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.
The good news is that Pfizer’s vaccine, with the first inoculations expected within days, is finally 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 percent 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 allergic reactions, of the kind that were 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.
Dr. Anthony Fauci, the nation’s foremost expert on infectious diseases, said on Wednesday afternoonthat allergic reactions suffered by two UK health care workers who got Pfizer’s coronavirus vaccine on Tuesday are ‘of some concern’.
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 today 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 Trump 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.
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.’
When asked about the possibility of allergic reactions to the vaccine, Marks said: ‘We have very good safety surveillance systems in place in conjunction with the Centers for Disease Control and Prevention, and we may have to modify things as we move forward.
‘For right now, we’re comfortable with this [vaccination rollout] and the extra piece of this is that [the CDC] will have the ability to treat allergic reactions.
‘I think that’s an extra precaution.’
The rollout of the vaccine comes at a perilous time in the US, where case numbers are expected to continue to surge as we move into the winter months.
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.