School closures led to more sleep and better quality of life for adolescents

 The school closures in spring 2020 had a negative effect on the health and well-being of many young people. But homeschooling also had a positive flipside: Thanks to sleeping longer in the morning, many teenagers reported improved health and health-related quality of life. The study authors from the University of Zurich therefore believe school days should begin later in the morning.

The first wave of the Covid-19 pandemic led to the closure of all schools nationwide from 13 March to 6 June 2020. According to multiple studies, symptoms of depression and anxiety among young people increased during this time, while satisfaction and quality of life decreased. The schoolchildren were also less physically active and spent more time sitting in front of screens.

Now, a study by the University of Zurich (UZH) has shown that the homeschooling phase also had a positive effect on the health and well-being of many teenagers. "The students got about 75 minutes more sleep per day during the lockdown. At the same time, their health-related quality of life improved significantly and their consumption of alcohol and caffeine went down," says the study's co-leader Oskar Jenni, UZH professor of developmental pediatrics. Because they no longer had to travel to school, they were able to get up later.

More sleep on school days improves young people's health-related quality of life

The researchers conducted an online survey with 3,664 high school students in the Canton of Zurich during the lockdown, asking about their sleep patterns and quality of life. They then compared the answers with a survey from 2017 with 5,308 young participants. The results showed that during the three months in which the schools were closed, the adolescents got up around 90 minutes later on school days, but went to bed only 15 minutes later on average -- meaning their total amount of sleep increased by about 75 minutes a day. On weekends, there was little difference in the sleep times of the two groups.

The students in the lockdown group rated their health-related quality of life higher, and the amount of alcohol and caffeine they reported consuming was less than the pre-pandemic group. "Although the lockdown clearly led to worse health and well-being for many young people, our findings reveal an upside of the school closures which has received little attention until now," says Jenni.

Unique opportunity to investigate the effect of later school starting times

Sleep deficits in adolescents can lead to general tiredness, anxiety and physical ailments. These in turn have a detrimental effect on cognitive functions such as concentration, memory and attention, making it significantly harder to function in everyday life. The early start of the school day in Switzerland conflicts with the natural, biologically determined sleeping habits of teenagers. Because they have to get up early for school, many young people therefore suffer from chronic lack of sleep. The topic has recently made its way onto the political agenda in several cantons across the country.

"Our findings clearly indicate the benefit of starting school later in the morning so that youngsters can get more sleep," says Jenni. He speculates that the positive effects on health and health-related quality of life would have been even greater had there not also been the negative effects of the pandemic on mental health.

Story Source:

Materials provided by University of Zurich. Note: Content may be edited for style and length.

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Journal Reference:

1. Joëlle N. Albrecht, Helene Werner, Noa Rieger, Natacha Widmer, Daniel Janisch, Reto Huber, Oskar G. Jenni. Association of Adolescent Sleep Duration During COVID Pandemic High School Closure – Effects of homeschooling on adolescents’ sleep and health. JAMA Network Open, 2022 DOI: 10.100/jamanetworkopen.2021.42100

https://www.sciencedaily.com/releases/2022/01/220105111355.htm

Cell-reprograming therapy for heart failure closer to reality

 Not too long ago the idea of taking, for instance a skin cell and transforming it into a muscle cell was unthinkable. About 10 years ago, however, revolutionary research showed that it is indeed possible to reprogram differentiated adult cells into other types fully capable of conducting new functions.

Cell reprogramming is a main interest of the lab of Dr. Todd Rosengart, chair and professor of the Michael E. DeBakey Department of Surgery at Baylor College of Medicine, whose research focuses on finding innovative therapeutic approaches for heart failure.

"Heart failure remains the leading cause of death from heart disease," said Rosengart, DeBakey-Bard Chair in Surgery and professor of molecular and cellular biology at Baylor. "Nearly 5 million Americans can be expected to develop advanced congestive heart failure, and heart transplant or mechanical circulatory support implantation currently are the only options for patients with end-stage heart disease. However, these options are limited. We need to improve how to treat this devastating condition."

