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A Canadian spin studio followed public health guidelines. But 61 people still caught the covid-19.

Now, despite appearing to have complied with public health regulations, at least 61 people linked to the studio have tested positive for the novel coronavirus.

“They had done all sorts of things to remove the potential for spread,” Richardson told reporters. “Unfortunately, gyms are a higher-risk place because of the fact that generally people are taking off their masks, they’re breathing at a higher rate.”

Although Hamilton requires masks to be worn in most public settings, the law includes an exemption for anyone “actively engaged in an athletic or fitness activity.” In keeping with that policy, the studio, SPINCO, allowed riders to remove their masks once clipped into their bikes, and told them to cover up again before dismounting.

In a recent Instagram post, SPINCO’s owners said that they had been “hesitant” to reopen after getting the green light in July, and would not resume classes “until it is safe to do so.” Health officials have said that the studio is temporarily closed and cooperating fully with the investigation.

“We took all the measures public health offered, even added a few, and still the pandemic struck us again!’” the owners wrote. SPINCO has more than a dozen locations across Canada.

As of Tuesday, 44 cases linked to specific classes were detected, Richardson said. An additional 17 instances of “secondary cases” were found among other contacts.

The city will reexamine gym protocols, Richardson added Tuesday, but in the meantime, “what seems to be the case is that you need to wear that mask” even though government guidelines do not strictly require it.

“It’s still a good idea to do it, in terms of keeping others safe,” she said.

People should also avoid “classes where you’ve got that kind of yelling or coaching over music.”

She declined to use the term “superspreader” to describe the event but said it is a “very large outbreak.”

“It is concerning that it is extended beyond the initial cases who were related to the classes but gone into of course their household contacts and other contacts,” she said. “We continue to look at what does it mean, what do we need to understand about exercise classes?”

The outbreak offers further evidence of the dangers of people gathering indoors without masks, as health experts warn that cases could spike further in the coming months as winter weather sets in and outdoor gatherings and exercise classes will be harder to maintain.

In August, South Korea confirmed dozens of cases linked to a single Starbucks in the city of Paju where many customers did not wear masks. The store employees, who wore masks, were not infected. The outbreak prompted Starbucks to limit its indoor seating in the country and encourage masks among patrons.

In other instances, mask usage has been credited with preventing potential outbreaks. In May, after the reopening of a hair salon in Missouri that required masks, two stylists — who had worked with more than 100 clients — tested positive for the virus. But masks were

California releases guidelines for private gatherings with friends

Ahead of the Halloween and Thanksgiving holidays, California Health and Human Services Secretary Dr. Mark Ghaly addressed new guidelines the state released this week allowing private outdoor gatherings with friends if specific conditions are met.

Ghaly said attendees must be from no more than three separate households and gatherings should last no more than two hours.

Gatherings “should be and must be done outside,” he added. People are also expected to take safety precautions, including wearing masks, practicing physical distancing and washing hands.

In the past, the state discouraged any gatherings outside of a single household.


Ghaly said the guidelines are meant to recognize that many close friends and relatives have been apart a long time and increasingly want to be together, especially with the holidays ahead.

The intention of the guidelines is not to encourage gatherings, but to inspire people to socialize safely when they do.

“Guidance here does not mean go,” he said. “It does not mean that we’re endorsing or suggesting small gatherings happen. We just want to provide important ways to reduce your risk, so you protect yourselves, your families and your communities.”

“We believe and still really support the messaging that spending time with your household alone is the way we can reduce transmission the best,” he said.

While much of the country and European nations are seeing a resurgence, coronavirus indicators in California are near their record lows. Hospitalizations are at their lowest level since early April and those in intensive care at their second-lowest level since officials began keeping track in late March. The rate of positive tests has been hovering at 2.6% for two weeks.

“We don’t see the surge other parts of the country are experiencing and other parts of the globe,” he said. “We don’t want to see the spike that could rightfully happen.”

The Associated Press contributed to this story.

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Sam Houston State University’s new Conroe campus adjusts to COVID guidelines

This is the first semester that the new Sam Houston State University College of Osteopathic Medicine in Conroe has welcomed students to campus, but because of the COVID-19 pandemic, the year is not starting as anticipated.

The College of Osteopathic Medicine received its pre-accreditation status in September of last year, which allowed the college to start recruiting new students. The school’s first class is 75 students but in about two years the school plans to double that number to meet its full capacity of 150 students.

As the COVID-19 pandemic made its way into Montgomery County, Sam Houston State University began to plan for changes to the new year, keeping in mind all the requirements their students will have to meet to become medical practitioners. Back in March, faculty were asked to work remotely and the school began to plan for a year that looked very different from what was originally planned.


