COVID’s deadliest day: 3,309 people die from coronavirus on day FDA finally approves Pfizer vaccine

The United States recorded more than 3,300 deaths from COVID-19 on Friday – the largest single-day toll since the start of the pandemic – as it authorized the use of Pfizer’s vaccine, with the first inoculations expected within days, marking a turning point in a country where the pandemic has killed more than 295,000 people.

The Food and Drug Administration granted an emergency use authorization for the vaccine, developed with German partner BioNTech, which was shown to be 95 per cent effective in preventing the disease in a late-stage trial. It said the vaccine can be given to people aged 16 and older.

Healthcare workers and elderly people in long-term care facilities are expected to be the main recipients of a first round of 2.9 million doses this month.

FDA Commissioner Dr. Stephen Hahn held a virtual press conference on Saturday morning in which he reassured the American public that the vaccine was safe and that doctors are prepared to deal with possible severe allergic reactions of the kind that was witnessed in a few cases in the United Kingdom. 

According to researchers at Johns Hopkins University, 3,309 Americans died from coronavirus on Friday.

The US also reported 231,775 new cases as the pandemic shows no signs of ebbing – despite the FDA’s approval of a new vaccine.

As of early Saturday morning, there have been 15,851,735 confirmed cases of COVID-19. So far, 295,539 Americans have died. 

A healthcare worker at LAC USC Medical Center tests a person at a drive through testing center during the outbreak of the coronavirus disease in Los Angeles on Thursday

A healthcare worker at LAC USC Medical Center tests a person at a drive through testing center during the outbreak of the coronavirus disease in Los Angeles on Thursday

A healthcare worker at LAC USC Medical Center tests a person at a drive through testing center during the outbreak of the coronavirus disease in Los Angeles on Thursday

Based on the percentage infected in each state, as pictured above, the University of Washington's Institute for Health Metrics and Evaluation revealed that 15 percent of Americans have been infected with coronavirus as of December 7

Based on the percentage infected in each state, as pictured above, the University of Washington's Institute for Health Metrics and Evaluation revealed that 15 percent of Americans have been infected with coronavirus as of December 7

Based on the percentage infected in each state, as pictured above, the University of Washington’s Institute for Health Metrics and Evaluation revealed that 15 percent of Americans have been infected with coronavirus as of December 7

New daily deaths dropped to 2,749 on Friday, yet the seven-day average climbed to 2,379, according to the COVID Tracking Project. The 7-day average for the three metrics that mark the severity of the nation’s outbreak – new cases, new deaths and overall hospitalizations – all broke new records for the second day in a row and a record was also set for hospitalizations

New daily deaths dropped to 2,749 on Friday, yet the seven-day average climbed to 2,379, according to the COVID Tracking Project. The 7-day average for the three metrics that mark the severity of the nation’s outbreak – new cases, new deaths and overall hospitalizations – all broke new records for the second day in a row and a record was also set for hospitalizations

New daily deaths dropped to 2,749 on Friday, yet the seven-day average climbed to 2,379, according to the COVID Tracking Project. The 7-day average for the three metrics that mark the severity of the nation’s outbreak – new cases, new deaths and overall hospitalizations – all broke new records for the second day in a row and a record was also set for hospitalizations

The severe allergic reactions suffered by two UK health care workers who got Pfizer’s coronavirus vaccine on Tuesday are ‘of some concern,’ Dr. Anthony Fauci, the nation’s foremost expert on infectious diseases, said on Wednesday afternoon.

During a Harvard University forum hosted by CNN ‘s Dr Sanjay Gupta, Fauci did not seem particularly shocked that these reactions occurred, but he did warn that the US should brace for the same thing to happen here.

‘It’s obviously of some concern,’ he said.

‘Once you start implementing the actual utilization of the vaccine in a clinical setting, you’re talking about millions of individuals getting vaccinated. You might start seeing effects that might not have been picked up.’

Hahn on Saturday said he was ready for a vaccination as soon as available. The FDA chief also defended the fastest-ever vaccine process, saying the agency did not sacrifice safety in return for speed.

He also described as inaccurate press reports that said President Donald Trump’s administration had threatened to fire him if the FDA did not approve the authorization by a certain date.

