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Moderna to begin trial of new COVID vaccine to address virus variant first found in South Africa – USA TODAY

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Karen Weintraub
 
| USA TODAY

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Mobile clinic helps distribute COVID-19 vaccine at DC church

In the District today, a pilot program using churches to help distribute the coronavirus vaccine was introduced.

Fox – 5 DC, Fox – 5 DC

CAMBRIDGE, Mass. — Moderna, which makes one of the two authorized COVID-19 vaccines, is set to launch a clinical trial of a new vaccine designed to combat a variant of the virus, the company announced Wednesday. 

The company says it has produced enough of its variant-specific candidate vaccine, called mRNA-1273.351 to begin testing it in people.

Any change to address variants, which other vaccine makers also are working on, would need to be approved by the U.S. Food and Drug Administration. 

In a study published last week, Moderna showed that blood from people who received the current vaccine includes neutralizing antibodies against the major known variants. But only one-sixth of their antibodies were protective against the B.1.351 variant of the virus, which originated in South Africa, and which is the target of its new vaccine. 

It is not clear whether this reduced antibody level is sufficient to protect people against symptomatic or serious cases of COVID-19 from this new variant.

That’s why “out of an abundance of caution,” the company said in a news release it has begun pursuing two possible strategies against the variant: giving people a booster dose of the original vaccine to increase antibody levels, and developing two variant-specific vaccines, which could be given instead of the original one.

It will test several variations of a booster, the company said, including a single, low-dose shot of the variant-specific vaccine; a shot that includes both the original vaccine and the variant-specific one; and a third low-dose version of the original vaccine. 

According to FDA guidance, the company plans to evaluate the safety and immune effects of these approaches in people who have not been vaccinated against COVID-19 and in those who received the original vaccine, mRNA-1273.

The National Institute of Allergy and Infectious Disease will help lead the clinical studies to see if mRNA-1273.351 can boost immunity against the variant. In its announcement Wednesday, the company said it already has shipped sufficient doses of this variant-specific vaccine needed for testing. 

“As we seek to defeat COVID-19, we must be vigilant and proactive as new variants of SARS-CoV-2 emerge,” Stéphane Bancel, Moderna’s CEO, said in a prepared statement, referring to the virus that causes COVID-19. “We are moving quickly to test updates to the vaccines that address emerging variants of the virus in the clinic.”

The lower doses hopefully will work for the booster, Bancel said, allowing the company to stretch its limited vaccine supply.

Other leaders in the COVID-19 vaccine effort – Pfizer-BioNTech, Novavax, Johnson & Johnson and AstraZeneca-Oxford University – also have said they are working on new versions of their vaccines or boosters to increase their protection.

A third vaccine on the way: One-dose J&J COVID-19 vaccine meets criteria as safe and effective, FDA report finds

It’s not yet clear whether a booster shot, which amps up the immune system, will be enough to protect against a new variant, or if an entirely new vaccine is needed.

Moderna is the first to release details about its effort. 

In a Congressional subcommittee meeting Tuesday, Pfizer’s chief business officer, John Young, said his company is “preparing to respond quickly to initiate a study to investigate the effectiveness of a third booster of our vaccine in trial participants who have already received two doses.”

He said Pfizer is discussing trial designs with the FDA. “We will fight every step of the way until a devastating pandemic is under control,” he said.

The Moderna vaccine, like the Pfizer-BioNTech one, is based on mRNA technology in which a simple change to the code will enable the recipient to make a slightly different protein. That’s why they were both made so quickly last year, once it became clear which protein on the SARS-CoV-2 virus they should target. By getting the body to produce a protein from the virus, the vaccine trains the immune system to recognize that protein and immediately attack if the recipient is exposed to the virus.

On Monday, the FDA laid out guidelines for companies that want to change their vaccines to adapt to new variants. They will not be required to start from scratch, running gigantic clinical trials over many months as they have to win FDA authorization.

Instead, as with the flu vaccine, which is altered every year to cope with changing strains, COVID-19 vaccine versions will be tested in smaller groups to confirm safety and to examine immune responses for effectiveness.

Lab studies and some real-world evidence suggests that current vaccines will remain effective against a variant called B.1.1.7, which originated in the United Kingdom.

Lessons from the UK: COVID-19 variant found in UK spreads ‘like wildfire.’ British experts fear what will happen if US won’t lock down

But they may not all work against B.1.351. Studies of AstraZeneca-Oxford University’s collaborative vaccine showed it was barely protective at all against B.1.351 in South Africa, and that country has passed on using doses of the vaccine.

Johnson & Johnson’s vaccine does seem to provide some protection there, and lab studies suggest that Pfizer-BioNTech’s vaccine, like Moderna’s, would continue to provide some protection against that variant, though it’s not clear how much.

Even if it proves unnecessary to reconfigure vaccines to fight the B.1.351 variant, there may be another that comes along that will require a new vaccine, public health officials have said.

New variants of the virus will continue to emerge as COVID-19 continues to infect people across the globe. The only way to stop these variants is to reduce the spread of the virus, public health officials, including Dr. Anthony Fauci, America’s top infectious disease doctor, have said.

“It really is the time to study effects of booster doses to new, emerging viral variants,” Dr. Jesse Goodman, a professor of Medicine at Georgetown University and former chief scientist with the FDA, said in a Wednesday call with media.

Studies are needed to show whether people respond as expected to booster doses, and whether they cause any concerning safety problems. 

And even if the virus doesn’t escape protection from current vaccines, people might need boosters eventually, Goodman said.

“We don’t know,” he said, “how long immunity will last from these vaccines.” 

Contact Karen Weintraub at kweintraub@usatoday.

Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.

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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.

___

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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