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Omicron may have FDA rethinking vaccine strategy for kids under 5 – Ars Technica

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Enlarge / A child getting a vaccination on February 19, 2021, in Bonn, Germany.

Update 1/31/2022, 10:15pm ET: Pfizer and its partner BioNTech are expected to submit a request to the Food and Drug Administration as early as Tuesday, February 1, for emergency authorization of a two-dose COVID-19 vaccine for children ages six months to four years, according to officials familiar with the situation who spoke with the Washington Post and the New York Times. According to the Post, FDA officials encouraged Pfizer and BioNTech to submit the request and data in hopes of authorizing the two doses as early as the end of February. Meanwhile, the companies will continue to collect data on a third dose for the age group.

The original story follows.

Original story 1/31/2022, 5:21pm ET: The Food and Drug Administration may be reconsidering its criteria for authorizing COVID-19 vaccine doses for children under age five, according to Scott Gottlieb, a former FDA commissioner and a current board member of vaccine-maker Pfizer. This opens the possibility that vaccine-ineligible youngsters could get protection from severe COVID-19 sooner than anticipated.

In an interview Sunday, Dr. Gottlieb told CBS’s Face the Nation that he sensed a shift in federal health officials’ thinking on the younger group. “And I’m hopeful that you could see some movement on trying to entertain that application earlier,” he said. “Ultimately, the decision resides with FDA, but there is some indication that there may be an early reaction on that application.”

If Gottlieb’s inkling is correct, vaccines could begin going into little arms as soon as March.

For now, vaccine authorization for children aged six months to four years is on hold as vaccine makers and regulators await more clinical trial data. Last month, Pfizer and its partner BioNTech announced that, although two doses of vaccine formulated for children are safe, the jabs did not produce the same high levels of immune responses seen in older age groups given the vaccines. The young children’s formulation is a 3-microgram dose of the vaccine. The same vaccine is given at 30-microgram doses in adults and 10-microgram doses in children ages 5 to 11. With the inferior immune responses in younger children, the companies announced they would add a third 3-microgram dose—given at least two-months after the second dose—in an attempt to boost levels of protection.

The third dose adds months onto the timeline of when the vaccines may be up for FDA authorization—and prolongs the agony of the parents and caregivers of unvaccinated young children. Pfizer and BioNTech said last month that they could submit data to the FDA sometime in the first half of this year. Before the setback, there was hope that regulators could be reviewing such data at the start of 2022.

Safe and effective

But in his interview Sunday, Gottlieb told Face the Nation host Margaret Brennan that the “decision matrix” around the authorization may be changing. Previously, the goal was that vaccines would prevent infection, Gottlieb noted. Early clinical trials in adults found remarkably high levels of protection from infection, and that was the benchmark and the reasoning behind adding a third dose to the children’s trial. But with the rise of the omicron coronavirus variant—which can evade some immune responses—vaccines are no longer expected to stop infections at high rates. Instead, their strength is to provide and maintain strong protection against severe COVID-19 cases, hospitalization, and death. That shift lessens the need for that third dose in younger children, Gottlieb argued.

“Now, if the goal of the vaccine is to get baseline immunity in the kids to prevent really bad outcomes, and you’re really not using the vaccine as a tool to prevent infection in the first place, two doses could do that,” Gottlieb said. “Getting two doses into a child can provide baseline immunity that protects them from severe disease, from hospitalization. And I think that may be why federal health officials are rethinking this if, in fact, they decide to authorize this on the basis of two doses.”

In an email to Ars, the FDA said it cannot confirm or comment on interactions it’s having with the vaccine makers. When Ars reached out to Pfizer, a company representative indicated that there were no updates it could share yet on vaccines for children under five.

In a White House press briefing last Wednesday, top infectious disease expert Anthony Fauci indicated that he was still expecting a three-dose regimen but noted that he hadn’t seen any of the data that Pfizer is sharing with the agency. He emphasized that the FDA is “very scrupulous” and that if and when vaccine doses are approved for the younger age group, “we can be certain that [the vaccines] will be safe and that they will be effective.”

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Toronto Public Health hosting pop-up COVID-19 vaccination clinics throughout Canada Day weekend – Toronto.com

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Toronto Public Health continues to host summer pop-up vaccination clinics across the city in partnership with Toronto’s Canada Day festivals and special events. This is part of Team Toronto’s continued efforts to bring COVID-19 vaccination opportunities to places residents live, work and play.

“As people gather to celebrate Canada Day across the city, Team Toronto will be out helping residents get vaccinated against COVID-19 and keep their vaccinations up to date,” said Mayor John Tory. “We have made such progress thanks to our world-leading vaccination efforts, and that’s why we’re continuing to work throughout this holiday and into the summer to help deliver vaccine doses.”

TPH will host the following vaccination clinics in early July:

• High Park Canada Day Festival at High Park, 1873 Bloor St. W., Friday, July 1, 10 a.m. to 2 p.m.

• East York Canada Day Festival at Stan Wadlow Park. 373 Cedarvale Ave., Friday, July 1, 11 a.m. to 5 p.m.

