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Catch up on coronavirus stories and special reports, curated by Mike Allen everyday

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Photo: Visby Medical

The first single-use, highly accurate rapid coronavirus test has received the all-clear from the Food and Drug Administration to be used in a wide variety of settings, per its manufacturer, Visby Medical.

Why it matters: Even with vaccines, widespread coronavirus testing is still essential for safely returning to normal life.

The big picture: Many rapid tests aren't as reliable as gold-standard PCR tests, but PCR tests can take days to process and require expensive equipment.

What they're saying: "This is the first time that anyone has been able to take this gold-standard laboratory equipment…and put it in a [form] that anyone can just carry in their hand," Visby CEO Adam de la Zerda said.

  • “The fact that it's single use means you don’t have to worry about an instrument and you have unlimited testing capacity," he added. Results take only 30 minutes.

State of play: The FDA authorized the PCR test for use in labs and hospitals a few months ago. This week, the agency said the test can be used in places like airports, schools and businesses, as long as they've received a waiver from the FDA requirement that tests be run by a laboratorian.

  • The company is producing tens of thousands of tests a month, but is "anticipating to start scaling to the hundreds of thousands of devices per month, and work our way up from there," de la Zerda said.
  • He said the hope is for the tests to eventually be accessible for at-home use, and beyond that, for the technology to be used for other diseases as well.

Go deeper

Feb 9, 2021 - Health

J&J CEO: Annual COVID-19 vaccine shots may be necessary for a few years

Alex Gorsky. Photo: Lucas Jackson/Reuters/Bloomberg via Getty Images

People might need the coronavirus vaccine annually in years to come, much like the seasonal flu shot, Johnson & Johnson CEO Alex Gorsky told CNBC on Tuesday.

What he's saying: "Unfortunately, as [the virus] spreads it can also mutate," Gorsky said at an event. "Every time it mutates, it’s almost like another click of the dial so to speak where we can see another variant, another mutation that can have an impact on its ability to fend of antibodies or to have a different kind of response not only to a therapeutic but also to a vaccine."

Feb 10, 2021 - Health

FDA grants emergency use authorization for Eli Lilly COVID antibody drug

Photo: Igor Golovniov/SOPA Images/LightRocket via Getty Images

The FDA announced Tuesday it has issued an emergency use authorization for a new combination antibody drug from Eli Lilly that can treat mild to moderate COVID-19.

Why it matters: The treatment contains bamlanivimab and etesevimab which, administered together, can reduce the risk of hospitalizations and death by 70%, per an FDA statement. It can be used on patients at high risk of developing severe illnesses.

Updated 6 hours ago - Politics & Policy

Coronavirus dashboard

Illustration: Aïda Amer/Axios

  1. Vaccines: U.S. to mandate vaccines for anyone who crosses borders starting in January — Shots lagged data by months — The next big bottleneck in the global vaccination effort.
  2. Health: The Thanksgiving bouncers — Axios-Ipsos poll: Thanksgiving roulette — Experts criticize CDC's language on vaccine boosters — America's Thanksgiving gamble.
  3. Politics: Biden administration asks appeals court to reinstate vaccine mandate — Michigan recommends face masks for all residents amid surge.
  4. Education: A COVID strategy backfires at schools — Schools across the U.S. offer vaccine drivesBenefits of in-person school outweigh risks, study finds.
  5. World: EU drug regulator recommends Pfizer COVID vaccine for kids — Italy announces new COVID restrictions for unvaccinated people — European health agency urges expanding booster shot access.
  6. Variant tracker: Where different strains are spreading.

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