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Trump says FDA hold on blood treatment therapy use for coronavirus patients 'could be a political decision' – CNBC

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U.S. President Donald Trump takes questions during a briefing on the coronavirus disease (COVID-19) pandemic at the White House in Washington, August 11, 2020.

Kevin Lamarque | Reuters

President Donald Trump on Wednesday said he was “surprised” to learn about the Food and Drug Administration’s hold on granting emergency use for an experimental blood treatment for coronavirus patients, saying it may be politically motivated.

“I hear great things about it … that’s all I can tell you,” Trump said during a White House press briefing referring to convalescent plasma therapy. “It could be a political decision because you have a lot of people over there who don’t want to rush things because they want to do it after November 3, and you’ve heard that one before.” 

The FDA reportedly placed its emergency use authorization for convalescent plasma on hold last week after a number of top health officials, including White House coronavirus advisor Dr. Anthony Fauci and Dr. Francis Collins, who was appointed to run the National Institutes of Health by former President Barack Obama in 2009, voiced concern about data on the potential treatment, according to the New York Times

The experimental treatment uses the blood from recovered coronavirus patients who have built antibodies against the diseases and infuses it into people with Covid-19 to prevent severe disease, according to the Mayo Clinic, which is conducting studies on the treatment.

“People are dying, and we should have it approved if it’s good,” Trump said. “And I’m hearing it’s good, I heard from people at the FDA that it’s good.” Trump said that he would “check” on the report after the press briefing. 

While there are currently no FDA-approved drugs or vaccines against the coronavirus, the administration has issued emergency use authorization to clear unapproved products to be used to treat coronavirus patients.

“Per policy, we are not able to comment on whether or not we will take any action regarding emergency use authorization for convalescent plasma and will render a decision at the appropriate time,” said Dr. Anand Shah, FDA’s deputy commissioner for medical and scientific affairs, in a statement. 

The National Institute of Health treatment guidelines, last updated on July 17, say there’s “insufficient data” to support convalescent plasma as a Covid-19 treatment, though thousands of patients in the U.S. have received the treatment as part of clinical trials. 

However, Trump said at the press briefing that he’s heard success rates for convalescent plasma “way over 50%” and said the White House would encourage the therapy’s use if the “numbers are as good” as he’s hearing. 

“I don’t want delays. I don’t want people dying,” Trump said. 

The NIH isn’t involved in the authorization process at the FDA and “does not have the entirety of confidential data” to help make regulatory decisions, Shah said. Convalescent plasma therapy still remains available to some patients through clinical trials, a national expanded access program or for use in a single patient if requested and approved, he added. 

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Toronto ties four COVID cases to local club – Caledon Enterprise

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Nearly 20 per cent of COVID-19 infections among health-care workers by late July – Powell River Peak

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VANCOUVER — Health care workers in Canada made up about 20 per cent of COVID-19 infections as of late July, a figure that was higher than the global average.

In a report released earlier this month, the Canadian Institute for Health Information said 19.4 per cent of those who tested positive for the virus as of July 23 were health-care workers. Twelve health care workers, nine from Ontario and three from Quebec, died from COVID-19, it said.

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The World Health Organization said in July that health-care workers made up 10 per cent of global COVID-19 infections.

A national federation of nurses’ unions blames the infection rate on a slow response to the pandemic, a shortage of labour and a lack of personal protective equipment.

Mahi Etminan, a registered oncology nurse who was working at a hospital in Vancouver in mid-March, says she doesn’t know how she was infected by COVID-19.

“It could have been anywhere in the hospital,” she said.

“In March, we weren’t required to really wear any masks or anything.”

Etminan said she has tested negative for the virus twice but still feels the after-effects of her illness. She tires easily, has lost her sense of taste — even salt — and is losing chunks of her hair.

She agrees with the Canadian Federation of Nurses Unions that proper precautions weren’t put in place to deal with COVID-19.

“I think we were behind in putting a proper protocol in place,” Etminan said.

Linda Silas, president of the 200,000-member nurses’ federation, said Canadian hospitals approached COVID-19 based on the findings of a 2003 Ontario government commission into SARS.

“I thought we were ready,” Silas said in an interview.

“And then mid-March, early March, we realized how unready we were. And that’s one of the reasons that we have one of the highest levels of health-care workers getting infected.”

She said with the routes of transmission for the virus being uncertain — and later research showing it was possible the virus could be airborne — it was critical that health care workers get full protection.

The Ontario government convened the commission to investigate the origin, spread and response to SARS. One of the key recommendations of the report was improving the safety of health-care workers.

Ontario Health Ministry spokesman David Jensen said lessons learned from SARS have been implemented, including giving more powers to the chief medical officer of health to issue directives to workers and organizations.

The province recommends health-care workers use appropriate precautions when conducting clinical assessments, testing and caring for patients who are suspected or confirmed to have COVID-19, he said.

The approach to the novel coronavirus was taken on a precautionary basis because little information was available about its transmission and clinical severity, Jensen said in an email response to questions.

“The majority of cases are linked to person-to-person transmission through close direct contact with someone who has COVID-19. There is no evidence that COVID-19 is transmitted through the airborne route.”

