Pfizer Says Its Vaccine is 90.7% Effective Against Symptomatic Covid-19 In Children Ages 5 To 11

Bridgette Melo, 5, holds the hand of her father, Jim Melo, during her inoculation of one of two reduced 10 ug doses of the Pfizer BioNtech COVID-19 vaccine during a trial at Duke University in Durham, North Carolina September 28, 2021 in a still image from video. Video taken September 28, 2021. Shawn Rocco/Duke University/Handout via REUTERS NO RESALES. NO ARCHIVES. THIS IMAGE HAS BEEN SUPPLIED BY A THIRD PARTY.

In a new document posted ahead of a key meeting of the US Food and Drug Administration’s vaccine advisers, Pfizer says its vaccine is safe and 90.7% effective against symptomatic Covid-19 in children ages 5 to 11.

In the trial, which included around 2,000 children, there were three Covid-19 cases among the group that received the vaccine and 16 cases in the placebo group. In the trial, twice as many children received the vaccine as the placebo.

Pfizer/BioNTech are seeking FDA emergency use authorization of a two-dose regimen of their 10-microgram dose for children ages 5 to 11. The two doses would be administered three weeks apart. Last month, Pfizer released details of a Phase 2/3 trial that showed its Covid-19 vaccine was safe and generated a “robust” antibody response in children ages 5 to 11. The trial included 2,268 participants ages 5 to 11.

Participants’ immune responses were measured by looking at neutralizing antibody levels in their blood and comparing those levels to a control group of 16- to 25-year-olds who were given a two-dose regimen with the larger 30-microgram dose. Pfizer said the levels compared well with older people who received the larger dose, demonstrating a “strong immune response in this cohort of children one month after the second dose.”

The FDA’s Vaccines and Related Biological Products Advisory Committee is scheduled to meet October 26 to discuss whether to recommend the vaccine for authorization for those ages 5 to 11.

If authorized, this would be the first Covid-19 vaccine for younger children. The Pfizer/BioNTech vaccine is approved for people age 16 and older and has an EUA for people ages 12 to 15.

The data summarized from this Phase 2/3 study, which is enrolling children 6 months to 11 years of age, was for 2,268participants who were 5 to 11 years of age and received a 10 µg dose level in a two-dose regimen. In the trial, the SARS-CoV-2–neutralizing antibody geometric mean titer (GMT) was 1,197.6 (95% confidence interval [CI, 1106.1, 1296.6]), demonstrating strong immune response in this cohort of children one month after the second dose.

This compares well (was non-inferior) to the GMT of 1146.5 (95% CI: 1045.5, 1257.2) from participants ages 16 to 25 years old, used as the control group for this analysis and who were administered a two-dose regimen of 30 µg. Further, the COVID-19 vaccine was well tolerated, with side effects generally comparable to those observed in participants 16 to 25 years of age.

Pfizer and BioNTech plan to share these data with the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and other regulators as soon as possible. For the United States, the companies expect to include the data in a near-term submission for Emergency Use Authorization (EUA) as they continue to accumulate the safety and efficacy data required to file for full FDA approval in this age group.

A request to the EMA to update the EU Conditional Marketing Authorization is also planned. Topline readouts for the other two age cohorts from the trial – children 2-5 years of age and children 6 months to 2 years of age – are expected as soon as the fourth quarter of this year.

Pfizer and BioNTech plan to share these data with the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and other regulators as soon as possible. For the United States, the companies expect to include the data in a near-term submission for Emergency Use Authorization (EUA) as they continue to accumulate the safety and efficacy data required to file for full FDA approval in this age group.

A request to the EMA to update the EU Conditional Marketing Authorization is also planned. Topline readouts for the other two age cohorts from the trial – children 2-5 years of age and children 6 months to 2 years of age – are expected as soon as the fourth quarter of this year. Pfizer and BioNTech plan to submit data from the full Phase 3 trial for scientific peer-reviewed publication.

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Source: Pfizer says its vaccine is 90.7% effective against symptomatic Covid-19 in children ages 5 to 11 – ABC17NEWS

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Other Sources:

Patients should always ask their healthcare providers for medical advice about adverse events. Individuals are encouraged to report negative side effects of vaccines to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit http://www.vaers.hhs.gov or call 1-800-822-7967. In addition, side effects can be reported to Pfizer Inc. at www.pfizersafetyreporting.com

or by calling 1-800-438-1985.

Please click here for full Prescribing Information (16+ years of age). Please click here for Fact Sheet for Vaccination Providers (12+ years of age)

Public Assessment Report Authorisation for Temporary Supply COVID-19 mRNA Vaccine BNT162b2 (BNT162b2 RNA) concentrate for solution for injection (PDF). Regulation 174 (Report). Medicines and Healthcare products Regulatory Agency (MHRA). 15 December 2020. Archived (PDF) from the original on 16 December 2020. Retrieved 23 April 2021. Burger L (15 March 2020). “BioNTech in China alliance with Fosun over coronavirus vaccine candidate”. Reuters. Archived

FDA Committee Says It’s Safe For All Adults Who Got J&J’s COVID-19 Vaccine To Get a Booster

The Food and Drug Administration should authorize a second “booster” dose of Johnson & Johnson’s JNJ, +0.74% COVID-19 vaccine for adults who were initially vaccinated with this vaccine, according to a group of scientists and clinicians that advises the regulator.

The FDA’s Vaccines and Related Biological Products Advisory Committee voted 19-0 that allowing adults who were initially vaccinated with the J&J shot to get a booster is safe and effective. Their recommendation is based on giving a booster to those 18 years old and older at least two months after they got their first shot.

“This does look more like a two-dose vaccine,” Dr. Michael Nelson, a professor of medicine UVA Health and the UVA School of Medicine and a temporary voting member of the FDA committee.

One difference with this booster recommendation is that the group of people who would qualify for the J&J booster can get it two months after getting their first dose, compared with six months after the primary series of shots for the mRNA vaccines developed by Moderna Inc. MRNA, -2.31% and BioNTech SE BNTX, -1.06% /Pfizer Inc. PFE, -0.43%.

If the FDA follows the advice of the committee, which it is not required to do but often does, it means that all three COVID-19 vaccines that are available in the U.S. have authorized boosters, with the caveat that there are restrictions in place on who can get a mRNA booster.

The mRNA boosters are reserved at this time for people older than 65 years old, adults who are at high risk of severe disease, and those who face higher exposure to the virus because of their jobs.

About 15 million people in the U.S. have received the J&J’s adenovirus-based COVID-19 vaccine. J&J’s stock is up 2.6% so far this year, while the broader S&P 500 SPX, +0.75% has gained 18.1%.

By: Jaimy Lee

Jaimy Lee is a health-care reporter for MarketWatch. She is based in New York.

Source: FDA committee says it’s safe for all adults who got J&J’s COVID-19 vaccine to get a booster – MarketWatch

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Critics:

The Janssen COVID‑19 Vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized by FDA through an Emergency Use Authorization (EUA) for active immunization to prevent Coronavirus Disease 2019 (COVID‑19) in individuals 18 years of age and older.