“At first, students had limited time in the building but we felt very strongly that their experiential learning, their lab learning, we needed them in the building to do that, we needed them with their faculty to do that,” said Mari Hopper, associate dean for Biomedical Sciences at the campus.

In order to bring the students to campus safely for their experiential learning, the class was divided into four groups that rotated into the building throughout the day to keep the population in the building low. Before students even arrived, the school put together a video message for them that outlined the expectations in place for being in the building (masks, hand washing, social distancing, etc) with a message from the dean. Classes started on Aug. 10 as planned.

Portions of the classes that were not lab-based are being offered through remote learning. Students can access that work through Blackboard. While some of it is synchronous learning, students accessed it while it was happening, much of it was asynchronous, so they could access it on their own time.

Within the four groups that met together, students were split into even smaller groups of five and six to study and practice together with self-directed work.

“We also recognize that students, frankly, were in need of learning support,” Hopper said. “Those small groups provided the opportunity to collaborate with their peers, and medical students really need and request that.”

The groups also help meet the students’ need for social interactions in a safe space. As of Oct. 7, Hopper said the college had not had any cases of COVID-19 in its students. Students are self-monitoring for symptoms at home and before they come to campus they sign an attestation that they are not ill. When they get to the lab their temperature is taken before they can enter.

In response to the pandemic, the school created a student response team for the possibility of a student becoming ill. The team, Hopper said, made of clinicians and faculty, isn’t there to treat

Explore the CDC’s school reopening guidelines in augmented reality

The Centers for Disease Control and Prevention has promoted preparing schools for the safe return of students to the classroom this fall amid the continuing coronavirus pandemic across the United States. The CDC has shared its recommended strategies to slow the spread of COVID-19 in schools, which includes measures like social distancing, wearing masks and practicing proper hand hygiene. 

The CDC suggests providing physical guides, such as tape on the floor, to remind people to stay at least six feet apart. Students and staff should wash their hands or use hand sanitizer frequently, and staff should disinfect surfaces often to prevent the spread of the virus in the classroom. Students should also learn how to properly wear masks, which is especially important when they’re indoors and when social distancing is difficult. Listen along to the CDC’s recommendations to help slow the spread of the coronavirus in schools, and explore the scene in this immersive 3D experience.

The 3D experience can be viewed on both desktop and mobile.

For desktop:

For mobile (optimal experience):

  • Click on “View in 3D” above

  • Tap on the camera icon in the upper right-hand corner of the browser

  • Press “allow” (this prompt should come up multiple times)

  • Place the object in your space, use your fingers to resize and rotate in augmented reality

  • To take a photo of what you’re seeing, tap on the screen and a camera icon will appear

_____

 

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ASH Releases Clinical Practice Guidelines on the Use of Preventive Anticoagulation in Patients with COVID-19

ASH Releases Clinical Practice Guidelines on the Use of Preventive Anticoagulation in Patients with COVID-19

PR Newswire

WASHINGTON, Oct. 8, 2020

Evidence-based recommendations will inform prevention of COVID-related blood clotting

WASHINGTON, Oct. 8, 2020 /PRNewswire/ — Today, ASH released new guidelines to help clinicians prevent serious blood clotting complications affecting COVID-19 patients. The recommendations suggest that clinicians should use a standard prophylactic anticoagulant dose over higher doses to prevent clotting in patients who have been hospitalized with COVID-19, including those in intensive care.

American Society of Hematology logo.
American Society of Hematology logo.

Abnormal blood clotting has been reported as a complication associated with increased risk of death in patients with COVID-19, particularly hospitalized patients. The guidelines address both critically ill hospitalized patients – people who are ill enough to require intensive care – and acutely ill hospitalized patients – people who require monitoring and treatment in the hospital but not intensive care. It is common for clinicians to administer anticoagulants to these patients upon admission to try to prevent formation of blood clots; however, there is uncertainty regarding the right dose to give. For both acutely and critically ill patients, the guidelines suggest the use of a standard prophylactic dose of anticoagulation upon admission to the hospital. The use of higher doses of anticoagulants is not recommended, as it may pose greater risk for serious bleeding that outweighs potential benefits. However, the guideline panel highlighted the importance of individualized decision-making and acknowledged that a higher dose of anticoagulants may be appropriate in patients judged to be at especially high clotting risk and low bleeding risk.

