MPP Sarah Jama asked to leave Ontario legislature for wearing keffiyeh
MPP Sarah Jama was asked to leave the Legislative Assembly of Ontario by House Speaker Ted Arnott on Thursday for wearing a keffiyeh, a garment that is banned at Queen’s Park.
AstraZeneca said Thursday that it intends to seek U.S. approval for its COVID-19 vaccine later this year, further delaying the application even as the company announced it had already delivered more than 1 billion doses to other countries.
The Anglo-Swedish drugmaker said the application has been delayed because it has decided to ask the U.S. Food and Drug Administration for full regulatory approval, rather than the fast-track emergency use authorization originally anticipated. As part of this “biologics license application,” the FDA has requested extensive data from clinical trials around the world, as well as data on real world use of the vaccine.
“We have an enormous amount of data, clinical data and all of the data coming from the work we've done around the world," AstraZeneca CEO Pascal Soriot said on a conference call with reporters. “A BLA is a much bigger submission than the emergency use approval.”
AstraZeneca has promoted its relatively cheap, easy-to-handle shot as a “vaccine for the world” and has already received authorization from more than 170 countries. The company, which has promised to deliver the vaccine on a non-profit basis throughout the pandemic, says it provided about 90% of the doses distributed by the COVAX facility for low- and middle-income countries in the first half of the year.
AstraZeneca is the second drugmaker to say it has delivered more than 1 billion doses of COVID-19 vaccine, following U.S.-based Pfizer's announcement on Wednesday.
Oxford University scientists who developed the AstraZeneca vaccine applauded the company and its partners for reaching the landmark but noted that most people around the world haven't been inoculated against a disease that has already killed more than 4.1 million people worldwide.
“There is still so much to do, and all in the supply chain are pushing on knowing the next billion people are still waiting for their doses,” said Andrew Pollard, director of the Oxford Vaccine Group.
Plans for AstraZeneca's U.S. application are being closely watched because the timetable has slipped in recent months. When AstraZeneca released data from its U.S. vaccine trial on March 22, company officials said they expected to seek FDA authorization in April.
Among the concerns AstraZeneca will have to address are reports that the vaccine may be linked to rare blood clots, which have caused some countries to limit its use in younger people.
While the U.S. is currently “well supplied” with vaccines, AstraZeneca believes its shot could “play a role in the future,” Soriot said.
“It's a good vaccine, and we just want to make sure it's ready to be used if needed,” he said.
AstraZeneca said Thursday that sales of its COVID-19 vaccine generated $1.17 billion in revenue during the first six months of the year. By contrast, Pfizer reported $11.3 billion of revenue from its vaccine during the same period.
When asked about Pfizer's results, Soriot said he had no regrets about AstraZeneca's strategy.
“We don't envy anybody,” he said.
The vaccine was developed by Oxford University researchers, who licensed the technology to AstraZeneca to tap into the company's global manufacturing and distribution capacity. AstraZeneca, in turn, authorizes other companies to produce the shots around the world.
During the first half of the year, AstraZeneca and its partners delivered more than 700 million doses of the vaccine, data ending June 30 showed. That included about 319 million doses produced by AstraZeneca and 381 million doses produced by the Serum Institute of India and other sub-licensees.
Despite complaints from the EU about its vaccine supply, the 27-nation bloc received more doses directly from AstraZeneca than any other single entity in the six months through June.
The company shipped 97 million doses to the EU, while Brazil got 65 million doses and the U.K. 52 million, AstraZeneca said. Gavi, an alliance that secures vaccines for low-income countries, received 49 million doses, and another 57 million doses went to other countries.
Ruud Dobber, president of AstraZeneca's BioPharmaceuticals business unit, said the company is working with the EU to resolve the bloc's concerns and avoid a protracted legal dispute.
“We don't think it's useful for both parties to continue this,” he said. “And I'm very hopeful that in the next few weeks we will come to an agreement.”
MPP Sarah Jama was asked to leave the Legislative Assembly of Ontario by House Speaker Ted Arnott on Thursday for wearing a keffiyeh, a garment that is banned at Queen’s Park.
Two teenagers have been charged with second-degree murder in connection to an alleged homicide near the Halifax Shopping Centre earlier this week.
Bob Cole, a welcome voice for Canadian hockey fans for a half-century, has died at the age of 90. Cole died Wednesday night in St. John's, N.L., surrounded by his family, his daughter, Megan Cole, told the CBC.
Here's what you need to know about why movie mogul Harvey Weinstein's rape conviction was thrown out and what happens next.
When Gen-chan arrived at a zoo in Japan in 2017, no one questioned whether the then-five-year-old hippopotamus was a boy. Seven years later, zoo staff made a surprising discovery: Gen-chan, now 12, was female.
A rural Manitoba school trustee is facing calls to resign over comments he made about Indigenous people and residential schools earlier this week.
The B.C. Humanist Association has threatened legal action against the City of Vancouver for allowing prayers at council, following a similar warning issued earlier this month to a smaller community on Vancouver Island.
A London man has become the first person in Canada to receive a robotic assisted surgery on his spine. Dave Myeh suffered from debilitating, chronic back pain that led to sciatica in his right now and extreme pain in his lower back.
Honda is set to build an electric vehicle battery plant next to its Alliston, Ont., assembly plant, which it is retooling to produce fully electric vehicles, all part of a $15-billion project that is expected to include up to $5 billion in public money.
Mounties in Nanaimo, B.C., say two late-night revellers are lucky their allegedly drunken antics weren't reported to police after security cameras captured the men trying to steal a heavy sign from a downtown business.
A property tax bill is perplexing a small townhouse community in Fergus, Ont.
When identical twin sisters Kim and Michelle Krezonoski were invited to compete against some of the world’s most elite female runners at last week’s Boston Marathon, they were in disbelief.
The giant stone statues guarding the Lions Gate Bridge have been dressed in custom Vancouver Canucks jerseys as the NHL playoffs get underway.
A local Oilers fan is hoping to see his team cut through the postseason, so he can cut his hair.
A family from Laval, Que. is looking for answers... and their father's body. He died on vacation in Cuba and authorities sent someone else's body back to Canada.
A former educational assistant is calling attention to the rising violence in Alberta's classrooms.
The federal government says its plan to increase taxes on capital gains is aimed at wealthy Canadians to achieve “tax fairness.”
At 6'8" and 350 pounds, there is nothing typical about UBC offensive lineman Giovanni Manu, who was born in Tonga and went to high school in Pitt Meadows.