The emergency use of this product is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the medical product under Section 564(b)(1) of the FD&C Act, unless the declaration is terminated or authorization revoked sooner.

Healthcare professionals should be alert to the signs and symptoms of thrombosis with thrombocytopenia in individuals who receive the Janssen COVID-19 Vaccine. In individuals with suspected thrombosis with thrombocytopenia following administration of the Janssen COVID-19 Vaccine, the use of heparin may be harmful and alternative treatments may be needed.

Consultation with hematology specialists is strongly recommended. The American Society of Hematology has published considerations relevant to the diagnosis and treatment of thrombosis with thrombocytopenia following administration of the Janssen COVID-19 Vaccine (https://www.hematology.org/covid-19/vaccine-induced-immune-thrombotic-thrombocytopenia).

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This Is What Long COVID Feels Like Fatigue Dizziness Brain Fog and Muscle Spasms

When the novel coronavirus began to spread across the world in February 2020, Freya Sawbridge was caught in a bind. The 27-year-old was living in Scotland, but when businesses and borders began to close she packed up and flew home to Auckland, New Zealand. On arrival, she felt feverish and couldn’t smell or taste food.

In those early months of COVID-19, every new symptom made global headlines. Freya got tested and the result came back positive. Panic began to set in.  “I was in the first wave,” she says.

“There weren’t many people that had had it by that stage, so I knew no-one could tell me anything about it, no-one could offer me any real guidance because it was a new disease.

“No-one can tell you anything about it or when it might end. You’re just existing in the unknown.”

Freya found herself on a vicious merry-go-round of symptoms — fever, sore throat, dizziness, muscle spasms, numbness, chest pains and fatigue. The symptoms kept coming around and around and around.

After 12 days, she stabilised, but four days later the pains returned with a vengeance. It would be a sign of things to come. Freya would relapse five more times over the next six months.

“Each relapse, the depth of it would last about 10 days and then I would take about four or five days emerging from it, have about two or three symptom-free days before another relapse would kick off,” Freya says. “The symptoms would come and then dissipate…

“I’d have a fever for an hour, a sore throat for four hours, then dizziness for two hours, then I was OK for an hour.

“…it was just a cycle like that.”

By April 2020, “long COVID” was being mentioned in Facebook support groups. It’s not an official medical term; it was coined out of necessity by the public. It’s sometimes also referred to as long-haul COVID, chronic COVID and post-acute sequelae of COVID-19 (PASC).

Exactly what constitutes long COVID remains extremely broad. Earlier this month, the World Health Organization released its clinical case definition of what it calls ‘post COVID-19 condition’, which affects people at least two months after a COVID-19 infection with symptoms that “cannot be explained by an alternative diagnosis”.

For Freya, symptoms like chest pain and a sore throat were manageable, but the dizziness and “brain pain” she experienced were debilitating. “It’s as if there was like a mini person in my brain and he was scraping my whole brain with a rake, it was just pain,” Freya says.

“And then it would feel like it would flip on itself continuously and so it makes it really hard to sleep because you’re lying there and it feels like your brain is doing somersaults and then it’s also spinning.”

The memory loss was especially unnerving. “Heaps of people say, ‘Oh, I get that and I’m young,’ but it just feels different… you’d be mid-sentence and then completely forget what you’re talking about.”

Doctors couldn’t give Freya any clarity about what was happening to her because the reality was no-one knew enough about COVID-19.

The hardest was month four, when Freya ended up in hospital from her long COVID symptoms. In a journal entry dated August 24, 2020, she wrote: “Must stay hopeful. Must believe I will get better.” After so many relapses, she had fallen into a depression filled with grief, for her healthy body and her old life.

To this day, we still know very little about long COVID, including just how many people it affects.

Various studies over the past 18 months estimate long COVID can affect anywhere from 2.3 per cent to 76 per cent of COVID-19 cases. It’s important to remember these studies vary in method, with some tracking only hospitalised cases and some relying on self-reported surveys.

A comprehensive study by the University of NSW places the figure at around 5 per cent. Researchers tracked 94 per cent of all COVID-19 cases in NSW from January to May 2020. Of the 3,000 people surveyed, 4.8 per cent still had symptoms after three months.

The uncertainty doesn’t end there. We also have no idea why long COVID hits certain people, but not others. It’s been likened to a kind of “Russian roulette”.

Studies have consistently found long COVID to be more prevalent in women, older people and those with underlying conditions, but there’s evidence to indicate children are capable of developing long COVID too.

Being young and fit is no guarantee you’re safe either, and nor is having a minor initial COVID case. The longer-term symptoms can strike even those who had few initial symptoms.

Those with long COVID report a constellation of symptoms including fatigue, dizziness, shortness of breath, brain fog, memory loss, loss of taste and smell, numbness, muscle spasms and irritable bowels.

One of Australia’s leading researchers in the area, Professor Gail Matthews, says long COVID is likely a spectrum of different pathologies.

Dr Matthews is the Head of Infectious Diseases at St Vincent’s Hospital and Head of the Therapeutic Vaccine and Research Program at the Kirby Institute at UNSW. She says the issue of long COVID will be huge on a global scale and it’s crucial to understand it better.

One theory is that COVID-19 can trigger the immune system to behave in an abnormal way, releasing cytokines that can make you feel unwell with fatigue and other symptoms.

Another is that there could be some elements of the virus — called antigen persistence — somewhere in the body that continues to trigger an ongoing activation in the immune system.

There’s also early evidence that vaccination might help reduce or even prevent long-term symptoms. Freya stopped relapsing around month seven, although her senses of taste and smell still haven’t fully recovered. She says rest was a big part of her recovery.

“Other people, if they don’t have parental support, or they have to work because they’ve got no savings, or they can’t rely on their parents, or they have young kids — I have no idea how they got through it, because it would have been impossible in my eyes,” Freya says.

Judy Li is in an impossible situation. An all-encompassing fatigue has taken hold of her mind and body, stripping away her ability to work, parent or plan for the future.

The 37-year-old got COVID-19 in March 2020 while an inpatient at a Melbourne hospital. She had been struggling after giving birth to her second child and was getting the help she needed.

Despite her anxieties, Judy’s case was very mild and it wasn’t until three months later when her three-year-old brought a bug home from day care that she realised something was wrong.

As day-care bugs so often do, it ripped through the young family. “It felt like I hit a brick wall, I was a lot worse than everyone else,” Judy says.

“It wasn’t the usual symptoms… I was just really lethargic, really fatigued and I remember at about the three-week mark of having those symptoms, that kind of fatigue, I thought, ‘this isn’t right, this is a bit odd.’”

Her fatigue is not like being tired, it’s a different kind of exhaustion, a severe lack of energy that doesn’t replenish after sleep.

