FDA authorizes first fully at-home test as more Covid-19 patients are hospitalized than ever before
Posted December 15, 2020 3:03 a.m. EST
Updated December 15, 2020 6:05 p.m. EST
CNN — After a day of celebration and heartache, Americans face a harsh reality with the Covid-19 crisis.
A record 110,549 Covid-19 patients were hospitalized Monday, according to the Covid Tracking Project.
That will inevitably lead to more deaths as Christmas and New Year's Day get closer.
And while more doses of the Pfizer/BioNTech vaccine are sent across the country this week, there won't be enough for everyone who wants it for months.
"This vaccine, as wonderful as it is, is not going to change the trajectory of what we experience this winter," said Dr. Richard Besser, former acting director of the US Centers for Disease Control and Prevention.
"It's not going to change what we need to do. It's not going change the need for us all to wear masks, and social distance and wash our hands."
The FDA authorizes a fully at-home test
The US Food and Drug Administration gave emergency authorization Tuesday for the first Covid-19 test that can be fully taken at home.
Other at-home tests require a prescription or require people to send test samples to a lab to get results. But the Covid-19 home test developed by Australian company Ellume is sold over-the-counter and produces results that can be read at home.
"Today's authorization is a major milestone in diagnostic testing for COVID-19," FDA Commissioner Dr. Stephen Hahn said in a written statement. "By authorizing a test for over-the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test and find out their results in as little as 20 minutes."
The test uses an analyzer that connects with a software application on a smartphone to help users perform the test and interpret results, the FDA said.
The Ellume test is an antigen test that "correctly identified 96% of positive samples and 100% of negative samples in individuals with symptoms," the FDA said.
In people without symptoms, the test correctly identified 91% of positive samples and 96% of negative samples, the FDA said.
Because the test isn't perfect, people who get a negative result should still presume they may be infected and act accordingly -- wearing a mask and keeping away from others.
Ellume expects to produce more than 3 million tests in January. When it applied for emergency use authorization, the company said it would charge $30 for the test.
What's next with vaccine distribution
About 2.9 million doses of the Pfizer/BioNTech vaccine either have been or will be received nationwide this week. Another 2.9 million doses are being held back because they are required in 21 days for the second dose, officials have said.
In all, about 20 million people should get their first shots this month.
By the end of this week, the FDA could give emergency use authorization to another vaccine -- this one made by Moderna.
If authorized, the US plans to start by shipping about 6 million doses across the country, said Gen. Gustave Perna, chief operating officer of Operation Warp Speed.
Just like the Pfizer/BioNTech vaccine, the Moderna vaccine requires two doses. It's up to states to allocate their share of vaccines.
The CDC has recommended that health care workers and residents of long-term care facilities get the vaccine first.
But vaccines will have little impact on what's already happening: a devastating season that just saw record-high deaths, hospitalizations and new cases.
In the past week, the US has reported an average of more than 215,000 new infections a day, according to Johns Hopkins University.
Infections have increased significantly since Thanksgiving gatherings, and officials say upcoming holiday gatherings will add fuel to the fire.
More than 300,000 people in the US have died from coronavirus in 10 months, according to Johns Hopkins.
And another 186,000 are projected to die over the next three months, according to the University of Washington's Institute for Health Metrics and Evaluation.
Overcoming vaccine hesitancy
To help the US get to the other side of this crisis, health officials are trying to tackle skepticism about the vaccine.
"Nothing has been in my heart more than this issue over the past several weeks to months," US Surgeon General Dr. Jerome Adams said.
"I've been working with Pfizer, with Moderna, with AstraZeneca, with Johnson & Johnson to make sure we have appropriate numbers of minorities enrolled in these vaccine trials so that people can understand that they are safe."
"There are tens of thousands of Black and brown people dying every year because they are distrustful of the system," Adams said. "In many cases, rightly so, but also because they're not getting the facts to help restore their trust in the system."
Sandra Lindsay, an intensive care unit nurse at Long Island Jewish Medical Center in Queens, New York City, was among the first Americans to get a shot of the vaccine.
"I understand the mistrust among the minority community," said Lindsay, who is Black. "I don't ask people to do anything that I would not do myself. And so I was happy to volunteer to be among the first."
She said she didn't know she'd make history as one of the first members of the public to get a Covid-19 vaccine.
"That's not why I did it," Lindsay said. "I wanted to do it to inspire people who may be skeptical about taking the vaccine and trust in the science."
States and cities crack down
In the meantime, the US is preparing to face some of the pandemic's darkest days yet.
Georgia Gov. Brian Kemp asked residents to "hunker down" and follow recommended public health measures.
"We are not out of the woods yet," he told reporters on Tuesday. Kemp said he knew that Georgians are tired of dealing with the pandemic but "we are too close to the finish line to grow weary."
In California, Gov. Gavin Newsom said that while the vaccines offer a moment of hope, he added that "we are in the midst of the worst moment of this pandemic."
The state added more than 30,000 new Covid-19 cases for the fourth straight day and hospitalizations and ICU admissions are at all-time highs.
Los Angeles County health officials said Monday new cases have increased 625% since November 1, with "younger people continuing to drive the increase in community transmission."
More than 4,200 people are hospitalized with Covid-19, officials said, and 21% of those are in the ICU.
"Our reality is frightening at the moment," according to a health department statement. "By next weekend, there are likely to be over 5,000 patients hospitalized and more than 50% of ICU beds occupied by COVID-19 patients."
In New York City, Mayor Bill de Blasio hinted at tighter restrictions in the coming weeks, saying the city was on a "very troubling" trajectory, "in terms of the number of people who get sick, the number of people we would lose ... and obviously the impact on hospitals, their ability to treat people."
"We've got to start planning on bigger actions now," he said Monday. "I think the natural time to do that is immediately after Christmas."
In Nevada, Gov. Steve Sisolak announced this week he was extending Covid-19 restrictions through January 15, saying the state was "at a critical point."
"We will be monitoring and evaluating our current situation day to day and ... (we) will remain under the current restrictions for now, with the goal of getting through the next month."
"But I need to be clear," the governor added. "If officials and experts agree that our trends are going beyond our ability to respond, I will be forced to come in front of you all again with tougher actions."