Widow looking for answers after Quebec man dies in Texas Ironman competition
The widow of a Quebec man who died competing in an Ironman competition is looking for answers.
The U.S. Food & Drug Administration on Friday said Johnson & Johnson must throw away millions of doses of its COVID-19 vaccine that were manufactured at a problem-plagued Baltimore factory but also cleared millions for use.
Two sources familiar with the situation told Reuters that the agency had cleared about 10 million doses. The New York Times said that the batches being discarded amount to around 60 million doses, citing people familiar with the matter.
Without disclosing or confirming the number of vaccine doses, the FDA said in a news release that it had authorized two batches of the vaccine for use, that several other batches were not suitable for use and that others were being evaluated.
The agency said it was not yet ready to authorize Emergent BioSolutions Inc's plant for manufacturing the J&J vaccine. Production of J&J's vaccine at the Baltimore site was halted by U.S. authorities in April and J&J was put in charge of manufacturing at the plant.
One source familiar with the matter told Reuters that the J&J doses are expected to be exported to other countries. The doses are already in vials and ready for use, the other source said.
Safety concerns about the J&J vaccine paired with flagging U.S. demand for vaccinations in general have slowed rollout of the one-shot vaccine to a crawl. Close to half of the 21 million doses produced for the United States sit unused.
The FDA said its decision allows for the J&J doses to be used in the United States or exported. The agency said the drugmaker and Emergent must agree that the FDA can share relevant information about the manufacturing of the doses with regulators where the vaccine is shipped.
J&J, in a statement, confirmed that the FDA authorized the two batches, but did not acknowledge the doses regulators decided should be tossed.
"Today's decisions represent progress in our continued efforts to make a difference in this pandemic on a global scale," Kathy Wengel, J&J's chief global supply chain officer, said in the statement.
The FDA declined to comment beyond its statement.
Last month, Emergent Chief Executive Robert Kramer said it was his understanding that there are 100 million doses of J&J's vaccine ready for FDA review and that regulators had begun the review process.
The April halt followed the discovery that ingredients from AstraZeneca's COVID-19 vaccine, also being produced at the plant at the time, contaminated a batch of J&J's vaccine. AstraZeneca's shot is no longer being made there.
An FDA inspection also turned up a long list of sanitary problems and bad manufacturing practices at the Emergent plant.
Separately, Europe's drug regulator said on Friday that batches of J&J COVID-19 vaccine made for the region around the time the contamination issues were revealed at the Baltimore plant would, as a precaution, not be used.
The European Medicines Agency did not say how many shots were affected, but Reuters has reported it involves millions of doses, making it harder for J&J to meet a target of delivering 55 million to Europe by end of June.
(Reporting by Michael Erman in Maplewood, N.J.; Additional reporting by Mrinalika Roy and Ankru Bannerjee in Bengaluru; Editing by Bill Berkrot)
The widow of a Quebec man who died competing in an Ironman competition is looking for answers.
Facing pushback from physicians and businesspeople over the coming increase to the capital gains inclusion rate, Prime Minister Justin Trudeau and his deputy Chrystia Freeland are standing by their plan to target Canada's highest earners.
The world is seeing a near breakdown of international law amid flagrant rule-breaking in Gaza and Ukraine, multiplying armed conflicts, the rise of authoritarianism and huge rights violations in Sudan, Ethiopia and Myanmar, Amnesty International warned Wednesday as it published its annual report.
A photographer who worked for Megan Thee Stallion said in a lawsuit filed Tuesday that he was forced to watch her have sex, was unfairly fired soon after and was abused as her employee.
Former NDP leader Tom Mulcair says that what's happening now in a trash-littered federal park in Quebec is a perfect metaphor for how the Trudeau government runs things.
The Senate passed legislation Tuesday that would force TikTok's China-based parent company to sell the social media platform under the threat of a ban, a contentious move by U.S. lawmakers that's expected to face legal challenges.
People living near a wildfire burning about 15 kilometres southwest of Peace River are being told to evacuate their homes.
The U.S. Senate has passed US$95 billion in war aid to Ukraine, Israel and Taiwan, sending the legislation to President Joe Biden after months of delays and contentious debate over how involved the United States should be in foreign wars.
A Winnipeg man said a single date gone wrong led to years of criminal harassment, false arrests, stress and depression.
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.
Molly Knight, a Grade 4 student in Nova Scotia, noticed her school library did not have many books on female athletes, so she started her own book drive in hopes of changing that.
Almost 7,000 bars of pure gold were stolen from Pearson International Airport exactly one year ago during an elaborate heist, but so far only a tiny fraction of that stolen loot has been found.