“This is like something you feel in your limbs; you feel like they’re really heavy, they’ve got this kind of, I wouldn’t say ouch-kind of pain, but it’s sort of an achiness to your limbs,” she says.

The fatigue comes and goes, but Judy has noticed it can flare up when she gets sick or when she expends herself physically or mentally.

One of the worst episodes came after an eight-hour trip to Canberra for Christmas to visit her in-laws. “I woke up and I was completely paralysed,” Judy says. Distressed, in tears, she could only call out to her partner for help.

“I just did not have the strength to move my limbs and I kept trying and trying and trying and eventually he helped me up. “I sort of dragged my arm up, I could barely hold a glass of water and he’d help me to drink out of it. If I had to go to the toilet, he had to basically carry me.”

This fatigue has derailed Judy’s life because when it sets in, she never knows how long it’s going to last or whether it will go away.  It makes work and parenting impossible. Judy’s two young children don’t understand what’s wrong with mum or why she can’t get out of bed.

“When the kids are crying at home, I can’t go and soothe them,” she says.

“This is not a lack of motivation, it’s like I want to get up and I want to go to my children.

“I want to get up, I’ve got work I need to do. I want to get up and even go get something to eat, I’m hungry, but I can’t actually tell my body to move in that way.”

Fatigue or post-exertional malaise is one of the most common symptoms of long COVID, but it’s also a very common symptom in myalgic encephalomyelitis or chronic fatigue syndrome (ME/CFS), a biological disease affecting an estimated 250,000 Australians.

There are striking similarities between long COVID and ME/CFS. Both can cause symptoms such as fatigue, dizziness, memory loss or ‘brain fog’, and irritable bowel, and both are likely to encompass a range of different pathologies.

ME/CFS is usually triggered by a viral infection — ebola, dengue fever, glandular fever, epstein barr, ross river virus, SARS and even the more common influenza have all left trails of chronically ill people in their wake.

Experts have even questioned whether long COVID could be ME/CFS by another name, although the jury is still out on that theory. ME/CFS has been around for decades but we still don’t know much about it.

Australian advocacy groups desperately want to see more research and support to help people with this chronic illness navigate medical, financial and accommodation services. They also say doctors need better education to diagnose and treat the condition early on.

Bronwyn Caldwell knows what it’s like to live with a condition that no-one understands or knows how to treat. She’s lived with ME/CFS for 20 years, ever since a suspected case of glandular fever in her 20s.

The 46-year-old from South Australia is adamant the early advice from her doctor to rest was the reason her condition didn’t immediately worsen. She was able to work part-time as a brewer up until 2013 but a relapse has left her mostly bed-bound.

Bronwyn considers herself lucky — her illness was validated by doctors and family, she doesn’t have cognitive difficulties and isn’t in pain. But her voice begins to break when mentioning that most people with ME/CFS face stigma that they’re being lazy or faking their illness.

“I can’t imagine what it’s really like to have everyone in your life say you’re just being lazy, because the reality is all of us beat ourselves up to that all the time,” she says.

A 2018 study published in the Journal of Health Psychology looking at links between people with chronic illness and suicidal ideation found stigma, misunderstanding and unwarranted advice exacerbates patients’ feelings of overall hopelessness.

Long COVID is creating a cohort of people vulnerable to the same thing, and Judy herself has sometimes wondered whether her family would be better off without her (which, of course, it wouldn’t).

“I honestly go through periods where I wish COVID had killed me instead of just left me with this, this big burden,” she says. With no sick leave left, Judy has had to take unpaid time off work.

It’s a big blow for the high-earning, career-driven project manager who took pride in handling stressful situations and juggling multiple tasks. These days, her mind doesn’t work like it used to.

“It’s just little things like struggling to find the word that I just knew… I would know… sorry… like being able to construct sentences,” she says with an ironic laugh.

“I can try to read something but it just seems like I have to read it over and over and over again. “I frequently walk into a room and can’t remember why, when I would put something down, seriously, two minutes later I have no idea where it is. “I just feel like I’m losing my mind.”

In the COVID-ravaged UK, daily cases peaked at more than 68,000 and daily deaths at more than 1,300. It’s a situation few in Australia — where we have enjoyed long periods of little-to-no community transmission — can fully appreciate.

Adam Attia was living in London through most of 2020 and says it was almost rare if you hadn’t had COVID-19. “I’ve known of people that had given it to their parents and it killed their parents,” the 30-year-old Australian says. “People that we knew on our street had passed away.”

So one day around August, when Adam couldn’t taste the wasabi on his sushi, he immediately knew what was wrong. “I just started to go through the kitchen for things like garlic — I had a whole garlic, I couldn’t taste anything. I ate a lemon like an apple and couldn’t taste a thing.

“I ate ginger like a cannibal, like I ate it with all of the bumps and things on it and couldn’t taste a thing.”

But Adam’s infection was mild and he spent his 10-day isolation staying active. Life went on as normal until three months later, after a trip to Croatia. On the flight back to London, somewhere above Germany, Adam felt an excruciating pain in his stomach. He felt like he was going to vomit, he couldn’t breathe and his head began to spin.

The flight crew didn’t know what to do, contemplating an emergency landing in Berlin while Adam desperately sucked air from a vent they’d given to help him breathe.

The flight managed to land in London and Adam was escorted off the plane. At the hospital, doctors ran tests for internal bleeding and signs of reflux or gastritis but they all turned up empty.

In the weeks and months after that flight, as little as two hours of work would leave Adam shattered and disorientated.

His symptoms are like dominoes. Exhaustion leads to stomach pain, which leads to nausea, faintness and breathlessness.

Adam has learned to manage his symptoms and as soon as he feels the exhaustion creeping in he takes an anti-nausea pill, uses the asthma puffer he now has to carry with him and finds somewhere to lie down.

He ended up moving back to Australia to sort out his health issues, but it wasn’t until a doctor at St George Hospital in Sydney mentioned Adam’s symptoms could be an effect of COVID-19 that he twigged.

“Is it from COVID? Look, I could be shooting in the dark, I don’t actually know,” Adam says. “But what I do know is I didn’t have these [symptoms] before COVID, so I guess it’s more of an educated guess.”

Much about long COVID remains exactly that. More research is needed to really know what’s going on.

The US and UK have allocated billions of dollars into research and set up long COVID clinics to help patients find the right treatment. The Australian government has provided $15 million for research grants into the long-term health effects of COVID-19 and the nation’s vaccination efforts through the Medical Research Future Fund.

As Australia moves beyond lockdowns towards a future where most Australians are vaccinated, borders are open and COVID-19 is actively spreading through communities, this research will be crucial in our understanding of the long-term health issues and the impact on individuals, families, workplaces and the economy.

For now, Dr Matthews says the biggest take-home is that we don’t know who is or isn’t susceptible to long COVID.

“One of the biggest messages is that it’s very hard to know who this will strike.”

Health officials in Victoria have already highlighted the plight of long COVID patients as part of their drive to encourage more people to get vaccinated, as experts say it probably can prevent long COVID.

