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Global quest underway to speed COVID-19 vaccine trials

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Scientists are working on a benchmark for COVID-19 vaccine efficacy that would allow drugmakers to conduct smaller, speedier human trials to get them to market and address a huge global vaccine shortage.

Researchers are trying to determine just what level of COVID-19 antibodies a vaccine must produce to provide protection against the illness. Regulators already use such benchmarks – known as correlates of protection – to evaluate flu vaccines without requiring large, lengthy clinical trials.

“You could use it to predict efficacy from a vaccine, which will be more important as we are less able to conduct placebo-controlled trials,” said Stanley Plotkin, inventor of the Rubella vaccine and an expert on correlates of protection.

“The information is flowing in,” he said. “By the end of this year, I think there will be enough data to convince everyone.”An established benchmark for COVID-19 would allow drugmakers to conduct vaccine trials in just a few thousand people, about one-tenth the size of the studies conducted to gain authorization for currently widely-used coronavirus shots, researchers and drugmakers told Reuters. Those studies, involving tens of thousands of volunteers, compared the rate of COVID-19 infections in people who received the shot with the rate in participants who got a placebo. Such randomized, controlled trials may no longer be considered ethical in some countries, as researchers cannot give a dummy shot to people where an effective vaccine is widely available. In addition, many of the new shots are being developed by small companies that may not be able to conduct very large trials without government funding or a partner with deep pockets. With an established correlate, drugmakers could test blood samples from a smaller number of trial participants who receive an experimental vaccine to see whether they produced that benchmark level of protective antibodies.

Such a benchmark is “urgently needed” to help overcome challenges faced by vaccine developers and boost availability of shots, Dr. Florian Krammer, a virologist at the Icahn School of Medicine at Mount Sinai in New York wrote this month in the journal Nature. Researchers at Oxford University late last month proposed a potential correlate of protection based on antibodies found in people who had received the AstraZeneca vaccine. The work awaits peer reviewed by other scientists. Results from a U.S.-backed study of Moderna’s vaccine are expected to be published in a medical journal later this summer. “We’re writing the paper right now,” said Dr. Peter Gilbert, a biostatistician from the Fred Hutchinson Cancer Research Center. Some vaccine experts question whether antibody levels will be a strong enough indicator of protection. Other components of the immune system, such as T-cells and B-cells, are thought to provide important defenses against COVID-19, but are more difficult to measure.

That has been the contention of some top vaccine experts at Pfizer, maker along with BioNTech of one of the most effective COVID-19 vaccines, produced in the largest quantities globally. It is also possible that each different type of coronavirus vaccine will require its own correlate, some experts said. Drugmakers working on a new type of vaccine likely would not be able to rely on the correlates based on Moderna’s messenger RNA shot, they say.

BRIDGING THE GAP Meanwhile, vaccine developers are trying to devise acceptable substitutes to huge, placebo-controlled trials. Some aim to show their shot provokes antibody responses at least as good as those seen with currently authorized shots. European and UK health regulators are working with companies to set standards for these so-called “immunobridging” studies. The U.S. Food and Drug Administration declined to say whether it would accept such trials for next-generation vaccines.

“It doesn’t have to be an established correlate of protection, but we have to … arrive at the right pre-specified criteria, because we cannot risk that a second-generation vaccine … is of low or modest vaccine efficacy,” FDA vaccine official Dr. Marion Gruber told fellow regulators at a World Health Organization Meeting in May. “That would undermine confidence in the vaccine enterprise.”

Italy’s ReiThera Srl is developing a vaccine using technology similar to AstraZeneca’s and will try to demonstrate that its shot is at least as effective.

The company has an agreement in principle on trial design with European and British regulators, ReiThera’s senior director Stefano Colloca told Reuters. Massive clinical trials are “no longer ethical and feasible in most countries worldwide,” he said. French biotech Valneva and Taiwan’s Medigen Vaccine Biologics Corp plan to test their vaccines against the AstraZeneca shot, even though both use a different technology. Valneva’s trial design was approved by UK regulators. Medigen has a green light from Taiwan.

Sanofi, with partner GlaxoSmithKline, and Canada’s Medicago are still opting for placebo-controlled trials involving thousands of participants, including in countries with high infection rates and fewer authorized vaccines available.

NEED FOR BOOSTERS? The hunt for a correlate is underway from the UK to the United States and Australia. Scientists are comparing antibody levels in vaccinated people who became infected with COVID-19 to those who did not, to find a threshold of protection that made the difference. Oxford University researchers said work is needed to address correlates for emerging virus variants, such as the highly transmissible Delta that has quickly become dominant globally. Their proposed antibody model is based on trial volunteers who had mainly contracted the earlier Alpha variant, first identified in the UK.

U.S. government-backed scientists are studying infections in people who received the Moderna vaccine. Moderna spokesman Ray Jordan said the company is also working on the analysis and will publish updates when available. The correlate benchmark might also indicate when and whether people need vaccine boosters.

Pfizer has sought authorization for a third booster dose of its vaccine, citing evidence of waning neutralizing antibody levels. But the company has pushed back against the idea that those same antibodies could be used to predict vaccine efficacy.

“No formal timeline is in place to have correlates of protection established,” a Pfizer spokesperson said. “We will continue to work with the scientific community to better understand what immune responses, whether neutralizing antibodies or otherwise, might contribute to protection.”

(Reporting by Julie Steenhuysen in Chicago and Ludwig Burger in Frankfurt; Additional reporting by Emilio Parodi in Milan, Matthias Blamont in Paris, Michael Erman in Maplewood, New Jersey, Allison Martell in Toronto and Ben Blanchard in Taipei; Editing by Michele Gershberg and Bill Berkrot)

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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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