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

October 7, 2020

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

Knox County Health Department discusses local trick-or-treating guidelines

October 7, 2020

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| Dept Of Health

In past years, one neighborhood Sequoyah Hills saw thousands of trick-or-treaters. That may look different this year.

KNOXVILLE, Tenn — So many things have looked different this year, and now that may include Halloween celebrations.

The CDC and the Knox County Health Department released new guidelines about how to safely celebrate Halloween. They are meant to keep people safe while having fun.

In past years, Knoxville neighborhood Sequoyah Hills saw thousands of trick-or-treaters.

“I think last year we were told there were 2,000 – 3,000 children that showed up whether they lived here or not,” said neighbor Doug Peek. He said he knows his family won’t see that many kids this year.

“The fact we’re going to be wearing masks for Halloween but also wearing masks for Halloween it’s just a different world,” he said.

He’s ready to get creative for trick or treaters, along with his neighbors, but hopes

New guidelines from Department of Health excites parents wishing to watch kids play

October 7, 2020

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The Pennsylvania Department of Health released new guidelines Tuesday for ‘safe gathering limits’ across the Commonwealth amid the COVID-19 pandemic.

New guidelines from DOH reaction

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Among the highlights are definitions of what an event or gathering is defined as by the Department of Health, how businesses must conduct business, and an amendment to two sections of the July 15 mitigation orders that will now include a “maximum occupancy calculator” for both indoor and outdoor events.

Of course, this raises the question of how this affects the prospective spectators of high school sports across the state.

Meanwhile parents are reacting to the news, and some are excited at the chance to watch their kids play.

Including Cristi Hinderer, whose son, lineman Lake Hinderer is a Senior at Central York.

Hinderer has been anxiously looking forward to the season’s kick off, but due to the COVID-19 pandemic,

Halloween Is Almost Here. Here Are The NJ Department Of Health Guidelines For The Tri-Boro Area

October 7, 2020

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| Dept Of Health

Oct. 6, 2020

Halloween Celebration Guidance October 5, 2020- Traditional Halloween celebrations often involve crowds, close contact between individuals, and activities in closed spaces. It is important to plan early and identify safer alternatives for celebrating the fall season. Outdoor activities, as opposed to indoor parties and events, are recommended. Those planning celebrations or participating in Halloween activities should keep in mind public health recommendations of social and physical distancing, wearing masks that cover the nose and mouth, and hand hygiene. Costume masks are not an acceptable substitute for cloth or disposable masks. Individuals should minimize interaction and contact with others who are not a part of their household. As a reminder, no one should participate in these activities if they or a household member have a known exposure to COVID-19, are sick/symptomatic, or have been diagnosed with COVID-19 and has not yet met the criteria for discontinuing isolation. This

FDA posts vaccine guidelines blocked by White House

October 6, 2020

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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

Department of Health’s new guidelines raise questions for school sports capacity limit

October 6, 2020

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The Pa. Department of Health has released new guidelines for ‘safe gathering limits’ across the Commonwealth. How will that affect spectators of high school sports?

PENNSYLVANIA, USA — Editor’s note: The above video is from September 24.

The Pennsylvania Department of Health has released new guidelines for ‘safe gathering limits’ across the Commonwealth amid the COVID-19 pandemic.

The guidelines were announced via a press release Tuesday morning.

Here are the calculators:

Maximum Occupancy Calculator for indoor events:

For every event with 0-2,000 people, the allowable indoor rate of maximum occupancy a venue can allow is 20 percent.

For every event

Despite the White House’s COVID-19 Outbreak, the Trump Campaign Continues to Ignore Public Health Guidelines

October 6, 2020

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It’s safe to say that if most political campaigns had seen its candidate, campaign manager, and more than a dozen associates test positive for COVID-19 within days of each other, they would likely reassess the strategy of holding large, in-person events that could be potential breeding grounds for the highly-infectious and deadly disease.

a person looking at the camera: A car with U.S. President Trump drives past supporters in a motorcade outside of Walter Reed Medical Center in Bethesda, Maryland on October 4, 2020.

© Alex Edelman—AFP/Getty Images
A car with U.S. President Trump drives past supporters in a motorcade outside of Walter Reed Medical Center in Bethesda, Maryland on October 4, 2020.

Not so with the Trump campaign.

While briefly pausing in-person events after President Trump and First Lady Melania Trump disclosed their positive diagnoses on Oct. 2, the campaign announced, just a day later, that “Operation MAGA”—a series of in-person events that the campaign touted as a way to “energize and mobilize the MAGA universe to maintain full speed until the President returns to the campaign trail”—will commence

Trump flouts health guidelines as Biden questions his ‘macho’ refusal to wear masks.

October 6, 2020

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| Health Current Events

President Trump and Joseph R. Biden Jr. interpreted leading by example very differently on Monday.

Mr. Trump, infected with the contagious and sometimes lethal coronavirus, returned by helicopter to the White House in a nationally televised hospital departure. Once back, he climbed to a White House balcony, removed the mask that reduces the risk to those around him and posed for pictures. Then he walked inside, where people wearing masks appeared to be standing.

“Now I’m better, and maybe I’m immune,” Mr. Trump declared in a video post from the balcony (physicians warn he is still at a precarious stage of recovery). Earlier in the day, Mr. Trump wrote on Twitter of the virus: “Don’t be afraid of Covid. Don’t let it dominate your life.”

The White House quickly cut Mr. Trump’s return into a triumphant video, replete with a salute to a departing military helicopter. The soundtrack for the

WH nixes FDA guidelines on vaccine approval

October 6, 2020

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

At issue was the FDA’s planned requirement that participants in mass clinical trials for vaccines be followed for two months to ensure there are no side effects and the vaccines provide lasting protection. Despite the move by the White House, FDA officials say companies are aware of the standards and are expected to comply with them.

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.

President Donald Trump has repeatedly insisted that a vaccine could be authorized before Election Day, despite top government scientists saying that timeline is very

White House nixes updated FDA guidelines on vaccine approval

October 6, 2020

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| Health Article

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.

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

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Tag: guidelines

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

Knox County Health Department discusses local trick-or-treating guidelines

New guidelines from Department of Health excites parents wishing to watch kids play

Halloween Is Almost Here. Here Are The NJ Department Of Health Guidelines For The Tri-Boro Area

FDA posts vaccine guidelines blocked by White House

Department of Health’s new guidelines raise questions for school sports capacity limit

Despite the White House’s COVID-19 Outbreak, the Trump Campaign Continues to Ignore Public Health Guidelines

Trump flouts health guidelines as Biden questions his ‘macho’ refusal to wear masks.

WH nixes FDA guidelines on vaccine approval

White House nixes updated FDA guidelines on vaccine approval