• Canada Day event at Mel Lastman Square, 5100 Yonge St. Friday, July 1, 2 to 7 p.m.

• CIMA Mayor’s Cricket Trophy event at Sunnybrook Park, 1132 Leslie St. Saturday, July 2, 9 a.m. to 4 p.m.

• Lakeshore Ribfest at 1 Colonel Samuel Smith Park Dr. Saturday July 2 and Sunday, July 3, 11 a.m. to 6 p.m.

• Afrofest at Woodbine Park, 1695 Queen St. E. Saturday, July 9 and Sunday, July 10, 1 to 7:30 p.m.

• Dragon Boat Challenge (GWN Sport Regatta) at Marilyn Bell Park, 1095 Lakeshore Blvd. W. Saturday July 9, 8:30 a.m. to 3:30 p.m.

These family-friendly and youth-friendly clinics will provide first, second, third, fourth and children’s COVID-19 doses to eligible residents age five and up on a walk-in basis, with no appointment or health card required. Pfizer and Moderna vaccines will be offered by TPH nurses, who will also answer COVID-19 and vaccine-related questions.

Residents can continue to get vaccinated at city-run immunization clinics, primary care offices and more than 525 pharmacies. A full list of clinic locations and hours is available on the City’s COVID-19: Where to Get Vaccinated webpage.

As of Monday, July 4, the city-run immunization clinic at Metro Hall will operate Monday to Friday noon to 6 p.m. and Saturday and Sunday 10 a.m. to 4 p.m. Residents can find a pharmacy offering COVID-19 vaccination by using the Government of Ontario’s COVID-19 pharmacy vaccine locations webpage.

All eligible residents are encouraged to get their third and fourth dose as soon as possible. As with vaccines for other diseases, people are protected best when they stay up to date. COVID-19 vaccines have been scientifically proven to lower the risk of illness, hospitalization and death while protecting oneself, loved ones and the community, and residents with three doses had the lowest rates of hospitalization, ICU and death over any other level of vaccination.

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Style File: Smart sunscreens – Montreal Gazette

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Sunscreen is always a good idea.

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Skin cancers are the most common forms of cancer in Canada, according to Statistics Canada. And severe sunburns are noted as “an important risk factor for melanoma and non-melanoma skin cancers,” according to the agency.

With this in mind, it’s important to slather, smooth, spray — or whatever your chosen format of sun protection may be — this summer.

Here are four smart sunscreen options to consider adding to your daily sun-protection plan:

Tint time

From the French brand La Roche-Posay, this “ultralight” sunscreen formula features a universal tint to match most skin tones. See you later, face makeup. The Anthelios Mineral Tinted Ultra Fluid boasts a sun protection factor (that’s the SPF) of 50, thanks to 100 per cent mineral filters. Suitable for sensitive skin, the broad-spectrum sunscreen — it blocks both UVA and UVB rays, is sweat resistant and water resistant for up to 40 minutes.

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$35.95 | Shoppers Drug Mart, Laroche-posay.ca

Double duty

This advanced sunscreen formula from Shiseido acts as a moisturizer, sunscreen and face primer all-in-one formula. The Urban Environment Oil-Free Sunscreen has an SPF of 42 and features skin-loving ingredients such as spirulina and hyaluronic acid to hydrate and smooth skin while broad-spectrum UV filters protect against ultraviolet rays.

$45 | Sephora, Shiseido.com

Smooth operator

Perfect for those who struggle with acne, this Clear as Day SPF 46 from the brand Starface is vegan and cruelty-free, while also being oil-free and non-comedogenic. The fragrance-free formula features a unique gel texture and is completely clear so there’s no fear of a white cast on skin. Water resistant for up to 80 minutes, so you can spend a little extra time splish-splashing about.

$32 | Starfaceworld.ca

All-over option

Sun protection doesn’t stop at the face, neck and décolletage. Introduce head-to-toe coverage to your summer routine with the Garnier Ombrelle Sensitive Expert Body Lotion SPF 60. The hypoallergenic sunscreen formula features broad-spectrum coverage, is fragrance-free, dermatologist-tested, non-comedogenic and water resistant for up to 80 minutes. Plus, the lotion formula is easy to apply, and absorbs quickly.

$24.99 | London Drugs, Londondrugs.com

Aharris@postmedia.com

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Mysterious staggering disease in cats down to previously unknown virus – New Scientist

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A previously unknown rustrela virus might be the cause of a staggering disease that affects cats in some parts of Europe



Life



1 July 2022

Pet cats in some parts of Europe can sometimes develop a mysterious disease

Laurie 4593/Shutterstock

The cause of a brain disease in cats that makes them develop symptoms such as staggering is a previously unknown virus, a study suggests. The pathogen is a rustrela virus and is probably carried by wood mice.

The findings show that rustrela viruses are more diverse and widespread than previously thought, according to Kaspar Matiasek at the Ludwig Maximilian University of Munich and his colleagues. They write that the viruses might cause neurological diseases in other mammals …

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