John Hopkins professor slams the FDA for 'holding up COVID vaccine approval' and dubs agency's progress 'Operation Turtle Speed' as another 2,563 die, hospitalizations hit a record 101K and new model projects almost 539,000 fatalities by April

Professor Marty Makary slammed the FDA for meeting to review the Pfizer vaccine on December 10 even though it had already gained approval in the U.K. on Wednesday

A professor at Johns Hopkins slammed the Food and Drug Administration for continuing to hold off their approval of the COVID-19 vaccine - dubbing the agency's progress 'Operation Turtle Speed' - as the United States saw its third worst day of the pandemic with 2,563 people dying, hospitalizations hitting a record 101,000 and new projections showing that there could be almost 539,000 deaths by April.

A new record was set for hospitalizations on Friday, with a total of 101,276 people receiving professional medical care.

The number of new cases - 224,831 - also set a grim new record.

The data means that more Americans died from coronavirus this week than heart disease, lung cancer or chronic obstructive pulmonary disease.

A total of 11,820 died from COVID-19 over the past week, according to the Institute for Health Metrics and Evaluation . By comparison 10,724 died from ischemic heart disease; 3,965 from tracheal, bronchus and lung cancer; and 3,766 from chronic obstructive pulmonary disease.

The University of Washington's IHME now estimate that the death toll could reach 538,893 in the U.S. by April without greater attention to social distancing and mask-wearing. With a rapid vaccine rollout, the prediction is that the number could drop slightly to 527,000. If universal mask-wearing was practiced, that figure is projected to be even lower, with 472,000 deaths by April.

As of Friday, 278,872 Americans have died from coronavirus and 14.3 million cases have been confirmed.

In an op-ed for The Dispatch, professor Marty Makary said there needed to be more urgency in approving the vaccine.

He critcized the agency for waiting, as he saw it, to meet to review the Pfizer vaccine on December 10 even though it had already gained approval in the U.K. on Wednesday. 'FDA regulators are wasting precious time in greenlighting a COVID vaccine as more than 2,000 Americans are dying each day and the pandemic continues to starve American society,' Makary wrote in the scathing op-ed.

Britain on Wednesday became the first country in the world to approve the jab, after regulators gave it the green light in the wake of evidence showing it was up to 95 per cent effective and safe.

It prompted a major international row, with both the EU and the United States lashing out at the speed at which it was approved.

Donald Trump's top medic Dr Anthony Fauci accused the UK drug regulator of failing to adequately scrutinize data from manufacturers.

A healthcare worker in Houston, Texas, comforts a patient on Friday as the virus rages across the US

Britain on Wednesday became the first country in the world to approve the jab, after regulators gave it the green light

But Makary asserted that the FDA's review could be done 'within 24 to 48 hours without cutting any corners.'

'They just need to work harder,' he added.

'Contrary to popular belief, the FDA process is not hands-on — it does not interview vaccine trial patients or look under a microscope at the immune cells.

'It's doing a statistical analysis and looking at data.

'For the vaccine trial, the data set is small and straightforward.

'If my research team, normally tasked with analyzing data on millions of patients, was asked to review the smaller Pfizer vaccine study of 43,000 patients, it would take about one hour.'

'FDA regulators are wasting precious time in greenlighting a COVID vaccine as more than 2,000 Americans are dying each day and the pandemic continues to starve American society,' Makary declared in the scathing op-ed

'For the vaccine trial, the data set is small and straightforward,' he claimed. 'If my research team, normally tasked with analyzing data on millions of patients, was asked to review the smaller Pfizer vaccine study of 43,000 patients, it would take about one hour'

Makary credited the European Medications Agency for using rolling reviews, reviewing data in the real time for the sake for efficiency. He implored the FDA to begin doing that as well.

'Today, as the career FDA staff sit on the Pfizer and Moderna vaccine applications, we health care workers continue to work in highly infected ICUs and testing centers,' he said.

'Vulnerable seniors grow lonelier, and more American families fall behind financially. During a health emergency, the FDA should be convening a single, day-long meeting immediately when the data is submitted, in the same way American businesses have emergency board meetings when a crisis occurs.

'The FDA has a moral and civil obligation to review the data with a sense of urgency. It's not too late—the FDA could call an emergency meeting today.'

WHY THE FDA IS TAKING SO LONG TO APPROVE PFIZER VACCINE

FDA Commissioner Steve Hahn said on Wednesday that scientists needed more time to review the raw data from the Pfizer vaccine trial before they'd make a decision.

