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U.S. FDA gives marketing nod to an e-cigarette for the first time

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The U.S. Food and Drug Administration (FDA) on Tuesday allowed British American Tobacco Plc (BAT) to market its Vuse Solo e-cigarettes and tobacco-flavored pods, making it the first-ever vapor product to get clearance from the health regulator.

The FDA said the approval came after analysis of data from the manufacturer that showed that using Vuse’s tobacco-flavored products could help users reduce exposure to harmful chemicals emitted by combustible cigarettes.

“Today’s order represents an important moment for Reynolds,” a British American Tobacco spokesperson said, referring to the company’s American unit R.J. Reynolds Vapor Co, which had filed for Vuse’s marketing approval.

The FDA granted permission to R.J. Reynolds to market its Vuse Solo closed electronic nicotine-delivery device and two accompanying tobacco-flavored e-liquid pods, which have a nicotine strength of 4.8%, which is roughly equivalent to a pack of cigarettes.

Nicotine is a chemical released during the combustion of tobacco and is the addictive stimulant that gives smokers a rush. It isn’t immediately clear what diseases it causes.

The agency denied the company’s request to sell flavored products for failing to demonstrate they would appropriately protect public health. An application to keep selling a menthol version continues to be evaluated, however.

The FDA’s decision comes on the heels of a 2021 survey conducted by the CDC that indicated that an estimated 2.06 million U.S. middle and high school students are still using e-cigarettes, with Vuse and Juul among the most popular brands. Most users said they used flavored products, with fruit, candy and desserts among the most common.

A broader U.S. study tracking adolescents between the ages of 12 and 15 for three years showed that adolescents who used e-cigarettes before trying any other tobacco products were more than four times as likely to be smoking traditional cigarettes within a couple of years compared to those who tried any vapes.

The BAT Group spokesperson said FDA’s “market denial orders” were for five flavored products that were currently not being sold in the market and said it was carefully studying the “FDA’s limited concerns” with those applications.

BAT last month announced that Vuse was now the No. 1 global vaping brand by retail sales in the United States, Canada, France, the United Kingdom and Germany, which account for an estimated 77% of the closed system vapour market.

BAT said it is now awaiting approvals for its other e-cigarette products, including Vuse Alto, whose marketing approval application was submitted nearly a year after Vuse Solo, and Vuse Vibe and Ciro, whose applications “share a foundational science” similar to Vuse Solo.

“We remain confident in the quality of our applications,” the spokesperson said.

In September, the FDA delayed its decision on whether BAT rival Juul and other major manufacturers including BAT could sell their e-cigarette products in the United States, as it weighed the public health impact of the products.

The FDA on Tuesday also imposed strict digital, radio and television advertising restrictions on R.J. Reynolds.

Juul did not immediately respond to a Reuters request for comment.

BAT shares were up marginally in afternoon trading.

 

(Reporting by Amruta Khandekar and Siddharth Cavale; Editing by Devika Syamnath and Bernadette Baum)

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Parents more hesitant to vaccinate kids than themselves, researcher says – Clearwater Times

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Jennifer Hubert jumped at the opportunity to get her COVID-19 vaccine, but she’s not looking forward to having to make the decision about whether to vaccinate her three-year-old son Jackson.

She recognizes the safety and effectiveness of vaccines, but said she also understands her son is at a much lower risk for serious illness than older adults.

“To me it’s not a clear benefit,” she said.

While many parents were overjoyed at the news that Health Canada is considering approval of the first COVID-19 vaccine for kids age five to 11 in Canada, parents like Hubert are feeling more trepidatious, and public health officials said they are going to have a much more nuanced conversation with parents about vaccination than they did with adults.

While 82 per cent of eligible Canadians aged 12 and up are already fully vaccinated, a recent survey by Angus Reid shows only 51 per cent of parents plan to immediately vaccinate their kids when a pediatric dose becomes available.

Of parents with children in the five to 11 year age range, 23 per cent said they would never give their kids a COVID-19 vaccine, 18 per cent said they would wait, and nine per cent said they weren’t sure, according to the survey of 5,011 Canadians between Sept. 29 and Oct. 3, which cannot be assigned a margin of error because online surveys are not considered random samples.

“Most of the research that I’ve seen sort of indicates that parents are more hesitant to vaccinate their kids against COVID than themselves,” said Kate Allan, a post-doctoral fellow at the Centre for Vaccine-Preventable Diseases at the University of Toronto.

There are several reasons parents might pause, she said.

It’s true that children are at a much lower risk of serious outcomes associated with COVID-19, and there have been very rare incidents of mRNA vaccines like Pfizer or Moderna linked to cases of myocarditis, a swelling of the heart muscle.

As of Oct. 1, Health Canada has documented 859 cases associated with the vaccines, which mainly seem to affect people under 40 years old, and people who’ve developed the complication have typically been fine.

