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Pfizer says 3 COVID-19 shots protect children under 5 – CBC News

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Three doses of Pfizer-BioNTech’s COVID-19 vaccine offer strong protection for children younger than five, the companies announced Monday. Pfizer plans to give the data to U.S. regulators later this week in a step toward letting the littlest kids get the shots.

The news comes after months of anxious waiting by parents desperate to vaccinate their babies, toddlers and preschoolers, especially as the number of U.S. COVID-19 cases once again is rising. The 18 million children under five are the only group in the U.S. not yet eligible for COVID-19 vaccination.

Health Canada has not yet approved mRNA COVID-19 vaccines for children under five. 

Pfizer told CBC News Monday morning that they are in discussions with Health Canada regarding a vaccine for children under five, but cannot comment on timelines.

The U.S. Food and Drug Administration has begun evaluating data from Pfizer’s rival Moderna, which hopes to begin offering two kid-sized shots by summer.

A young child prepares to receive a dose of the pediatric Pfizer vaccine at Scotiabank Arena in Toronto. In Canada, 41 per cent of the five to 11 year old population is considered fully vaccinated. (Mike Cole/CBC)

Pfizer has had a bumpier time figuring out its approach. It aims to give children under five just one-10th of the amount adults receive — an even lower dose than the one for kids age five to 12. However, the company discovered during its trial that two shots at that dose didn’t seem quite strong enough for preschoolers. So researchers gave a third shot to more than 1,600 youngsters — from age six months to four years — during the winter surge of the Omicron variant.

In a media release, Pfizer and its partner BioNTech said the extra shot did the trick, revving up the children’s levels of virus-fighting antibodies enough to meet FDA criteria for emergency use of the vaccine with no safety problems.

Preliminary data suggested the three-dose series is 80 per cent effective in preventing symptomatic COVID-19, the companies said, but they cautioned the calculation is based on just 10 cases diagnosed among study participants by the end of April. The study rules state that at least 21 cases are needed to formally determine effectiveness, and Pfizer promised an update as soon as more data is available.

The companies already had submitted data on the first two doses to the FDA, and BioNTech’s CEO, Dr. Ugur Sahin, said the final third-shot data would be submitted this week.

“The study suggests that a low, 3-microgram dose of our vaccine, carefully selected based on tolerability data, provides young children with a high level of protection against the recent COVID-19 strains,” he said in a statement.

Regulatory approvals still required

What’s next? FDA vaccine chief Dr. Peter Marks has pledged the agency will “move quickly without sacrificing our standards” in evaluating dose sizes for children under five from both Pfizer and Moderna.

The agency has set tentative dates next month for its scientific advisers to publicly debate data from each company.

Katrina Taormina draws the Pfizer-BioNTech COVID-19 vaccine into a syringe at Lehman High School, on Tuesday, July 27, 2021, in New York. Pfizer’s rival Moderna is seeking to be the first to vaccinate the littlest kids. (Mark Lennihan/The Associated Press)

Moderna is seeking to be the first to vaccinate the littlest kids. It submitted data to the FDA saying small children develop high levels of virus-fighting antibodies after two shots that contain a quarter of the dose given to adults. The Moderna study found effectiveness against symptomatic COVID-19 was 40 to 50 per cent during the Omicron surge, much like for adults who’ve only had two vaccine doses.

Complicating Moderna’s progress, the FDA so far has allowed its vaccine to be used only in adults.

Last month, the company told CBC News that it hopes to complete the application for regulatory approval of its COVID-19 vaccine in children ages five and under shortly.

The FDA is expected to review Moderna’s data on both the youngest age group and its study of teens and elementary-age children. Health Canada authorized Moderna’s shots for kids between the ages of six and 11 in March. Last fall, it expanded the Pfizer shot to kids between the ages of five and 11.

While COVID-19 generally isn’t as dangerous to youngsters as to adults, some children do become severely ill or even die. And the Omicron variant hit children especially hard, with those under five hospitalized at higher rates than at the peak of the previous Delta surge.

It’s not clear how much demand there will be to vaccinate the youngest kids. Pfizer shots for five- to 11-year-olds opened in November, but only about 30 per cent of that age group have gotten the recommended initial two doses. In Canada, 41 per cent of the five- to 11-year-old population is considered fully vaccinated.

Last week, U.S. health authorities said elementary-age children should get a booster shot just like everyone 12 and older is supposed to get, for the best protection against the latest coronavirus variants.

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Japan’s SoftBank returns to profit after gains at Vision Fund and other investments

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TOKYO (AP) — Japanese technology group SoftBank swung back to profitability in the July-September quarter, boosted by positive results in its Vision Fund investments.

Tokyo-based SoftBank Group Corp. reported Tuesday a fiscal second quarter profit of nearly 1.18 trillion yen ($7.7 billion), compared with a 931 billion yen loss in the year-earlier period.

Quarterly sales edged up about 6% to nearly 1.77 trillion yen ($11.5 billion).

SoftBank credited income from royalties and licensing related to its holdings in Arm, a computer chip-designing company, whose business spans smartphones, data centers, networking equipment, automotive, consumer electronic devices, and AI applications.

