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.
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Two men have been sentenced to 6 1/2 years in prison for their roles in the blockade of the Canada-U.S. border crossing at Coutts, Alta.
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Thousands of passengers could be stranded as early as Sunday if Air Canada doesn't reach a deal with its pilots' union. Here's what you can do if labour disruptions affect your flight.
Former Canadian fashion mogul Peter Nygard has been sentenced to 11 years in prison. The sentence was handed to Nygard, 83, by Ontario Superior Court Justice Robert Goldstein in Toronto on Monday. Last November, a jury found Nygard guilty of four counts of sexual assault following a six-week trial.
A man wanted for allegedly throwing scalding coffee on a baby in an unprovoked attack at a park in the northern Australian state of Queensland is now the subject of an international manhunt.
Catherine, Princess of Wales, announced Monday she is 'cancer free,' after completing chemotherapy treatment. Here is her message in full.
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Former employees of the company that owned an experimental submersible that imploded on its way to the wreck of the Titanic are scheduled to testify before a Coast Guard investigatory board at an upcoming hearing.
A federal trial is set to begin Monday over claims that supporters of former U.S. president Donald Trump threatened and harassed a Biden-Harris campaign bus in Texas four years ago, disrupting the campaign on the last day of early voting.
Pope Francis received a raucous welcome Monday as he arrived in East Timor to celebrate its recovery from a bloody and traumatic independence battle, even as he indirectly acknowledged an abuse scandal involving its Nobel Peace Prize-winning hero.
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Health Minister Mark Holland says his government will still work on policies it promised to pursue under its now-defunct deal with the NDP.
The Canadian Medical Association says there should be better tracking of health-care spending, following health-care agreements the federal government has signed with the provinces and territories.
Dozens of women who say they suffered excruciating pain at a Yale University fertility clinic because a nurse stole fentanyl for her own use and replaced it with saline have settled their lawsuits against the Ivy League school.
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Former Canadian fashion mogul Peter Nygard has been sentenced to 11 years in prison. The sentence was handed to Nygard, 83, by Ontario Superior Court Justice Robert Goldstein in Toronto on Monday. Last November, a jury found Nygard guilty of four counts of sexual assault following a six-week trial.
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Officers stopped a vehicle allegedly speeding more than 50 kilometres over the posted limit in Kawartha Lakes, netting the driver a lengthy licence suspension.
Windsor police have arrested a suspect after a 36-year-old woman was found with life-threatening injuries in east Windsor.
Starting today, federal workers are required to be in the office three days per week.
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A convicted killer who was serving a life sentence for the 1993 murder of a woman in the British Columbia Interior has died in prison.
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Wednesday marks 11 years since Sudbury teen Meagan Pilon was reported missing and police are appealing to the public again for information.
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Jim Lester’s farm hopped on the cow-cuddling trend in early August, and his time slots have been pretty well sold out ever since.
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