Pfizer plans to ask U.S. regulators to authorize a booster dose of its COVID-19 vaccine within the next month, the drugmaker’s top scientist said on Thursday, based on evidence of greater risk of reinfection six months after inoculation and the spread of the highly contagious delta variant.
In a joint statement, however, the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) said that Americans who have been fully vaccinated do not need a booster COVID-19 shot at this time.
Some scientists have also questioned the need for booster shots.
Pfizer’s chief scientific officer, Mikael Dolsten, said the recently reported dip in the vaccine’s effectiveness in Israel was mostly due to infections in people who had been vaccinated in January or February. The country’s health ministry said vaccine effectiveness in preventing both infection and symptomatic disease fell to 64 per cent in June.
“The Pfizer vaccine is highly active against the delta variant,” Dolsten said in an interview. But after six months, he said, “there likely is the risk of reinfection as antibodies, as predicted, wane.”
Pfizer did not release the full set of Israeli data on Thursday, but said it would be published soon.
A youth receives a vaccination at a mobile vaccination centre in Tel Aviv, Israel. Israel’s health ministry said vaccine effectiveness in preventing both infection and symptomatic disease fell to 64 per cent in June. (Ammar Awad/Reuters)
“It’s a small data set, but I think the trend is accurate: Six months out, given that delta is the most contagious variant we have seen, it can cause infections and mild disease,” Dolsten said.
The FDA and CDC, in their joint statement, said: “We are prepared for booster doses if and when the science demonstrates that they are needed.”
Dolsten said Pfizer’s own data from the United States showed an erosion of the vaccine’s efficacy to the mid-80s after six months against the variants circulating there in the spring.
Promising protection
He stressed that data from Israel and Britain suggests that even with waning antibody levels, the vaccine remains around 95 per cent effective against severe disease.
The vaccine, developed with German partner BioNTech SE, showed 95 per cent efficacy in preventing symptomatic COVID-19 in a clinical trial the companies ran last year.
Dolsten said early data from the company’s own studies shows that a third booster dose generates antibody levels that are five- to 10-fold higher than after the second dose, suggesting that a third dose will offer promising protection.
He said multiple countries in Europe and elsewhere have already approached Pfizer to discuss booster doses, and some may begin administering them before a potential U.S. authorization.
A health-care worker prepares a dose of the Pfizer vaccine in Angers, France. Pfizer’s chief executive has said people will ‘likely’ need a third booster dose within 12 months and could need annual shots. (Stephane Mahe/Reuters)
Dolsten said he believes booster shots are particularly important in older age groups.
Dr. Eric Topol, a professor of molecular medicine and director of the Scripps Research Translational Institute in La Jolla, Calif., said basing the decision on waning antibody protection ignores the role of other parts of the immune response, including memory B cells, which can make antibodies on demand when challenged by the virus.
“You need better studies to be able to assert that. It isn’t just neutralizing antibodies,” Topol said.
Some scientists question need for booster
Pfizer has previously said people will likely need a booster dose, though some scientists have questioned when, or if, boosters will be needed.
Pfizer plans to soon launch a placebo-controlled efficacy trial of the booster with 10,000 participants. The study will run throughout the fall, Dolsten said, meaning it will not be completed ahead of the company’s filing with the Food and Drug Administration.
Dr. William Schaffner, a vaccine expert at Vanderbilt University Medical Center, said even if Pfizer succeeds in getting its booster authorized by the FDA, that would only be the first step. The booster would still need to be reviewed and recommended by advisers to the CDC.
A elderly woman receives a shot at an assisted living facility, in Netanya, Israel, in January. (Ronen Zvulun/Reuters)
“It’s not automatic by any means,” he said. Schaffner said realistically, most of the public health bandwidth in the United States is still focused on encouraging Americans to get their first and second doses of the vaccine.
Because boosters would drive increasing demand for vaccines while much of the world is still unvaccinated, Dolsten said Pfizer is looking at ways to boost production.
It is already targeting production of three billion doses this year and four billion next year. Dolsten declined to give a forecast of exactly how many more doses the company could add, but said, “We can step up billion after billion in ’22.”
Dolsten also said Pfizer and BioNTech are designing a new version of the vaccine targeting the delta variant, but said the companies do not believe that the current version will need to be replaced in order to combat the variant.
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.
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.
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.