Dr Matthews says it’s important Australia recognises long COVID as a real issue and makes sure there is appropriate support to help people.

“Even if it’s just an understanding that this condition exists, and recognition that it exists, as opposed to expecting these people to return to full health,” she says.

But until we know more, those like Freya, Judy and Adam won’t have the closure of knowing exactly what’s happened to them.

“It’s hard to wrap your head around,” Judy says, “to say this is potentially a life sentence”. “There’s no defining this is as bad as it gets, you know?  “This is just the big mystery question mark.”

By:  Emily Sakzewski, Georgina Piper, and Colin Gourlay

Source: This is what long COVID feels like — fatigue, dizziness, brain fog and muscle spasms – ABC News

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“March 24 Update on NASA Response to Coronavirus – Administrator Jim Bridenstine”. blogs.nasa.gov. Archived

The COVID Vaccine For Kids Is Almost Here. Let’s Not Forget The Children Who Made This Possible

This week Pfizer and BioNTech said that their COVID-19 vaccine was safe for children aged 5 to 11. If approved by the FDA for emergency use, it could be ready for children as early as late October. Since the emergence of the delta variant, children have accounted for more than one in five new cases, and more children are hospitalized now, as a result of the coronavirus, than at any other time in the pandemic.

The concern and frustration surrounding relatively slow approval of treatment for kids under 12 years old is nothing new. For decades, kids with cancer have had to wait for trials to improve drug options and improve patient outcomes.

The call to do more, faster, has gone unanswered by drug companies who don’t invest in trials for a small number of unprofitable kids and by the National Cancer Institute (NCI), which allocates only 4% of its annual $6.56 billion budget to pediatric cancer and other rare diseases.

Less than 6% of our budget comes from government support. WBUR only exists because readers like you fund our quality reporting. Donate Now.

Trials are a key component to curing cancer and achieving vaccine safety, yet come with a caveat that most parents aren’t willing to risk. It feels good to help mankind, but not at the expense of their child’s growing body.

In 2010, my husband and I agreed to send my 4-year-old daughter to trial to treat her stage IV high-risk neuroblastoma. Emily’s oncologist was desperate to enroll kids in the trial and we were desperate to get rid of the cancer. It was the most difficult decision we’ve ever made.

Emily received two back-to-back stem cell transplants. The theory was that two transplants — as opposed to one that was the protocol of care — would be better at killing the tricky neuroblastoma cells that often lurked and caused a relapse.

It would seem a no-brainer to want two opportunities to kill the cancer cells, but it wasn’t. Kids died during the transplants. The amount of chemo they got in one transplant would kill an adult instantly, but kids metabolized it quicker, so they lived, but just barely. Three weeks after being discharged from the first transplant, a kid in the trial would be admitted into the hospital for the second one. If the neuroblastoma didn’t kill them, the trial protocol might.

We wanted to do everything possible to prevent Emily from dying, so we agreed to the trial. We weren’t about to wait around for her cancer.

We watched her claw her way through line infections, thick mucus in her lungs and ICU visits. We doubted whether we made the right decision with every obstacle, especially when she needed surgery to drain seven ounces of liquid from her heart during her second transplant.

We wanted to do everything possible to prevent Emily from dying, so we agreed to the trial. We weren’t about to wait around for her cancer.

Emily almost got kicked out of the trial in the last few months when her damaged kidneys were failing and dipped below the trial parameters. After her tandem stem cell transplants, 21 rounds of radiation, and months of an experimental antibody therapy, she was so close to finishing. Yet somehow, with the help of smart doctors and more medicine, she finished the trial.

After 18 months, the trial was successful in eliminating Emily’s body of neuroblastoma cells, but it stole parts of her she’d never get back.

Emily, who’s now 16, has chronic kidney disease, estrogen levels of a post-menopausal woman, stunted growth, frail hair and a 65% bi-lateral hearing loss from the toxic drugs used during the trial protocol. It’s been the catch-22 of a lifetime: Agreeing to have her participate in a trial that saved her life, but also compromised the quality of it.

About a year after Emily finished treatment, when she was 5, the trial she’d been enrolled in was stopped early. The data showed that the kids who had received two transplants were relapsing less and had a significantly better chance of survival than the kids who had received one transplant. It worked.

As a result, 300 to 400 kids a year who are diagnosed with stage IV neuroblastoma receive the protocol of care that Emily helped pioneer 10 years ago.

Despite the dark days of treatment and unpredictable secondary effects from chemo, I would make the same decision again, and send her into the trial. Emily would agree, though she longs for the hair that didn’t grow back well after treatment. We know how much worse the alternative could have been. She might not be alive, picking out a homecoming dress and watching Tik Tok videos for hours a day. She might be a statistic.

[The COVID vaccine trials] serve as a gatekeeper to kids’ health from a nation that doesn’t like to wait.

And now a nation of parents looks toward science to approve a COVID-19 vaccine to keep their kids from being statistics, too. The American Academy of Pediatrics reported 225,978 child COVID-19 cases last week, nearly 26% of the weekly reported cases. It’s the second-highest total of new diagnoses among children over the course of the pandemic.

As desperate as we are for our children to get their COVID-19 vaccines, the trial pharmaceutical companies are running — and the in-depth data analysis the FDA undertakes — exists to protect millions of kids from adverse effects that can’t be predicted. It serves as a gatekeeper to kids’ health from a nation that doesn’t like to wait.

When the FDA approves a vaccine for kids — and they will — let’s acknowledge the kids who, like Emily, answered the call. They’re the unsung heroes in getting a nation back to health.

Follow Cognoscenti on Facebook and Twitter.

By: Amy McHugh

Cognoscenti contributor
Amy McHugh is a high school teacher on Cape Cod where she lives with her husband, two teenage daughters, and two goldendoodles. She’s helped raise over $750,000 for neuroblastoma research at Dana-Farber’s Jimmy Fund Clinic.

Source: The COVID Vaccine For Kids Is Almost Here. Let’s Not Forget The Children Who Made This Possible | Cognoscenti

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Mandatory Face Masks In The Workplace, Everything Employers Need To Know

A well-fitted, clean face mask is essential to help stop the spread of COVID-19. Different states and territories may have different rules about wearing face masks or coverings at work. This can depend on whether an enforceable government or public health direction applies so make sure you check if any of these directions apply to your business. You can be held legally accountable if you do not fulfil your employer health and safety obligations, as well as if you put your employees’ health at serious risk.

In this post we explain why ensuring your employees have correct face mask protection is crucial to avoiding legal issues and keeping your staff and customers safe. We’ll explain how to make sure you adhere to the rules correctly, avoid fines, and help you protect your staff and customers.

What are my employer obligations for employee face mask protection?

