Grandparent scam: London, Ont., senior beats fraudsters not once, but twice
It was a typical Tuesday for Mabel Beharrell, 84, until she got the call that would turn her world upside down. Her teenaged grandson was in trouble and needed her help.
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.
It was a typical Tuesday for Mabel Beharrell, 84, until she got the call that would turn her world upside down. Her teenaged grandson was in trouble and needed her help.
The deaths of four people on a farm near the Saskatchewan village of Neudorf have been confirmed a murder-suicide.
The Canada Revenue Agency announced Thursday it will not require 'bare trust' reporting from Canadians that it introduced for the 2024 tax season, just four days before the April 2 deadline.
The Parole Board of Canada has granted full parole to one of three men convicted in the brutal murders of three McDonald's restaurant workers in Cape Breton more than 30 years ago.
Calgary police shut down a number of bridges into and out of the downtown core as officers dealt with a distraught individual. The incident lasted almost 20 hours.
Ontario released its annual sunshine list Thursday afternoon, noting that the largest year-over-year increases were in hospitals, municipalities, and post-secondary sectors.
Genetic analysis has shed light on a long-standing mystery surrounding the fates of U.S. President George Washington's younger brother Samuel and his kin.
A spokesman for a regional Muslim advocacy group says Conservative Leader Pierre Poilievre's stance on the Israel-Hamas war could complicate his party's relationship with Muslim Canadians.
Former U.S. President Donald Trump is officially selling a copy of the Bible themed to Lee Greenwood’s famous song, 'God Bless the USA.' But the concept of a Bible covered in the American flag has raised concern among religious circles.
B.C. conservation officers recently seized a nine-foot-long Burmese python from a home in Chilliwack.
A New Brunswicker will go to bed Thursday night much richer than he was Wednesday after collecting on a winning lottery ticket he let sit on his bedroom dresser for nearly a year.
The Ontario government is introducing changes to auto-insurance, but some experts say the move is ill-advised.
A Toronto restaurant introduced a surprising new rule that reduced the cost of a meal and raised the salaries of staff.
Newfoundland’s unique version of the Pine Marten has grown out of its threatened designation.
A Toronto man is out $12,000 after falling victim to a deepfake cryptocurrency scam that appeared to involve Prime Minister Justin Trudeau.
It started small with a little pop tab collection to simply raise some money for charity and help someone — but it didn’t take long for word to get out that 10-year-old Jace Weber from Mildmay, Ont. was quickly building up a large supply of aluminum pop tabs.
There’s a group of people in Saskatoon that proudly call themselves dumpster divers, and they’re turning the city’s trash into treasure.
Ontario is facing a larger than anticipated deficit but the Doug Ford government still plans to balance its books before the next provincial election.