‘First of all, the representations in the press that I was threatened to be fired if we didn’t get it done by a certain date is inaccurate,’ Hahn told reporters in a joint news conference held with Dr. Peter Marks, who heads the FDA’s vaccine and biologicals branch.

‘Dr. Marks and I have been very clear from the beginning that we are going to maintain the integrity of the scientific process. 

‘We are going to let our scientists do their job and review and go through the fairness of that review – the gold standard, if you will.’

Hahn said that his agency reviewed original source data in addition to that provided by Pfizer and BioNTech in their summary of the clinical trial that involved some 40,000 volunteers.

A British man receives the first of two Pfizer/BioNTech COVID-19 vaccine jabs at Guy's Hospital in London on Tuesday. US regulators are trying to reassure the American public that the vaccines are safe despite a few reported cases of adverse allergic reactions in the United Kingdom

A British man receives the first of two Pfizer/BioNTech COVID-19 vaccine jabs at Guy's Hospital in London on Tuesday. US regulators are trying to reassure the American public that the vaccines are safe despite a few reported cases of adverse allergic reactions in the United Kingdom

A British man receives the first of two Pfizer/BioNTech COVID-19 vaccine jabs at Guy’s Hospital in London on Tuesday. US regulators are trying to reassure the American public that the vaccines are safe despite a few reported cases of adverse allergic reactions in the United Kingdom

The FDA said their analysis confirmed that the vaccine was safe and provided 95 per cent protection.

‘Our incredible team, heroic efforts, night and day worked to get this out the door,’ Hahn said. 

‘As Dr. Marks said, thousands of people are dying a day.’  

New data from a leading COVID-19 model has revealed that 15 percent of Americans have been infected with coronavirus as hospitalizations and new daily cases broke records once again on Friday.

The University of Washington’s Institute for Health Metrics and Evaluation (IHME) also revealed its latest projections for COVID-19 deaths as part of Friday’s report, stating that 502,000 Americans are predicted to die from the virus by April 1.

It also predicts that new daily fatalities will climb even higher, peaking in mid-January at close to 4,000 deaths a day if states don’t continue with safety measures such as mask mandates.

On Friday, a record 232,105 news daily cases were reported in the US and hospitalizations climbed to an all-time high of 108,044.

The 7-day average for the three metrics that mark the severity of the nation’s outbreak – new cases, new deaths and overall hospitalizations – all broke new records for the second day in a row.

The new fatality projections came just hours before a COVID-19 vaccine was finally approved in the United States.

Pfizer’s vaccine was given emergency authorization by regulators late Friday, according to the New York Times.

The IHME laid out six scenarios based on mask use and vaccine rollout. The green line shows the model it currently thinks is most likely which predicts that 502,000 Americans will have died from COVID-19 by April 1

The IHME laid out six scenarios based on mask use and vaccine rollout. The green line shows the model it currently thinks is most likely which predicts that 502,000 Americans will have died from COVID-19 by April 1

The IHME laid out six scenarios based on mask use and vaccine rollout. The green line shows the model it currently thinks is most likely which predicts that 502,000 Americans will have died from COVID-19 by April 1

The green line again shows how IHME predicts that COVID-19 daily deaths will peak in mid-January

The green line again shows how IHME predicts that COVID-19 daily deaths will peak in mid-January

The green line again shows how IHME predicts that COVID-19 daily deaths will peak in mid-January

Dr. Joseph Varon (L) and other medical staff members perform an intubation procedure on a patient in the COVID-19 intensive care unit (ICU) at the United Memorial Medical Center on Friday in Houston, Texas

Dr. Joseph Varon (L) and other medical staff members perform an intubation procedure on a patient in the COVID-19 intensive care unit (ICU) at the United Memorial Medical Center on Friday in Houston, Texas

Dr. Joseph Varon (L) and other medical staff members perform an intubation procedure on a patient in the COVID-19 intensive care unit (ICU) at the United Memorial Medical Center on Friday in Houston, Texas

The move comes after the Trump administration pressed regulators to move quickly as the country’s healthcare systems face increasing strain over the rise in hospitalizations. 

On Friday, Nevada overtook South Dakota as the state with the highest number of hospitalizations per million people, as of IHME data up until December 7.