Before December 10, when the will all meet to discuss it, this is what happens;

STEP 1

Multiple teams examine different data sets

Hahn said that ordinarily, 150 scientists would look at an application. It's unclear if more have been added for the Pfizer application or the Moderna application given the urgency of the situation

They will separately look at data for different components of the vaccine including;

1) EFFICACY

2) SAFETY

3) MANUFACTURING

All the different groups will then come together on the 10th to discuss their findings and if, collaboratively, they can recommend approval

STEP 2

The FDA scientists make a recommendation to the advisory council

The advisory council has already started meeting to discuss who would get the vaccine first if it is approved.

They also have to decide, ultimately, if it is safe for approval.

If they do that, the doses will start being shipped out on December 15.

The number of Texans hospitalized with COVID-19 increased to over 9,000 this week.

According to a White House Coronavirus Task Force report, Texas is seeing an 'unsustainable increase in hospitalizations' from the virus and 'statewide mitigation must increase.'

The situation is particularly dire in West Texas, and experts worry the holidays could exacerbate an already dangerous situation.

In New York, meanwhile, Governor Andrew Cuomo urged the exhausted residents of his state to keep their guard up.

'I understand COVID fatigue - we all are tired and exhausted by this pandemic,' he wrote in his nightly email.

'But we can't give in to it. We can't let hospitalizations climb.'

The state reported over 10,000 positive cases, and 11,271, or 5.41 per cent of all tests, were positive.

There were 795 patients in ICU, Cuomo said - an increase of 12 from the previous day - and 60 new deaths from the virus.

Cuomo said that contact tracing data suggested that small indoor gatherings are a source of 70 per cent of infections, and warned New Yorkers to steer clear of the traditional celebrations.

'While I can understand why there is a desire to gather, we can't give in to it this holiday season,' he said.

'We have regulations in place for a compelling reason: to safeguard the public health, keep people out of hospitals and save lives.'

Cuomo emphasized the new guidelines by the CDC, updated on Friday, which stressed the need for people to wear masks in all non-household indoor settings.

On Wednesday Joe Biden, the president-elect, amplified the bleak forecast during a roundtable with workers and small business owners hard hit by the devastating economic fallout of the pandemic.

'Christmas is going to be a lot harder. I don't want to scare anybody here, but understand the facts - we're likely to lose another 250,000 people dead between now and January. You hear me?' Biden said.

The op-ed by the Johns Hopkins' professer also comes as President-elect Joe Biden raised concerns Friday about what he said was a lack of detailed planning for end-stage distribution of the coronavirus vaccine, following discussions with current Trump administration officials.

Biden made the statement after speaking in Wilmington about a 'grim' jobs report that he also called 'dire.'

'There is no detailed plan that we've seen anyway as to how you get the vaccine out of a container into an injection syringe into somebody's arm,' Biden said.

A U.S. Food and Drug Administration panel of outside advisers is due to meet on Dec. 10 to discuss whether to recommend emergency-use authorization of the Pfizer vaccine. Moderna's vaccine, also found to be nearly 95% effective, is expected to be reviewed a week later.

While some U.S. health officials described a rollout timeline that assumed FDA authorization would come within days of the Dec. 10 meeting, FDA officials have said it could take weeks.

Pfizer, Moderna and a third producer, AstraZeneca Plc, have already started manufacturing their vaccines and say distribution could begin almost immediately after approval. AstraZeneca, however, may have to conduct an additional trial to gain U.S. approval after a dosing error led to better results in recently released data than for its planned regimen.

Beyond regulatory hurdles, vaccinations face opposition from significant numbers of Americans who reject medical science and fear vaccines as harmful.

Similarly, many Americans still refuse to follow basic public health guidance on wearing masks and avoiding crowds.

In hopes of increasing compliance, the CDC on Wednesday added new guidelines to shorten the duration of quarantines.

The health agency said seven days with a negative COVID-19 test and 10 days without a test would suffice for individuals showing no symptoms after exposure to the virus. But it still recommends a 14-day quarantine as preferable.

Across the country on Friday, state health departments were preparing local hospitals for the first shipments of Pfizer Inc's COVID-19 vaccine, if approved.

The first shipment is expected to cover inoculations of 3.2 million people - nowhere near enough for the 21 million U.S. healthcare workers.