After a heart attack, the parts of the heart muscle that die do not regenerate into new heart tissue; instead, they are replaced by a scar that does not help the heart to beat. "The idea behind cell reprograming is to coach the heart to heal itself by inducing the scar tissue, which is made mostly of fibroblasts, to change into functional heart muscle," said Rosengart, professor of heart and vascular disease at the Texas Heart Institute.

Researchers have succeeded at reprograming fibroblasts from small animals to become heart muscle, with dramatic improvements in heart function. The challenge has been to apply this technology to human cells -- human fibroblasts are more resistant to reprograming. In this study, Rosengart and his colleagues explored a novel strategy to enhance the reprogramming efficiency of human fibroblasts.

"While human fibroblasts resist being reprogramed, endothelial cells, those that line the blood vessels, are known to be more flexible -- they have the capacity to naturally transdifferentiate or change into other cells," said co-first author Dr. Megumi Mathison, associate professor of surgery at Baylor. "This gave us the idea of using this endothelial cell plasticity to improve the reprograming efficiency."

The researchers' idea was to first induce fibroblasts to transition into an endothelial cell-like state and then treat these cells with their reprograming cocktail that directs them to change into cardiomyocytes. The expectation was that transitioning into endothelial cell-like cells, a cell type more open to reprogramming than fibroblasts, would facilitate the desired change into heart muscle.

"We were delighted to see that our approach significantly enhanced reprogramming efficiency both in human and rat fibroblasts," Mathison said. "Previously, inducing cardiomyocytes from fibroblasts directly was only 3% efficient. With our new approach, the efficiency increased 5 times. It took about two to three weeks for the fibroblasts to transition into cardiomyocytes in the lab. It was exciting to see the reprogrammed cells contracting in synchrony with surrounding cardiomyocytes."

The researchers' experimental results with the rat model show that their new strategy can revert large scar tissue into working muscle, supporting continuing their investigations to bring this procedure to the clinic.

"Although more research is needed, we anticipate that this novel approach can become part of the next generation of biological therapies," Rosengart said. "In a future scenario, patients with congestive heart failure would come to the catheterization laboratory, commonly referred to as the cath lab, in a hospital. The cath lab has diagnostic imaging equipment that helps surgeons visualize the chambers of the heart and surrounding blood vessels as they conduct procedures. Assisted by this equipment, the surgeon would inject the factors that promote the transition from fibroblasts to endothelial cells and then to cardiomyocytes directly into the heart. Follow ups would monitor the progress of the procedure."

This work strongly ties into the prominent role Baylor College of Medicine has played in the history of the artificial heart and heart transplants pioneered by Dr. Michael E. DeBakey and Dr. Denton A. Cooley in the 1950s and 60s.

"Years ago, Dr. Cooley said to me, regarding the next procedures needed to help people with heart failure, 'Todd, you got to do something that is dramatic.' For me, cell reprograming is a 21st century answer to this request," Rosengart said.

This study was funded by the National Heart, Lung and Blood Institute (R01HL121294?01A1, R01HL 152280, 5T32HL139430), the Baylor College of Medicine Cytometry and Cell Sorting Core (National Institutes of Health grants P30AI036211, P30CA125123, S10RR024574; the National Institute of Allergy and Infectious Diseases grant AI036211), and the Baylor College of Medicine Integral Microscopy Core (NIH DK56338, CPRIT RP150578, and RP170719).

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Story Source:

Materials provided by Baylor College of Medicine. Original written by Ana María Rodríguez, Ph.D.. Note: Content may be edited for style and length.

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Journal Reference:

1. Megumi Mathison, Deepthi Sanagasetti, Vivek P. Singh, Aarthi Pugazenthi, Jaya Pratap Pinnamaneni, Christopher T. Ryan, Jianchang Yang, Todd K. Rosengart. Fibroblast transition to an endothelial “trans” state improves cell reprogramming efficiency. Scientific Reports, 2021; 11 (1) DOI: 10.1038/s41598-021-02056-x

https://www.sciencedaily.com/releases/2022/01/220106133300.htm

CMS proposes Part D price concessions applied at point-of-sale, new requirements for MA plans

 The Biden administration wants Medicare Part D plans to apply any price concessions they get from drugmakers to the point-of-sale and require Medicare Advantage plans to be more transparent in how they spend money on supplemental benefits.

