The Grueling Impact The COVID-19 Pandemic Has Had On This Group Of People

The year m2020 was, in the words of Queen Elizabeth II, an “annus horribilis” for the entire planet. While the pandemic affected all 7+ billion of us, some were harder-hit than others, including anyone who was infected, of course, as well as the millions who lost loved ones to the virus. Countless others were put out of work, and many remain so — even as the travel, entertainment, and restaurant industries slowly start to rebound from their mandatory shutdowns, there’s still no way to make up for months’ worth of lost revenue and many businesses are gone for good.

If there’s one group that may be said to have born the brunt of the suffering, that would be healthcare workers. Instead of staying home to bake banana bread and have Zoom happy hours, they had to leave the house every day to spend long working hours rushed off their feet in an incredibly dangerous environment — and one where they had to confront all of the pain and sorrow caused by this deadly disease, all the while knowing they themselves were in imminent danger of infection. It’s no exaggeration to use the analogy of soldiers in wartime, but few, if any, healthcare workers were awarded medals for their heroism in the line of duty. Dr. Dorothy Dulko, Ph.D., a faculty member with Walden’s MSN program who specializes in healthcare provider burnout, spoke with The List about the terrible toll the pandemic has taken on those who work in the healthcare system.

Survey says: over 90 percent of healthcare workers are beyond stressed

As Dulko tells us, the impact of the COVID-19 pandemic on healthcare workers has caused “emotional and physical exhaustion,” and goes on to say that “longer shifts and sleep disruptions have contributed to anxiety, depression and worsening of existing, possibly undiagnosed, mental health issues.” As she explains, Mental Health America (MHA) says that anxiety, depression, and loneliness have all been on the rise, particularly among frontline healthcare workers. According to a survey MHA conducted of over 1,000 healthcare workers, over 90% said they felt stressed out, while 76% admitted feeling exhausted and burned out and 70% were having trouble sleeping.

One of healthcare workers’ biggest fears, Dulko points out, is the safety of loved ones. “Despite healthcare workers accepting their risk for infection as part of their duty to care,” she says, “they worry about family member risk.” She cites an article published in the Journal of the American Medical Association suggesting that healthcare workers’ families be prioritized for vaccinations as being a possible solution to healthcare worker stress, but as the vaccine is now available to all adults, that is no longer an issue.

Exhaustion, stress, and burnout among healthcare workers have not gone away, however, so Dulko feels that “supportive, reassuring conversations and efforts to reduce anxiety should be an organizational priority” in the healthcare industry going forward.

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French-Austrian COVID vaccine in last trial stage

COVID vaccine

French-Austrian vaccine developer Valneva on Wednesday announced that it had launched a Phase 3 trial of its candidate vaccine against COVID-19—the last testing stage before seeking regulatory approval.

The study, which has been dubbed “Cov-Compare”, will compare how participants’ immune systems respond to Valneva’s VLA2001 vaccine with how they respond to AstraZeneca’s coronavirus shot.

“Approximately 4,000 participants will receive two doses of either vaccine,” said Valneva, adding that the study would be carried out at around 25 sites in the United Kingdom.

The main objective of the study is to show the superiority of VLA2001 compared to the AstraZeneca shot two weeks after vaccination, in terms of the level of antibodies that fight the coronavirus, the company added.

If the results of the trial are positive, “Valneva aims to make regulatory submissions for initial approval in the autumn of 2021.”

Unlike most high-profile coronavirus shots, which use various methods to prime the immune system to fight the coronavirus, Valneva’s version is based on an “inactivated” version of the coronavirus itself.

The company said earlier Wednesday that it would “deprioritise” centralised talks with the European Commission to supply its coronavirus shot across the 27-nation EU, switching instead to “a country by country basis”.

Chief executive Thomas Lingelbach complained of a lack of “meaningful progress” in talks with the European Commission.

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Study probes COVID among vaccinated at US nursing home

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An unvaccinated worker infected with a COVID variant sparked an outbreak at a US nursing home where nearly all the residents had been inoculated, said a study out on Wednesday.

