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Trump official says vaccine expected starting in January

A Trump administration official leading the response to the coronavirus pandemic says the U.S. can expect delivery of a vaccine starting in January 2021, despite statements from the president that inoculations could begin this month.

And a growing, bipartisan chorus of lawmakers, experts and public health officials says the country is ill prepared for a projected winter surge of COVID-19.

Dr. Robert Kadlec said in an email Friday that the administration “is accelerating production of safe and effective vaccines … to ensure delivery starting January 2021.” Kadlec is the Department of Health and Human Services’ assistant secretary of preparedness and response. HHS says a vaccine could be approved before the end of the year but will take time to distribute.

President Donald Trump has said at rallies, debates and press conferences that a vaccine could arrive within weeks. “We think we can start sometime in October,” Trump said at a White House press briefing last month.


Kadlec wasn’t the first health official to counter the president’s optimistic timeline. Health and Human Services Secretary Alex Azar said Thursday that there could be 100 million vaccine doses available by the end of the year “pending FDA authorizations.” And Dr. Moncef Slaoui, who is leading the government’s vaccine effort, told Marketwatch on Friday that researchers could know “by late October, or November, or in December” whether one of the vaccines in development is effective, but that it would then take weeks to get emergency authorization to administer it.

When asked about the disparity, the White House was not specific on a date but said Trump’s priority is to distribute a vaccine “as soon as possible.” Kadlec said, without elaborating, that it wasn’t correct to conclude that this meant the country couldn’t see a vaccine sooner than January.

Kadlec was responding to a series of questions from The Associated Press and FRONTLINE about the administration’s response to the pandemic and, in particular, about shortages of critical medical supplies.

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EDITOR’S NOTE: This story is part of an ongoing investigation by The Associated Press, the PBS series FRONTLINE and the Global Reporting Centre that examines the deadly consequences of the fragmented worldwide medical supply chain and includes the film America’s Medical Supply Crisis.

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The AP and FRONTLINE reported earlier this week that a breakdown in the supply chain for critical medical equipment including masks, gloves, gowns and ventilators hobbled the U.S. response to COVID-19 and was likely a factor in the country’s death rate, which is higher per capita than almost every other country in the world.

Experts say those shortages could now extend to the syringes, needles and glass vials that are vital to a future nationwide vaccination program.

Kadlec agrees that supply chain disruptions led to shortages. He said the administration needs more, consistent, flexible funding from Congress to shore up the Strategic National Stockpile of medical supplies and drugs and expand domestic manufacturing.

“There seems to be universal consensus from both sides of the aisle in Congress, from the health care

Federal Official Threatens Nevada for Halting Rapid Tests in Nursing Homes

The leader of the nation’s coronavirus testing efforts condemned Nevada’s health department on Friday for ordering nursing homes to discontinue two brands of government-issued rapid coronavirus tests that the state had found to be inaccurate.

“Bottom line, the recommendations in the Nevada letter are unjustified and not scientifically valid,” Adm. Brett Giroir, an assistant secretary of Health and Human Services, said in a call with reporters on Friday. The state’s actions, he said, were “unwise, uninformed and unlawful” and could provoke unspecified swift punitive action from the federal government if not reversed.

The rapid tests, which were distributed to nursing homes around the country in August by the federal government, were supposed to address the months of delays and equipment shortages that had stymied laboratory-based tests.

“The important issue is to keep seniors safe,” Admiral Giroir said in an interview on Friday. Antigen tests, he added, were “lifesaving instruments” that had been called “godsends” by some nursing home representatives. About 40 percent of the country’s known Covid-19 deaths came from nursing homes, according to a New York Times analysis.

But Nevada officials had discovered a rash of false positives among two types of rapid tests, manufactured by Quidel and Becton, Dickinson and Company, that had been used in the state’s nursing homes. Both tests look for antigens, or bits of coronavirus proteins, and had been advertised as producing no false positives.

Among a sample of 39 positive test results collected from nursing homes across the state, 23 turned out to be false positives, the state reported. (The bulletin did not specify whether negative results from the antigen tests, of which there were thousands, had been confirmed, leaving the number of false negatives unknown.)

“I would consider that to be a significant number of false positives,” said Omai Garner, a clinical microbiologist at the University of California, Los Angeles.

Admiral Giroir contended that such rates of false positives are to be expected, and are “actually an outstanding result.” No test is perfect, he said.

He also said that the federal government expected the state to promptly rescind its unilateral prohibition, which he described as a violation of the Public Readiness and Emergency Preparedness Act.

An Aug. 31 guidance from Admiral Giroir’s office stipulated that PREP Act coverage “preempts” states from blocking the use of coronavirus tests that have been authorized by the Food and Drug Administration on people in congregate settings, like nursing facilities.