Workplace health and safety legislation in each state and territory stipulate employers’ obligations to protect workers from harm and provide a safe working environment.  This means ensuring that all employees wear face masks in the workplace if a health direction is in place to this effect. Even if there are no mandatory face mask restrictions in your workplace’s area, a health and safety risk assessment that you conduct in consultation with your workers may conclude that wearing face masks is a reasonable control measure to manage the risk of infectious respiratory disease transmission.

If a requirement to wear face masks is in place and an employee doesn’t have a clean mask to use, you must provide them with this protection. The type of face mask used will depend on the setting and it is your responsibility to provide training, instruction and correct information on how to handle the appropriate use, storage, decontamination and disposal of face mask protection where a government or public health direction is in place, or your risk assessment concludes that wearing masks is a reasonably necessary control measure.

How do I as an employer ensure we comply to the face mask rules correctly?

With active restrictions, it’s essential you regularly check up to-date public health orders on government websites. You have an obligation to conduct a risk assessment in consultation with your workers with respect to COVID-19 and it may be a mandatory requirement in specific circumstances such as where a worker has tested positive to COVID-19. When conducting a risk assessment, take into account how people move around the workplace, if your employees have contact with the public in the workplace as well as if there are any vulnerable workers in your business, then factor this in.

If wearing face masks is mandatory, it’s important to communicate this clearly. For employers, a written communication to staff can be a reassuring record of their responsibility to enforce the public health order.

As part of your duty to keep your staff safe, it’s vital you ensure employees have a clean supply of face masks in the workplace, and that they are properly informed on safe handling, use, storage, decontamination, and disposal of face masks.

Providing personal protective equipment such as a face mask can be an effective control measure to reduce the spread of COVID-19 and comply with health and safety obligations in the workplace. Therefore, if you run out of your supply of face masks, or they become unusable, you will need to replace them as soon as possible, this may mean closing the workplace temporarily, whilst more protection is purchased. If your employee’s mask becomes unusable during work-related travel, be assured you may reimburse them any costs in purchasing new protection and ask them to keep receipts and records.

What if my employee refuses to wear a face mask? 

First, discuss with the employee the reason for their refusal, if there is a valid reason such as a medical condition or illness or a disability. It is recommended to seek expert advice on alternatives for individual employees who fall into this category as employers need to balance an employee’s anti-discrimination, unfair dismissal, and general protections while ensuring that their refusal does not cause the business to breach its health and safety and public health directive obligations. At Employsure we offer expert advice to ensure a fair and safe workplace.

If the employee refuses to wear a face mask and has a valid reason, consider alternative duties for the employee or if the employee is able to work from home, you can allow then to do so. If working from home is absolutely not an option, then you can agree with the employee to take any accrued annual or long service leave or leave without pay while you investigate alternative options for the employee’s ongoing employment.

If the employee steadfastly refuses to wear a face mask and it is not for a valid reason and no agreement can be reached, employers may be in a position to initiate a disciplinary process. Always seek expert advice before initiating such a process.

Remember, it’s your responsibility to keep your employees safe and eliminate or reduce health risks as far as reasonably practicable. Gather as much expert knowledge as you can and be armed with information to adhere to your employer obligations. 

Employsure

Source: Mandatory Face Masks In The Workplace, Everything Employers Need To Know – Dynamic Business

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How to Hire With a Vaccine Mandate in Place

Asking prospective employees about their vaccination status can be awkward–and possibly lead to legally sticky situations. Some prospective employees will appreciate it if your company is mandating Covid-19 vaccinations. While surgical-grade facemasks have proven somewhat effective at preventing the spread of Covid-19, a vaccine is currently the only true way to protect yourself and others from getting sick.

Others are less convinced. And if your company is in a hiring bind, as many are these days, you might need to codify and justify your safety policies. Here’s a primer on how to hire with a vaccine mandate in place.

Be transparent.

Nicolas Holand–founder of GooseSmurfs, a gaming company based in Indianapolis–has needed to hire nine new workers since July, when he added the vaccine to his company’s job requirements. He wants to avoid compromising the safety of his existing 46 employees.

“We also emphasize that this is a good thing for the candidates who may soon work in the workplace,” says Holand, noting that employees who are vaccinated are at a lower risk of contracting Covid-19 than those who remain unvaccinated. “They are more protected and resistant to any potential infection of Covid and therefore their workdays won’t be affected,” he adds.

While Holand says that so far, all of the candidates he’s hired has agreed to GooseSmurfs’s vaccination policy and most of them already had their full dose. The founder suspects he’s had a smoother time with the process because the company has been transparent and direct with its requirements on the job post itself. He says most candidates who were hesitant about the mandate likely didn’t apply. “Overall, being straightforward about the policy made the hiring process easier and seamless,” he says.

Make the vaccine a condition of employment.

When people take a job, they do so with an understanding of a job’s requirements. As an employer, you don’t want to violate that contractual agreement because it could lead to turnover. That’s why it’s crucial to outline any vaccine policies with candidates before they accept the position, says John Hooker, professor of business ethics and social responsibility at Carnegie Mellon University.

Additionally, if you have a policy in which some workers are required to be vaccinated, such as those in the office, and others are not, that rationale should be clear upfront. “It’s critical to have these kind of [policies] run across the entire company, as opposed to allowing them for some people and not for others,” says Hooker.

And if you do require a vaccine for some and not others, Hooker suggests making your reasoning known: “There must be a reason for that distinction and it shouldn’t be arbitrary.” Employees are less likely to push back on policies when they understand the rationale behind them, he says.

Don’t ask about a prospective worker’s vaccination status.

If you have a mandate in place, you likely want to know whether you will have to accommodate a new employee who isn’t vaccinated. While it’s fine to ask about a person’s vaccination status, you can’t make your hiring decision based on that person’s status alone. If a candidate is turned down for a job, and is told it is because he or she won’t receive the vaccine, they can file a discrimination lawsuit.

It is illegal both under federal and state laws to discriminate against an employee based on his or her medical condition with regard to employment decisions. It is, however, difficult for applicants to prove that a company didn’t hire them because of a health condition, says Jared Pope, HR law specialist CEO of Work Shield, a Dallas-based HR software company.

If you do decide to pass on candidates after having a conversation about their vaccination status, be cordial. Thank them for applying and let them know that you’ll keep them in mind should a position open up that would be a better fit.

An even better idea? Don’t ask at all. Talk about the company’s policy regarding vaccines during the interview process. Let the candidate know if any exceptions can be made if they choose to move forward. “Questions about the workplace can be asked and answered in an interview, and are not discriminatory or illegal in nature,” says Pope. Down the line, you can require proof of vaccination, he adds.

By Brit Morse, Assistant editor, Inc.@britnmorse

Source: https://www.inc.com/

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Why Some COVID-19 Infections May Be Free of Symptoms But Not Free of Harm

Scientists are studying the potential consequences of asymptomatic COVID-19 and how many people may suffer long term health problems. Eric Topol was worried when he first saw images of the lungs of people who had been infected with COVID-19 aboard the Diamond Princess, a cruise ship that was quarantined off the coast of Japan in the earliest weeks of the pandemic.