The dozens of cases, including 22 among fully vaccinated residents and staff, highlighted the importance of broad vaccine coverage and prevention measures, according to the research released by the Centers for Disease Control and Prevention.

During the March outbreak at a nursing home in the state of Kentucky, 46 cases were identified, with three residents dying, including two who were not vaccinated, the study said.

The spread was traced back to a worker who had symptoms and was not vaccinated. The variant was R.1, which is “not currently identified as a CDC variant of concern or interest,” the paper said.

While the researchers noted the flare up of the disease showed the strong effect the vaccine had in preventing symptoms in the sick, they also noted its limits.

“This underscores the importance… that all persons, including those who have recovered from COVID-19, be vaccinated,” the authors wrote.

“A continued emphasis on strategies for prevention of disease transmission, even among vaccinated populations, is also critical,” they added.

Their findings, released alongside a study of a similar outbreak at a Chicago nursing home, pointed to the results of vaccinated and unvaccinated people mixing.

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EMA Reviewing GSK’s Monoclonal Antibody to Treat COVID Patients

(Reuters) – The European Medicines Agency said on Thursday it is reviewing available data on the use of GlaxoSmithKline’s monoclonal antibody to treat COVID-19 patients.

The agency said its review of VIR-7831, which GSK is developing with Vir Biotechnology Inc, will include data from a study comparing its effect with that of a placebo in patients with mild to moderate COVID-19 who were at high risk of progressing to a more severe condition.

While a more comprehensive rolling review is expected to start at a later time, the agency said the current review will provide European Union-wide recommendations for national authorities who may take decisions on early use of the medicine.

The companies reported in March that VIR-7831 reduced the risk of hospitalisation and deaths among patients by 85%, based on interim data from a study.

VIR-7831 has not been granted a marketing authorisation anywhere in the world. The companies said in a statement on Thursday they planned to submit a full marketing authorisation application to the EMA, and talks with global regulators were on to make VIR-7831 available to patients with COVID-19.

In late March, the companies filed an application to U.S. regulators for emergency use authorization of VIR-7831 to treat early-stage COVID-19 infections.

The United States has already recommended similar therapies from Eli Lilly and Co and Regeneron Pharmaceuticals Inc.

European health regulators are reviewing treatments from this class of medicines called monoclonal antibodies, which are synthetically manufactured copies of the human body’s natural infection-fighting proteins and are already being used to treat some types of cancers.

GSK and Vir announced a partnership in 2020 to research COVID-19 treatments, and earlier this year said they will expand that partnership to develop monoclonal antibody treatments for influenza and other respiratory illnesses.

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Pfizer CEO says a THIRD Covid vaccine may be needed

BREAKING NEWS: Pfizer CEO says a THIRD Covid vaccine dose will be needed as soon as six months after someone receives two shots – and then be vaccinated annually

  • Pfizer CEO Albert Bourla said it is ‘likely’ people will need a booster shot of the COVID-19 vaccine
  • The potential booster shot will be given within 12 months of someone being fully vaccinated
  • Bourla said it is possible that people will need to be immunized against the novel coronavirus annually

Pfizer Inc’s CEO says he believes people will ‘likely’ need a third dose of the COVID-19 vaccine. 

During a panel discussion hosted by CNBC in conjunction with CVS Health taped on April 1, Albert Bourla said a potential booster shot would be administered six to 12 months of being fully vaccinated.  

Bourla added that he thinks it is possible that people will need to be immunized against coronavirus annually.    

‘There are vaccines that are like polio that one dose is enough…and there are vaccines like flu than you need every year,’ he said in the segment, aired on Wednesday.

‘The Covid virus looks more like the influenza virus than the polio virus.’  

Pfizer CEO Albert Bourla said it is ‘likely’ people will need a booster shot of the COVID-19 vaccine

Pfizer and its German partner BioNTech began studying a third dose of their vaccine in late February.

The booster shot is aimed at protecting against future variants, which may be better at evading antibodies from vaccine than earlier strains of the virus.

