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.
MONTREAL – Travel company Transat AT Inc. reported a loss in its latest quarter compared with a profit a year earlier as its revenue edged lower.
The parent company of Air Transat says it lost $39.9 million or $1.03 per diluted share in its quarter ended July 31.
The result compared with a profit of $57.3 million or $1.49 per diluted share a year earlier.
Revenue in what was the company’s third quarter totalled $736.2 million, down from $746.3 million in the same quarter last year.
On an adjusted basis, Transat says it lost $1.10 per share in its latest quarter compared with an adjusted profit of $1.10 per share a year earlier.
Transat chief executive Annick Guérard says demand for leisure travel remains healthy, as evidenced by higher traffic, but consumers are increasingly price conscious given the current economic uncertainty.
This report by The Canadian Press was first published Sept. 12, 2024.
Dollarama Inc.’s food aisles may have expanded far beyond sweet treats or piles of gum by the checkout counter in recent years, but its chief executive maintains his company is “not in the grocery business,” even if it’s keeping an eye on the sector.
“It’s just one small part of our store,” Neil Rossy told analysts on a Wednesday call, where he was questioned about the company’s food merchandise and rivals playing in the same space.
“We will keep an eye on all retailers — like all retailers keep an eye on us — to make sure that we’re competitive and we understand what’s out there.”
Over the last decade and as consumers have more recently sought deals, Dollarama’s food merchandise has expanded to include bread and pantry staples like cereal, rice and pasta sold at prices on par or below supermarkets.
However, the competition in the discount segment of the market Dollarama operates in intensified recently when the country’s biggest grocery chain began piloting a new ultra-discount store.
The No Name stores being tested by Loblaw Cos. Ltd. in Windsor, St. Catharines and Brockville, Ont., are billed as 20 per cent cheaper than discount retail competitors including No Frills. The grocery giant is able to offer such cost savings by relying on a smaller store footprint, fewer chilled products and a hearty range of No Name merchandise.
Though Rossy brushed off notions that his company is a supermarket challenger, grocers aren’t off his radar.
“All retailers in Canada are realistic about the fact that everyone is everyone’s competition on any given item or category,” he said.
Rossy declined to reveal how much of the chain’s sales would overlap with Loblaw or the food category, arguing the vast variety of items Dollarama sells is its strength rather than its grocery products alone.
“What makes Dollarama Dollarama is a very wide assortment of different departments that somewhat represent the old five-and-dime local convenience store,” he said.
The breadth of Dollarama’s offerings helped carry the company to a second-quarter profit of $285.9 million, up from $245.8 million in the same quarter last year as its sales rose 7.4 per cent.
The retailer said Wednesday the profit amounted to $1.02 per diluted share for the 13-week period ended July 28, up from 86 cents per diluted share a year earlier.
The period the quarter covers includes the start of summer, when Rossy said the weather was “terrible.”
“The weather got slightly better towards the end of the summer and our sales certainly increased, but not enough to make up for the season’s horrible start,” he said.
Sales totalled $1.56 billion for the quarter, up from $1.46 billion in the same quarter last year.
Comparable store sales, a key metric for retailers, increased 4.7 per cent, while the average transaction was down2.2 per cent and traffic was up seven per cent, RBC analyst Irene Nattel pointed out.
She told investors in a note that the numbers reflect “solid demand as cautious consumers focus on core consumables and everyday essentials.”
Analysts have attributed such behaviour to interest rates that have been slow to drop and high prices of key consumer goods, which are weighing on household budgets.
To cope, many Canadians have spent more time seeking deals, trading down to more affordable brands and forgoing small luxuries they would treat themselves to in better economic times.
“When people feel squeezed, they tend to shy away from discretionary, focus on the basics,” Rossy said. “When people are feeling good about their wallet, they tend to be more lax about the basics and more willing to spend on discretionary.”
The current economic situation has drawn in not just the average Canadian looking to save a buck or two, but also wealthier consumers.
“When the entire economy is feeling slightly squeezed, we get more consumers who might not have to or want to shop at a Dollarama generally or who enjoy shopping at a Dollarama but have the luxury of not having to worry about the price in some other store that they happen to be standing in that has those goods,” Rossy said.
“Well, when times are tougher, they’ll consider the extra five minutes to go to the store next door.”
This report by The Canadian Press was first published Sept. 11, 2024.
TORONTO – The U.S. Consumer Financial Protection Bureau has ordered TD Bank Group to pay US$28 million for repeatedly sharing inaccurate, negative information about its customers to consumer reporting companies.
The agency says TD has to pay US$7.76 million in total to tens of thousands of victims of its illegal actions, along with a US$20 million civil penalty.
It says TD shared information that contained systemic errors about credit card and bank deposit accounts to consumer reporting companies, which can include credit reports as well as screening reports for tenants and employees and other background checks.
CFPB director Rohit Chopra says in a statement that TD threatened the consumer reports of customers with fraudulent information then “barely lifted a finger to fix it,” and that regulators will need to “focus major attention” on TD Bank to change its course.
TD says in a statement it self-identified these issues and proactively worked to improve its practices, and that it is committed to delivering on its responsibilities to its customers.
The bank also faces scrutiny in the U.S. over its anti-money laundering program where it expects to pay more than US$3 billion in monetary penalties to resolve.
This report by The Canadian Press was first published Sept. 11, 2024.