What Nevada has done is “illegal,” he said. “They cannot supersede the PREP Act.”

The federal government’s formal response to Nevada’s health department, dated Oct. 8 and signed by Admiral Giroir, portrayed the state’s officials as scientifically incompetent and their actions as “improper” under federal law. “Your letter can only be based on a lack of knowledge or bias, and will endanger the lives of our most vulnerable,” Admiral Giroir wrote.

Should the state hold its ground, “there can be penalties from the federal side,” he said in an interview on Friday, but declined to provide details.

Official says vaccine expected in January, countering Trump

A Trump administration official leading the response to the coronavirus pandemic says the U.S. can expect delivery of a vaccine starting in January 2021, despite statements from the president that inoculations could begin this month.

Kadlec wasn’t the first health official to counter the president’s optimistic timeline. Health and Human Services Secretary Alex Azar said Thursday that there could be 100 million vaccine doses available by the end of the year “pending FDA authorizations.” And Dr. Moncef Slaoui, who is leading the government’s vaccine effort, told Marketwatch on Friday that researchers could know “by late October, or November, or in December” whether one of the vaccines in development is effective, but that it would then take weeks to get emergency authorization to administer it.

When asked about the disparity, the White House was not specific on a date but said Trump’s priority is to distribute a vaccine “as soon as possible.” Kadlec said, without elaborating, that it wasn’t correct to conclude that this meant the country couldn’t see a vaccine sooner than January.

Kadlec was responding to a series of questions from The Associated Press and FRONTLINE about the administration’s response to the pandemic and, in particular, about shortages of critical medical supplies.

———

EDITOR’S NOTE: This story is part of an ongoing investigation by The Associated Press, the PBS series FRONTLINE and the Global Reporting Centre that examines the deadly consequences of the fragmented worldwide medical supply chain and includes the film America’s Medical Supply Crisis.

———

The AP and FRONTLINE reported earlier this week that a breakdown in the supply chain for critical medical equipment including masks, gloves, gowns and ventilators hobbled the U.S. response to COVID-19 and was likely a factor in the country’s death rate, which is higher per capita than almost every other country in the world.

Experts say those shortages could now extend to the syringes, needles and glass vials that are vital to a future nationwide vaccination program.

Kadlec agrees that supply chain disruptions led to shortages. He said the administration needs more, consistent, flexible funding from Congress to shore up the Strategic National Stockpile of medical supplies and drugs and expand domestic manufacturing.

“There seems to be universal consensus from both sides of the aisle in Congress, from the health care sector and from the manufacturing base, that it is critical to move from a just-in-time manufacturing model to a

Senior Official Explains VP’s Health After Mysterious Case At Debate

A flurry of speculation has surrounded the health of Vice President Mike Pence after he appeared to have pink eye at Wednesday’s debate with Sen. Kamala Harris. A senior Trump administration official told Politico that Pence likely suffered from a broken blood vessel, rather than a pink eye infection. 

Pence’s eye problem, as well as a fly that settled on his head, drew attention on social media.

Dr. Daniel Volland, an optometrist based in Seattle, also diagnosed Pence with a broken blood vessel.

“Eye doctor, here! Temporal Subconjunctival Hemorrhage OS is my diagnosis; it’s a broken blood vessel, not infectious,” Volland tweeted. 

Although some debate viewers thought Pence’s eye could be a symptom of COVID-19, the vice president tested negative for the virus prior to the event. Pink eye is a rare symptom of a COVID-19 infection.

“The number of COVID-19 patients that have been reported to have eye symptoms is relatively low. And when you have a population that small, it’s really hard to get a picture of the story because we just don’t have as many data points,” optometrist Alexandra Williamson, OD, recently told the Cleveland Clinic. 

Pence’s health condition is noteworthy, due to President Donald Trump’s positive COVID-19 diagnosis. If Trump were to become incapacitated, Pence would likely have to take over presidential duties per the 25th amendment.

Numerous members of the Trump administration and campaign have been infected with the virus. First lady Melania Trump, campaign manager Bill Stepien, senior adviser for policy Stephen Miller, Press Secretary Kayleigh McEnany and former New Jersey Gov. Chris Christie are just a few high-profile members of Trump’s inner circle to test positive for COVID-19.