About 144 volunteers will be given the third dose, mostly those who participated in the vaccine’s early-stage U.S. testing last year.

The vaccine uses part of the pathogen’s genetic code called messenger RNA, or mRNA, to get the body to recognize the coronavirus and attack it if a person becomes infected.

In the jab, known as BNT162b2, the mRNA encodes for all of the spike protein found on the outside of the virus that it uses to enter and infect cells.

It was authorized for emergency use by the U.S. Food and Drug Administration (FDA) after a clinical trial involving 44,000 volunteers found the shot was 95 percent effective at preventing symptomatic COVID-19. 

Real-world data six months later showed that the vaccine offered 91 percent protection six months later. 

However, the company’s current two-dose regimen produced a weaker immune response against the South African variant.

This is a breaking news story and will be updated.

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3 mRNA vaccines researchers are working on (that aren’t COVID)

3 mRNA vaccines researchers are working on (that aren't COVID)

The world’s first mRNA vaccines—the COVID-19 vaccines from Pfizer/BioNTech and Moderna—have made it in record time from the laboratory, through successful clinical trials, regulatory approval and into people’s arms.

The high efficiency of protection against severe disease, the safety seen in clinical trials and the speed with which the vaccines were designed are set to transform how we develop vaccines in the future.

Once researchers have set up the mRNA manufacturing technology, they can potentially produce mRNA against any target. Manufacturing mRNA vaccines also does not need living cells, making them easier to produce than some other vaccines.

So mRNA vaccines could potentially be used to prevent a range of diseases, not just COVID-19.

Remind me again, what’s mRNA?

Messenger ribonucleic acid (or mRNA for short) is a type of genetic material that tells your body how to make proteins. The two mRNA vaccines for SARS-CoV-2, the coronavirus that causes COVID-19, deliver fragments of this mRNA into your cells.

Once inside, your body uses instructions in the mRNA to make SARS-CoV-2 spike proteins. So when you encounter the virus’ spike proteins again, your body’s immune system will already have a head start in how to handle it.

So after COVID-19, which mRNA vaccines are researchers working on next? Here are three worth knowing about.

1. Flu vaccine

Currently, we need to formulate new versions of the flu vaccine each year to protect us from the strains the World Health Organization (WHO) predicts will be circulating in flu season. This is a constant race to monitor how the virus evolves and how it spreads in real time.

Moderna is already turning its attention to an mRNA vaccine against seasonal influenza. This would target the four seasonal strains of the virus the WHO predicts will be circulating.

But the holy grail is a universal flu vaccine. This would protect against all strains of the virus (not just what the WHO predicts) and so wouldn’t need to be updated each year. The same researchers who pioneered mRNA vaccines are also working on a universal flu vaccine.

The researchers used the vast amounts of data on the influenza genome to find the mRNA code for the most “highly conserved” structures of the virus. This is the mRNA least likely to mutate and lead to structural or functional changes in viral proteins.

They then prepared a mixture of mRNAs to express four different viral proteins. These included one on the stalk-like structure on the outside of the flu virus, two on the surface, and one hidden inside the virus particle.

Studies in mice show this experimental vaccine is remarkably potent against diverse and difficult-to-target strains of influenza. This is a strong contender as a universal flu vaccine.

2. Malaria vaccine

Malaria arises through infection with the single-celled parasite Plasmodium falciparum, delivered when mosquitoes bite. There is no vaccine for it.

However, US researchers working with pharmaceutical company GSK have filed a patent for an mRNA vaccine against malaria.

The mRNA in the vaccine codes for a parasite protein called PMIF. By teaching our bodies to target this protein, the aim is to train the immune system to eradicate the parasite.

There have been promising results of the experimental vaccine in mice and early-stage human trials are being planned in the UK.

This malaria mRNA vaccine is an example of a self-amplifying mRNA vaccine. This means very small amounts of mRNA need to be made, packaged and delivered, as the mRNA will make more copies of itself once inside our cells. This is the next generation of mRNA vaccines after the “standard” mRNA vaccines seen so far against COVID-19.