Hospitalizations in Arizona are also climbing again and have almost reached the levels seen at the state’s peak during the summer.

The record number of hospitalizations is placing extreme pressure on intensive care units throughout the country.

The IHME models predicts that 48 states are expected to have high or extreme stress on ICUs at some point in the next four months.

Forty-two states will also have high or extreme stress on hospital beds at some point in December through February

The models, and predictions on death rates, could change if states increase mask use and introduce more intervention policies, the IHME said.

They estimated that, on average, 73 percent of people always wore a mask when leaving the home, but the practice was far lower in certain states.

For example, mask use was lower than 50 percent in Wyoming, while it remains higher on the east and west coasts.

After two days in which at least 3,000 Americans died from coronavirus, new daily deaths dropped to 2,749 on Friday, the seven-day average climbed to 2,379, according to the COVID Tracking Project. 

Deaths in North Dakota spiked in the past 24 hours, as it climbed above New York to become the state with the fifth highest death rate per million people.

New Jersey’s death rate is still the highest in the country.

The IHME predicted that there will be 221,000 additional deaths in the US from December 7 to April 1.

This model, however, assumes that 32 states will re-impose mandates by April 1, lessening the number of new infections, it warns. It predicts that many of these states will implement mandates by the end of December.

It also predicted that universal mask coverage – where 95 percent of the country wears a mask when they leave home – would result in 56,000 less Americans dying from COVID-19 in the coming months.

If mask mandates are eased, however, the total number of deaths by April 1 could potentially reach 598,000.

Texas has reached over 1,400,000 cases, including over 23,950 deaths. Staff above treat a patient at the United Memorial Medical Center in Houston, Texas on Friday

Texas has reached over 1,400,000 cases, including over 23,950 deaths. Staff above treat a patient at the United Memorial Medical Center in Houston, Texas on Friday

Texas has reached over 1,400,000 cases, including over 23,950 deaths. Staff above treat a patient at the United Memorial Medical Center in Houston, Texas on Friday

The IHME models shows how new daily cases rose dramatically to 200,000 as of December 7

The IHME models shows how new daily cases rose dramatically to 200,000 as of December 7

The IHME models shows how new daily cases rose dramatically to 200,000 as of December 7

Currently, the daily death rate is greater than 4 per million in 35 states, according the IHME models

Currently, the daily death rate is greater than 4 per million in 35 states, according the IHME models

Currently, the daily death rate is greater than 4 per million in 35 states, according the IHME models

More than 40 states are predicted to be reporting at least 20 percent of their residents have been infected by April 1 (pictured top), while most states' death rates will remain under 4 people per million of population (pictured bottom), the IHME predicts

More than 40 states are predicted to be reporting at least 20 percent of their residents have been infected by April 1 (pictured top), while most states' death rates will remain under 4 people per million of population (pictured bottom), the IHME predicts

More than 40 states are predicted to be reporting at least 20 percent of their residents have been infected by April 1 (pictured top), while most states’ death rates will remain under 4 people per million of population (pictured bottom), the IHME predicts

In  the US, 73 percent of people always wore a mask when leaving the home, but the practice was far lower in certain states. For example, mask use was lower than 50 percent in Wyoming, while it remains higher on the east and west coasts

In  the US, 73 percent of people always wore a mask when leaving the home, but the practice was far lower in certain states. For example, mask use was lower than 50 percent in Wyoming, while it remains higher on the east and west coasts

In  the US, 73 percent of people always wore a mask when leaving the home, but the practice was far lower in certain states. For example, mask use was lower than 50 percent in Wyoming, while it remains higher on the east and west coasts

It comes as cases in the northeast begin to spike again while new infections appear to be leveling off in the Midwest, according to the IHME.

North Dakota and South Dakota still have the highest percentage of cases per population with more than 25 percent of their residents infected. Their death rates also remain among the highest in the country.

More than 40 states are predicted to be reporting at least 20 percent of their residents have been infected by April 1.

IHME data showed that new weekly cases dropped to 162,300 per day on average in the past seven days compared to 171,400 on average in the previous week.

Yet they warned, as did the COVID Tracking project, that this drop in new cases could be as a result of a lag in testing and results following the Thanksgiving holiday period.