The Centers for Medicare and Medicaid Services released a proposed rule on late Thursday that outlined major regulatory changes for MA and Part D starting in 2023. The rule covers a swath of major areas that include new changes for dual-eligible special needs beneficiaries and updates to calculations of star ratings, which can affect quality bonuses delivered to plans.

“Today’s proposed actions follow our guiding principles by improving health equity and enhancing access to prescription medications,” said CMS Administrator Chiquita Brooks-LaSure in a statement.

The proposal takes a major aim at price concessions that Part D plans extract from drug makers. Under the concessions, the plan pays less money to a pharmacy if it doesn’t meet several metrics. CMS is concerned, however, that the end-user doesn’t know about the arrangement and the lower prices are not passed on at the point-of-sale.

The proposed rule also said that the negotiated prices “typically do not reflect any performance-based pharmacy price concessions that lower the price a sponsor ultimately pays for the drug.”

The proposed rule wants to require all Part D plans to apply the concessions at the pharmacy counter.

“CMS is proposing to redefine the negotiated price at the baseline, or lowest possible, payment to a pharmacy, effective January 1, 2023,” a fact sheet on the regulation said. “This policy would reduce beneficiary out-of-pocket costs and improve price transparency and market competition in the Part D program.”

Since the changes are coming next year, Part D plans should account for them in their bids for the coming contract year, the rule said.

CMS is also proposing several policies that affect how MA plans are evaluated.

The agency is proposing that plan applicants must show they have a sufficient network of contracted providers before the agency approves an application for any new or expanded MA plan. The agency also hopes to provide MA insurers with information on their network adequacy before they submit a bid, giving them time to make any changes.

But CMS said it recognizes that it may be hard for plans to meet the network adequacy requirements within one year in advance of a contract year. It is therefore proposing to allow a “10-percentage point credit toward the percentage of beneficiaries residing within published time and distance standards for new or expanding service area applicants,” the fact sheet said. “Once the coverage year start (Jan. 1), the 10-percentage point credit would no longer apply and plans would need to meet full compliance.”

The agency is also calling for greater transparency in the reporting of medical loss ratios (MLRs), which require insurers to spend a certain percentage of their premium dollars on medical claims and the rest on administrative costs.

Currently, MA and Part D plans must meet an MLR of 85% of a premium dollar going to medical claims.

“Our proposal would require MA organizations and Part D sponsors to report the underlying cost and revenue information needed to calculate and verify the MLR percentage and remittance amount, if any,” the fact sheet said.

MA plans must also report the amount spent on supplemental benefits that aren’t offered by traditional Medicare, such as dental or vision. These benefits are major marketing tools for plans to Medicare beneficiaries.

CMS also wants to tighten oversight of third-party marketing organizations to prevent any deceptive tactics in marketing to seniors.

Improving care for dual-eligibles

CMS included several policies aimed at dual-eligible beneficiaries in both Medicare and Medicaid, part of a greater shift by the agency and Biden administration to tackle health equity.

A major proposal aims to better reflect plan performance on dual eligibles in star ratings, which can help beneficiaries to comparison shop for plans and are used to calculate quality bonuses to insurers.

Most of the time a plan contract could contain dual-eligible beneficiary and non-special needs MA plans. This can make it hard to fully assesses how a plan performs care for a dual-eligible beneficiary, a fact sheet on the rule said.

“CMS is proposing a pathway to allow certain states with integrated care programs to require that MA organizations establish a contract that only includes one or more [dual-eligible special needs plans], which would allow for star ratings for that contract to reflect the [dual-eligible] local performance,” the fact sheet added.

The agency also is proposing that dual-eligible plans use new integrated materials that make it easier for such beneficiaries to understand the scope of the Medicare and Medicaid benefits available to them.

https://www.fiercehealthcare.com/payer/cms-proposes-part-d-price-concessions-be-applied-at-point-sale-new-requirements-for-ma-plans

Kaufman Hall: Consumers may again be avoiding care as hospital margins stay depressed

 Hospital volumes softened in November overall as operating margins remain depressed, signaling that once again consumers could be delaying or avoiding care due to the pandemic, a new report from consulting firm Kaufman Hall found.

