned by difficulties in obtaining food and fears of being separated from family members should they be infected with COVID, others like the Kayes opted to wait it out. They purchased their new house in Washington D.C. online during lockdown.
For many departing foreign residents, the lockdown was the last straw, after two years of strict COVID curbs that made it immensely difficult to fly in and out of China.

The country, whose zero-COVID approach towards the virus has increasingly made it out of step with the rest of the world, has slashed the quarantine time for inbound travellers from 14 days in a central facility to seven days, its biggest change to border restrictions put in place in early 2020.
According to the European Chamber, the number of foreigners in China has halved since the pandemic began. It predicts that number could halve again this summer, with few international workers coming in to replenish the numbers leaving.
"Talking to people who were scheduled to move (to Shanghai) in the summer, they are not, they're going to Singapore, they're going to Bangkok," Kaye said. "Being based here, so many people can't really do their jobs anymore, because they do require so much travel and so that's made it prohibitive for so many."
With ageing parents in the United States, travel restrictions were also a big part of Kaye and her husband's decision to leave, she said, describing how they had already made up their minds before the lockdown.

EXODUS

Kaye moved to Shanghai to work for a fashion label and became enthralled by the fast charging energy of a China on the rise. She later started her own business, now known as eco-swimsuit brand Loop.

Her husband left behind his career as a banker in the United States and quickly immersed himself in Chinese culture and learnt to speak Mandarin. He eventually started his own sustainable bamboo toy business.

They further cemented their ties to the city by purchasing their apartment, considered an unusual move for foreigners in Shanghai both then and now.

"Anything you can imagine, you can build it here. Anything you want to be, you can make it happen here," said Kaye.

Since Shanghai eased its lockdown curbs on June 1, Kaye has busied herself with packing but also made sure she found time to reminisce over her time in the city with bike rides to the Bund and a last plate of dumplings from a favourite local haunt.

The safe streets of Shanghai will be particularly missed, she said, recounting how she would walk her dog late at night and felt able to let her children take the subway by themselves when they were as young as 10 years old.

The Kaye family's last few years in Shanghai have been tinged by China's growing isolation due to COVID border curbs and a worsening relationship between Washington and Beijing, but Kaye said it has not marred their experience.

"I think people are around the world basically the same. We all want to be safe, and be able to go about our work and do creative things and get a good education for our kids, and have a home and shelter and community," she said. "I think on the government level is where things get so misunderstood.”

Three days after Kaye and her daughters landed in the United States all three tested positive for COVID, but they have no regrets about their move.

(Reporting by Casey Hall; Editing by Brenda Goh and Michael Perry)

"

 

[missy]

"

Second COVID Booster: Get it Now, or Wait Until Fall?​

— A doctor's dilemma: When to reduce "the likelihood of ending up dead"​

by Cheryl Clark, Contributing Writer, MedPage Today July 13, 2022

The 60-year-old woman with several health issues took her octogenarian mother to her primary care doctor this spring. The subject of whether they should update their COVID immunizations came up.
They each had received two primary doses and one booster, and wondered whether getting the second booster was worth it.
The physician recommended waiting. Cases were ebbing at the time, and there might be a more potent booster available later in the year. But most of all, the doctor told them, if they waited until August or September, they could be better protected against an anticipated winter surge.

So that's what they did, leaving themselves unprotected against new and highly transmissible variants now surging in their community through the summer, but potentially better shielding them closer to the holidays.
But not everyone thinks such clinical guidance was the best.
"In my view, this would be very bad advice," said Robert Schooley, MD, an infectious disease expert at the University of California San Diego, who has been a member of FDA vaccine advisory committees.
BA.5 is now the dominant variant in the U.S., and it has drifted so much that protection from the first vaccine doses are now less effective, Schooley said: "It is clear that those boosted once last year have seen substantial reductions in immunity since their vaccinations last year."
Likelihood of Ending up Dead
People who are vulnerable, including older people and those with significant health issues, "are at substantial risk of becoming infected over the next eight to 12 weeks given the extremely high contagiousness of these strains and the broad community spread," Schooley added. "Being current on vaccination is the best way to reduce the likelihood of ending up in the hospital or dead."

