Quebec nurse had to clean up after husband's death in Montreal hospital
On a night she should have been mourning, a nurse from Quebec's Laurentians region says she was forced to clean up her husband after he died at a hospital in Montreal.
Moderna said Monday it plans to expand the size of its COVID-19 vaccine study in younger children to better detect rare side effects, such as a type of heart inflammation recently flagged by U.S. health authorities.
The company said it is in talks with the Food and Drug Administration to enroll more study participants under age 12. It had intended to test the vaccine in about 7,000 children, with some as young as 6 months. The Cambridge, Massachusetts-based company said via email it hasn't decided on how many kids might be added.
The announcement comes as U.S. COVID-19 cases are rising and schools prepare to welcome students back to classrooms. At the same time, regulators continue to review cases of a rare type of heart inflammation called myocarditis that has been reported in a small number of teenagers who got the Moderna or Pfizer shots.
Pfizer said on Monday that if it makes changes to its vaccine testing in children, it will provide an update then. The New York-based company is testing its vaccine in up to 4,500 children in the United States and Europe.
The FDA said in a statement it could not comment on its discussions with companies, but added “we do generally work with sponsors to ensure the number of participants in clinical trials are of adequate size to detect safety signals.”
The news was first reported by the New York Times.
U.S. officials and independent medical experts said last month the benefits of the vaccines far outweigh the risks of the side effect, which has been reported in several hundred people younger than 30. But any vaccine safety issues could slow uptake, particularly among parents wary of taking any health risk with their children.
Currently, Pfizer has the only U.S. vaccine authorized for children 12 years and up, while Moderna is expecting an FDA ruling on its application in the coming days.
While teens receive the same dose as adults, younger children may need smaller doses. That additional complexity adds time to drugmakers' research and application timelines.
Moderna said Monday it expects to have enough data to apply for FDA authorization in younger kids by late this year or early 2022.
Pfizer has previously said it expects to apply in September for children ages 5 through 11. Results for two younger age groups that began testing a little later should be available by October or November, according to the company.
Johnson reported from Fairless Hills, Pennsylvania.
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Department of Science Education. The AP is solely responsible for all content.
On a night she should have been mourning, a nurse from Quebec's Laurentians region says she was forced to clean up her husband after he died at a hospital in Montreal.
A North Bay, Ont., lawyer who abandoned 15 clients – many of them child protection cases – has lost his licence to practise law.
Members of the Bank of Canada's governing council were split on how long the central bank should wait before it starts cutting interest rates when they met earlier this month.
Toronto Maple Leafs forward William Nylander sat out his third straight game to open the playoffs Wednesday night because of an undisclosed injury.
Cuba's foreign affairs minister has apologized to a Montreal-area family after they were sent the wrong body following the death of a loved one.
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.
The federal government's proposed change to capital gains taxation is expected to increase taxes on investments and mainly affect wealthy Canadians and businesses. Here's what you need to know about the move.
The daughter of a New Brunswick man recently exonerated from murder, is remembering her father as somebody who, despite a wrongful conviction, never became bitter or angry.
Prime Minister Justin Trudeau is accusing Conservative Leader Pierre Poilievre of welcoming 'the support of conspiracy theorists and extremists,' after the Conservative leader was photographed meeting with protesters, which his office has defended.
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.
Kevin the cat has been reunited with his family after enduring a harrowing three-day ordeal while lost at Toronto Pearson International Airport earlier this week.