READ MORE: 51% of parents ready for COVID jab, as Pfizer asks for Health Canada OK to vaccinate kids

“I know it’s rare, I know it’s not deadly, but I also see the risk of severe symptoms from COVID as being rare and not deadly for Jackson,” Hubert said when asked about weighing up the risks and benefits of the vaccine.

But public health experts stress that some children do suffer from rare but serious impacts from COVID-19, which can also cause myocarditis as well as the little-understood impacts of the condition known as long COVID.

They say parents should consider the less tangible benefits of vaccination as well.

“It’s less of a conversation about a direct benefit to them, and more of a community benefit,” Allan said.

The pandemic has taken a heavy toll on children, depriving them of school, time with their peers, extracurriculars — and their mental health has suffered as a result, said Dr. Vinita Dubey, associate medical officer of health with Toronto Public Health.

“Not one child has been spared from this pandemic. I mean every single child has had to bear a sacrifice because of the pandemic in one way or the other,” Dubey said.

So far Pfizer-BioNtech is the only manufacturer to request approval for its pediatric COVID-19 vaccine and Health Canada is still reviewing the data.

The regulator has promised the review will be thorough, and the vaccine will only be approved for children if the benefits outweigh the potential risks.

Policy-makers know they’re going to have to take parents’ concerns seriously as well.

On a recent tour of the Children’s Hospital of Eastern Ontario in Ottawa, Prime Minister Justin Trudeau spoke with Dr. Anne Pham-Huy, a pediatric infectious diseases physician.

“Vaccine confidence is going to be the most important part of it this time around,” Pham-Huy said, to which Trudeau agreed.

Dubey has published research on improving parents’ vaccine confidence when it comes to long-established inoculations like mumps and rubella.

While she offered several tips, they mainly come down to building trust. Her research focused on the role of family doctors, but she said during the pandemic anyone can be that trusted sounding board.

“It could be a faith leader, it could be an important family member or friend, someone who you trust, to help guide you to the right sources to make that decision,” she said.

With that in mind, several students from across North America launched a peer-to-peer education program called Students for Herd Immunity to allow kids to have those conversations among themselves.

The public health experts agree, the debate around vaccines has become polarized and open conversations will be the key to addressing parents’ concerns.

“I think one thing to say to parents is you don’t have to make your decision right away,” Dubey said. “I mean for those who are ready to make their decision, but it’s fine but if you have questions, seek the answers.”

Her only advice is to get those answers from a trusted source, and not social media.

READ MORE: Pfizer will ship millions of vaccine doses for kids as soon as it’s approved, Trudeau says

Laura Osman, The Canadian Press


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Sask. to offer monoclonal antibodies to some COVID-19 patients – Flipboard

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Saskatchewan won’t impose more COVID-19 measures: Premier Scott Moe

The Toronto Star – The Canadian Press • 16h

REGINA – Saskatchewan Premier Scott Moe says he will not bring in additional COVID-19 measures because it ultimately takes away people’s personal …

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EOHU recommending flu shots for area residents, as winter approaches – The Review Newspaper

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As the fall and cooler weather arrive, they bring with them the start of flu season. According to the Eastern Ontario Health Unit, the flu shot is the best protection against the flu, and with the presence of COVID-19 in the community, getting your flu shot is more important now than ever. The flu shot has been approved for use alongside COVID-19 vaccines and is a key step in keeping healthy this season.

“It’s especially important that people get their flu shot this year,” says Dr. Paul Roumeliotis, Medical Officer of Health at the Eastern Ontario Health Unit (EOHU). “Both COVID and the flu share symptoms and, despite their similarities, being fully vaccinated for COVID won’t protect you from the flu.”

“Getting the flu shot can help you stay healthy and reduce the pressure on health care centres.”

Getting the flu shot could also help reduce the demand on COVID-19 assessment centres. The fewer number of people who develop flu symptoms, the fewer who will need to get tested for COVID-19.

The flu shot is available at various locations throughout the five Eastern Counties and Cornwall, including through some healthcare providers, community health centres, participating pharmacies and by appointment at the EOHU for children ages 6 months to under 5 years, and their immediate family.

Appointments for children at the EOHU will be available as of November 1. Call to book your child’s appointment starting on October 25. Residents must bring a piece of identification to their appointment. To find out more about where you can get the flu shot, visit EOHU.ca.

Certain groups of people are at higher risk of complications from the flu and are strongly encouraged to get immunized. These include:

  • children 6 months to less than 5 years of age
  • people aged 65 and older
  • people with chronic medical conditions

If you live with or provide care to someone who falls under one of the groups listed above, or care for newborn infants and children under 6 months of age, it is also highly recommended that you get immunized. This simple step will help protect you and those around you.

For more information about the flu shot, visit EOHU.ca or call  613-933-1375 or 800-267-7120.

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