'He's in our hearts': Family and friends still seek answers one year after Nathan Wise’s disappearance
It’s been a year since Nathan Wise went missing and his family is no closer to finding out what happened to him.
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’s been a year since Nathan Wise went missing and his family is no closer to finding out what happened to him.
Dozens of Ontarians are expressing frustration in the province’s health-care system after their family doctors either dropped them as patients or threatened to after they sought urgent care elsewhere.
An Ottawa pizzeria is being recognized as one of the top 20 deep-dish pizzas in the world.
Amazon's paid subscription service provides free delivery for online shopping across Canada except for remote locations, the company said in an email. While customers in Iqaluit qualify for the offer, all other communities in Nunavut are excluded.
The fire burning near Fort McMurray grew from 25 hectares to 5,500 hectares over the weekend.
Russia’s President Vladimir Putin began a Cabinet shakeup on Sunday, proposing the replacement of Sergei Shoigu as defence minister as he begins his fifth term in office.
Police are searching for a male suspect after a man was “slashed in neck” on Sunday morning in downtown Toronto and died.
There were some scary moments for several people on a northern Ontario highway caught on video Thursday after a chain reaction following a truck fire.
Health Canada announced various product recalls this week, including electric adapters, armchairs, cannabis edibles and vehicle components.
English, history, entertainment, math and geography: high school trivia teams could be quizzed on any of it when they compete at the Reach for the Top Nationals in Ottawa in June.
An Ottawa pizzeria is being recognized as one of the top 20 deep-dish pizzas in the world.
A family of fifth generation farmers from Ituna, Sask. are trying to find answers after discovering several strange objects lying on their land.
A Listowel, Ont. man, drafted by the Hamilton Tigercats last week, is also getting looks from the NFL, despite only playing 27 games of football in his life.
The threat of zebra mussels has prompted the federal government to temporarily ban watercraft from a Manitoba lake popular with tourists.
A small Ajax dessert shop that recently received a glowing review from celebrity food critic Keith Lee is being forced to move after a zoning complaint was made following the social media influencer’s visit last month.
The Canada Science and Technology Museum is inviting visitors to explore their poop. A new exhibition opens at the Ottawa museum on Friday called, 'Oh Crap! Rethinking human waste.'
The Regina Police Service says it is the first in Saskatchewan and possibly Canada to implement new technology in its detention facility that will offer real-time monitoring of detainees’ vital health metrics.
Just as she had feared, a restaurant owner from eastern Quebec who visited Montreal had her SUV stolen, but says it was all thanks to the kindness of strangers on the internet — not the police — that she got it back.