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Pfizer applies for FDA emergency approval for the Covid vaccine TOMORROW


The first application for approval by the Food and Drug Administration (FDA) of a coronavirus vaccine for a coronavirus vaccine in the United States will be submitted on Friday by Pfizer's partner BioNTech, Health and Human Services Secretary Alex Azar said on Thursday a rare briefing from the White House coronavirus task force.

The final data released Wednesday showed the vaccine was 95 percent effective in studies – even better than the 90 percent prevention rate found in previous data.

Dr. Returning to the White House for the first time in months, Anthony Fauci hailed Pfizer and Moderna's recordings as "extremely impressive" before it was announced that Pfizer would apply for FDA approval.

But he urged the Americans not to lose their vigilance and compare the vaccine with the cavalry.

"When the cavalry is on the move, you never stop shooting," said the best expert on infectious diseases.

A vaccine may be just around the corner, but the U.S. is far from the woods and in some ways in a more dangerous position than ever before, warned Task Force coordinator Dr. Deborah Birx.

The US is being inundated with "more cases, faster than before," she said as she displays dismal graphs showing the much steeper rise in cases compared to the spring and summer floods.

Vice President Mike Pence offered a more optimistic assessment of the status of the coronavirus in the US, despite the increase in cases, hospitalizations and more than a quarter of a million deaths.

He assured Americans that the coronavirus death rate is now 80 percent below what it was – but did not provide any further details about which time periods he compared.

According to Pence, President Donald Trump ordered the briefing to take place on Thursday, but Trump was not present.

The task force also revealed exactly how vaccines manufactured by both Moderna and Pfizer are rolled out within 24 hours of emergency approval by FDA regulators in every single US state and jurisdiction – which in the case of Pfizer could be weeks within a few days, ”said Vice President Pence.

Trump himself has remained silent about the recent spread of the virus after mistakenly saying during the campaign that "we are rounding the turnaround" and that the virus would be little discussed after the November 3 elections.

According to Pence, America "has never been more prepared to fight this virus than it is today".

Health and Human Services Secretary Alex Azar (pictured) announced Thursday that Pfizer's partner BioNTech will apply for emergency approval for its COVID-19 vaccine on Friday (file).

If the Pfizer vaccine submits its application for emergency use approval tomorrow as scheduled, it will be on track to be the first COVID-19 shot to be distributed in the US, Vice President Pence said within weeks

If the Pfizer vaccine submits its application for emergency use approval tomorrow as scheduled, it will be on track to be the first COVID-19 shot to be distributed in the US, Vice President Pence said within weeks

Dr. Fauci described the coronavirus vaccines Pfizer and Moderna developed as "extraordinarily impressive," but warned Americans to continue wearing masks and social distancing during Thursday's briefing

Dr. Fauci described the coronavirus vaccines Pfizer and Moderna developed as "extraordinarily impressive," but warned Americans to continue wearing masks and social distancing during Thursday's briefing

Dr. FAUCI TALKS ABOUT THE VACCINES: PFIZER AND MODERNA HAVE NOT COMPROMISED SAFETY.

For months, Dr. Fauci told Americans to patiently wait for vaccine trials to complete to keep the vaccine safe. However, he also stands behind the testing and review processes used by companies and the FDA.

On Thursday he was determined to address vaccine safety concerns.

Dr. Fauci said he was aware of the "reluctance" to take a vaccine among Americans who wonder, "Did you speed it up, was it too fast, is it really safe, and is it really effective?"

"The process and speed have not compromised security or scientific integrity," he said.

& # 39; It was a reflection of the extraordinary scientific advances made in these types of vaccines that allowed us to do things in months that had taken years before. I really want to resolve this people's concern. & # 39;

He reiterated that vaccines are assessed and reviewed by external bodies that are "loyal to anyone, not this administration, me or the company".

In late October, a Gallup poll found that the proportion of Americans who would receive a COVID-19 vaccine today, if one were available, had risen to nearly 60 percent.

But that number has been going down for months, with a 50/50 split in September between Americans who were determined to get the shot or not.

Dr. Fauci has estimated that at least 70 percent of the population needs to be vaccinated to keep the coronavirus at bay (although he would like a higher rate, closer to 85 percent).