The firm released Tuesday its latest hospital flash report detailing revenues and volumes for November before the omicron-fueled surge of COVID-19 took hold. The report found hospitals are still facing major pressures from rising expenses and labor shortages.

“Hospitals are grappling with higher labor costs despite lower staffing levels, due to intense competition for qualified healthcare workers,” said Erik Swanson, Kaufman’s senior vice president of data and analytics, in a statement. “In addition, the highly contagious omicron variant could put more pressure on hospitals in the months to come.”

Kaufman found that hospital volumes softened in November, with discharges dropping nearly 5% and adjusted discharges by 3.9% compared to the month before. Discharges were also down 6.1% compared with pre-pandemic levels.

Meanwhile, the average length of stay at hospitals increased by 0.8% compared to October and 8.6% compared with November 2019.

The report estimates consumers could be postponing non-COVID-19 care.  

“The potential impact of the omicron variant in future months may influence this trend further,” Kaufman’s analysis said.

The volume fluctuation helped contribute to a month-to-month decline in total revenues. The report found gross operating revenues that did not includes CARES Act relief funding declined 0.6% from October to November.

Inpatient revenue dropped down to 2.6%, and outpatient revenue was only down by 0.7%.

However, net patient service revenue per adjusted discharge rose 2.5% thanks in part to payments for higher acuity patients.

Expenses continued to be a drain on hospital operating margins.

“Total expense per adjusted discharge increased 24.7%, labor expense per adjusted discharge rose 26.4%,” the report said.

Labor expenses were particularly vexing for hospitals; even though expenses rose 2.7% month to month, there was a 1% decline in full-time equivalent staff per adjusted occupied bed.

“Hospitals in the west had the biggest increase in labor expenses for the month, with labor expense per adjusted discharge up 28.8% [year-over-year],” Kaufman Hall added.

The flash report relies on data from more than 900 hospitals across the country.

https://www.fiercehealthcare.com/hospitals/kaufman-hall-consumers-may-again-be-avoiding-getting-care-as-hospital-margins-remain

Fed Judge Rejects FDA's 75 Year Delay On Vax Data, Cuts To Just 8 Months

 A federal judge has rejected a request by the FDA to produce just 500 pages per month of the data submitted by Pfizer to license its Covid-19 vaccine - and has ordered them to produce 55,000 pages per month. Assuming there are roughly 450,000 pages, that means it will take just over eight months for the world to see what's under the hood.

Attorney Aaron Siri, who represents the plaintiff in the case, has provided this stunning update via his blog, Injecting Freedom:

On behalf of a client, my firm requested that the FDA produce all the data submitted by Pfizer to license its Covid-19 vaccine.  The FDA asked the Court for permission to only be required to produce at a rate of 500 pages per month, which would have taken over 75 years to produce all the documents. 

I am pleased to report that a federal judge soundly rejected the FDA’s request and ordered the FDA to produce all the data at a clip of 55,000 pages per month!

This is a great win for transparency and removes one of the strangleholds federal “health” authorities have had on the data needed for independent scientists to offer solutions and address serious issues with the current vaccine program – issues which include waning immunity, variants evading vaccine immunity, and, as the CDC has confirmed, that the vaccines do not prevent transmission.

No person should ever be coerced to engage in an unwanted medical procedure.  And while it is bad enough the government violated this basic liberty right by mandating the Covid-19 vaccine, the government also wanted to hide the data by waiting to fully produce what it relied upon to license this product until almost every American alive today is dead.  That form of governance is destructive to liberty and antithetical to the openness required in a democratic society. 

In ordering the release of the documents in a timely manner, the Judge recognized that the release of this data is of paramount public importance and should be one of the FDA’s highest priorities.  He then aptly quoted James Madison as saying a “popular Government, without popular information, or the means of acquiring it, is but a Prologue to a Farce or a Tragedy” and John F. Kennedy as explaining that a “nation that is afraid to let its people judge the truth and falsehood in an open market is a nation that is afraid of its people.” 

