Pfizer asks FDA to allow COVID-19 vaccine for kids under 5 - CP24 Toronto's Breaking News | Canada News Media
Connect with us

Business

Pfizer asks FDA to allow COVID-19 vaccine for kids under 5 – CP24 Toronto's Breaking News

Published

 on


Lauran Neergaard And Matthew Perrone, The Associated Press


Published Tuesday, February 1, 2022 8:23AM EST


Last Updated Tuesday, February 1, 2022 4:48PM EST

WASHINGTON (AP) – Pfizer on Tuesday asked the U.S. to authorize extra-low doses of its COVID-19 vaccine for children under 5, potentially opening the way for the very youngest Americans to start receiving shots as early as March.

In an extraordinary move, the Food and Drug Administration had urged Pfizer and its partner BioNTech to apply earlier than the companies had planned.

The nation’s 19 million children under 5 are the only group not yet eligible for vaccination against the coronavirus. Many parents have been pushing for an expansion of shots to toddlers and preschoolers, especially as the omicron wave sent record numbers of youngsters to the hospital.

If the FDA agrees, Pfizer shots containing just one-tenth of the dose given to adults could be dispensed to children as young as 6 months.

An open question is how many shots those youngsters will need. Pfizer is testing three shots after two of the extra-low doses turned out to be strong enough for babies but not for preschoolers, and the final data from the study isn’t expected until late March.

That means the FDA may consider whether to authorize two shots for now, with potentially a third shot being cleared later if the study supports it.

The agency’s decision could come within weeks, but that isn’t the only hurdle. The Centers for Disease Control and Prevention also has to sign off.

The Biden administration has been trying to speed the authorization of COVID-19 shots for children, contending vaccinations are critical for opening schools and day care centers and keeping them open, and for freeing up parents from child care duties so they can go back to work.

Yet vaccination rates have been lower among children than in other age groups. As of last week, just 20% of kids ages 5 to 11 and just over half of 12- to 17-year-olds were fully vaccinated, according to the American Academy of Pediatrics. Nearly three-quarters of adults are fully vaccinated.

While young children are far less likely than adults to get severely ill from the coronavirus, it can happen, and pediatric COVID-19 infections are higher than at any other point in the pandemic.

“What we’re seeing right now is still a lot of hospitalizations and unfortunately some deaths in this age group,” said Dr. Sean O’Leary of the University of Colorado, who is on the AAP’s infectious disease committee. If the FDA clears vaccinations for these youngsters, “that’s going to be really important because all of those hospitalizations and deaths essentially are preventable.”

For kids under 5, Pfizer‘s study is giving participants two shots three weeks apart, followed by a third dose at least two months later. The company is testing whether the youngsters produce antibody levels similar to those known to protect teens and young adults.

In December, Pfizer announced that children under 2 looked to be protected but that the antibody response was too low in 2- to 4-year-olds. It’s not clear why, but one possibility is that the extra-low dose was a little too low for the preschoolers.

Since the preliminary results showed the shots were safe, Pfizer added a third dose to the testing in hopes of improving protection.

Given how well boosters are working for older age groups, “it makes some sense” that younger children could benefit from a third shot, O’Leary said. “I certainly can understand where both the company and the FDA are coming from in terms of wanting to move this along, anticipating that there’s going to be a third dose down the line.”

AP journalist Emma H. Tobin contributed.

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

Adblock test (Why?)



Source link

Continue Reading

Business

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

Published

 on

 

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.

___

Yuri Kageyama is on X:

The Canadian Press. All rights reserved.

Source link

Continue Reading

Business

Trump campaign promises unlikely to harm entrepreneurship: Shopify CFO

Published

 on

 

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)

The Canadian Press. All rights reserved.

Source link

Continue Reading

Business

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

Published

 on

 

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)

The Canadian Press. All rights reserved.

Source link

Continue Reading

Trending

Exit mobile version