Numerous polls – including those from Gallup and Reuters – have shown that the main reason Americans hesitate to get coronavirus vaccines is because of concern that the shots were rushed and may not be safe or have been proven to be safe.

"This is really solid," said Dr. Fauci.

& # 39; Help is on the way. & # 39;

He explained that Pfizer's study data suggests that his vaccine not only prevents infections that would likely have been mild without the shot, but that it prevented people from getting seriously ill, while people given a placebo could prevent severe COVID-19 received.

"We will be introducing high-priority vaccines against people in late December," said Dr. Fauci.

"You want to take part in it."

In Pfizer's study of nearly 42,000 people, there were 10 cases of severe COVID-19. Nine of them were in the placebo group and only one suffered from someone who received the two doses of the vaccine.

There were 11 severe cases in Moderna's vaccine study. None of the seriously ill people had received the real vaccine, which was 94.5 percent effective. Moderna is expected to apply for an emergency permit in a few days, the White House task force said.

"That's extraordinary, almost as high as measles," said Dr. Fauci.

How are vaccines rolled out and who will get them first?

Even after Pfizer announced the success of its vaccine in studies, public health concerns became that the distribution and storage of the vaccine would be a logistical nightmare that could slow down adoption and potentially lead to wasted vials of valuable vaccine.

That's because, unlike Moderna's, Pfizer's vaccine needs to be stored at -70 ° C. This is far colder than most recordings and requires extremely cold transport and storage. Many institutions and transport companies do not have an integrated function.

On Thursday, General Gustave Perna assured the Americans that Operation Warp Speed ​​had a thorough plan to address this steep challenge.

Pfizer is able to sell itself and will likely be able to supply partners, UPS and Fedex with cold storage rooms. The federal government will send syringes, needles, alcohol wipes and other relief supplies to deliver the vaccines to their destinations.

"We will be able to deliver the vaccine within 24 hours of the EEA (emergency approval"), promised General Perna.

"Spread (will) throughout the United States, including territories and metropolitan areas."

A diagram shown by General Gustave Perna explains how Pfizer will manage its own cold chain, while McKesson will help distribute Moderna vaccine kits - and each vaccine will be shipped to all states and states within 24 hours of emergency approval Sent areas, he said

A diagram shown by General Gustave Perna explains how Pfizer will manage its own cold chain, while McKesson will help distribute Moderna vaccine kits – and each vaccine will be shipped to all states and states within 24 hours of emergency approval Sent areas, he said

Within another 24 hours, he said, the first high-priority doses will be injected into Americans.

An FDA panel to advise regulators on vaccine distribution and planning is expected to meet between December 8th and 10th. The order of who will be vaccinated will only be determined after the panel has officially made its recommendations.

However, global experts largely agree with preliminary statements from the panel that health care workers should come first

Other people at risk are likely to be next, including non-healthcare workers, people with chronic illnesses who are more likely to develop or die from severe COVID-19, and the elderly who make up the majority of coronavirus deaths .

Dr. Fauci has estimated that the vaccine will be available to the general public by spring so that life in the US can return to a semblance of normalcy.

Dr. Fauci and President-elect Biden have both warned of a "dark winter" (President Trump has not yet commented on the announcement that Pfizer will seek an EEA, although he is actively tweeting about the election).

Hope for a vaccine in the coming weeks, said Dr. Fauci, should prompt Americans to redouble current measures to slow the spread of the coronavirus, which remains of unprecedented importance.

COVID-19 PATIENTS OVERCOME HOSPITALS IN NORTH AND SOUTH DAKOTA WHEN THE POSITIVITY OF NATIONAL EXAMS DRIVEN 10% OF ASYMPTOMATIC SPREAD

More than 20 percent of all patients in hospitals in North and South Dakota and Guam are being treated for COVID-19, said Dr. Birx.

The Air Force dispatched 60 medics to North Dakota Thursday evening to support their healthcare system, which is under the debilitating influence of coronavirus patients.

And the cases, which have risen more than ever before, are only increasing. Around 10 percent of all tests carried out nationwide are positive for COVID-19.

She urged Americans to limit indoor interactions because there are a lot of asymptomatic cases and people are spreading (coronavirus) because they don't know they are wearing it, "she said.