The results were also helped by the absence of losses related to SoftBank’s investment in office-space sharing venture WeWork, which hit the previous fiscal year.

WeWork, which filed for Chapter 11 bankruptcy protection in 2023, emerged from Chapter 11 in June.

SoftBank has benefitted in recent months from rising share prices in some investment, such as U.S.-based e-commerce company Coupang, Chinese mobility provider DiDi Global and Bytedance, the Chinese developer of TikTok.

SoftBank’s financial results tend to swing wildly, partly because of its sprawling investment portfolio that includes search engine Yahoo, Chinese retailer Alibaba, and artificial intelligence company Nvidia.

SoftBank makes investments in a variety of companies that it groups together in a series of Vision Funds.

The company’s founder, Masayoshi Son, is a pioneer in technology investment in Japan. SoftBank Group does not give earnings forecasts.

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Yuri Kageyama is on X:

The Canadian Press. All rights reserved.

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Trump campaign promises unlikely to harm entrepreneurship: Shopify CFO

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Shopify Inc. executives brushed off concerns that incoming U.S. President Donald Trump will be a major detriment to many of the company’s merchants.

“There’s nothing in what we’ve heard from Trump, nor would there have been anything from (Democratic candidate) Kamala (Harris), which we think impacts the overall state of new business formation and entrepreneurship,” Shopify’s chief financial officer Jeff Hoffmeister told analysts on a call Tuesday.

“We still feel really good about all the merchants out there, all the entrepreneurs that want to start new businesses and that’s obviously not going to change with the administration.”

Hoffmeister’s comments come a week after Trump, a Republican businessman, trounced Harris in an election that will soon return him to the Oval Office.

On the campaign trail, he threatened to impose tariffs of 60 per cent on imports from China and roughly 10 per cent to 20 per cent on goods from all other countries.

If the president-elect makes good on the promise, many worry the cost of operating will soar for companies, including customers of Shopify, which sells e-commerce software to small businesses but also brands as big as Kylie Cosmetics and Victoria’s Secret.

These merchants may feel they have no choice but to pass on the increases to customers, perhaps sparking more inflation.

If Trump’s tariffs do come to fruition, Shopify’s president Harley Finkelstein pointed out China is “not a huge area” for Shopify.

However, “we can’t anticipate what every presidential administration is going to do,” he cautioned.

He likened the uncertainty facing the business community to the COVID-19 pandemic where Shopify had to help companies migrate online.

“Our job is no matter what comes the way of our merchants, we provide them with tools and service and support for them to navigate it really well,” he said.

Finkelstein was questioned about the forthcoming U.S. leadership change on a call meant to delve into Shopify’s latest earnings, which sent shares soaring 27 per cent to $158.63 shortly after Tuesday’s market open.

The Ottawa-based company, which keeps its books in U.S. dollars, reported US$828 million in net income for its third quarter, up from US$718 million in the same quarter last year, as its revenue rose 26 per cent.

Revenue for the period ended Sept. 30 totalled US$2.16 billion, up from US$1.71 billion a year earlier.

Subscription solutions revenue reached US$610 million, up from US$486 million in the same quarter last year.

Merchant solutions revenue amounted to US$1.55 billion, up from US$1.23 billion.

Shopify’s net income excluding the impact of equity investments totalled US$344 million for the quarter, up from US$173 million in the same quarter last year.

Daniel Chan, a TD Cowen analyst, said the results show Shopify has a leadership position in the e-commerce world and “a continued ability to gain market share.”

In its outlook for its fourth quarter of 2024, the company said it expects revenue to grow at a mid-to-high-twenties percentage rate on a year-over-year basis.

“Q4 guidance suggests Shopify will finish the year strong, with better-than-expected revenue growth and operating margin,” Chan pointed out in a note to investors.

This report by The Canadian Press was first published Nov. 12, 2024.

Companies in this story: (TSX:SHOP)

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RioCan cuts nearly 10 per cent staff in efficiency push as condo market slows

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TORONTO – RioCan Real Estate Investment Trust says it has cut almost 10 per cent of its staff as it deals with a slowdown in the condo market and overall pushes for greater efficiency.

The company says the cuts, which amount to around 60 employees based on its last annual filing, will mean about $9 million in restructuring charges and should translate to about $8 million in annualized cash savings.

The job cuts come as RioCan and others scale back condo development plans as the market softens, but chief executive Jonathan Gitlin says the reductions were from a companywide efficiency effort.

RioCan says it doesn’t plan to start any new construction of mixed-use properties this year and well into 2025 as it adjusts to the shifting market demand.

The company reported a net income of $96.9 million in the third quarter, up from a loss of $73.5 million last year, as it saw a $159 million boost from a favourable change in the fair value of investment properties.

RioCan reported what it says is a record-breaking 97.8 per cent occupancy rate in the quarter including retail committed occupancy of 98.6 per cent.

This report by The Canadian Press was first published Nov. 12, 2024.

Companies in this story: (TSX:REI.UN)

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