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10% of the world may have been infected by Covid-19, WHO official says



a person in a car: Health care workers greet people as they arrive at a temporary drive-through COVID-19 testing site at East Orange District Park on October 1, 2020 in Orlando, Florida. (Photo by Paul Hennessy/NurPhoto via Getty Images)


© Paul Hennessy/NurPhoto via Getty Images
Health care workers greet people as they arrive at a temporary drive-through COVID-19 testing site at East Orange District Park on October 1, 2020 in Orlando, Florida. (Photo by Paul Hennessy/NurPhoto via Getty Images)

The novel coronavirus may have infected about one in 10 people globally, meaning the majority of the world remains vulnerable to Covid-19, a World Health Organization official has said.

“Our current best estimates tell us that about 10% of the global population may have been infected by this virus,” Dr. Mike Ryan, director of the WHO’s Health Emergencies Programme, said at a WHO executive board meeting Monday.

“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.

There are more than 35.5 million confirmed Covid-19 cases globally, according to the widely-used Johns Hopkins University dashboard, but WHO and other experts say that is almost certainly an enormous undercount. Over the summer, the US Centers for Disease Control and Prevention said cases in the US had likely been 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.

Ryan noted Monday that Southeast Asia continues to see a surge in cases, while Europe and Eastern Mediterranean regions were seeing an increase in cases and deaths. However, he noted that the situation in Africa and the Western Pacific was “currently rather more positive.”

Worldwide, countries are struggling to contain resurgent outbreaks and are reintroducing measures in a bid to curb the spread of the virus.

“We are now heading into a difficult period. The disease continues to spread,” Ryan said.

Only four European countries are now measuring below a crucial level of Covid-19 cases, according the latest figures Monday, with the European Centre for Disease Prevention and Control’s (ECDC) warning in its latest risk assessment the risk of Covid-19 is high, with a very high probability of infection, while vulnerable individuals face a “very high impact” from the disease.

Overall cases in the US are on the rise as well, with the country reporting more than 50,000 daily cases on Friday and Saturday. The last time the US saw more than 50,000 cases back to back was in mid-August, and the country’s leading infectious disease expert Dr. Anthony Fauci has warned that the country is still behind on testing.

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Trump’s medical team says he is doing ‘very well’; official warns next 48 hours are ‘critical’

President Trump is “doing very well” and has no difficulty breathing, his medical team said Saturday — although a senior administration official warned that the next 48 hours will be “critical.”

White House physician Dr. Sean Conley and other members of the medical team briefed reporters on Trump’s condition. Conley said they were “extremely happy with the progress” Trump is making.

TRUMP TRANSFERRED TO WALTER REED ‘OUT OF AN ABUNDANCE OF CAUTION’ AFTER TESTING POSITIVE FOR CORONAVIRUS 

“This morning, the president is doing very well,” he said.

However, a senior administration official told Fox News that on Friday morning, Trump was showing troubling signs of a possible progression from mild to more severe form of the disease.

The official said that medical professionals moved quickly and decided to transfer the President to Walter Reed out of an abundance of caution over what was seen as a very concerning trajectory of disease progression.

“Twenty-four hours ago, there was real concern about the President’s vitals,” the official said. “For the past 12 hours, there has been zero concern.”

The official added: “Early indications are for an extremely good prognosis – but the next 48 hours will be critical.”

TRUMP TESTS POSITIVE FOR CORONAVIRUS: HERE’S WHO ELSE IS POSITIVE

At the press conference, Dr. Sean Dooley said that cardiac, kidney and liver functions are all normal, that Trump is not on oxygen and is not having any difficulty breathing or walking.

He quoted Trump as saying: “I feel like I could walk out of here today.” Separately, Dr. Brian Garibaldi described Trump as being in “such great spirits.”

The doctors also said Trump had been fever-free for 24 hours, and that symptoms of a nasal cough and fatigue had all “resolved.” However, they did not give a date for when Trump may leave the center.

Conley reiterated that Trump had received an antibody cocktail, as well as zinc, Vitamin D, famotidine, melatonin and a daily aspirin. He also said Trump was taking a five day course of Remdesivir.

Conley caused some confusion on Saturday when he said they were “72 hours into the diagnosis,” suggesting that Trump was actually diagnosed on Wednesday. However, he later clarified in a memorandum that he meant to say it was “day three” of the diagnosis — since Trump was diagnosed on Thursday.

Separately, he said that Trump had received the antibody cocktail “48 hours ago” when he meant to say “day two.”

“The President was first diagnosed with COVID-19 on the evening of Thursday, October 1st and had received Regeron’s [sic] antibody cocktail on Friday, October 2nd,” he said.

Trump announced Friday morning that he and first lady Melania Trump had tested positive. A number of White House and campaign officials have also tested positive – including senior White House adviser Hope Hicks and Trump campaign manager Bill Stepien. On Saturday former New Jersey Gov. Chris Christie, who was on Trump’s prep team for Tuesday’s presidential debate, announced that he had tested positive.

Trump was moved to