Air turbulence: When can it become dangerous?
Flight turbulence like that encountered by a Singapore Airlines flight on Tuesday is extremely common, but there's one aspect of severe turbulence an aviation expert says can lead to serious injury.
The U.S. Food and Drug Administration has raised concerns about a possible risk of heart inflammation from Novavax Inc.'s COVID-19 vaccine, even as the company's data showed it could reduce the chances of mild-to-severe disease.
In Novavax's nearly 30,000 patient trial, conducted between December 2020 and September 2021, there were four cases of a type of heart inflammation called myocarditis detected within 20 days of taking the protein-based shot.
"These events raise the concern for a causal association with this vaccine, similar to the association documented with mRNA COVID-19 vaccines," FDA staff wrote in briefing documents released on Friday.
Shares of the company fell nearly 14 per cent after the FDA's analysis of data from the company's trial.
The agency said it had requested Novavax to flag myocarditis and another kind of heart inflammation called pericarditis as an "important identified risk" in its materials. The company has not yet agreed to do so.
Novavax, in response to the safety concerns flagged by the FDA, said natural background events of myocarditis can be expected in any sufficiently large database.
"Based on our interpretation of all the clinical data supporting NVX-CoV2373 ... we believe there is insufficient evidence to establish a causal relationship," the company said in a statement.
One patient in the trial reported myocarditis after receiving placebo.
Novavax has said the shot, NVX-CoV2373, will play a role in driving vaccination among those who have been hesitant to get immunized and it has started an educational effort on vaccine choices.
"Despite the wide availability of authorized or approved vaccines, the SARS-CoV-2 pandemic is not well controlled in the U.S. ... there remains a desire for vaccines that have been developed using well-understood technology platforms," it said.
The FDA analyzed data from Novavax's trial before the Omicron and Delta variant became the dominant strains.
"Based on the efficacy estimate in the clinical trial of this vaccine, it is more likely than not that the vaccine will provide some meaningful level of protection against COVID-19 due to Omicron, in particular against more severe disease," the FDA staff said.
The vaccine showed an efficacy of 90.4 per cent in Novavax's study, which enrolled adults across the United States and Mexico.
The FDA's comments came in a briefing note initially prepared ahead of a May 7 meeting of the agency's outside advisers.
Its staff comments will be used by those advisers to guide their decision on whether or not to recommend authorizing the vaccine on Tuesday. The FDA is not mandated to follow the advise of its outside experts, but usually does.
Flight turbulence like that encountered by a Singapore Airlines flight on Tuesday is extremely common, but there's one aspect of severe turbulence an aviation expert says can lead to serious injury.
British Columbia serial killer Robert Pickton was attacked and sustained life-threatening injuries in a Quebec prison Sunday in what officials described as a 'major assault.'
In his latest column for CTVNews.ca, former NDP leader Tom Mulcair argues that if there's an unofficial frontrunner in the eventual race to replace Justin Trudeau as Liberal leader, it has to be former Bank of Canada governor Mark Carney.
The Toronto Blue Jays have offered tickets and a signed baseball to a fan who says she was struck in the face by a 110 m.p.h (177 km/h) foul ball at Friday’s game.
Members of a killer whale pod related to an orphan orca calf that escaped a remote British Columbia tidal lagoon last month have been spotted off the northeast coast of Vancouver Island.
Ontario Provincial Police continue to investigate a long weekend fatal boat collision on Bobs Lake, north of Kingston, Ont.
An investigation has been opened into the death of Matthew Perry and how the “Friends” actor received the anesthetic ketamine, which was ruled a contributing factor in his death.
House of Commons Speaker Greg Fergus is facing fresh Conservative-led calls to resign, this time over "very partisan" and 'inflammatory' language used – the Liberals say mistakenly – to promote an upcoming event.
As Prime Minister Justin Trudeau continues the 'Team Canada' charm offensive to U.S. lawmakers and business leaders, Canada's ambassador to the United States downplayed the effect of another Trump presidency on Canada.
Montreal photographer captured the moment a Canada Goose defended itself from a fox at the Botanical Garden.
Public libraries in Atlantic Canada are now lending a broader range of items.
Flashes of purple darting across the sky mixed with the serenading sound of songs will be noticed more with spring in full force in Manitoba.
Catching 'em all with impressive speed, a 7-year-old boy from Windsor, Ont. who only started his competitive Pokémon journey seven months ago has already levelled up to compete at a world championship level.
A sanctuary dedicated to animals with disabilities is celebrating the third birthday of one of its most popular residents.
2b Theatre recently moved into the old Video Difference building, seeking to transform it into an artistic hub, meeting space, and temporary housing unit for visiting performers in Halifax.
A B.C. woman says her service dog pulled her from a lake moments before she had a seizure, saving her life.
A Starbucks fan — whose name is Winter — is visiting Canada on a purposeful journey that began with a random idea at one of the coffee chain's stores in Texas.
Members of Piapot First Nation, students from the University of Winnipeg and various other professionals are learning new techniques that will hopefully be used for ground searches of potential unmarked grave sites in the future.