3. Cancer vaccines

We already have vaccines that prevent infection with viruses that cause cancer. For example, hepatitis B vaccine prevents some types of liver cancer and the human papillomavirus (HPV) vaccine prevents cervical cancer.

But the flexibility of mRNA vaccines lets us think more broadly about tackling cancers not caused by viruses.

Some types of tumors have antigens or proteins not found in normal cells. If we could train our immune systems to identify these tumor-associated antigens then our immune cells could kill the cancer.

Cancer vaccines can be targeted to specific combinations of these antigens. BioNTech is developing one such mRNA vaccine that shows promise for people with advanced melanoma. CureVac has developed one for a specific type of lung cancer, with results from early clinical trials.

Then there’s the promise of personalized anti-cancer mRNA vaccines. If we could design an individualized vaccine specific to each patient’s tumor then we could train their immune system to fight their own individual cancer. Several research groups and companies are working on this.

Yes, there are challenges ahead

However, there are several hurdles to overcome before mRNA vaccines against other medical conditions are used more widely.

Current mRNA vaccines need to be kept frozen, limiting their use in developing countries or in remote areas. But Moderna is working on developing an mRNA vaccine that can be kept in a fridge.

Researchers also need to look at how these vaccines are delivered into the body. While injecting into the muscle works for mRNA COVID-19 vaccines, delivery into a vein may be better for cancer vaccines.

The vaccines need to be shown to be safe and effective in large-scale human clinical trials, ahead of regulatory approval. However, as regulatory bodies around the world have already approved mRNA COVID-19 vaccines, there are far fewer regulatory hurdles than a year ago.

The high cost of personalized mRNA cancer vaccines may also be an issue.

Finally, not all countries have the facilities to make mRNA vaccines on a large scale, including Australia.

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Why women may be better equipped to fight COVID

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When it comes to COVID-19, women seem to be the stronger sex, suffering severe disease at about half the rate as men, but the reason for this has been elusive.

Now, a chance experiment by an ophthalmology researcher at Duke Health has led to an insight: Women have more of a certain type of immune cell that fights infections in mucosal tissue, and these immune cells amass in the lungs, poised to attack the COVID virus.

“Better armed with these specialized immune cells, women appear to be more equipped to fight some of the most severe impacts of COVID-19, notably the respiratory infections that can become life-threatening,” said Daniel Saban, Ph.D., an associate professor in Duke’s Department of Ophthalmology and in the Department of Immunology.

Saban, who led the study that appears online in the Cell Press journal Med, said the investigation began last spring as COVID first spread and he was sidelined from his normal caseload studying eye diseases. A piece of equipment in his lab—a device that can perform 36-color flow cytometry—was sitting idle, so he decided to use it to examine blood samples from COVID patients.

“We didn’t start with a hypothesis,” Saban said. “It was a completely unbiased approach, where we asked our colleagues to provide blood and tissue samples from COVID patients as well as healthy people. We had no idea what we would find, if anything.”

Saban and the members of his lab, including Chen Yu, Ph.D. and Sejiro Littleton, quickly saw that a white blood cell called mucosal associated invariant T cells, or MAIT cell, circulated more abundantly in the blood from healthy women compared to healthy men. MAIT cells are highly specialized white blood cells that contribute to immune defenses in mucosal organs and tissues.

Among COVID patients, however, there were few MAIT cells circulating in the blood, even among women, where the population of MAIT cells radically fell off, leading the researchers to question where these cells had gone.

They found their answer in tissue samples from the lungs of COVID patients. Overall, there were an abundance of MAIT cells in the lung tissue of people with COVID, but upon closer inspection, they found night-and-day differences between the sexes.

“We first found this dichotomy in healthy blood,” Saban said. “Circulating MAIT cells in women expressed genes indicative of a robust profile poised for fighting an infection, but this was not the case in males. Then we looked in the tissue and were able to find evidence of this same pattern by sex.”