“COVID-19 is the most important public health problem of our lifetime, with more than one million deaths worldwide. Data suggest that abnormal blood clotting plays an important role in why patients die or get very sick from this disease. Thus, it is important that these patients be given anticoagulants to try to prevent clots, and data available right now suggest that standard dosing provides the best balance of benefits and risks,” said ASH President Stephanie Lee, MD, of Fred Hutchinson Cancer Research Center. “Equipping clinicians with evidence-based guidelines that focus on the prevention of clotting has the potential to save lives.”

In June 2020, ASH formed a multidisciplinary, internationally representative panel to develop the guidelines. The panel was chaired by Drs. Adam Cuker, of the University of Pennsylvania; Holger Schunemann, of McMaster University; and Reem Mustafa, of University of Kansas Medical Center. The panel urgently examined all available evidence, including early reports from observational studies. Development of these guidelines, including systematic evidence review, was supported by the McMaster University GRADE Centre, a world leader in guideline development. At this time, the best available evidence is very low quality, and the recommendations are framed with conditions, explanations, and a call for more research. The systematic reviews and recommendations will continue to be maintained and updated, especially as better evidence from randomized clinical trials becomes available.

“The development of these guidelines

Trump returns from Walter Reed, White House backs FDA vaccine guidelines

The White House has reportedly backed away from a battle with the U.S. Food and Drug Administration (FDA), which has been advancing a timeline for a coronavirus vaccine that suggested an approval wouldn’t happen before Election Day.

The FDA has said it will need two months of observation in late-stage trials of any coronavirus vaccine in order to consider an emergency use authorization — an objective that conflicted with President Donald Trump’s desire to have an inoculation by early November. However, the White House signed off on the new guidelines Tuesday afternoon, backing away from a potential standoff that had worried health experts.

Trump, fresh from a stint in the hospital after being diagnosed with COVID-19, re-ignited the political debate over a vaccine timeline, putting him at odds with the FDA. In a video Monday evening, Trump also said that “vaccines are coming, momentarily” — even as FDA guidelines suggest a release wouldn’t happen until well after Election Day.

Trump said as much late Tuesday on Twitter, tagging FDA Commissioner Stephen Hahn while posting, “New FDA Rules make it more difficult for them to speed up vaccines for approval before Election Day. Just another political hit job!”

The White House was previously citing pharmaceutical companies’ objections to the two-month period.

Pfizer (PFE) CEO Albert Bourla said Tuesday the company has not been in touch with the White House on the topic and “we believe (FDA)’s independence is today more important than ever as public trust in (COVID-19) vaccine development has been eroded by the politicization of the process.”

In interviews in the past 24 hours, FDA’s top vaccine official, Dr. Peter Marks said a minimum of 7 weeks would be acceptable.

“We’ve made it clear we want to see a median of two months of follow-up for any of the vaccines…while it would be nice to have much more, we have to balance the safety we get up front with the need to try to save lives,” Marks said in an interview with the Journal of the American Medical Association.

He added that an emergency use authorization of a vaccine is likely by the end of the year, since it only takes weeks to review an EUA filing, compared to months of review for a full license approval.

But even that EUA filing could remain a question. Moncef Slaoui, head of Operation. Warp Speed, said during a symposium co-hosted by Johns Hopkins University and the University of Washington that he has advised companies not to file for an EUA until they have enough vaccine to distribute.

A critical date will come on October 22, the date established by a key FDA advisory body to determine official guidelines, even though Trump could still override any decision made then.

“Data from Phase 3 studies that includes a median follow-up duration of at least two months after completion of the full vaccination regimen to help provide adequate information to assess a vaccine’s benefit-risk profile,” according to the Vaccines and Related

The F.D.A. releases stricter guidelines for vaccine developers after a holdup at the White House.

The Food and Drug Administration released updated, stricter guidelines on Tuesday for coronavirus vaccine developers — a step that was blocked for two weeks by top White House officials. The guidelines make it highly unlikely that a vaccine could be authorized by Election Day.

The move, which was cleared by the Office of Management and Budget, appeared to be an abrupt reversal a day after The New York Times reported that White House officials, including Mark Meadows, the chief of staff, were blocking the guidelines.

The new recommendations, which do not carry the force of law, call for gathering comprehensive safety data in the final stage of clinical trials before an emergency authorization can be granted.

On Tuesday evening, President Trump showed his displeasure at the action of his own White House, and charged that the new guidelines were a conspiracy against his reelection prospects.

“New F.D.A. Rules make it more difficult for them to speed up vaccines for approval before Election Day. Just another political hit job!” he tweeted, tagging Dr. Stephen M. Hahn, the F.D.A. commissioner.