"Everyone looks healthy, but those people could include people who already have coronavirus."

She estimated that more than 50 percent of people in the United States, especially those under the age of 35, could be unknowingly infected.

Dr. Birx attributed the timing of the recent surge in cases to "an unusual cold snap that began in the north (Midwest) and moved down into the heartland".

Dr. Birx warned the US is "seeing more cases faster than before" during Thursday's briefing

Dr. Birx warned the US is "seeing more cases faster than before" during Thursday's briefing

More than 20 percent (dark red) of all patients in hospitals in North and South Dakota and Guam are being treated for COVID-19, such as one by Dr. Birx showed the film

More than 20 percent (dark red) of all patients in hospitals in North and South Dakota and Guam are being treated for COVID-19, such as one by Dr. Birx showed the film

With the sudden drop in temperature, more people moved indoors and gathered in a confined space and without a mask.

This is particularly worrying in the coming winter vacation. Dr. Birx reflected the CDC's advice to travel for Thanksgiving, which was released Thursday.

"As you bring individuals together, remember what the Vice President was talking about: everyone needs to be vigilant right now because when we know we can mitigate this virus and stop the spread together," she said.

COVID-19 hospital stays in the US have more than doubled in the past month, breaking new records every day this week as overwhelmed hospitals mask chapels, cafeterias and even parking garages in patient treatment areas to cope with the surge in new admissions.

Conditions in the country's hospitals are worsening day by day as COVID-19 infections continue to skyrocket in the US and the national death toll surpasses 250,000.

CDC strongly advises Americans not to travel for Thanksgiving

The U.S. Centers for Disease Control strongly advises Americans not to travel for Thanksgiving or vacation with people outside their homes amid a nationwide surge in COVID-19.

The recommendation from the country's top health authority on Thursday is one of the government's firmest guidance to date on curbing traditional gatherings to combat the outbreak.

The travel advisory is a "strong recommendation" and not a requirement, said CDC official Henry Walke, adding that the agency gave the advice after the majority of states saw a surge in coronavirus cases in recent weeks.

The CDC warns that large household gatherings this holiday season could make things worse.

The CDC has advised against arranging the incubation period for the coronavirus with people who have not lived in the same household for at least 14 days.

If families choose to involve returning college students, military personnel, or anyone else for turkey and stuffing, the CDC recommends hosts take additional precautions: Meetings should be outdoors where possible, with people 6 feet apart and Wear masks and serve food to only one person.

The number of people hospitalized with COVID-19 rose to another record high of 79,000 yesterday, and the number of cases, which are on the rise in all 50 states, rose to 170,000.

Daily deaths rose to 1,800 yesterday and now averages 1,200 per day based on a seven-day moving average, its highest level in months.

The Midwest is currently the hardest hit region in terms of the number of cases per capita. North Dakota, South Dakota, Wisconsin, Iowa, and Nebraska are the five states hardest hit. North Dakota had the highest number of infections and deaths per capita in the world for the past week.

Long lines to get tested for COVID-19 have resurfaced in the U.S. as cases rise across the country and people rush to get tested before reuniting with relatives for Thanksgiving, even as federal health officials are on Thursday called on citizens not to gather for the holiday fearing the spread of the virus.

The lines stretched across several city blocks at test locations in New York City this week, so people had to wait three or more hours before they could even enter clinics. In Los Angeles, thousands of people lined up in front of Dodger Stadium to conduct drive-through tests.

The U.S. Centers for Disease Control on Thursday advised Americans not to travel for Thanksgiving to help mitigate the spread of the virus and advised against meeting with anyone who had not lived in the same household for at least 14 days. This is the incubation period for the virus.

The recommendation from the country's top health authority on Thursday is one of the government's firmest guidance to date on curbing traditional gatherings to combat the outbreak.

To curb the spread, the CDC warns that large indoor household gatherings this holiday season could make things worse.

If families choose to involve returning college students, military personnel, or anyone else for turkey and stuffing, the CDC recommends hosts take additional precautions: Meetings should be outdoors where possible, with people 6 feet apart and Wear masks and serve food to only one person.

For those who still choose to travel, the CDC recommends doing so "as safely as possible". This includes wearing a mask in public, maintaining social distance, and frequent hand washing with soap and water.