An April study in Nature with 563,465 participants ages 60 to 100 who had received their first booster more than four months previously found substantial reductions in hospitalizations and deaths among those who received a second booster compared with those who had received only their first booster.
Only 270 of the 328,597 people who received a second booster were hospitalized during the 40-day study period, compared with 550 of the 234,868 who did not get a second booster. Additionally, 92 of those who received the second booster during the study period died due to COVID-19 compared with 232 who had received just one dose. The likelihood of death increased with age.
At a White House COVID-19 Response Team briefing on Tuesday, team coordinator Ashish Jha, MD, offered guidance: "In terms of what to recommend to people right now, if you're over 50 and if you've not gotten a shot in 2022, first of all, getting one now protects you for the rest of the summer into the fall. Second, it does not preclude you from being able to get a bivalent vaccine in the fall. So that's why I think for me, it's a very, very clear recommendation."

According to CDC's COVID Data Tracker, in April 2022, people age 50 and up who received the primary vaccine series but only one booster dose had a 4-fold higher risk of death from COVID-19 compared with those who received both booster doses.
A CDC public affairs official said in an email that the failure of those eligible to get up to date with their COVID immunizations is a growing problem that has resulted in "a doubling of hospital admissions since spring, and it's essential that eligible individuals get their booster shots right away."
The tracker shows that only 27.7% of those age 50 and up and only 34.4% of those age 65 and up have received their second booster.
Some clinicians told MedPage Today that if their patients express any reluctance to get all of their booster shots, he refers them for blood work to see whether and how much protection from prior doses may have waned. San Diego internist Paul Speckart, MD, says that armed with declining numbers, he can make a more persuasive case.

It's not uncommon to hear physicians take a more relaxed attitude, Speckart said, although he disagrees that delaying a booster shot was wise advice to give a patient.
One eligible San Diego man said he was deterred from getting the booster after reviewing county statistics showing more cases and a slightly higher number of hospitalizations in people who were boosted than people who were not. However, the county charts are not adjusted for the likelihood that many people who got boosted were older with more comorbidities and had a higher risk of being hospitalized.
For those still deciding, the CDC's booster calculator provides guidance for anyone unsure about their eligibility. Generally speaking, for people age 60 and older, a first booster is recommended for those who received primary immunization more than 5 months previously, and a second booster is recommended for those who received their first booster more than 4 months ago.

James Grisolia, MD, a San Diego neurologist, described it as a physician's dilemma. "While we were between surges, I would have given similar advice (to wait before getting the second booster) but as of several weeks ago, it was obvious we were going into another surge. I began encouraging older folks to get their second booster."
It's a dilemma, he said, because it was reasonable before the latest surge to give patients protection that would be most effective this fall and through the winter, and that would require delaying the dose until August.
Besides, he said, "they only announced they were working on an Omicron-flavored booster in the last few weeks, and it's still speculative that Moderna or Pfizer will find coverage for the variants we will actually have then."
Relaxed Attitude
Grisolia said what he most worries about are the people "who just won't get vaxxed, period."

This reporter has also noticed that even in healthcare settings, there is a relaxed attitude about masking and other precautions. In the last several weeks, some clinical settings have removed the signs and yellow ribbons on chairs that prohibited people from sitting less than 6 feet apart.
And healthcare staff at a San Diego physician's office and a physical therapy practice had to be reminded on the proper way to wear a mask, covering both the mouth and the nose, even though most were wearing cloth masks instead of N95s or surgical masks.
Grisolia agreed. "It's certainly right that folks are psychologically 'over it' and not being careful," even as hospitalizations are creeping upward, and many area clinical staff have been calling in sick, he said.
Meanwhile, in anticipation of new demand for vaccines this fall, the Biden administration has agreed to purchase more than 100 million doses of Pfizer's COVID-19 vaccine. Last month, an FDA advisory committee voted 19 to 2 to recommend that future COVID-19 vaccine boosters include an Omicron-specific target, though how soon that will happen remains unclear.