The following is the full text of the Judge’s order, a copy of which is also available here.

UNITED STATES DISTRICT COURT

PHMPT, Plaintiff v. FDA, Defendant, No. 4:21-cv-1058-P

ORDER

This case involves the Freedom of Information Act (“FOIA”). Specifically, at issue is Plaintiff’s FOIA request seeking “[a]ll data and information for the Pfizer Vaccine enumerated in 21 C.F.R. § 601.51(e) with the exception of publicly available reports on the Vaccine Adverse Events Reporting System” from the Food and Drug Administration (“FDA”). See ECF No. 1. As has become standard, the Parties failed to agree to a mutually acceptable production schedule; instead, they submitted dueling production schedules for this Court’s consideration. Accordingly, the Court held a conference with the Parties to determine an appropriate production schedule.[1] See ECF Nos. 21, 34.

“Open government is fundamentally an American issue” – it is neither a Republican nor a Democrat issue.[2] As James Madison wrote, “[a] popular Government, without popular information, or the means of acquiring it, is but a Prologue to a Farce or a Tragedy; or, perhaps, both. Knowledge will forever govern ignorance: And a people who mean to be their own Governors, must arm themselves with the power which knowledge gives.”[3] John F. Kennedy likewise recognized that “a nation that is afraid to let its people judge the truth and falsehood in an open market is a nation that is afraid of its people.”[4] And, particularly appropriate in this case, John McCain (correctly) noted that “[e]xcessive administrative secrecy . . . feeds conspiracy theories and reduces the public’s confidence in the government.”[5]

Echoing these sentiments, “[t]he basic purpose of FOIA is to ensure an informed citizenry, [which is] vital to the functioning of a democratic society.” NLRB v. Robbins Tire & Rubber Co., 437 U.S. 214, 242 (1977). “FOIA was [therefore] enacted to ‘pierce the veil of administrative secrecy and to open agency action to the light of public scrutiny.’” Batton v. Evers, 598 F.3d 169, 175 (5th Cir. 2010) (quoting Dep’t of the Air Force v. Rose, 425 U.S. 352, 361 (1976)). And “Congress has long recognized that ‘information is often useful only if it is timely’ and that, therefore ‘excessive delay by the agency in its response is often tantamount to denial.’” Open Soc’y Just. Initiative v. CIA, 399 F. Supp. 3d 161, 165 (S.D.N.Y. 2019) (quoting H.R. REP. NO. 93-876, at 6271 (1974)). When needed, a court “may use its equitable powers to require an agency to process documents according to a court-imposed timeline.” Clemente v. FBI, 71 F. Supp. 3d 262, 269 (D.D.C. 2014).

Here, the Court recognizes the “unduly burdensome” challenges that this FOIA request may present to the FDA. See generally ECF Nos. 23, 30, 34. But, as expressed at the scheduling conference, there may not be a “more important issue at the Food and Drug Administration . . . than the pandemic, the Pfizer vaccine, getting every American vaccinated, [and] making sure that the American public is assured that this was not [] rush[ed] on behalf of the United States . . . .” ECF No. 34 at 46. Accordingly, the Court concludes that this FOIA request is of paramount public importance.

“[S]tale information is of little value.” Payne Enters., Inc. v. United States, 837 F.2d 486, 494 (D.C. Cir. 1988). The Court, agreeing with this truism, therefore concludes that the expeditious completion of Plaintiff’s request is not only practicable, but necessary. See Bloomberg, L.P. v. FDA, 500 F. Supp. 2d 371, 378 (S.D.N.Y. Aug. 15, 2007) (“[I]t is the compelling need for such public understanding that drives the urgency of the request.”). To that end, the Court further concludes that the production rate, as detailed below, appropriately balances the need for unprecedented urgency in processing this request with the FDA’s concerns regarding the burdens of production. See Halpern v. FBI, 181 F.3d 279, 284–85 (2nd Cir. 1991) (“[FOIA] emphasizes a preference for the fullest possible agency disclosure of such information consistent with a responsible balancing of competing concerns . . . .”).

