Next on FDA's agenda: Booster shots of Moderna, J&J vaccines - Winnipeg Free Press | Canada News Media
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Next on FDA's agenda: Booster shots of Moderna, J&J vaccines – Winnipeg Free Press

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FILE – This May 13, 2021, file photo shows syringes filled with the Johnson & Johnson vaccine at a mobile vaccination site in Miami. Starting Thursday, Oct. 14, 2021, the Food and Drug Administration convenes its independent advisers for the first stage in the process of deciding whether extra shots of Moderna or Johnson & Johnson vaccines should be dispensed and, if so, who should get them and when. (AP Photo/Wilfredo Lee, File)

WASHINGTON (AP) — With many Americans who got Pfizer vaccinations already rolling up their sleeves for a booster shot, millions of others who received the Moderna or Johnson & Johnson vaccine wait anxiously to learn when it’s their turn.

Federal regulators begin tackling that question this week.

On Thursday and Friday, the Food and Drug Administration convenes its independent advisers for the first stage in the process of deciding whether extra doses of the two vaccines should be dispensed and, if so, who should get them and when. The final go-ahead is not expected for at least another week.

After the FDA advisers give their recommendation, the agency itself will make a decision on whether to authorize boosters. Then next week, a panel convened by the Centers for Disease Control and Prevention will offer more specifics on who should get them. Its decision is subject to approval by the CDC director.

The process is meant to bolster public confidence in the vaccines. But it has already led to conflicts and disagreements among experts and agencies.

For example, last month the CDC advisory panel backed Pfizer boosters at the six-month point for older Americans, nursing home residents and people with underlying health problems. But CDC Director Dr. Rochelle Walensky overruled her advisers and decided boosters should also be offered to those with high-risk jobs such as teachers and health care workers, adding tens of millions more Americans to the list.

Some health experts fear the back-and-forth deliberations are muddling the public effort to persuade the unvaccinated to get their first shots. They worry that the talk of boosters will lead people to wrongly doubt the effectiveness of the vaccines in the first place.



FILE – In this May 21, 2021, file photo, two people wait to receive the Moderna COVID-19 vaccine at Providence Edwards Lifesciences vaccination site in Santa Ana, Calif. Starting Thursday, Oct. 14, 2021, the Food and Drug Administration convenes its independent advisers for the first stage in the process of deciding whether extra shots of Moderna or Johnson & Johnson vaccines should be dispensed and, if so, who should get them and when. (AP Photo/Jae C. Hong, File)

As the FDA’s panel meets to review the Moderna and J&J vaccines, its decisions this time are likely to be even more complicated, with experts discussing whether a third Moderna shot should contain just half the original dose and what’s the best timing for a second shot of the single-dose J&J vaccine.

The panel will also look into the safety and effectiveness of mixing-and-matching different brands of vaccine, something regulators have not endorsed so far.

An estimated 103 million Americans are fully vaccinated with Pfizer’s formula, 69 million with Moderna’s and 15 million with J&J’s, according to the CDC. Regulators took up the question of Pfizer boosters first because the company submitted its data ahead of the other vaccine makers.

The two initial Moderna shots contain 100 micrograms of vaccine each. But the drugmaker says 50 micrograms ought to be enough for a booster for healthy people.

A company study of 344 people gave them a 50-microgram shot six months after their second dose, and levels of virus-fighting antibodies jumped. Moderna said the booster even triggered a 42-fold rise in antibodies able to target the extra-contagious delta variant.

Side effects were similar to the fevers and aches that Moderna recipients commonly experience after their second regular shot, the company said.

As for people who got the J&J vaccine, the company submitted data to the FDA for different options: a booster shot at two months or at six months. The company did not signal its preference.

J&J released data in September showing that a booster given at two months provided 94% protection against moderate-to-severe COVID-19 infection. The company has not yet disclosed patient data on a six-month booster, but early measures of virus-fighting antibodies suggest it provides even higher protection.

Even without a booster, J&J says, its vaccine remains about 80% effective at preventing COVID-19 hospitalizations in the U.S.

Scientists emphasize that all three vaccines used in the U.S. still offer strong protection against severe disease and death from COVID-19. The issue is how quickly, and how much, protection against milder infection may wane.

In one recent study, researchers compared about 14,000 people who had gotten their first Moderna dose a year ago with 11,000 vaccinated eight months ago. As the delta variant surged in July and August, the more recently vaccinated group had a 36% lower rate of “breakthrough” infections compared with those vaccinated longer ago.

Still, medical experts continue to debate the science and rationale for giving extra shots to those who already have significant protection.

The White House and its top medical advisers announced sweeping plans in August to offer boosters to nearly all adults, citing signs of waning protection and the then-surging delta variant. But they were rebuffed by many experts who said there is little data showing whether such broad use would stop breakthrough infections or curb the overall trajectory of cases.

While the FDA and CDC ultimately scaled back use of Pfizer boosters, Biden administration officials, including Dr. Anthony Fauci, have suggested that extra shots will eventually be recommended for most Americans.

They point to data from Israel showing lower rates of infections and severe disease among people who received a third Pfizer shot.

The FDA meetings come as U.S. vaccinations have climbed back above 1 million per day on average, an increase of more than 50% over the past two weeks. The rise has been driven mainly by Pfizer boosters and employer vaccine mandates.

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

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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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