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U.S. COVID-19 booster shot plan faces complications, some may miss Sept. 20 – CP24 Toronto's Breaking News

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WASHINGTON (AP) – President Joe Biden’s plans to start delivery of booster shots by Sept. 20 for most Americans who received the COVID-19 vaccines are facing new complications that could delay the availability of third doses for those who received the Moderna vaccine, administration officials said Friday.

Biden announced last month that his administration was planning for boosters to be available for all Americans who received the mRNA vaccines in an effort to provide more enduring protection against the coronavirus, pending approvals from the Centers for Disease Control and Prevention and the Food and Drug Administration.

Those agencies, though, are awaiting critical data before signing off on the third doses, with Moderna’s vaccine increasingly seen as unlikely to make the Sept. 20 milestone.

According to one official, Moderna produced inadequate data for the FDA and CDC to recommend the third dose of its vaccine and FDA has requested additional data that is likely to delay those boosters into October. Pfizer, which is further along in the review process, in part because of data collected from the vaccine’s use in Israel, is still expected to be approved for a third dose for all by Sept. 20. A key FDA panel is to review Pfizer’s data on boosters on Sept. 17.

Data for boosters on Johnson & Johnson’s single-dose vaccine won’t be available for months, since that shot wasn’t approved until February, officials said.

Dr. Janet Woodcock, the acting FDA commissioner, and CDC Director Dr. Rochelle Walensky, briefed White House COVID-19 coordinator Jeff Zients and other officials about the expected Moderna delay on Thursday, officials said.

Most of the 206 million Americans at least partially vaccinated against COVID-19 received the Pfizer shot, but about 80 million received the Moderna vaccine, according to CDC data.

The administration’s public pronouncement about booster availability, a break from the more deliberate and behind-the-scenes planning that defined its early vaccination campaign, sparked concerns from some that the White House was getting ahead of the science on boosters.

“The announcement in August kinda jumped the gun,” said Dr. Stephen Ostroff, former acting FDA commissioner during the Obama administration. “They needed to say something, but they could have just said, `we’re working on boosters, more to come.”’

The White House said it was merely preparing for the boosters‘ eventual approval, and that the reviews were “all part of a process that is now underway.”

“We are awaiting a full review and approval by the FDA and a recommendation by the ACIP,” said White House spokesman Chris Meagher, referencing the CDC’s Advisory Committee on Immunization Practices. “When that approval and recommendation are made, we will be ready to implement the plan our nation’s top doctors developed so that we are staying ahead of this virus.”

Even before Biden’s announcement last month, his administration had been preparing for months for the possibility that boosters would be required, maintaining America’s supply of doses and devising promotion plans with the same “intensity” that it brought to the initial vaccination campaign, Zients told reporters Thursday.

Biden on Aug. 18 touted boosters as a protection against the more transmissible delta variant of the virus, which is raging across the country and slowing the economic recovery from the pandemic, as well as potential variants to come.

“Just remember, as a simple rule – rule: Eight months after your second shot, get a booster shot,” he said then, adding that health experts were aiming to be ready to administer them by Sept. 20, pending approval by the regulatory agencies.

Dr. Anthony Fauci, the nation’s top infectious disease expert, has become an outspoke champion of the booster campaign, as the Biden administration looks to curtail the delta variant.

He told reporters on Thursday he believes it is likely that Americans will all need to get a third dose of the mRNA vaccines to be considered fully vaccinated against COVID-19.

“From my own experience as an immunologist, I would not at all be surprised that the adequate, full regimen for vaccination will likely be three doses,” he said.

A formal determination that the third dose is required for “full vaccination” would have broad implications for schools, businesses and other entities that have implemented vaccination mandates.

AP writer Matthew Perrone contributed.

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Pfizer sends kids’ COVID-19 vaccine trial data to U.S. FDA – Global News

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Pfizer Inc. and BioNTech SE on Tuesday submitted initial trial data for their COVID-19 vaccine in children aged 5 to 11 and said they would make a formal request with U.S. regulators for emergency use in the coming weeks.

Coronavirus infections have soared in children, hitting their highest point in early September, according to data from the American Academy of Pediatrics.

The vaccine, which is already authorized in teens aged 12 to 15 and fully approved for ages 16 and up, induced a strong immune response in the target age group in a 2,268-participant clinical trial, the companies said on Sept. 20.


Click to play video: 'U.S. to donate half a billion additional Pfizer COVID-19 vaccines'



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U.S. to donate half a billion additional Pfizer COVID-19 vaccines


U.S. to donate half a billion additional Pfizer COVID-19 vaccines

The Pfizer-BioNTech vaccine was authorized in kids aged 12-15 roughly a month after the companies filed for authorization. If the same timeline is followed for this application, younger children could start receiving their shots as soon as late October.

A rapid authorization could help mitigate a potential surge of cases this fall, with schools already open nationwide.

While kids are less susceptible to severe COVID-19, they can spread the virus to others, including vulnerable populations that are more at risk of severe illness.

The companies said they plan to submit the data to the European Medicines Agency and other regulatory authorities.