Despite the lowering cases, daily deaths last week increased to 1,800 per day on average compared to 1,670 the week before, making COVID-19 the number one cause of death in the United States over the past seven days.  

The 12,597 deaths last week surpassed fatalities from heart disease, and tracheal, bronchus, and lung cancer.

The daily death rate is greater than 4 per million in 35 states.

Just before the news of the vaccine approval broke, the IHME report revealed that the percentage of people who were open to taking the shot also varied significantly by state.

Those willing receive a COVID-19 vaccine ranges from 68 percent in Alabama to 84 percent in California, according to results from a Facebook survey.

They estimated that 98.5 million people are expected to be vaccinated by April 1 but that with faster scale-up, the number vaccinated could reach 228.75 million.

IHME predicts that 25,200 lives will be saved by the projected vaccine rollout while 44,500 could be saved if a more rapid rollout is achieved.

The models assume that the states highlighted in orange will introduce new mandates this month to fight rising infections

The models assume that the states highlighted in orange will introduce new mandates this month to fight rising infections

The models assume that the states highlighted in orange will introduce new mandates this month to fight rising infections

Just before the news of the vaccine approval broke, the IHME report revealed that the percentage of people who were open to taking the shot also varied significantly by state, from 8 percent in Alabama to 84 percent in California (pictured above)

Just before the news of the vaccine approval broke, the IHME report revealed that the percentage of people who were open to taking the shot also varied significantly by state, from 8 percent in Alabama to 84 percent in California (pictured above)

Just before the news of the vaccine approval broke, the IHME report revealed that the percentage of people who were open to taking the shot also varied significantly by state, from 8 percent in Alabama to 84 percent in California (pictured above)

COVID-19 deaths last week increased to 1,800 per day on average compared to 1,670 the week before, making it the leading cause of death in the US over the past seven days. The 12,597 deaths last week surpassed fatalities from heart disease

COVID-19 deaths last week increased to 1,800 per day on average compared to 1,670 the week before, making it the leading cause of death in the US over the past seven days. The 12,597 deaths last week surpassed fatalities from heart disease

COVID-19 deaths last week increased to 1,800 per day on average compared to 1,670 the week before, making it the leading cause of death in the US over the past seven days. The 12,597 deaths last week surpassed fatalities from heart disease

After approval for the Pfizer vaccine was awarded on Friday night, it is estimated that 2.9 million doses will ship to every U.S. state and territory in the next 24 hours 

It will be up to states to decide who gets vaccinated first, but the CDC has recommended injecting health care workers and nursing home residents (who have equal priority) first. 

The Department of Health and Human Services said Friday morning that the first Americans would be vaccinated Monday or Tuesday. At the time, Secretary Alex Azar was expecting the vaccine to be approved within ‘a couple of days,’ he said on Good Morning America. 

But President Trump urged the FD to speed its approval and hurled insults at regulators, calling the agency a ‘big, old, slow turtle’ as hours ticked by after the FDA’s expert panel said it should approve the vaccine. 

The UK and Canada have already approved Pfizer’s shot, and the first Britons got their first of two doses on Tuesday. 

Moving up the approval time is not expected to move up the timeline for Americans getting injected, HHS sources told the New York Times. 

The approval of Pfizer’s vaccine is an historic step toward curbing the pandemic, and comes at the end of America’s deadliest week since its first COVID-19 case in January 2020. Nearly 16,000 people died of coronavirus in the past seven days, according data from the COVID Tracking Project. Total U.S. infections are nearing 16 million. 

Emergency approval to vaccinate Americans 16 and older is a crucial step, but plenty of challenges lie ahead. 

Pfizer’s 95 percent effective vaccine has to be stored at ultra-cold temperatures, raising concerns it will take longer to ship or accidents in the complicated administration process will ruin precious doses. 

Already, supply chain issues forced the firm to reduce its planned global distribution for 2020 from 100 million to 50 million. 

The US has a contract for 100 million doses in total, with the option to purchase more, but the Trump administration reportedly turned down Pfizer’s offer to purchase more earlier this year. 

Other countries have snapped up doses, so the US may struggle to acquire more in the coming months.

Nationwide, there have been more than 15.8 million coronavirus cases and 295,539 deaths.       

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