Saban said there are numerous examples of sexual differences in the immune responses to infections, noting those differences have been prevalent all along with COVID-19.

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Swiss ease COVID restrictions despite ‘fragile’ situation

COVID-19

Switzerland’s government announced Wednesday it will significantly ease its COVID-19 restrictions despite acknowledging that the country’s virus situation “remains fragile” and has even worsened recently.

As of Monday, Swiss restaurants and bars, which have been closed since December, will be permitted to open outdoor seating areas, the government said.

Cinemas and other leisure facilities will reopen, as will outdoor and indoor sports facilities.

Public events with up to 50 people indoors and 100 people outdoors will be permitted, as will face-to-face teaching at universities and other higher education institutions.

The government acknowledged it is lifting restrictions despite the fact that the epidemiological situation in the landlocked country “remains fragile and has even worsened in recent weeks”.

But, it estimated that “the risks associated with this easing (of restrictions) are acceptable”.

Switzerland, a country of 8.6 million people, has to date counted more than 625,000 coronavirus cases and 9,790 deaths.

Daily case rates in the landlocked, Alpine nation are roughly the same as in neighbours Germany and Italy, though lower than the European Union average—and nearly a third of the rate in neighbouring France.

Swiss daily case rates bottomed out in the second half of February but have been on the rise since early March.

‘Maintain control’

Health Minister Alain Berset told reporters that a strategy of slowly lifting restrictions in recent months had allowed the country to “maintain control over the pandemic”.

“We’re not facing an explosion,” he said.

While the case incidence rate remains too high, the government pointed out that hospitals are not overburdened.

It also highlighted progress made on vaccinations, with nearly half of people aged over 80 and around 30 percent of those aged between 70 and 79 now fully immunised.

Switzerland has administered 1.8 million vaccine doses, with 686,000 people now having received both injections—giving the country one of Europe’s higher fully-vaccinated rates.

Berset cautioned that the easing of restrictions should not be seen as a signal that the danger is over and the population can let down its guard.

“That is not at all the case,” he said. “We need to continue being careful.”

Virtually all the activities again permitted from Monday should be practised only while wearing a face mask and with appropriate physical distancing, the government said.

And as far as possible, activities should take place outdoors, where the risk of infection is far lower.

The government meanwhile said that other restrictions, including a requirement for most people to work from home and the closure of indoor restaurants and bars, would remain in place for the time being.

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Tweaked COVID vaccines in testing aim to fend off variants

Tweaked COVID vaccines in testing aim to fend off variants

Dozens of Americans are rolling up their sleeves for a third dose of COVID-19 vaccine—this time, shots tweaked to guard against a worrisome mutated version of the virus.

Make no mistake: The vaccines currently being rolled out across the U.S. offer strong protection. But new studies of experimental updates to the Moderna and Pfizer vaccines mark a critical first step toward an alternative if the virus eventually outsmarts today’s shots.

“We need to be ahead of the virus,” said Dr. Nadine Rouphael of Emory University, who is helping to lead a study of Moderna’s tweaked candidate. “We know what it’s like when we’re behind.”

It’s not clear if or when protection would wane enough to require an update but, “realistically we want to turn COVID into a sniffle,” she added.

Viruses constantly evolve, and the world is in a race to vaccinate millions and tamp down the coronavirus before even more mutants emerge. More than 119 million Americans have had at least one vaccine dose, and 22% of the population is fully vaccinated, according to the Centers for Disease Control and Prevention. Much of the rest of the world is far behind that pace.

Already an easier-to-spread version found in Britain just months ago has become the most common variant now circulating in the United States, one that’s fortunately vaccine-preventable.

But globally, there’s concern that first-generation vaccines may offer less protection against a different variant that first emerged in South Africa. All the major vaccine makers are tweaking their recipes in case an update against that so-called B.1.351 virus is needed. Now experimental doses from Moderna and Pfizer are being put to the test.

In suburban Atlanta, Emory asked people who received Moderna’s original vaccine a year ago in a first-stage study to also help test the updated shot. Volunteer Cole Smith said returning wasn’t a tough decision.