Read more:
Pfizer launches large study of oral COVID-19 prevention drug

Data from the companies’ trial showed the two-shot vaccine generated an immune response in children that matched what was previously observed in 16-to-25 year olds. The safety profile was also comparable to the older age group, Pfizer said.

The drugmakers are also testing the vaccine in children aged 2-to-5 and those aged 6 months-to-2 years, with data expected in the fourth quarter.

Moderna’s COVID-19 vaccine is not yet authorized for use in adolescents in the United States, while it has gained authorization for that age group in Europe.

(Reporting by Manas Mishra in Bengaluru; Editing by Saumyadeb Chakrabarty)

© 2021 Reuters

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Trapped miners expected to emerge this morning as rescue operation continues: Vale – CP24 Toronto's Breaking News

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Liam Casey, The Canadian Press


Published Tuesday, September 28, 2021 7:54AM EDT


Last Updated Tuesday, September 28, 2021 11:14AM EDT

Thirty-three of 39 miners who were trapped underground in northern Ontario since Sunday have returned safely to the surface, the workers’ union said Tuesday as a rescue operation continued.

United Steelworkers, which represents workers trapped in Totten Mine near Sudbury, Ont., said they are pleased with the rescue operation thus far.

“A team of doctors is on site, checking workers as they emerge,” said the union, which represents 30 of the 39 staff members trapped in the mine. “No one has been physically injured in the incident or in the evacuation.”

Vale, the company that owns the mine, said it expects everyone to emerge Tuesday.

The employees were trapped in the mine on Sunday when a scoop bucket being sent underground detached and blocked the mine shaft, Vale said.

As a result, it said the “conveyance system” for taking workers to and from the surface became unavailable.

Vale said the trapped miners have been staying in underground “refuge stations,” some 900 to 1,200 metres underground, as part of the company’s standard procedures.

The workers began making their way out Monday night through a “a secondary egress ladder system,” the company said.

“We thank the impacted employees for their patience and perseverance and the mine rescue teams for their tireless dedication and support,” said Gord Gilpin, head of mining for Vale’s Ontario operations. “This has been an incredible team effort.”

A rescue team met the miners Monday and prepared them for the long journey to the surface.

The union said the miners had to scale a system of ladders, with each ladder being about six metres long and with a staging area at every break.

“When an incident like this unfortunately happens, everyone comes together,” said Nick Larochelle, president of USW Local 6500

“The miners support each other, the highly trained mine rescue teams come together and the whole community waits patiently praying for the safe return of every one of the 39 miners to surface.”

The company said the trapped miners had access to food, water and medicine. The union added that miners had been able to make phone calls to both communicate with rescuers and to call loved ones.

Totten Mine opened in 2014, in Worthington, Ont., and produces copper, nickel and precious metals. It employs about 200 people.

The province’s Ministry of Labour, Training and Skills Development, said an inspection team will investigate the incident once the rescue operation is finished.

This report by The Canadian Press was first published Sept. 28, 2021.

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33 trapped miners safe after rescue, 6 more on long trek out of mine near Sudbury – CP24 Toronto's Breaking News

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Liam Casey, The Canadian Press


Published Tuesday, September 28, 2021 7:54AM EDT


Last Updated Tuesday, September 28, 2021 11:14AM EDT

Thirty-three of 39 miners who were trapped underground in northern Ontario since Sunday have returned safely to the surface, the workers’ union said Tuesday as a rescue operation continued.

United Steelworkers, which represents workers trapped in Totten Mine near Sudbury, Ont., said they are pleased with the rescue operation thus far.

“A team of doctors is on site, checking workers as they emerge,” said the union, which represents 30 of the 39 staff members trapped in the mine. “No one has been physically injured in the incident or in the evacuation.”

Vale, the company that owns the mine, said it expects everyone to emerge Tuesday.

The employees were trapped in the mine on Sunday when a scoop bucket being sent underground detached and blocked the mine shaft, Vale said.

As a result, it said the “conveyance system” for taking workers to and from the surface became unavailable.

Vale said the trapped miners have been staying in underground “refuge stations,” some 900 to 1,200 metres underground, as part of the company’s standard procedures.

The workers began making their way out Monday night through a “a secondary egress ladder system,” the company said.

“We thank the impacted employees for their patience and perseverance and the mine rescue teams for their tireless dedication and support,” said Gord Gilpin, head of mining for Vale’s Ontario operations. “This has been an incredible team effort.”

A rescue team met the miners Monday and prepared them for the long journey to the surface.

The union said the miners had to scale a system of ladders, with each ladder being about six metres long and with a staging area at every break.

“When an incident like this unfortunately happens, everyone comes together,” said Nick Larochelle, president of USW Local 6500

“The miners support each other, the highly trained mine rescue teams come together and the whole community waits patiently praying for the safe return of every one of the 39 miners to surface.”

The company said the trapped miners had access to food, water and medicine. The union added that miners had been able to make phone calls to both communicate with rescuers and to call loved ones.

Totten Mine opened in 2014, in Worthington, Ont., and produces copper, nickel and precious metals. It employs about 200 people.

The province’s Ministry of Labour, Training and Skills Development, said an inspection team will investigate the incident once the rescue operation is finished.

This report by The Canadian Press was first published Sept. 28, 2021.

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