Officials said they also posted recommendations on their website on how to be safe during the vacation for those Americans who choose to travel.

The American Hospital Association and the American Medical Association have also issued a joint plea urging people to cut back on the Thanksgiving celebration.

They cited spikes after Memorial Day, July 4th, and Labor Day as evidence that Thanksgiving travel will in some cases lead to spikes.

"The record-breaking increase is leading to uncontrolled spread and infection of the population, which has already overloaded health systems in some areas and ultimately consumes the capacity of our health system and potentially reduces the availability of care in many places in our country," the respondent said.

Hospitals across the country are being overwhelmed, not only converting rooms into areas to treat patients, but staff are desperately calling to other medical centers in search of open beds as fatigue and frustration occur among the frontline staff.

According to an analysis by STAT, a medical news organization, at least 25 states are currently reporting shortages of nurses and doctors.

The situation is now so serious that some patients are moved hundreds of kilometers to other states for treatment.

Long queues have resurfaced in the United States in recent weeks – a reminder that the national testing system is still unable to keep up with the virus.

The delays occur as the country prepares for winter weather, flu season, and vacation travel that is expected to compound a U.S. outbreak.

The laboratories warned that a persistent lack of key deliveries is likely to lead to more bottlenecks and delays, especially as cases increase across the country and people need to be tested quickly before reuniting with relatives.

The US COVID-19 tests were back on their way for vacation

With the number of coronavirus cases growing and the hope that families will gather safely for Thanksgiving, long lines have resurfaced in the US – a reminder that the national testing system is still unable to keep up with the virus.

The delays occur as the country prepares for winter weather, flu season, and vacation travel. All of this is expected to compound a U.S. outbreak that has already surged over 11.5 million cases and 250,000 deaths.

The laboratories warned that a persistent lack of key deliveries is likely to lead to more bottlenecks and delays, especially as cases increase across the country and people need to be tested quickly before reuniting with relatives.

"As these cases increase, demand and lead times can increase," said Scott Becker, CEO of the Association of Public Health Laboratories. "So it's like a dog chasing its tail."

On the one hand, the fact that testing problems are only now emerging – more than a month after the recent surge in viruses – is evidence of the country's increased capacity. The US test an average of over 1.5 million people a day, more than twice as many as in July when many Americans last faced long lines.

Trump administration officials estimate the U.S. has enough tests this month to screen between 4 and 5 million people a day.

Adm. Brett Giroir, the U.S. official overseeing the tests, downplayed reports of lines and delays earlier this week. In some cases, he said, leads are caused by lack of planning by test sites, which should postpone appointments.

"As these cases increase, demand and lead times can increase," said Scott Becker, CEO of the Association of Public Health Laboratories. "So it's like a dog chasing its tail."

On the one hand, the fact that testing problems are only now emerging – more than a month after the recent surge in viruses – is evidence of the country's increased capacity. The US test an average of over 1.5 million people a day, more than twice as many as in July when many Americans last faced long lines.

However, experts like Johns Hopkins University researcher Gigi Gronvall said the US is still lagging far behind on what it takes to fight the virus.

Gronvall said the current test rate is "on the way, but nowhere near what it takes to postpone the course of this epidemic." Many experts have requested between 4 and 15 million tests a day to suppress the virus.

Trump administration officials estimate the U.S. has enough tests this month to screen between 4 and 5 million people a day.

Adm. Brett Giroir, the U.S. official overseeing the tests, downplayed reports of lines and delays earlier this week. In some cases, he said, leads are caused by lack of planning by test sites, which should postpone appointments.

In California, health officials have issued mixed messages about whether residents should be tested before vacation.

The San Francisco Emergency Management Department warned people should not use a test to determine if they can travel. But Contra Costa County across the bay suggested that anyone who insists on meeting up with friends or relatives should be tested.

On Tuesday, federal regulators approved the first rapid coronavirus test that can be done at home. It delivers results in 30 minutes and costs around $ 50. However, the Lucira Health test kit is only available by prescription and will not be introduced nationwide until spring.

As bad as the wait for tests has become, it's still better than in July, when the US relied almost entirely on tests that often take two or more days to process, even under ideal conditions. As the number of cases rose over 70,000 a day, many people had to wait a week or more to hear their results, making the information nearly worthless for isolating and tracking cases.