Since the start of the coronavirus pandemic, the F.D.A. has said that it has been seeking ways to accelerate the development of vaccines without sacrificing safety. In June, the agency released an initial set of guidelines to give vaccine developers a better idea of how the F.D.A. would decide if a vaccine were acceptable, either for an emergency use authorization or for a full license.

Four vaccines have reached the final stage of testing, known as a Phase 3 trial, in the United States. A fifth is expected to start this month. President Trump has repeatedly suggested that a vaccine would be ready by Election Day, if not before.

But with public confidence declining in opinion polls about what could be a rushed coronavirus vaccine, the F.D.A. submitted a new set of guidelines to the White House for approval on Sept. 21.

Among the recommendations, the agency advised vaccine makers to follow volunteers for a median of two months after the final dose. The F.D.A. also expected vaccine makers to document five cases of severe infection in people who received the placebo instead of the vaccine.

The F.D.A. submitted the guidelines to the Office of Management and Budget for approval more than two weeks ago, but they stalled in part because of Mr. Meadows’s involvement, according to a senior administration official and others familiar with the situation.

The White House objected that the guidelines would add more time before a vaccine could be authorized. In a conversation with Dr. Hahn days after the guidelines were submitted, Mr. Meadows said the recommendations amounted to changing the rules on drugmakers in the throes of clinical trials, according to one senior administration official. He also suggested that Dr. Hahn was overly influenced by career scientists, who had drafted the document, the official said.

Trump administration officials have the authority to intervene with such nonbinding documents, partly because of a 2019 executive order that tightened

U.S. FDA Safety Guidelines Likely to Push COVID-19 Vaccine Authorization Past Election | Top News

By Michael Erman and Manas Mishra

(Reuters) – The U.S. Food and Drug Administration told coronavirus vaccine developers on Tuesday it wants at least two months of safety data before authorizing emergency use, a requirement that would likely push any U.S. vaccine availability past the Nov. 3 presidential election.

A senior administration official confirmed the White House had approved the plan, which undercuts President Donald Trump’s hopes of getting a vaccine before voters go to polls.

Trump voiced his displeasure in a Twitter post late on Tuesday: “New FDA Rules make it more difficult for them to speed up vaccines for approval before Election Day. Just another political hit job!”

The FDA released the guidance laying out more stringent recommendations for drugmakers hoping to apply for an emergency use authorization (EUA) for their experimental vaccines.

The New York Times reported on Monday that the guidelines had been blocked by the White House. The senior administration official said there he had been no holdup of the guidance, which underwent normal regulatory review.

The move is the latest effort by U.S. officials to play down politics around the vaccine and assure public safety.

“Being open and clear about the circumstances under which the issuance of an emergency use authorization for a COVID-19 vaccine would be appropriate and is critical to building public confidence and ensuring the use of COVID-19 vaccines once available,” Dr. Peter Marks, director of the FDA division responsible for approving vaccines, said in a statement.

The White House could still force authorization of a vaccine without that additional safety data. Doing so would put it in open disagreement with the FDA and its career scientists, and add to the perception that politics was playing a role in pushing out a vaccine.

If the agency follows its own guidelines, it is unlikely to authorize a vaccine before sometime in late November. It wants two months of data from half of a trial’s volunteers.

Pfizer Inc and partner BioNTech <22UAy.F> are expected to be the first to announce results from a late-stage U.S. clinical trial.

About half the volunteers in the 44,000-subject Phase III trial had received the second dose of the two-shot vaccine by late September.

Pfizer had previously said it expected to release efficacy data as early as this month and provide FDA with safety data, including the median of two months’ safety data after the second dose, on a rolling basis.

The head of the U.S. government’s Operation Warp Speed vaccine development program said on Tuesday efficacy data on one or two vaccines will be available within the next month or two, and that there should be enough supply to immunize 30 million people during November and December.

Moderna Inc

appears likely to be the second company after Pfizer that will have U.S. trial data available for an EUA review.

Pfizer Chief Executive Albert Bourla tweeted on Tuesday that the company had not discussed the FDA’s standards with the White House, saying that could compromise the agency’s independence.

FDA posts vaccine guidelines blocked by White House

Nurse Kathe Olmstead prepares a shot that is part of a possible COVID-19 vaccine, developed by the National Institutes of Health and Moderna Inc., in Binghamton, N.Y.

Hans Pennink | AP

The Food and Drug Administration laid out updated safety standards Tuesday for makers of Covid-19 vaccines after the White House blocked their formal release, the latest political tug-of-war between the Trump administration and the government’s public health scientists.