Accordingly, having considered the Parties’ arguments, filings in support, and the applicable law, the Court ORDERS that:

1. The FDA shall produce the “more than 12,000 pages” articulated in its own proposal, see ECF No. 29 at 24, on or before January 31, 2022.

2. The FDA shall produce the remaining documents at a rate of 55,000 pages every 30 days, with the first production being due on or before March 1, 2022, until production is complete.

3. To the extent the FDA asserts any privilege, exemption, or exclusion as to any responsive record or portion thereof, FDA shall, concurrent with each production required by this Order, produce a redacted version of the record, redacting only those portions as to which privilege, exemption, or exclusion is asserted.

4. The Parties shall submit a Joint Status Report detailing the progress of the rolling production by April 1, 2022, and every 90 days thereafter.[6]

SO ORDERED on this 6th day of January, 2022.

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[1] Surprisingly, the FDA did not send an agency representative to the scheduling conference.

[2] 151 CONG. REC. S1521 (daily ed. Feb. 16, 2005) (statement of Sen. John Cornyn).

[3] Letter from James Madison to W.T. Barry (August 4, 1822), in 9 WRITINGS OF JAMES MADISON 103 (S. Hunt ed., 1910).

[4] John F. Kennedy, Remarks on the 20th Anniversary of the Voice of America (Feb. 26, 1962).

[5] America After 9/11: Freedom Preserved or Freedom Lost?: Hearing Before the S. Comm. on the Judiciary, 108th Cong. 302 (2003).

[6] Although the Court does not decide whether the FDA correctly denied Plaintiff’s request for expedited processing, the issue is not moot. Should the Parties seek to file motions for summary judgment, the Court will take up the issue then.

*  *  *

https://www.zerohedge.com/covid-19/judge-rejects-fdas-75-year-delay-vax-data-cuts-8-months

'Bad Since Christmas' - Subway Service Slows Dramatically As Worker Shortages Cause Mass Delays

 One day after New York's Gov. Kathy Hochul delivered her state of the state address - her first major address since taking over from her former boss Gov. Andrew Cuomo this past summer - the NYT and the rest of the media gallery praised her performance. But despite her alluring promises about ending "unproductive" rivalries between the elected leaders of NYC and the Empire State.

Unfortunately, she still has one major, economy-wrecking problem to solve, and it's this: on any day this week, some 1,300 people out of a work force of 6.3K (roughly 1/5th) have been absent from work from the MTA due the ongoing crush of omicron case.

The soaring jump in absenteeism, which the transportation authority attributes to the virus, has meant a lack of workers to keep up with the regular train schedules, leading officials to suspend service this week on three of the system’s 22 subway lines and reduce schedules on many others, leading to longer wait times.

NYC's shortage of workers has made it the most critically underserved public transit system in the country, the NYT reports.

"I feel like it’s been bad since Christmas," Jennifer Hall, 41, said Wednesday morning as she waited with her son for a D train in the Bronx.

The news comes as New York State confirmed 85K new cases on Thursday, a new daily record for the Empire State.

Source: NYT

The surge in worker absences comes as the transportation authority has already been contending with a smaller work force after a rush of retirements and a pandemic-related hiring freeze was lifted last February.

Unlike other public workers, MTA employees are not restricted by the vaccine mandate (although if they aren't vaccinated they must submit to a test every week).

The MTA's troubles are hardly unique; they're part of a wider issue of staffing shortages that has lead to thousands of flights being cancelled, along with train delays across the country.

In particular, sick calls have soared in recent weeks: "We have seen increased sick calls, more than we have seen in the past," said Craig Cipriano, the interim president of the division of the transportation authority. The number swelled through the end of the year, with unplanned absences currently more than three times higher than their typical levels before the pandemic.

The number of subway riders in NYC has fluctuated dramatically, often following the COVID case numbers in an inverse pattern. Unsurprisingly, this has forced the MTA to make some exceptions to its virus-related worker absences.

Subway ridership this week stood at about 40 percent of prepandemic numbers, transit officials said. That is a drop from levels that climbed above 50 percent in November, but still represents millions of passengers.

For now, at least, the MTA's leaders expect the worker shortages to get better, not worse.

