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FDA says Pfizer COVID vaccine looks effective for young kids – CP24 Toronto's Breaking News

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Lauran Neergaard And Matthew Perrone, The Associated Press


Published Friday, October 22, 2021 6:32PM EDT


Last Updated Friday, October 22, 2021 10:46PM EDT

Federal health regulators said late Friday that kid-size doses of Pfizer’s COVID-19 vaccine appear highly effective at preventing symptomatic infections in elementary school children and caused no unexpected safety issues, as the U.S. weighs beginning vaccinations in youngsters.

The Food and Drug Administration posted its analysis of Pfizer’s data ahead of a public meeting next week to debate whether the shots are ready for the nation’s roughly 28 million children ages 5 to 11. The agency will ask a panel of outside vaccine experts to vote on that question.

In their analysis, FDA scientists concluded that in almost every scenario the vaccine’s benefit for preventing hospitalizations and death from COVID-19 would outweigh any serious potential side effects in children. But agency reviewers stopped short of calling for Pfizer’s shot to be authorized.

The agency will put that question to its panel of independent advisers next Tuesday and weigh their advice before making its own decision.

If the FDA authorizes the shots, the Centers for Disease Control and Prevention will make additional recommendations on who should receive them the first week of November. Children could begin vaccinations early next month — with the first youngsters in line fully protected by Christmas.

Full-strength Pfizer shots already are recommended for anyone 12 or older, but pediatricians and many parents are anxiously awaiting protection for younger children to stem infections from the extra-contagious delta variant and help keep kids in school.

The FDA review affirmed results from Pfizer posted earlier in the day showing the two-dose shot was nearly 91% effective at preventing symptomatic infection in young children. Researchers calculated the figure based on 16 COVID-19 cases in youngsters given dummy shots versus three cases among vaccinated children. There were no severe illnesses reported among any of the youngsters, but the vaccinated ones had much milder symptoms than their unvaccinated counterparts.

Most of the study data was collected in the U.S. during August and September, when the delta variant had become the dominant COVID-19 strain.

The FDA review found no new or unexpected side effects, which mostly consisted of sore arms, fever or achiness that teens experience.

However, FDA scientists noted that the study wasn’t large enough to detect extremely rare side effects, including myocarditis, a type of heart inflammation that occasionally occurs after the second dose.

The agency used statistical modeling to try to predict how many hospitalizations and deaths from COVID-19 the vaccine would prevent versus the number of potential heart side effects it might cause. In four scenarios of the pandemic, the vaccine clearly prevented more hospitalizations than would be expected from the heart side effect. Only when virus cases were extremely low would the vaccine cause more hospitalizations than it would prevent. But overall, regulators concluded that the vaccine’s protective benefits “would clearly outweigh” its risks.

While children run a lower risk of severe illness or death than older people, COVID-19 has killed more than 630 Americans 18 and under, according to the CDC. Nearly 6.2 million children have been infected with the coronavirus, more than 1.1 million in the last six weeks as the delta variant surged, the American Academy of Pediatrics says.

The Biden administration has purchased enough kid-size doses – in special orange-capped vials to distinguish them from adult vaccine – for the nation’s 5- to 11-year-olds. If the vaccine is cleared, millions of doses will be promptly shipped around the country, along with kid-size needles.

More than 25,000 pediatricians and primary care providers already have signed up to get the shots into little arms.

AP Medical Writer Lindsey Tanner contributed to this story.

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Thinking of Buying Equipment for Your Business? Here’s What You Need to Know

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Many business owners in Canada rely on professional-grade equipment to keep the operations of their business running, but there are plenty of variables to consider before making a commitment this significant.

No matter the size of your business, if you’re tasked with acquiring equipment for your operations, there are certain factors to keep in mind as you begin the process. Here’s what you need to know if you’re considering purchasing equipment for your business:

Assessing Your Financing Options

Unless you’re a wildly successful, multi-million dollar corporation, there is a higher chance that you don’t have enough free-floating capital to purchase expensive equipment without any outside assistance. The upside is that there are plenty of financing options available for business owners across every major industry, from heavy equipment financing in Canada to agriculture, manufacturing, start-ups and more.

Before you commit to any major purchases, research the financing options available to your business so you can make the smartest purchases going forward without compromising your current equity and capital.

Make a List

Now that you have your financing options in order, it’s important to make a list of your needs and wants. This list will act as a way to organize your thoughts, so you’re spending your newly earned capital wisely. It may be helpful to divide your list into two categories, your needs and your wants.

Your needs will include essential pieces of inventory that contribute to the basic operations of your company. Once you’ve purchased the essentials, you can assess which items under the wants category will be best for your company, with your remaining capital.