A study of 104 passengers found that 76 of them had COVID but were asymptomatic. Of that group, CT scans showed that 54 percent had lung abnormalities—patchy grey spots known as ground glass opacities that signal fluid build-up in the lungs.

These CT scans were “disturbing,” wrote Topol, founder and director of the Scripps Research Translational Institute, with co-author Daniel Oran in a narrative review of asymptomatic disease published in the Annals of Internal Medicine. “If confirmed, this finding suggests that the absence of symptoms might not necessarily mean the absence of harm.”

One recent study estimated that a staggering 35 percent of all COVID-19 infections are asymptomatic. “That’s why it’s important to know if this is a vulnerability,” Topol says.

But Topol says he hasn’t seen any further studies investigating lung abnormalities in asymptomatic people in the more than a year and a half since the Diamond Princess cases were first documented. “It’s like we just gave up on it.”

He argues that asymptomatic disease hasn’t gotten the attention it should amid the race to treat severe disease and develop vaccines to prevent it. As a result, scientists are still largely in the dark about the potential consequences of asymptomatic infections—or how many people are suffering those consequences.

One stumbling block that scientists worry could keep them from truly understanding the scope of the problem is that it’s incredibly challenging to pinpoint how many people had asymptomatic infections. “There’s probably a pool of people out there who had asymptomatic disease but were never tested so they don’t know they had COVID at that time,” says Ann Parker, assistant professor of medicine at Johns Hopkins and a specialist in post-acute COVID-19 care.

Still, there is some evidence that asymptomatic disease can cause serious harm among some people—including blood clots, heart damage, a mysterious inflammatory disorder, and long COVID, the syndrome marked by a range of symptoms from breathing difficulties to brain fog that linger after an infection. Here’s a look at what scientists know so far about the effects of asymptomatic COVID-19 and what they’re still trying to figure out.

Heart inflammation and blood clots

Just as imaging scans have revealed damage to the lungs of asymptomatic individuals, chest scans have also shown abnormalities in the hearts and blood of people with asymptomatic infections—including blood clots and inflammation.

Thrombosis Journal and other publications have described several cases of blood clots in the kidneys, lungs, and brains of people who hadn’t had any symptoms. When these gel-like clumps get stuck in a vein, they prevent an organ from getting the blood it needs to function—which can lead to seizures, strokes, heart attacks, and death.

There have been relatively few of these case reports—and it’s unclear whether some patients might have had other underlying issues that could have caused a clot. But the Washington State researchers who reported on one case of renal blood clot write that it “suggests that unexplained thrombus in otherwise asymptomatic patients can be a direct result of COVID-19 infection, and serves as a call to action for emergency department clinicians to treat unexplained thrombotic events as evidence of COVID-19.”

Meanwhile, studies also suggest that asymptomatic infections could be causing harm to the heart. In May, cardiac MRI scans of 1,600 college athletes who had tested positive for COVID-19 revealed evidence of myocarditis, or inflammation of the heart muscle, in 37 people—28 of whom hadn’t had any symptoms, says Saurabh Rajpal, a cardiovascular disease specialist at the Ohio State University and lead author on the study.

Myocarditis can cause symptoms such as chest pain, palpitations, and fainting—but sometimes it doesn’t produce any symptoms at all. Rajpal says that while the athletes in the study were asymptomatic, “the changes on the MRI were similar to or almost the same as those who had clinical or symptomatic myocarditis.”

Although these chest scans are worrisome, Rajpal says that scientists don’t know yet what they ultimately mean for the health of asymptomatic patients. It’s possible that myocarditis might resolve over time—perhaps even before patients know they had it—or it could develop into a more serious long-term health issue. Long-term studies are necessary to suss that out.

The athletes’ heart inflammation might also be completely unrelated to their COVID-19 infection. Scientists would need to compare the scans with a set taken just before an individual was infected with COVID-19. So that, Rajpal says, will still need to be teased out.

Long COVID

Additionally, people with asymptomatic infections are at risk of becoming so-called COVID-19 long-haulers, a syndrome whose definition has been hard to pin down as it can include any combination of diverse and often overlapping symptoms such as pain, breathing difficulties, fatigue, brain fog, dizziness, sleep disturbance, and hypertension.

“There’s a myth out there that it only occurs with severe COVID, and obviously it occurs far more frequently in mild COVID,” Topol says.

Linda Geng, co-director of Stanford Health Care’s Post-Acute COVID-19 Syndrome Clinic in the U.S., agrees. “There is actually not a great predictive factor about the severity of your illness in the acute phase and whether you will get long COVID,” she says. “And long COVID can be quite debilitating, and we don’t know the endpoint for those who are suffering from it.”

Studies attempting to assess how many asymptomatic infections account for long COVID symptoms have varied. FAIR Health, a healthcare nonprofit in the U.S., found from an analysis of healthcare claims that about a fifth of asymptomatic patients went on to become long-haulers. Another study, which is under peer review, used data from the University of California’s electronic health records and estimated that number could be as high as 32 percent.

Melissa Pinto, a co-author of the latter study and associate professor in the Sue & Bill Gross School of Nursing at University of California Irvine, says the researchers examined healthcare records of people who tested positive for COVID-19 but hadn’t reported symptoms at the time of infection—only to come in later with symptoms associated with long COVID-19. To ensure they were identifying long-haulers, the researchers screened out anyone with a preexisting illness that could explain their later symptoms.

“This is not from another chronic disease,” she says. “These are new symptoms.”

But it’s unclear how accurate any of these estimates might be. Pinto says that some long-haulers are wary of seeking care after having their symptoms dismissed by physicians who weren’t familiar with long COVID-19 syndrome. That’s why she believes that the rates of asymptomatic infections among long-haulers are an underestimate.

Anecdotally, Geng and Parker both say that while they’ve seen plenty of patients with mild symptoms that initially went unrecognised, they’ve had little experience treating patients who were truly asymptomatic.

“We saw many patients who didn’t think they had symptoms except in retrospect because they found out that they had tested positive,” Geng says. “Because they’ve had these long unexplained symptoms of what’s presumed to be long COVID, they think, well, maybe that wasn’t allergies.”

But she thinks that most people who were truly asymptomatic are unlikely to have gotten tested and therefore wouldn’t think to consult a specialist in post-COVID-19 care if they started experiencing unexplained symptoms like brain fog and dizziness.

Parker says that ultimately physicians are still trying to understand the broad symptoms seen in long-haulers. “When a patient comes to see us, we do a very thorough evaluation because we still don’t know exactly what to attribute to COVID and what might be a pre-existing underlying syndrome,” she says. “The last thing I want to have happen is to say to a patient, yes, this is because you had COVID and miss something else that we could have addressed.”

Mysterious inflammation in children

Physicians have also seen troubling clinical manifestations of asymptomatic COVID-19 in children. Early in the pandemic, reports emerged of a rare and mysterious inflammatory syndrome similar to Kawasaki disease that typically sets in weeks after an initial infection.