And government officials said initial shipments would also go to five government agencies including the Departments of Defense, State and the Veterans Health Administration.

The subsequent two weekly vaccine distributions could cover 7 to 10 million people a week, provided a second vaccine - from Moderna Inc - is authorized early in the second half of December, and Pfizer meets its distribution estimates, according to data provided by Department of Health and Human Services and the companies.

Federal officials have not disclosed exactly how many doses will be in later shipments.

'For the time being, and the foreseeable future, the demand for vaccines is going to exceed the supply by a lot, even for the highest priority groups that are identified,' said Josh Michaud, Kaiser's associate director of global health policy.

States have the final word on how to distribute vaccines to their citizens, but federal officials have said that of some 330 million U.S. residents, healthcare workers and those in nursing homes should be considered first for vaccines.

With early supplies limited, the federal government is allocating doses based on state populations, rather than the proportion of the populations at high risk. That means some states' health workers will be better protected than others.

Alabama for instance, will receive enough vaccine for around 17% of its healthcare workers, while Illinois could cover only 13%, according to data from state officials.

The approach would initially leave out around 190,000 healthcare workers in Alabama and more than 570,000 in Illinois, according to Kaiser Family Foundation data on healthcare workers by state.

More than two million healthcare workers in California will have to wait as early vaccine supplies are doled out, based on figures provided to Reuters by state officials.

This first stage of the rollout illustrates the complexity of the government's goal to vaccinate most Americans by mid-2021.

U.S. officials maintain they will distribute 40 million doses by the end of the year - enough to inoculate 20 million people - with millions of shots shipping every week, assuming speedy approvals of both the Pfizer and Moderna vaccines.

Pfizer, which developed its vaccine with German partner BioNTech SE, told Reuters the United States will receive about half of the 50 million doses it will produce in 2020.

Moderna's vaccine could add at least another 12.5 million doses, federal officials have said.

The CDC expects about 5 million to 10 million doses to be shipped per week in the first weeks of the U.S. vaccine distribution effort.

States meanwhile are preparing for the first distribution to fall short, as hospitals across the country grapple with record numbers of COVID-19 patients and staffing shortages.

'Clinical staff are becoming infected, nurses and doctors. It's creating a workforce crunch and the beds are filling up,' said Alan Morgan, chief executive of the National Rural Health Association, an advocacy group for rural hospitals.

Arkansas's state epidemiologist Jennifer Dillaha said vaccines are urgently needed to keep up with the surge in patients.

'We want to ensure our hospital capacity as much as possible through vaccination for those healthcare workers who are at highest risk for infection,' she said.

More than half a dozen states including Alabama, California, New Mexico, and Wisconsin, told Reuters the first allocation estimates they have been given would not be near enough to cover all their healthcare workers, let alone other high-priority residents.

The size of initial allocation figures shared with Reuters ranges widely, from around 330,000 in California - the most populous U.S. state - to less than 7,000 in North Dakota, which has 50,000 healthcare workers, according to Kaiser data and figures provided to Reuters by state officials.

That means both states can vaccinate less than 20 per cent of their healthcare workforce with the first shots. New York state will receive 170,000 shots initially, enough for roughly 13 per cent of its healthcare workers.

The U.S. government expects the number of available doses to increase in January to about 60 million to 70 million.

It has made deals for 100 million doses of Pfizer's vaccine for $1.95 billion and 100 million of Moderna's for $1.5 billion, with options to buy more. It expects vaccines to be free to most Americans.

Sickening moment maskless 'Karen' COUGHS in the face of grocery store customer, then claims she doesn't have to wear a mask because she 'isn't sick'

A woman was captured on camera following a customer through a supermarket as she coughs on her after claiming she does not need a mask because she is not sick. Video of the incident, which has garnered hundreds of thousands of views on Twitter alone, allegedly took place in a Su per Saver in Lincoln, Nebraska according to Twitter user @davenewworld_2. In it, an unidentified woman was captured dramatically coughing as she smiles saying 'Excuse me! I'm coming through' in the direction of the customer recording her. Scroll down for video An unidentified woman was captured dramatically coughing as she smiles saying 'Excuse me! I'm coming through' in the direction of a woman recording her A woman was captured on camera following a customer as she coughs on her in a supermarket without a mask on claiming she does not need one because she is not sick @chaiteabugz #karen #covid #karens #karensgonewild #karensalert #masks we were just wearing a mask at the store. ¿ o

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