October 6 coronavirus news

The head of the Food and Drug Administration division that approves vaccines said Monday he expects to see at least one company seek emergency authorization for a coronavirus vaccine before the end of the year.

“I think it's possible we'll see something before the end of the year in terms of an emergency use authorization application from some company,” Dr. Peter Marks, director of the Center for Biologics Evaluation and Research (CBER) at the FDA, said in a YouTube interview with the Journal of the American Medical Association.

Five companies have Covid-19 vaccines in Phase 3 trials, the largest and most advanced stages of human testing, in the US. Two of them started in July, so it’s conceivable they could have enough data by the end of the year to ask the FDA to consider emergency authorization, Marks said. 

He said the FDA is sticking to a requirement that companies follow volunteers for an average of eight weeks after they get their second dose of vaccine to make sure it’s safe.

Marks said staff are trying to filter out political arguments as they focus on data from clinical trials involving tens of thousands of volunteers.

The FDA’s requirements for an emergency authorization are less strict than for a full Biologics License Application. The process for an EUA will take weeks, while the process for a BLA takes months, Marks said. 

FDA officials have repeatedly said they will not skimp on safety considerations for a coronavirus vaccine, even as President Donald Trump repeatedly said a vaccine could be ready by Election Day in November.

The United States is still lagging behind other countries when it comes to coronavirus testing, but Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, said things are improving.

“We're better off now than we were a couple of months ago, that's for sure,” Fauci told CNN’s Chris Cuomo in an interview Monday evening, although he said the US was not where he thought it should be in terms of testing.

The federal government plans to distribute 150 million of Abbott’s BinaxNow Covid-19 rapid antigen tests to schools and nursing homes, and Fauci says once that happens, coronavirus surveillance testing will really start to pick up.

The Abbott test, which received an Emergency Use Authorization from the US Food and Drug Administration in August, returns test results in 15 minutes. The company says the test is 97% accurate in detecting positives and 98.5% accurately identifying people who are not infected. Abbott had trouble with accuracy in one of its previous coronavirus tests.

“I've been saying that we need to flood the system with testing,” Fauci said. 

Testing is needed to identify cases so people can be isolated before they infect others, Fauci said. Testing is also needed for surveillance to find out what level of infection is occurring at the community level.

“That’s what we need to do,” Fauci said.

The US Centers for Disease Control and Prevention has again updated its guidance about how Covid-19 spreads to include information about potential for airborne transmission.

Still, the available data suggest "it is much more common for the virus that causes COVID-19 to spread through close contact with a person who has COVID-19 than through airborne transmission," the new guidance says.

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CDC again updates guidance to say Covid-19 can spread by airborne transmission

President Donald Trump staged a reckless departure from Walter Reed National Military Medical Center on Monday, telling his followers the virus that dangerously deprived him of oxygen and hospitalized him for 72 hours was nothing to fear before posing for a mask-less photo-op on the White House balcony.

It was a remarkable attempt to convert his still-ongoing disease into a show of strength, even as it underscored his longstanding practice of denying the pandemic's severity and downplaying its risks despite the more than 200,000 Americans dead.

Wearing a white cloth mask and a navy blue suit, Trump gave several thumbs up and a fist bump as he walked down the hospital's front steps toward his waiting helicopter. He would not answer when asked how many of his staffers had tested positive.

After a flight over Washington, Trump landed on the South Lawn and proceeded in an unusual route up a set of stairs the first-floor balcony, where aides had positioned a row of American flags.

Peeling off his mask, Trump posed in salute as his helicopter departed before walking inside.

The building he's returning to has become a center for viral contagion -- in part because of disregard for mitigation measures.

The message was jarring not only because it was irresponsible but that it came from a current coronavirus patient who has experienced serious symptoms of the disease and whose recovery has included experimental treatments unavailable to most Americans.

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White House focuses on optics while America wonders about health of the President

Less than a week after reopening, schools in some New York City neighborhoods will close beginning Tuesday as the city tries to get ahead of a worrisome spread of Covid-19.

Mayor Bill de Blasio on Sunday proposed temporarily closing all schools and nonessential businesses in nine ZIP codes with high test positivity rates in Brooklyn and Queens beginning Wednesday, pending state approval.

Gov. Andrew Cuomo approved part of that plan, agreeing to close schools in those nine hotspot areas and moving their closures up to Tuesday. He declined, though, to close nonessential businesses and religious institutions.

The decision to roll back reopenings in those areas highlights the challenge facing cities, states, universities and businesses as they try to balance the need to reopen the economy with ensuring public health and safety during the pandemic.

By any measure, the US has failed this challenge: temporary layoffs have become permanent, the President was in the hospital after a White House outbreak and more than 40,000 Americans are newly diagnosed with Covid-19 every day.

More than 2,000 Transportation Security Administration employees have now tested positive for coronavirus, according to new data the agency published on its website Monday. 

The TSA says of the 2,020 employees who have been infected with Covid-19, nearly 1,800 have fully recovered. Seven TSA employees have died as a result of the virus.

The agency has installed new acrylic barriers at security checkpoints, has changed passenger protocols in an effort to reduce touch points, and is experimenting with new facial recognition scanners to cut down on face-to-face interaction between fliers and workers.

The news comes after a weekend bump in pandemic air travel. TSA says it screened a total of 900,911 travelers at airports across the United States on Sunday, the third time air travel levels reached more than 900,000 since the pandemic low point of 87,000 on April 14. On average, air travel remains at a third of last year’s levels. 

Coronavirus has infected about 10% of the world’s population, Dr. Mike Ryan, director of the World Health Organization’s Health Emergencies Program, said Monday.

It varies from region to region, Ryan said at a WHO Executive Board meeting.

"This varies depending on country, it varies from urban to rural, it varies between different groups. But what it does mean is that the vast majority of the world remains at risk," Ryan added.

According to Johns Hopkins University, more than 35.3 million people have been diagnosed with coronavirus globally, but WHO and other experts say that is almost certainly an enormous undercount. The US Centers for Disease Control and Prevention says cases in the US are also undercounted by at least 90%.

With a global population of about 7.7 billion people, Ryan’s estimate would mean about 770 million have been infected -- but most have not been diagnosed or counted.

The UK government has launched an investigation into a technical issue which resulted in almost 16,000 cases of coronavirus to go unreported, a Downing Street spokesperson has confirmed.

The Downing Street spokesperson said the investigation will “determine why the issue was not identified sooner."

A spokesperson for Prime Minister Boris Johnson said the issued occurred in the “process that transfers positive test results into the reporting dashboards” and that additional contact tracers had been employed to deal with the backlog.

The error was first announced in a statement from Public Health England (PHE) on Sunday. According to the statement, “a technical issue was identified overnight on Friday 2 October in the data load process that transfers COVID-19 positive lab results into reporting dashboards."

The statement went on to say that PHE consequently “identified that 15,841 cases between 25 September and 2 October were not included in the reported daily COVID-19 cases.” PHE alongside NHS Test and Trace then “worked to quickly resolve the issue and transferred all outstanding cases immediately into the NHS Test and Trace contact tracing system.”