“Six weeks down the line these people, especially children, will develop inflammation throughout their body,” Rajpal says.

The condition—now called multisystem inflammatory syndrome in children, or MIS-C—typically causes fever, rash, abdominal pain, vomiting, and diarrhoea. It can have harmful effects on multiple organs, from hearts that have trouble pumping blood to lungs that are scarred. It is typically seen among children under 14, although adults have also been diagnosed with this syndrome.

MIS-C is incredibly rare. Kanwal Farooqi, assistant professor of paediatrics at Columbia University Vagelos College of Physicians and Surgeons, says that less than one percent of paediatric COVID-19 patients present with some type of critical disease—and MIS-C is just one of them. However, asymptomatic infections do play a role in the syndrome: A recent study of 1,075 children who had been diagnosed with MIS-C showed that three-quarters had originally been asymptomatic.

But there’s reason to hope that this syndrome might not cause long-term effects in patients, symptomatic or otherwise. Farooqi was the lead author on a recent study of 45 paediatric patients showing that their heart problems—which ranged from leaky valves to enlarged coronary arteries—mostly resolved within six months.

“That is reassuring,” Farooqi says. Still, she recommends administering follow-up MRI scans even to patients whose heart troubles seem to have resolved to make sure there’s no longer-term damage, such as scarring. She also says that it’s “really reasonable” to be cautious about asymptomatic infections and encourages parents to have their child evaluated if they have any persistent symptoms even if the original infection was mild or asymptomatic.

“What’s important is that we can’t right now say that there are no consequences,” she says.

Calls for more studies

Scientists caution that there’s still so much we don’t know about the potential harm of asymptomatic infections. Many have called for more rigorous studies to get to the bottom of the long-term effects of asymptomatic disease, why those effects occur, and how to treat them.

Rajpal points out that his study was only possible because the Big 10 athletic conference requires athletes to get tested every few days. Regular testing is key for uncovering asymptomatic cases, he says, which means that most data on asymptomatic disease is likely to come from healthcare workers, athletes, and other workplaces with strict testing protocols.

It’s also unclear what could be causing these lingering side effects. Scientists hypothesise that it could be an inflammatory response of the body’s immune system that persists long after an infection has been cleared. Others suggest there could be remnants of the virus lingering in the body that continue to trigger an immune reaction months after the COVID-19 infection peaked.

“This is all unchartered, unproven, just a lot of theories,” Topol says.

Yet even if asymptomatic infections aren’t linked in high rates to death and hospitalisation, Pinto and others say it’s important to keep in mind that long COVID-19 symptoms can be debilitating to a patient’s quality of life.

“Even if people survive, we don’t want them to be having a lifelong chronic disease,” Pinto says. “We don’t know what this does to the body, so it’s not something that I would want to take my chances with.”

The bottom line

With so much we don’t know about the long-term effects of asymptomatic COVID-19, scientists insist it’s better to err on the side of caution.

“The full impact can take years to show,” Rajpal says. Although the chances are slim that an individual with asymptomatic infection will have a really bad outcome, he points out that the continuing high rate of infections means that more people are going to suffer.

“Even rare things can affect a lot of people,” he says. “From a public health perspective if you can reduce the number of people that get this infection, you will reduce the number of people who get severe outcomes.”

Parker agrees, adding that it’s particularly important to prevent infection now as the more transmissible Delta variant drives surges in cases and hospitalisations across the country.

“We have had an amazing breakthrough in terms of the rapid development of effective and safe vaccines,” she says. Although Parker and other scientists remain uncertain of the health effects of asymptomatic COVID-19, “we do know that vaccinations are safe and effective and available.”

By Amy McKeever

Source: Why some COVID-19 infections may be free of symptoms but not free of harm | National Geographic

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Should Businesses Force Employees to Get Covid Vaccine? Advice From a Lawyer

With the Covid-19 vaccine rollout steadily gathering steam, and an overwhelming desire to get back to business, companies face a difficult choice: should they force employees to get vaccinated? And if not, how can they encourage workers to roll up their sleeves? Bloomberg Businessweek spoke to Kevin Troutman, a Houston-based lawyer who co-chairs the national healthcare practice of the law firm Fisher Phillips. This interview has been condensed.

Could an employer face some liability if its workers arent vaccinated?

Workers comp laws are the exclusive remedy for illnesses and injuries contracted in the workplace. But employers also have to be concerned about following OSHA guidance, and we expect that OSHA is going to be issuing some COVID-specific standards. They’re going to at least say, I think, make the vaccines available to your employees, and it will be a violation if then you fail to do it. You could be fined and penalized and, you know, OSHA can hand out some substantial fines. So it can be it can be pretty significant.

What should employers do then to encourage employees to take the vaccine?

One thing that is really important is to share reliable objective information with employees, to try to dispel any misunderstandings or misconceptions that are out there. Ideally, the information should come from local healthcare providers — maybe arrange for a doctor in the community to just come out and maybe talk to their employees, answer some questions and help employees to understand the issues better.

If leaders of the organization believe that vaccinations are the right thing to do, and they are out there explaining it, and providing reliable information, and even setting an example and saying, “Hey, I’m getting vaccinated,” I think those things will help get employees more comfortable with taking the vaccine.

What about offering incentives for getting vaccinated?

A lot of employers think, “Well, I’ll just offer some money and, and get people to take the vaccination, and it’s as simple as that.” Unfortunately, it’s not as simple as that. All medical information is supposed to be treated as confidential — you’re not supposed to get that information and then use disability-related information to discriminate against an employee.

The thinking has been that if an incentive is large enough, that might make some employees feel pressured to disclose medical information in order to qualify for the incentive. On January 7, the EEOC issued a proposed rule that you can only offer what they call a “de minimis incentive” — like a water bottle or a gift card of modest value, which we think is around $20 or $25. Those rules were put on hold as part of the transition in administration and then withdrawn, so right now the EEOC stance is in limbo.

Now, a lot of employers are saying, “we’ll pay you for your time to get vaccinated, and maybe allow two hours or something like that.” I think this is a good approach. The employer can say it’s not an incentive. If the EEOC disagreed, the next thing you do is say that’s not enough to be coercive.

What are the risks to requiring your employees to get vaccinated?

Well, if you’re able to work through the people who say they need an accommodation, because of disability or religion, then the risks are you’re going to have 20 to 40 percent of your workforce just very upset, very distracted and not as productive as they would be. Do you want to have to fire them? You probably could legally, but as a practical matter, do you want to fire that many employees?

Is that worse for your company than having 20 or 40 percent of your employees not vaccinated?

I think each company has to decide. It depends a little bit on what you do, and how much interaction do you have with the public. One place it would make a lot of sense to mandate vaccines would be health care, where you’ve got some responsibility for the health and safety not just of yourself and your employees, but of people who are placed in your care. But even in the healthcare industry, I’m not seeing a huge rush to mandate vaccines. They’re making it available. But they’re not mandating it, whereas they have required flu shots.