In briefing documents posted on its website, the FDA said vaccine makers should follow trial participants for at least two months to rule out safety issues before seeking emergency approval. That requirement would almost certainly preclude the introduction of a vaccine before Nov. 3.

President Donald Trump has repeatedly insisted a vaccine could be authorized before Election Day, even though top government scientists working on the effort have said that timeline is very unlikely. On Monday Trump said vaccines are coming “momentarily,” in a video recorded after he returned to the White House. 

Former FDA officials have warned that public perception that a vaccine was being rushed out for political reasons could derail efforts to vaccinate millions of Americans.

A senior administration official confirmed to the AP on Monday that the White House had blocked FDA’s plans to formally publish the safety guidelines based on the 2-month data requirement, arguing there was “no clinical or medical reason” for it.

But the FDA tucked the information into a memo posted ahead of an Oct. 22 meeting of its outside vaccine advisory panel. The group of non-governmental experts is scheduled to discuss general standards for coronavirus vaccines, part of FDA’s effort to publicize its process and rationale for vaccine reviews. While information prepared for such panels does not carry the weight of a formal FDA guidance document, the release of the information makes clear the FDA plans to impose the safety standards for any vaccine seeking an expedited path to market. 

To meet the FDA’s threshold, companies would need to submit two months of follow-up from half of their trial participants after they receive their last vaccine dose to show there are no major side effects or health problems. Because vaccines are normally given to otherwise healthy people the FDA requires strict evidence of their safety.

The requirements are aimed at companies seeking rapid approval through the FDA’s emergency authorization pathway. That accelerated process, reserved for health emergencies, allows medical products onto the market based on a lower bar than traditional FDA approval. 

Initial doses of vaccines for emergency use would likely be reserved for medical workers and people with health conditions that make them particularly vulnerable to coronavirus. Full FDA approval for the general population will require significantly more data and is not expected until mid-2021.

An FDA spokeswoman said Tuesday the vaccine guidelines are still “under review” but added that “the FDA has already communicated with individual manufacturers about its expectations.”

The White House’s attempt to block the information’s release follows a string of instances in which the Trump administration has

White House nixes updated FDA guidelines on vaccine approval

WASHINGTON (AP) — The White House has blocked new Food and Drug Administration guidelines on bringing potential vaccines for COVID-19 to market that would almost certainly have prevented their introduction before the Nov. 3 election.

At issue was the FDA’s planned instruction that vaccine developers follow patients enrolled in their trials for at least two months to rule out safety issues before seeking emergency approval from the agency. A senior administration confirmed the move Monday evening, saying the White House believed there was “no clinical or medical reason” for the additional requirement.

WATCH: Trump says he has final vaccine approval, not FDA

The White House action was first reported by The New York Times.

The intervention by Trump officials is the latest example of the administration undercutting its own medical experts working to combat the pandemic that has killed more than 210,000 Americans.

FDA Commissioner Stephen Hahn has been attempting to shore up public confidence in the FDA’s vaccine review for weeks, vowing that career scientists, not politicians, will decide if the shots are safe and effective for mass vaccination.

But President Donald Trump has repeatedly insisted that a vaccine could be authorized before Election Day, even though top government scientists working on the administration’s vaccine effort have stated that that timeline is very unlikely.

Last week seven former FDA commissioners blasted the administration for “undermining the credibility” of the FDA in a Washington Post op-ed and called for the release of the pending vaccine guidelines. The former FDA chiefs warned that public fears that a vaccine was rushed out for political reasons could derail efforts to vaccinate millions of Americans.

The senior administration official, who spoke on the condition of anonymity to discuss the action, said the White House was intent on getting a safe vaccine to market and wanted to make sure “additional loopholes” weren’t added that would slow down the process.

Beyond the damaging optics of overruling its own FDA, the practical impact of the White House move against the guidelines could be relatively limited.

Only one drugmaker, Pfizer, has suggested it could have data on the safety and effectiveness of its vaccine before Election Day. And a number of variables would still have to align for the company to submit, and the FDA to review and greenlight, a vaccine application before Nov. 3. Pfizer’s competitors Moderna, AstraZeneca and Johnson & Johnson are working on longer research timelines.

Additionally, FDA scientists have been discussing the contents of the guidelines publicly for weeks and have made clear that the recommendations have already been shared with each of the vaccine developers.

“There’s no there there to get all excited about this guidance,” said Dr. Peter Marks, the head of FDA’s vaccine division, in an online interview last week with the nonprofit Friends of Cancer Research. “The companies know what we’re expecting.”

Instead, Marks said, releasing the guidelines was