Schooley noted that while there are vaccines promised for fall, "the key word is 'promised.' They have not yet been reviewed by the FDA or the CDC and still need to be produced at industrial scale."
He noted delays in "promised" vaccines for children and that "there is no guarantee that these vaccines will be ready when projected. Furthermore, we know from past experience that if they are suddenly available on, for example October 1, it takes many weeks to work through the entire population and people hoping to be vaccinated as soon as the vaccines are approved might find themselves still waiting at Thanksgiving."
The 60-year-old woman who lives with her mother said that based on increasing case counts, she has now reconsidered, and that both are scheduled to receive their second boosters soon.

"

 

[missy]

"

Is Covid ever going to end?​

When will this surge end? And if transmission is this high now, during the summer when transmission has often been at its lowest, what does that mean for this fall and winter? Will we ever get a break? — Stephanie, New York City “Will we ever get a break?” I can’t tell you how many times I have asked myself this over the past year. Sometimes I think back to March 2020, when we all went into lockdown and groaned at the idea of having to stay in our houses for what we then thought would be just a few weeks, and am forced to laugh. It was impossible to imagine this would all still be going on years later. At this point — in our third year of the pandemic — it’s clear that the only reliable constant is that Covid is entirely unpredictable. Bertha Hidalgo, a University of Alabama epidemiologist, was faked out by a variant that never truly got off the launchpad. “A few weeks ago, I thought BA2.12.1 would drive the summer wave and it would be a small wave, with not too many infections, to be followed by a BA.5 wave when schools reopened,” she says. Instead, the BA.5 omicron variant decided that the summer of 2022 was its time to shine. The variant is now dominant in the US, according to the Centers for Disease Control and Prevention. Combined with BA.4, it is also powering a surge of the virus in Europe. This week, World Health Organization chief Tedros Adhanom Ghebreyesus warned that “new waves of the virus demonstrate again that Covid-19 is nowhere near over.” We may be done with Covid, but it does not appear to be done with us. “Will it peak in the next month or so? Possibly. Or will it run through the population before school starts in August? Also unclear,” says Hidalgo. And such questions, she says, are further complicated by the decrease in reported testing with many instead relying on home diagnostics. It means we have little idea how widespread the virus really is. But Covid's refusal to relent doesn’t mean we all have to lock ourselves in our houses for the foreseeable future. The good news is that we now know much more about what strategies are effective for reducing spread of the virus as we go about our lives in these very odd times. Hidalgo shared her list of best practices: Get vaccinated and get all available boosters Wear a mask indoors (and outdoors if in crowded spaces) Make sure to get a good quality, good fitting mask, like a KN95 Use rapid tests before gathering with others, or at the sign of any questionable symptoms If gathering indoors, consider improving ventilation through measures like opening windows or running a central HVAC system “All of these are layers of protection we can take advantage of that are preventive and can help reduce chances of infection and transmission,” she says. — Kristen V. Brown "

 

[TooPatient]

Seems like it is spreading fast right now. My cousin, his wife, and one of their kids got it a few weeks ago. Now my brother has it (unvaccinated retail worker) with mild symptoms along with a family friend (vaccinated, boosted, fully masked) with more severe symptoms. Not related cases as none had been around each other recently.

 

[missy]

"

The latest​

Dangerous superbug infections and deaths rose during the pandemic, according to a new report published by the Centers for Disease Control and Prevention. My colleague Lena H. Sun reports that the number of antibiotic resistant infections rose by 15 percent in 2020 compared to 2019, undoing years of progress in combating one of the most worrisome public health challenges in modern medicine. Sicker patients and antibiotic overuse early in the pandemic, along with staffing and supply shortages, fueled the rise in superbug infections, the CDC said.