In the past few months, federal health authorities have distributed around 60 million rapid tests at the treatment site that provide results within 15 minutes. These have helped ease the pressure on large laboratories. But not enough.

Since September 15, the daily number of US tests has increased nearly 100 percent, based on a seven-day moving average. However, according to an AP analysis, the daily average of new COVID-19 cases rose by over 300 percent to more than 161,000 on Wednesday.

A hospital bed is located in the parking garage at Renown Regional Medical Center, which has been converted into an alternative care facility for COVID-19 patients in Reno, Nevada

A hospital bed is located in the parking garage at Renown Regional Medical Center, which has been converted into an alternative care facility for COVID-19 patients in Reno, Nevada

Personal protective equipment is stacked in the parking garage at Renown Regional Medical Center after it is converted into an emergency COVID-19 care facility

Personal protective equipment is stacked in the parking garage at Renown Regional Medical Center after it is converted into an emergency COVID-19 care facility

Dozens of oxygen tanks are lined up in the Renown Regional Medical Center parking garage

Dozens of oxygen tanks are lined up in the Renown Regional Medical Center parking garage

The runaway spike has resulted in governors and mayors across the country reluctantly granting masked mandates, limiting the size of private and public gatherings before Thanksgiving, banning indoor dining, closing gyms, or restricting bars and shops opening hours and capacities other companies.

New York City's school system – the largest in the country with more than 1 million students – disrupted face-to-face classes on Wednesday amid a surge in infection, a painful setback in a corner of the country that suffered badly in the spring but that apparently hit back Virus months ago.

Texas brings thousands of additional medical workers to congested hospitals as the number of hospitalized COVID-19 patients rises to 8,000 nationwide for the first time since a fatal summer outbreak.

In the deteriorating rural Texas Panhandle, roughly half of the patients admitted at Lubbock's two main hospitals had COVID-19 and a dozen people with the virus were waiting in the emergency room for beds to open Tuesday night, Dr. Ron Cook. the Lubbock County Health Department.

"We're in trouble," said Cook.

In the Texas border town of El Paso, overwhelmed morgues pay prison inmates $ 2 an hour to move the bodies of virus victims. The crowd of patients is forcing the city to send its non-COVID-19 cases to hospitals in other parts of the state.

The state alone deployed more than 5,400 additional medical workers across Texas, said Lara Anton, a spokeswoman for the Texas Department of Health. And that doesn't include the aid pouring into Texas from military and volunteer organizations.

"There are only so many medical workers," said Dr. Mark McClellan, a former head of the Food and Drug Administration.

Das Ballad Health System, das sich in den Appalachen befindet und ein Krankenhaus in Tennessee umfasst, hat gewarnt, dass es und seine Mitarbeiter so dünn sind, dass seine Krankenhäuser ohne Kursänderung möglicherweise Patienten abweisen müssen. Ballad berichtete, dass am Mittwoch nur 16 Betten auf der Intensivstation verfügbar waren und etwa 250 Teammitglieder isoliert oder unter Quarantäne standen. Es wird versucht, Hunderte weiterer Krankenschwestern zu rekrutieren.

In Idaho warnten die Ärzte, dass die Krankenhäuser fast den Punkt erreicht haben, an dem sie die Versorgung rationieren müssen, und nicht in der Lage sind, alle zu behandeln, weil nicht genügend Betten oder Mitarbeiter vorhanden sind, um herumzugehen.

"Niemals in meiner Karriere hätte ich gedacht, dass wir überhaupt über die Idee einer Rationierung der Versorgung in den Vereinigten Staaten von Amerika nachdenken würden", sagte Dr. Jim Souza, Chefarzt des St. Luke's Health System.