The World Health Organization acknowledged in July the possibility that COVID-19 might be spread in the air under certain conditions.

It said those most at risk from airborne spread are doctors and nurses who perform specialized procedures, such as inserting a breathing tube or putting patients on a ventilator.

Michael Brauer, a professor at the University of British Columbia’s school of population and public health, said COVID-19 doesn’t fit the traditional airborne model where viruses remain infectious over long distances and time periods.

“There’s been a little bit of an evolution in our understanding of the transmission,” he said, adding there was evidence as early as March that showed the virus can be transmitted via air.

While early on more attention was paid to surface transmission, it now seems as though the airborne route is more prominent, he said.

Health Canada spokeswoman Tammy Jarbeau said long-term care facilities and retirement homes were among the hardest hit during the peak of COVID-19 in the spring, likely affecting health-care workers.

The federal government is working with the Canadian Institute for Health Information to better understand the virus, including expanding case data for health-care workers.

The Quebec government said the high rate of community contamination in the province coupled with a labour shortage at the beginning of the pandemic affected health-care workers who were working in several long-term care homes to maintain essential services.

“In recent months, Quebec has gone through an unprecedented health crisis,” said Robert Maranda, a spokesman for the ministry of health and social services.

The plan to deal with COVID-19 was based mainly on the experience gleaned from the 2009 swine flu pandemic, he said.

“However, H1N1 influenza is not the same virus that we are currently fighting against,” Maranda said.

“A person with COVID-19 can transmit the virus without having any symptoms, which is not the case with the flu.”

But as more is known about the new coronavirus, he said the province’s response has changed, including no longer allowing health-care workers to work in different places.

Silas said the nurses’ federation has started an investigation led by a former senior adviser to the SARS commission into why Canada didn’t better protect health-care workers from COVID-19. The report is expected later this year.

The Public Health Agency has done a poor job of gathering data about health-care workers infected with COVID-19, she said, adding that the federation has relied on data collected by Statistics Canada.

“There’s this lack of information flowing,” Silas said.

Natalie Mohamed, a spokeswoman for the Public Health Agency, said 25 per cent of all reported cases were among people who describe themselves as working in health care and it has been collecting data from the provinces and territories since March.

Those who identify themselves as health-care workers include physicians, nurses, dentists, physiotherapists, residential home workers, cleaners, janitorial staff and volunteers.

Some health-care workers may also be getting infected outside work, Mohamed said, although exposure data is incomplete.

The associate executive director of the Canadian Medical Protective Association, which provides advice and assistance in medical-legal matters to doctors, said it began fielding concerns from members about a lack of protective equipment when the virus started spreading.

Dr. Todd Watkins said the questions have shifted to how things will be handled in the future.

“Will there be a second wave and how am I going to respond to that? Is my clinic prepared for that? Will there be appropriate protective gear?”

Christine Nielsen, chief executive officer of the Canadian Society for Medical Laboratory Science, said the flow of information is affected by the fact the provinces and territories deliver health care and they could collect data differently.

“There’s room for improvement with how public health has responded,” she said. “Just the scale of the pandemic has really caught everyone off guard.”

This report by The Canadian Press was first published on Sept. 19, 2020.

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B.C. to publish a list of school COVID-19 exposures, outbreaks – Prince George Citizen

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The B.C. government intends to publish online all COVID-19 school exposure and outbreak events.

The move follows the first of five health authorities to provide its own online list of exposures or outbreaks, a ministry spokesperson confirmed.

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Fraser Health announced Wednesday a web page that will list all such events by school district.

The website does not provide any details of a so-called exposure and it’s not yet clear if more details will be provided for an outbreak and whether such details will be updated as cases are confirmed.

An exposure is when someone who attended the school tested positive for COVID-19 and does not mean the disease was transmitted. Only an outbreak notice is an indication public health authorities have determined transmission in a school setting.

Parents do not need to take action if there is an exposure event, unless contacted by a health official (contact tracer) or school official, states Fraser Health.

“We have a responsibility to be transparent, clear, and current in our communication to parents, teachers, and students about COVID-19 exposures in schools in our region, and the launch of our COVID-19 school exposures webpage provides us with an opportunity to do just that,” said Dr. Victoria Lee, Fraser Health president and CEO, via a media statement. “This new page is a tool for us to help keep the lines of communication open and give schools and families the resources they need to feel safe and reassured.”

Fraser Health oversees 11 school districts between Burnaby and Hope, including Delta and Surrey.

The list shows six exposure events, to date. One at Delta secondary school and five others in Surrey.

More details appear to be provided specifically to parents via the school districts, who are in cross communications with the health authority.

In a letter to parents Wednesday, Delta district superintendent Doug Sheppard noted a key point for families to remember is that Fraser Health will connect directly with any individuals who may have been exposed with further instructions via phone call or letter. If someone is contacted by Fraser Health, they’re asked to follow the health authority’s advice carefully.

Sheppard said the protocol in such circumstances includes:

  • Fraser Health Authority will initiate contact tracing
  • FHA will determine how the individual was infected and who they were in close contact with
  • The heath authority will determine if close contacts will be asked to self-isolate for 14 days
  • Only public health can determine who is a close contact.

With files from Delta-Optimist

gwood@glaciermedia.ca
 

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