Still, Mr. Cipriano said there was reason to believe that the suspensions and delays caused by virus-related worker absences would soon ease, though he would not specify when. Already this week, he said, the absentee numbers showed signs they may be reversing. Transit employees who test positive for the virus get up to two weeks of sick leave beyond their standard sick time, which is 12 days per year. In the transit authority’s guidance to employees, which mirrors recent guidance from the federal Centers for Disease Control and Prevention, it suggests that vaccinated workers who test positive for Covid-19 must isolate for at least five days and can return to work only if they have been without a fever for three days, have no runny nose and a “minimal cough."

Unvaccinated workers who have tested positive or been exposed to the virus must isolate for 10 days before returning to work. Transit officials have said that about 80 percent of its roughly 67,000 employees were vaccinated, and that they were unlikely to impose a stricter vaccine requirement out of concern that it might further disrupt service at a time when the system can scarcely afford it.

Fortunately, Cipriano and the rest of the MTA leadership don't expect to halt round-the-clock service any time soon. At the very least, they feel they would be able to run fewer trains per hour before they're stuck with having to dial back service, forcing passengers who keep odd hours to pay for cab fare after leaving work late at night or early in the morning.

https://www.zerohedge.com/covid-19/its-been-bad-christmas-subway-service-slows-dramatically-worker-shortages-cause-mass

Gritstone bio trumpets first data for ‘multivariant’ COVID jab

 A COVID-19 vaccine that could work against multiple variants of the coronavirus – developed by US biotech Gritstone bio – has generated encouraging immune response data in its first clinical trial.

The new vaccine differs from the currently approved shots because it delivers antigens for both the spike protein and other proteins found in SARS-CoV-2.

That could mean it is less susceptible to the loss of efficacy to vaccines that can occur when there are changes in the spoke protein – as witnessed with the new Omicron variant.

The results of the CORAL-BOOST are only in a few patients, but showed strong increases in neutralising antibody levels when Gritstone’s shot given as a booster after two doses of AstraZeneca’s Vaxzevria given as a primary course.

It also stimulated broad CD8+ T cell responses against the non-spike proteins, and boosted pre-existing responses against spike generated by AZ’s jab.

The focus on non-spike proteins is important “because the other proteins differ much less between the variants of SARS-CoV-2 than the spike protein, so we would expect a better degree of cross-protection against different variants,” commented Prof Charles Bangham, an immunology specialist at Imperial College London, who wasn’t involved in the trial.

Gritstone’s candidate is a self-amplifying messenger RNA vaccine (samRNA), which uses a slightly different technology to the mRNA-based jabs from Pfizer/BioNTech and Moderna.

samRNA vaccines instruct the body to make large amounts of mRNA, which in turn generates the protein antigens, and that means only a small dose is necessary, stretching supplies further.

It will now move into a larger 120-patient stage of the study, with the hope of advancing quickly into pivotal trials and getting a green light for use in booster campaigns.

The study in 20 people aged over 60 was run by the National Institute of Health Research Manchester Clinical Research Facility (NIHR Manchester CRF). Lead investigator Prof Andrew Ustianowski said the results are important because it is increasingly apparent that T cell immunity is an important factor in generating durable immunity with COVID-19 vaccines.

“We believe this vaccine, as a booster, will elicit strong, durable, and broad immune responses, which may well be likely to be critical in maintaining protection of this vulnerable elderly population who are particularly at risk of hospitalisation and death,” he said.

Another commentator, retired consultant in communicable disease control Dr Peter English, said while it is hard to gauge the significance of the results yet, they are encouraging.

“With new variants – like Omicron and B.1.640.2 – constantly evolving, vaccines that can more effectively prevent illness caused by variants of the virus may well have a place in our future armoury,” he added.

“Whether this particular vaccine will be such a vaccine – or will make it to market, be approved by regulators, and be widely used – will not become clear for some time,” continued English.

“But it may be; and if it doesn’t other novel vaccines with similar benefits may well take on this role.”

https://pharmaphorum.com/news/gritstone-bio-trumpets-first-data-for-multivariant-covid-jab/