The Food and Drug Administration approved the first over-the-counter coronavirus test just days before the agency is expected to authorize a second vaccine manufactured by Moderna.
The FDA issued an emergency use authorization Tuesday for the Ellume COVID-19 Home Test, the first over-the-counter diagnostic test for COVID-19. Ellume Health, a developer of diagnostic medical tests based in Australia, says the test can be used anywhere and returns results in 15 minutes.
The test employs nasal swabs to look for fragments of coronavirus proteins. The results are then sent to the user’s smartphone. It can be used to test anyone age 2 or older.
The FDA’s Vaccines and Related Biological Products Advisory Committee announced Tuesday that Moderna’s COVID-19 vaccine is both safe and effective for public use. The committee said its analysis “supported a favorable safety profile, with no specific safety concerns identified that would preclude issuance of an” emergency use authorization.
Similar to last week’s daylong review process of the Pfizer vaccine ending with a vote in favor of authorization, the Moderna vaccine will be reviewed by the FDA’s panel of immunologists, epidemiologists, and public health experts on Thursday, setting it up for a speedy authorization by the end of the week. Doses of the Pfizer vaccine will continue to be shipped this week.
To date, more than 16.6 million cases and roughly 302,700 deaths due to COVID-19 have been confirmed in the United States. Current case totals are undercounts, given that many infections go undetected and undiagnosed.
A group of restaurant owners and workers gathered in New York City Tuesday to rally against a new dining ban in the city and demand more support for an industry hobbled by months of restrictions amid the COVID-19 pandemic.
“We are rallying for rent relief, PPP, grants, local and state funding programs, insurance relief, and help from our local leaders,” the New York State Latino Restaurant, Bar, and Lounge Association said in a statement before the Tuesday rally.
Association President Jeffrey Garcia took the stage during the event to demand that Gov. Andrew Cuomo allow their businesses to reopen, citing that the governor’s own statistics show restaurants and bars account for only 1.4% of virus spread in the nation’s largest city.
The event came a day after Cuomo’s latest indoor dining ban took effect, and New York City Mayor Bill de Blasio warned residents to prepare for even more restrictions “quite soon.”
England will ramp up its in-school coronavirus testing program in January in an attempt to reduce the numbers being sent home, the BBC reported. Any students who have been in contact with a positive case will be offered seven days of daily testing, while teachers will be offered weekly testing.
The Supreme Court granted a temporary injunction to High Plains Harvest, an evangelical church in Colorado, arguing that Gov. Jared Polis’s restrictions on gathering sizes unlawfully targeted religion and violated the First Amendment. The top court threw out a lower-court ruling to uphold limits on gathering sizes in places of worship, which vary depending on the transmission rates in different regions of the state. Justice Elena Kagan dissented, along with Justices Stephen Breyer and Sonia Sotomayor, pointing to the fact that Colorado had preemptively lifted its church limitations once High Plains Harvest appealed to the high court.
Dr. Anthony Fauci urged President-elect Joe Biden and Vice President-elect Kamala Harris to get the COVID-19 vaccine as soon as possible “for security reasons.”
“I believe so,” the director of the National Institute of Allergy and Infectious Diseases told Good Morning America when asked if they should get vaccinated “right away,” adding, “I mean, this is a person who very soon will be the president of the United States. The president — Vice President-elect Kamala Harris will very soon be the vice president of the United States. For security reasons, I really feel strongly that we should get them vaccinated as soon as we possibly can. You want him fully protected as he enters into the presidency in January. So, that would be my strong recommendation.”
He added that both President Trump and Vice President Mike Pence should also be vaccinated.
With Congress still unable to pass a second relief bill and hundreds of thousands of people still out of work or short of work, food banks are expecting to see an uptick in people at risk of going hungry for the holidays. Food banks in the Washington, D.C., area say they expect an increase of people to come to their services in the next month as unemployment benefits are on the brink of expiring.
The United States Postal Service is struggling to process an inundation of packages now after online shopping surged more than 20% on Black Friday and more than 44% over a five-day period that included Black Friday and Cyber Monday. The influx of online shopping has helped retailers whose sales have dipped since the spring, but the Postal Service and other delivery services have struggled to handle the unprecedented volume of mail.
