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Covid-19 Vaccine Trails: What Older Volunteers Need To Know – Forbes

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By Arlene Weintraub, Next Avenue Contributor

When Karen Tibbals of Washington, N.J. heard that more than 100,000 volunteers would be needed for late-stage clinical trials of four Covid-19 vaccines, she wanted to roll up her sleeves and get one of the experimental shots.

Tibbals is 65 and has the autoimmune disease rheumatoid arthritis, raising her risk of suffering severe complications of Covid-19. But she also brings a unique perspective to the race to develop a vaccine: Tibbals is a retired pharmaceutical marketing executive who saw the clinical trial process up close during stints at Novartis and Merck

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(Read all of Next Avenue’s Covid-19 coverage geared toward keeping older generations informed, safe and prepared.)

Some of the coronavirus vaccines entail delivering bits of genetic material from the virus to prompt the body to launch an immune response — emerging technology that hasn’t been widely deployed before. But that doesn’t scare Tibbals.

‘I Have a Chance of Helping Other People’

“This is really cool new technology; I trust it. I have a chance of helping other people,” Tibbals said, adding that she’s confident the companies will follow procedures for safe clinical trials. She has volunteered for the trials on the site for the Covid-19 Prevention Network (COVPN), an initiative of the National Institutes of Health’s National Institute of Allergy and Infectious Diseases.

“People with pre-existing conditions are a priority population, as are adults over age 65.”

COVPN is managing the recruitment of volunteers for clinical trials of vaccines being developed by AstraZeneca, Novavax, Moderna and the Johnson & Johnson unit Janssen. The Moderna trial is expected to begin later this month, with the other three trials starting between August and December.

Maybe you’re interested in participating in a Covid-19 clinical trial, too. Here’s what you need to know:

Each company will need about 30,000 volunteers for its trials, and more Covid-19 vaccine developers could be added if their products advance to late-stage clinical trials, said Michele Andrasik, a scientist in the vaccine and infectious disease unit at the Fred Hutchinson Cancer Research Center and one of the managers of community outreach for COVPN.

Who the Vaccine Developers Want

Covid vaccine developers are particularly interested in recruiting clinical trial participants who are considered to be most vulnerable to Covid-19, Andrasik said.

“People with pre-existing conditions are a priority population, as are adults over age 65,” she noted. African Americans, Native Americans and Latinos also have a high chance of being admitted to a vaccine trial. So do people who are most likely to contract the disease because they work at health care facilities or in open work spaces, such as meatpacking plants.

Some people, however, might not qualify for the vaccine trials because of medications they’re taking to treat chronic diseases or other factors.

But because of the sheer number of participants who’ll be needed, Andrasik said, anyone who’s interested should volunteer. “Even if someone is not eligible, for example, for the Moderna trial, they may be eligible for a future trial,” she said.

Before signing up, though, you’ll want to understand what being in a Covid-19 vaccine trial will entail.

The Chance of Getting a Placebo

First and foremost, don’t assume you’ll be able to throw away your mask and stop social distancing after you get the shot. These trials will be placebo-controlled. That means every participant will have a 50-50 chance of getting a sham shot rather than an actual vaccine.

In fact, the vaccine developers are counting on some trial participants to actually get sick with Covid-19, said Dr. Richard Novak, professor of medicine and chief of the infectious disease unit at the University of Illinois and one of the clinical trial investigators for Moderna. All participants will be warned that they could get the coronavirus.

“We’re not exposing people to Covid-19 or giving it to them, but we do have to find people who have a high risk of getting it,” Novak said. That’s how the companies will be able to compare infection rates among people who received the vaccine and those who didn’t.

The protocol for each study will differ slightly depending on the company and vaccine being tested. But all volunteers selected for a trial will be expected to complete the enrollment process in person at one of the more than 80 sites running the trials.

Clinical trial volunteers will be asked to sign “informed consent” documents saying they understand they may get a placebo and that if they get the vaccine, they could suffer side effects.

Possible Side Effects for Covid-19 Vaccine Trial Participants

What kind of side effect? Sore arm, low fever and muscle aches — the typical side effects for all vaccines. Moderna said that chills, headache and fatigue were reported in its 45-person trial of the vaccine, too.