“The earlier one, it was a great success and, you know, millions of people are getting vaccinated now,” Smith told The Associated Press. “If we’re helping people with the old one, why not volunteer and help people with the new one?”

The study, funded by the National Institutes of Health, isn’t just testing Moderna’s experimental variant vaccine as a third-shot immune booster. Researchers at Emory and three other medical centers also are enrolling volunteers who haven’t yet received any kind of COVID-19 vaccination.

They want to know: Could people be vaccinated just with two doses of the variant vaccine and not the original? Or one dose of each kind? Or even get the original and the variant dose combined into the same injection?

Separately, the Food and Drug Administration has given Pfizer and its German partner BioNTech permission to start similar testing of their own tweaked vaccine. The companies called it part of a proactive strategy to enable rapid deployment of updated vaccines if they’re ever needed.

The Moderna and Pfizer vaccines, like the majority of COVID-19 vaccines being used around the world, train the body to recognize the spike protein that is the outer coating of the coronavirus. Those spikes are how the virus latches onto human cells.

Mutations occur whenever any virus makes copies of itself. Usually those mistakes make no difference. But if a lot of changes pile up in the spike protein—or those changes are in especially key locations—the mutant might escape an immune system primed to watch for an intruder that looks a bit different.

The good news: It’s fairly easy to update the Moderna and Pfizer vaccines. They’re made with a piece of genetic code called messenger RNA that tells the body how to make some harmless spike copies that in turn train immune cells. The companies simply swapped out the original vaccine’s genetic code with mRNA for the mutated spike protein—this time, the one from South Africa.

Studies getting underway this month include a few hundred people, very different than the massive testing needed to prove the original shots work. Scientists must make sure the mRNA substitution doesn’t trigger different side effects.

On the protection side, they’re closely measuring if the updated vaccine prompts the immune system to produce antibodies—which fend off infection—as robustly as the original shots do. Importantly, lab tests also can show if those antibodies recognize not just the variant from South Africa but other, more common virus versions, too.

Some good news: Antibodies aren’t the only defense. NIH researchers recently looked at another arm of the immune system, T cells that fight back after infection sets in. Lab tests showed T cells in the blood of people who recovered from COVID-19 long before worrisome variants appeared nonetheless recognized mutations from the South African version. Vaccines trigger T cell production, too, and may be key to preventing the worst outcomes.

Still, no vaccine is 100% effective—even without the mutation threat, occasionally the fully vaccinated will get COVID-19. So how would authorities know an update is needed? A red flag would be a jump in hospitalizations—not just positive tests—among vaccinated people who harbor a new mutant.

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A first-time look at how COVID hit every town in New Jersey

A first-time look at how COVID hit every town in New Jersey

A new report issued by the Senator Walter Rand Institute for Public Affairs at Rutgers University–Camden unmasks the broad, regional impact of COVID-19 upon New Jersey municipalities during two waves in 2020. The report, “Municipal Variations in COVID-19 Case Rates in New Jersey,” is posted here.

Rather than focus on county-level COVID case data, the Rutgers University–Camden research institute explores how municipalities truly fared during the pandemic. During the second wave (from June 30 through Dec. 13, 2020), for example, Hammonton in Atlantic County had much higher case rates (4,383/100K) than the nearby municipalities of Folsom (2,885/100K) and Mullica (1,353/100K), as well as higher rates than the county as a whole (3,237/100K).

Similarly, Camden City (4,445/100K) and Pennsauken (4,697/100K) had case rates much higher than their neighbors in Collingswood (2,329/100K), Haddon Heights (1,308/100K), and Haddonfield (1,768/100K). In northwest New Jersey, Union Township (4,808/100K), had much higher case rates than anywhere else in Hunterdon County (1,755/100K).

The new research report from Rutgers University–Camden offers a visualization of variations in COVID-19 rates across New Jersey municipalities and illustrates the reality that nearby municipalities can have COVID case rates that are very different from each and from average rates within their counties.

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