Have you seen any particular industries that are inclined to mandate vaccinations?

We did a flash survey among clients and people who maintain regular contact with us. We got about 700 responses, and the agricultural and food production industry was at the top of the list among our respondents as to who was expecting to mandate the vaccination. But that was still only about 18 percent of the group.

How might this conversation be different in, say, July or August?

I think the legal issues are going to stay largely the same unless we get more guidance on incentives. From a practical point of view, by mid summer, we should see that a lot more people have been vaccinated. And we’re also going to have more data and more information to tell us more about side effects, and effectiveness of the vaccination. And we may know more about the extent to which being vaccinated prevents a person from transmitting the virus.

All of which will enable us then to improve our messaging to our employees, about why the vaccine makes sense and the risks, or lack of risks, associated with it compared to the benefits. And that’s going to give businesses a better idea of what’s feasible and what they’re going to do.

By: Robb Mandelbaum

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Some Vaccinated Travelers Are Already Getting Covid-19 Booster Shots But Experts Say That May Be Counterproductive

Since January, all travelers must test negative for Covid-19 within 72 hours of entering the U.S. There are many reports in recent months of both vaccinated and unvaccinated travelers testing positive within the last three days of their trip.

This can completely upend re-entry plans because a positive test result means delaying a return to the U.S.. Travelers must get retested until they receive a negative test result and, in the meantime, they must remain in their destination at their own expense, often under quarantine or isolation orders.

To give themselves an extra insurance policy against becoming a breakthrough case, some fully vaccinated American travelers are finagling a third shot of the vaccine a few weeks before leaving on their trip — even though the U.S. Food and Drug Administration (FDA) has yet to give booster shots an official green light. In some cases, they are simply presenting themselves as unvaccinated at pharmacies or other vaccine providers in order to get another dose. Others are getting a booster with the blessing of their doctors.

“People are acting in their own self-interest, and that doesn’t shock me,” said Dr. Kavita Patel, a primary care physician in Washington, D.C., who served as an advisor on health policy in the Obama administration.

“It’s unfortunate, because there remains no evidence that if you’re under 65 years old and otherwise healthy, that you need a third shot right now,” said Dr. Vin Gupta, a pulmonary critical-care physician and an affiliate assistant professor at the Institute for Health Metrics and Evaluation (IHME) at the University of Washington. “There needs to be guardrails here. We need to understand what three doses mean. Are we protected for five years or just another eight months? There are lots of open questions.”

The Biden administration has urged the FDA to release a booster rollout plan as soon as possible, given that some Americans, including first responders and immunocompromised people, received their initial doses in 2020 and officials want the most vulnerable people to be at the front of the line for boosters.

The FDA is currently evaluating when a wider swath of vaccinated Americans should begin receiving Covid-19 booster shots, which is likely to be either six or eight months after completing their initial doses. “The administration recently announced a plan to prepare for additional Covid-19 vaccine doses, or ‘boosters,’ this fall, and a key part of that plan is FDA completing an independent evaluation and determination of the safety and effectiveness of these additional vaccine doses,” said the agency in a statement.

Pending FDA approval, booster doses might begin rolling out to eligible Americans as early as this month, said U.S. Surgeon General Dr. Vivek Murthy on a call yesterday that was hosted by the U.S. Health and Human Services Covid-19 Community Corps.

It’s important for individuals to adhere to the FDA’s recommended timing of a third shot, said Dr. Patel. Just as with any other three-shot vaccine series, the intervals between shots will be gauged to give people robust immunity for a longer period of time.

“That’s actually consistent with what we do with other vaccines. Think of the timing of any pediatric vaccine or the human papillomavirus vaccine,” said Dr. Patel. “What I tell patients is that there’s actually a downside from getting a booster too early. They could be potentially harming themselves six to 12 months down the line. I mean, Covid is not going away.”

While Dr. Patel thinks “it’s inevitable” that everyone will eventually need another shot, “there’s unfortunately a perception that in order to go on a trip and avoid getting sick or avoid potential additional costs, people think that a booster is going to be what they need to do to stay protected. I think a lot of people are just thinking, ‘Well, if two is better than one and three is better than two, at some point, I’ll get four.’ And that’s a very dangerous assumption.”

In other words, instead of rushing to get a third shot before a planned trip, it makes more sense to stick to the optimal timing for a booster shot, then plan future trips accordingly.

Follow me on LinkedIn. Check out my website. Send me a secure tip.

I watch trends in travel. Prior to working at Forbes, I was a longtime freelancer who contributed hundreds of articles to Conde Nast Traveler, CNN Travel, Travel + Leisure, Afar, Reader’s Digest, TripSavvy, Parade, NBCNews.com and scores of other outlets. Follow me on Instagram (@suzannekelleher) and Flipboard (@SRKelleher).

Source: Some Vaccinated Travelers Are Already Getting Covid-19 Booster Shots—But Experts Say That May Be Counterproductive

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Moderna Vaccine Creates Twice as Many Antibodies as Pfizer, Study Shows

Coronavirus: Modern vaccine generated more than double antibodies than Pfizer shot. Moderna Inc.’s Covid vaccine generated more than double the antibodies from a similar shot made by Pfizer Inc. and BioNTech SE in research that directly compared immune responses with inoculations.

A study of nearly 2,500 workers at a major hospital in Belgium found antibody levels among people who had not been infected with coronavirus before receiving two doses of the Moderna vaccine averaged 2,888 units per day. Milliliters, compared to 1,108 units / ml in a similar group that received two shots of the Pfizer shot.

The results, published Monday in a letter to the Journal of the American Medical Association, suggested that the differences could be explained by:

– larger amount of active ingredient in the Moderna vaccine – 100 micrograms versus 30 micrograms in Pfizer-BioNTech. Longer interval between doses of the Moderna vaccine – four weeks versus three weeks for Pfizer-BioNTech

Moderna’s vaccine was associated with a double risk reduction against breakthrough SARS-CoV-2 infections compared to Pfizers in a review of humans in the Mayo Clinic Health System in the United States from January to July. The results were reported in a separate study released prior to publication and peer review on 9 August.

The Moderna COVID‑19 vaccine (pINN: elasomeran), codenamed mRNA-1273 and sold under the brand name Spikevax, is a COVID-19 vaccine developed by Moderna, the United States National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA).

It is authorized for use in people aged twelve years and older in some jurisdictions and for people eighteen years and older in other jurisdictions to provide protection against COVID-19 which is caused by infection by the SARS-CoV-2 virus. It is designed to be administered as two or three 0.5 mL doses given by intramuscular injection at an interval of at least 28 days apart.

It is an RNA vaccine composed of nucleoside-modified mRNA (modRNA) encoding a spike protein of SARS-CoV-2, which is encapsulated in lipid nanoparticles

By:

Source: Covid: Moderna Vaccine Creates Twice as Many Antibodies as Pfizer, Study Shows – Bloomberg

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