Patients in the trials will likely receive some compensation to cover their time and basic expenses. That will vary based on the location and trial sponsor.

Participants will be followed with phone calls and further visits to the study sites.

The Moderna trial, for example, will likely require about seven follow-up visits, weekly phone conversations and electronic diaries that participants will be expected to complete, Novak said. “If they develop symptoms consistent with Covid-19, we’ll bring them in or go to their home for an interim visit, collect samples, then keep tabs on them to see how they do,” he added. (Moderna did not respond to requests for details about the study protocols.)

Although Moderna’s entire process will last two years, Novak estimated, the frequency of face-to-face contact between participants will go way down over time, to once a month or potentially less.

Safety First

Despite the urgent demand for Covid vaccines that work, trial volunteers shouldn’t worry that corners are being cut on safety, said Dr. William Schaffner, professor of infectious diseases at Vanderbilt University.

That’s because clinical trials always have data safety monitoring boards, panels of independent experts with access to information about how the people who receive the actual vaccines are doing compared to those who get placebos.

“If adverse reactions of a certain seriousness start to occur in the vaccinated group, but not the [placebo] group, the trial can be stopped,” said Schaffner, who is not involved in the Covid-19 trials.

Or if the monitoring board looks at the interim data and determines there’s little chance the vaccine is effectively preventing the disease, it can end the trial, “because there’s no need to recruit additional volunteers and expose them to a vaccine that’s not working,” Schaffner said.

As of late July, more than 154,000 people had already volunteered to participate in the Covid-19 vaccine trials through the COVPN website. People who are interested in volunteering for trials that aren’t listed there can also find opportunities by visiting Clinicaltrials.gov and searching the keyword Covid-19.

Tom Smith, a 62-year-old technology research analyst in Raleigh, N.C., is eager to enroll in a Covid-19 vaccine trial, even though he knows it will be a source of anxiety for some of his family members — especially his 87-year-old dad.

“They would be very wary of me doing this,” Smith said. “But you’ve got to have people who are willing to test the different technologies. Anything I can do to help, I want to do.”

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What’s the greatest holiday gift: lips, hair, skin? Give the gift of great skin this holiday season

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Give the gift of great skin this holiday season

Skinstitut Holiday Gift Kits take the stress out of gifting

Toronto, October 31, 2024 – Beauty gifts are at the top of holiday wish lists this year, and Laser Clinics Canada, a leader in advanced beauty treatments and skincare, is taking the pressure out of seasonal shopping. Today, Laser Clincs Canada announces the arrival of its 2024 Holiday Gift Kits, courtesy of Skinstitut, the exclusive skincare line of Laser Clinics Group.

In time for the busy shopping season, the limited-edition Holiday Gifts Kits are available in Laser Clinics locations in the GTA and Ottawa. Clinics are conveniently located in popular shopping centers, including Hillcrest Mall, Square One, CF Sherway Gardens, Scarborough Town Centre, Rideau Centre, Union Station and CF Markville. These limited-edition Kits are available on a first come, first served basis.

“These kits combine our best-selling products, bundled to address the most relevant skin concerns we’re seeing among our clients,” says Christina Ho, Senior Brand & LAM Manager at Laser Clinics Canada. “With several price points available, the kits offer excellent value and suit a variety of gift-giving needs, from those new to cosmeceuticals to those looking to level up their skincare routine. What’s more, these kits are priced with a savings of up to 33 per cent so gift givers can save during the holiday season.

There are two kits to select from, each designed to address key skin concerns and each with a unique theme — Brightening Basics and Hydration Heroes.

Brightening Basics is a mix of everyday essentials for glowing skin for all skin types. The bundle comes in a sleek pink, reusable case and includes three full-sized products: 200ml gentle cleanser, 50ml Moisture Defence (normal skin) and 30ml1% Hyaluronic Complex Serum. The Brightening Basics kit is available at $129, a saving of 33 per cent.