NYC: Die Linien erstreckten sich diese Woche über mehrere Stadtblöcke an Teststandorten in ganz New York City, sodass die Leute drei oder mehr Stunden warten mussten, bevor sie überhaupt in Kliniken eintreten konnten

NYC: Die Linien erstreckten sich diese Woche über mehrere Stadtblöcke an Teststandorten in ganz New York City, sodass die Leute drei oder mehr Stunden warten mussten, bevor sie überhaupt in Kliniken eintreten konnten

NYC: Dutzende standen am Donnerstag vor einer Gesundheitsklinik in New York City an, als die COVID-19-Tests zunahmen

NYC: Dutzende standen am Donnerstag vor einer Gesundheitsklinik in New York City an, als die COVID-19-Tests zunahmen

MIAMI: Fahrzeuge stehen an, während Mitarbeiter des Gesundheitswesens am Mittwoch beim Durchchecken von Personen, die getestet werden sollen, im Durchfahrtsprüfzentrum COVID-19 im Miami Beach Convention Center helfen

MIAMI: Fahrzeuge stehen an, während Mitarbeiter des Gesundheitswesens am Mittwoch beim Durchchecken von Personen, die getestet werden sollen, im Durchfahrtsprüfzentrum COVID-19 im Miami Beach Convention Center helfen

MIAMI: Die Leute stehen in der Schlange, um in der mobilen Testanlage COVID-19 im Miami Beach Convention Center in Miami Beach getestet zu werden

MIAMI: Die Leute stehen in der Schlange, um in der mobilen Testanlage COVID-19 im Miami Beach Convention Center in Miami Beach getestet zu werden

Mitarbeiter des Gesundheitswesens verarbeiten Personen, die am Donnerstag in Houston, Texas, an einem COVID-19-Teststandort des United Memorial Medical Center in der Schlange stehen

Mitarbeiter des Gesundheitswesens verarbeiten Personen, die am Donnerstag in Houston, Texas, an einem COVID-19-Teststandort des United Memorial Medical Center in der Schlange stehen

In Reno, Nevada, begann das Renown Regional Medical Center, einige Coronavirus-Patienten in sein Parkhaus zu bringen.

Das Video der umgebauten Garage, bevor sie für Patienten geöffnet wurde, zeigte Reihen und Reihen von Betten, die durch bewegliche weiße Bildschirme getrennt waren, die auf einer Ebene der kahlen, höhlenartigen Garage aufgestellt waren, wobei jeder Abschnitt durch Buchstaben gekennzeichnet war und jeder Bettraum durch eine Zahl auf dem Boden gekennzeichnet war. Die Garageneinheit beherbergt derzeit 27 Patienten, verfügt jedoch bei maximaler Kapazität über genügend Betten für mehr als 1.400 Patienten, sagte Dr. Paul Sierzenski, Chief Medical Officer für Akutversorgung bei Renown.

In Kansas wandeln Krankenhäuser Räume wie Kapellen und Cafeterien für COVID-19-Patienten um, sagte Cindy Samuelson, Sprecherin der Kansas Hospital Association.

Stormont Vail Health in Topeka, Kansas, widmete COVID-19-Patienten eine ganze Krankenhausetage, als ihre Zahl anstieg und am Mittwoch 90 erreichte. Das Krankenhaus baute auch zwei Operationswarteräume für nicht infizierte Patienten um, sagte Sprecher Matt Lara.

Dr. Lee Norman, Gesundheitschef von Kansas, sagte, dass ein System eingeführt wird, das er mit der Flugsicherung für Coronavirus-Patienten vergleicht, damit Krankenschwestern aus ländlichen Krankenhäusern einen einzigen Anruf tätigen können, um ein größeres Krankenhaus zu finden, das ihre kranksten Patienten aufnehmen kann.

In einigen Fällen haben Krankenschwestern und Ärzte in Kansas bis zu acht Stunden damit verbracht, nach einem großen Krankenhaus mit einer Öffnung in Städten zu suchen, die bis nach Denver, Omaha oder Kansas City reichen.

'The problem with this is, by the time you transfer these patients out they already are very ill at that point,' said Kansas nurse practitioner Perry Desbien.

At the same time, patience is wearing thin over the lack of mask wearing that is contributing to the problem in rural areas.

'It kind of feels like we're just, you know, yelling into the abyss,' said Cheyanne Seematter, a registered nurse at Stormont Vail. 'We keep telling everybody to stay home, wear a mask, that it is actually bad here.'

Maryland health officials similarly set up a centralized clearinghouse with information on available ICU beds so that hospitals need only make a single phone call. State authorities also issued an emergency order prohibiting most hospital visitors until further notice.

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