Choosing Quality over Flash

It may be easy to become tempted over the latest, flashiest pieces of equipment on the market, but have you done the research to assess its quality? No matter what you purchase in business or in your personal life, quality will always serve you better than aesthetics.

This is especially important when it comes to purchasing expensive equipment for your company. The more you prioritize quality, the more money you’ll save in the long run since you won’t have to worry about replacements.

Maintenance Requirements

Maintaining your equipment is a crucial component of its longevity and durability. Without proper maintenance, you’ll likely end up spending significant costs to repair or replace your inventory. Once you’ve begun to shop around for professional equipment, ensure you’ve taken the time to research the type of maintenance each piece requires. This will help you decide if you have the time and resources to handle the task.

If the equipment you’ve had your eye on requires too much manpower or capital to maintain, you may need to consider a lower price point with more attainable maintenance.

Safety & Certifications

Like anything connected to your business, safety is key. When it comes to purchasing expensive and often heavy equipment, ensure each item has the safety certifications you need — otherwise, your business could become liable if the equipment malfunctions. Prioritizing safely ensures your company, employees, and customers are out of harm’s way.

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P.E.I. announces 6 new COVID-19 cases, 17 exposure sites – CBC.ca

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P.E.I. announced six new cases of COVID-19 on Wednesday.

Two of the cases are in their 40s, one is in their 30s, one is in their 20s and two are children under 12.

Three of the announced cases are related to travel outside the province, and three are contacts of previously reported cases.

The two children are students at Westwood Primary School. The school will be closed on Thursday and Friday to allow for close contacts to get tested, and so the province can determine if there’s been any transmission within the school.

Classmates and other children who travelled on the same bus with the students will be contacted by public health and advised on testing and isolation requirements.

The province said other Westwood students and staff should monitor for symptoms and get tested and isolate if any develop.

Earlier on Wednesday, the Public Schools Branch said four schools in eastern P.E.I. will remain closed for another day to allow for mass testing amid worries of community transmission in the eastern Kings region.

The situation at Westwood is not considered an outbreak at this time.

17 exposure sites announced

Seventeen new public exposure site notifications were issued, including two on the Northumberland Ferry. Most of the exposures are in Charlottetown.

The province is also advising anyone who was at St. Francis Xavier University in Antigonish, N.S., between last Friday and Monday to get tested and isolate while they await results.

There are currently 27 active cases in P.E.I. and there have been 403 total cases.

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Pfizer says COVID booster ‘effective’ against Omicron variant – Al Jazeera English

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Lab tests show the three-shot course of Pfizer-BioNTech vaccine neutralises Omicron, while two shots appear less effective.

Pfizer has said a booster dose of its COVID-19 vaccine was able to neutralise the new Omicron variant in lab studies, even though the initial two doses appear significantly less effective.

The announcement on Wednesday is the first official statement from vaccine manufacturers on the efficacy of current shots against Omicron.

Pfizer and its partner BioNTech said that lab tests showed a booster dose increased by 25-fold the level of so-called neutralising antibodies against Omicron. Their results have not been peer-reviewed.

According to the early laboratory research using blood serum from vaccinated people, a booster third dose generated around the same level of antibodies against Omicron as is seen after a second dose with other variants.

Scientists have speculated that the high jump in antibodies that comes with a third dose of COVID-19 vaccines might be enough to counter any decrease in effectiveness.

Antibody levels predict how well a vaccine may prevent infection with the coronavirus but they are just one layer of the immune system’s defences. Pfizer said two doses of the vaccine may still induce protection against severe disease.

“Although two doses of the vaccine may still offer protection against severe disease caused by the Omicron strain, it’s clear from these preliminary data that protection is maximised with a third dose of our vaccine,” Pfizer CEO Albert Bourla said in a statement.

“Ensuring as many people as possible are fully vaccinated with the first two dose series and a booster remains the best course of action to prevent the spread of COVID-19,” Bourla said.

The companies also said an Omicron-specific version of their coronavirus vaccine, which is currently under development, would be available by March.

The findings are broadly in line with a preliminary study published by researchers at the Africa Health Research Institute in South Africa on Tuesday, saying that Omicron can partially evade protection from two doses of the Pfizer-BioNTech vaccine. The findings also suggested that a third shot might help fend off infection.

The detection of the first Omicron cases two weeks ago coincided with a spike in infection numbers across the world.

The variant has fuelled concerns about a global COVID-19 resurgence.

Omicron has so far been found in 57 countries, according to the World Health Organization, with many reimposing travel restrictions to stem the spread.

No deaths have yet been associated with the variant, with some health officials saying that while Omicron may be more contagious than previous variants, early signs suggest it may cause less severe disease.

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