Hydration Heroes is a mix of hydration essentials and active heroes that cater to a wide variety of clients. A perfect stocking stuffer, this bundle includes four deluxe products: Moisture 15 15 ml Defence for normal skin, 10 ml 1% Hyaluronic Complex Serum, 10 ml Retinol Serum and 50 ml Expert Squalane Cleansing Oil. The kit retails at $59.

In addition to the 2024 Holiday Gifts Kits, gift givers can easily add a Laser Clinic Canada gift card to the mix. Offering flexibility, recipients can choose from a wide range of treatments offered by Laser Clinics Canada, or they can expand their collection of exclusive Skinstitut products.

 

Brightening Basics 2024 Holiday Gift Kit by Skinstitut, available exclusively at Laser Clincs Canada clinics and online at skinstitut.ca.

Hydration Heroes 2024 Holiday Gift Kit by Skinstitut – available exclusively at Laser Clincs Canada clinics and online at skinstitut.ca.

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Here is how to prepare your online accounts for when you die

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LONDON (AP) — Most people have accumulated a pile of data — selfies, emails, videos and more — on their social media and digital accounts over their lifetimes. What happens to it when we die?

It’s wise to draft a will spelling out who inherits your physical assets after you’re gone, but don’t forget to take care of your digital estate too. Friends and family might treasure files and posts you’ve left behind, but they could get lost in digital purgatory after you pass away unless you take some simple steps.

Here’s how you can prepare your digital life for your survivors:

Apple

The iPhone maker lets you nominate a “ legacy contact ” who can access your Apple account’s data after you die. The company says it’s a secure way to give trusted people access to photos, files and messages. To set it up you’ll need an Apple device with a fairly recent operating system — iPhones and iPads need iOS or iPadOS 15.2 and MacBooks needs macOS Monterey 12.1.

For iPhones, go to settings, tap Sign-in & Security and then Legacy Contact. You can name one or more people, and they don’t need an Apple ID or device.

You’ll have to share an access key with your contact. It can be a digital version sent electronically, or you can print a copy or save it as a screenshot or PDF.

Take note that there are some types of files you won’t be able to pass on — including digital rights-protected music, movies and passwords stored in Apple’s password manager. Legacy contacts can only access a deceased user’s account for three years before Apple deletes the account.

Google

Google takes a different approach with its Inactive Account Manager, which allows you to share your data with someone if it notices that you’ve stopped using your account.

When setting it up, you need to decide how long Google should wait — from three to 18 months — before considering your account inactive. Once that time is up, Google can notify up to 10 people.

You can write a message informing them you’ve stopped using the account, and, optionally, include a link to download your data. You can choose what types of data they can access — including emails, photos, calendar entries and YouTube videos.

There’s also an option to automatically delete your account after three months of inactivity, so your contacts will have to download any data before that deadline.

Facebook and Instagram

Some social media platforms can preserve accounts for people who have died so that friends and family can honor their memories.

When users of Facebook or Instagram die, parent company Meta says it can memorialize the account if it gets a “valid request” from a friend or family member. Requests can be submitted through an online form.

The social media company strongly recommends Facebook users add a legacy contact to look after their memorial accounts. Legacy contacts can do things like respond to new friend requests and update pinned posts, but they can’t read private messages or remove or alter previous posts. You can only choose one person, who also has to have a Facebook account.

You can also ask Facebook or Instagram to delete a deceased user’s account if you’re a close family member or an executor. You’ll need to send in documents like a death certificate.

TikTok

The video-sharing platform says that if a user has died, people can submit a request to memorialize the account through the settings menu. Go to the Report a Problem section, then Account and profile, then Manage account, where you can report a deceased user.

Once an account has been memorialized, it will be labeled “Remembering.” No one will be able to log into the account, which prevents anyone from editing the profile or using the account to post new content or send messages.

X

It’s not possible to nominate a legacy contact on Elon Musk’s social media site. But family members or an authorized person can submit a request to deactivate a deceased user’s account.

Passwords

Besides the major online services, you’ll probably have dozens if not hundreds of other digital accounts that your survivors might need to access. You could just write all your login credentials down in a notebook and put it somewhere safe. But making a physical copy presents its own vulnerabilities. What if you lose track of it? What if someone finds it?