Covid-19 cases may jeopardize Democrats' plans to pass an economic deal along party lines. Senate Majority Leader Charles E. Schumer (D-N.Y.) and Sen. Richard Blumenthal (D-Conn.) tested positive and were not able to vote last week. Their absence did not affect the Senate’s agenda, but if other Democrats are out sick during critical votes, it could upend their efforts to move major legislation through the evenly split Senate.

A Twitter user dubbed one of the latest omicron variants “Centaurus” —and the nickname appears to have stuck. A man named Xabier Ostale gave the name to the BA.2.75 variant in a July 1 tweet. It quickly became a common way to refer to a variant that scientists are closely watching to see how dangerous it might be. The World Health Organization has not yet designated BA.2.75 a “variant of interest,” but international experts are monitoring the omicron subvariant as it spreads in at least 10 countries so far.

Other important news​

Experts recommend skipping summer travel if you’re feeling sick, and masking on flights if you’re feeling healthy, as BA.5 continues to spread in the United States.

These women, inspired by the challenges of the pandemic, switched careers to work in mental health services.
"

"

Your questions, answered​

Can we take the flu vaccine and the coronavirus vaccine at the same time? — Gail F., Hawaii

“The answer is an unequivocal yes,” said Kelly Moore, a preventive medicine specialist and CEO of the vaccine education and advocacy nonprofit Immunize.org.

That is true of every other routine vaccine, she said. They can all be administered at the same time as the mRNA vaccines or the new Novavax vaccine, which is worth keeping in mind as we move into fall and flu season.

Some people are hesitant to get multiple vaccines at the same time, particularly if they worry about their reactions to shots, including pain in the injection site.

You might want to consider getting those shots in different arms, Moore said. But think twice before spreading the shots out. Remember the added burden (and expense) of making two trips to your health-care provider or pharmacy.

“The longer people wait, the longer time they are at risk,” Moore said.

One caveat: There is a documented risk of myocarditis with one of two monkeypox vaccines, ACAM2000. Because the mRNA coronavirus vaccines also have a very small risk of myocarditis — much smaller than with ACAM2000 — and the other monkeypox vaccine, JYNNEOS, is new, the CDC recommends a four-week wait after vaccination with either of those vaccines before getting an mRNA vaccine. This is particularly the case for adolescent or young adult men, who have been found to be at greater risk for myocarditis, the swelling of the heart muscle, from the mRNA vaccines.

“It might be a good idea to wait 4 weeks after a monkeypox vaccination to get a COVID-19 vaccine,” Moore wrote in an email. “However, if you are told you need a monkey pox vaccine because you’re at risk now, you should not delay that monkeypox vaccine even if you just had a COVID-19 vaccine.”
"

 

[missy]

Sore Throat, Cough Now Top COVID Symptoms: UK Study​

Ralph Ellis
July 15, 2022


"
A study of COVID-19 patients in the United Kingdom has found that loss of taste and smell were no longer among the most telling symptoms of the virus.

The recent survey of about 17,500 patients who were asked about their symptoms found that 58% reported a sore throat, 49% a headache, 40% a blocked nose, 40% a cough with no phlegm, and 40% a runny nose, the BBC reported.

After that, 37% reported a cough with phlegm, 35% a hoarse voice, and 32% sneezing.


Only 27% reported fatigue, 13% altered smell, 11% shortness of breath, and 10% loss of smell, the BBC said. Loss of smell was ranked 20th among reported symptoms.







"

 

[missy]

"

Many People Becoming Reinfected as BA.5 Dominates New COVID-19 Cases​

Jay Croft
July 15, 2022


When the COVID-19 pandemic first began, the general thought was that once people were infected, they were then protected from the virus.
But a new analysis by ABC News shows that more and more Americans are getting the virus again.
It’s hard to say how many. The ABC News analysis found at least 1.6 million reinfections in 24 states, but the actual number is probably a lot higher.
"These are not the real numbers because many people are not reporting cases," Ali Mokdad, MD, an epidemiologist with the University of Washington, told ABC.

The latest variant, BA.5, has become the dominant strain in the U.S., making up more than 65% of all COVID-19 cases as of Wednesday, according to data from the CDC.


"