Instead, consider a password manager that has an emergency access feature. Password managers are digital vaults that you can use to store all your credentials. Some, like Keeper,Bitwarden and NordPass, allow users to nominate one or more trusted contacts who can access their keys in case of an emergency such as a death.

But there are a few catches: Those contacts also need to use the same password manager and you might have to pay for the service.

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Is there a tech challenge you need help figuring out? Write to us at onetechtip@ap.org with your questions.

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Pediatric group says doctors should regularly screen kids for reading difficulties

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The Canadian Paediatric Society says doctors should regularly screen children for reading difficulties and dyslexia, calling low literacy a “serious public health concern” that can increase the risk of other problems including anxiety, low self-esteem and behavioural issues, with lifelong consequences.

New guidance issued Wednesday says family doctors, nurses, pediatricians and other medical professionals who care for school-aged kids are in a unique position to help struggling readers access educational and specialty supports, noting that identifying problems early couldhelp kids sooner — when it’s more effective — as well as reveal other possible learning or developmental issues.

The 10 recommendations include regular screening for kids aged four to seven, especially if they belong to groups at higher risk of low literacy, including newcomers to Canada, racialized Canadians and Indigenous Peoples. The society says this can be done in a two-to-three-minute office-based assessment.

Other tips encourage doctors to look for conditions often seen among poor readers such as attention-deficit hyperactivity disorder; to advocate for early literacy training for pediatric and family medicine residents; to liaise with schools on behalf of families seeking help; and to push provincial and territorial education ministries to integrate evidence-based phonics instruction into curriculums, starting in kindergarten.

Dr. Scott McLeod, one of the authors and chair of the society’s mental health and developmental disabilities committee, said a key goal is to catch kids who may be falling through the cracks and to better connect families to resources, including quicker targeted help from schools.

“Collaboration in this area is so key because we need to move away from the silos of: everything educational must exist within the educational portfolio,” McLeod said in an interview from Calgary, where he is a developmental pediatrician at Alberta Children’s Hospital.

“Reading, yes, it’s education, but it’s also health because we know that literacy impacts health. So I think that a statement like this opens the window to say: Yes, parents can come to their health-care provider to get advice, get recommendations, hopefully start a collaboration with school teachers.”

McLeod noted that pediatricians already look for signs of low literacy in young children by way of a commonly used tool known as the Rourke Baby Record, which offers a checklist of key topics, such as nutrition and developmental benchmarks, to cover in a well-child appointment.

But he said questions about reading could be “a standing item” in checkups and he hoped the society’s statement to medical professionals who care for children “enhances their confidence in being a strong advocate for the child” while spurring partnerships with others involved in a child’s life such as teachers and psychologists.

The guidance said pediatricians also play a key role in detecting and monitoring conditions that often coexist with difficulty reading such as attention-deficit hyperactivity disorder, but McLeod noted that getting such specific diagnoses typically involves a referral to a specialist, during which time a child continues to struggle.

He also acknowledged that some schools can be slow to act without a specific diagnosis from a specialist, and even then a child may end up on a wait list for school interventions.

“Evidence-based reading instruction shouldn’t have to wait for some of that access to specialized assessments to occur,” he said.

“My hope is that (by) having an existing statement or document written by the Canadian Paediatric Society … we’re able to skip a few steps or have some of the early interventions present,” he said.

McLeod added that obtaining specific assessments from medical specialists is “definitely beneficial and advantageous” to know where a child is at, “but having that sort of clear, thorough assessment shouldn’t be a barrier to intervention starting.”

McLeod said the society was partly spurred to act by 2022’s “Right to Read Inquiry Report” from the Ontario Human Rights Commission, which made 157 recommendations to address inequities related to reading instruction in that province.

He called the new guidelines “a big reminder” to pediatric providers, family doctors, school teachers and psychologists of the importance of literacy.

“Early identification of reading difficulty can truly change the trajectory of a child’s life.”

This report by The Canadian Press was first published Oct. 23, 2024.

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