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

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Illustration: Aïda Amer/Axios

Vastly expanded approval and distribution of rapid, at-home tests represents a powerful tool in the fight against COVID-19 — and just possibly, the future of disease diagnostics.

Why it matters: Vaccines will take time to arrest the spread of the coronavirus — even without problems around distribution and acceptance. Some experts believe mass rapid testing could quickly identify who is really at risk of spreading COVID-19 and turn around the out-of-control pandemic in the U.S.

Driving the news: On Tuesday, the FDA granted emergency authorization to Ellume's over-the-counter antigen COVID-19 test for fully at-home usage — akin to a standard home pregnancy test.

  • This is the first test the FDA has approved that can be taken without a prescription and produce results — in about 20 minutes — without the need to either mail in a sample to a lab or wait in line for a clinic.
  • Michael Mina, an epidemiologist at the Harvard T.H. Chan School of Public Health, believes if just half the U.S. population were able to test themselves every four days, the country could quickly achieve vaccine-like "herd immunity" by letting people know in real time when they were contagiouss.
  • "Scale these tests up, get these into everyone’s home, put these at the door of a restaurant, put these at the door of a gym," Mina said in a press call last week. "We change the balance."

How it works: What Mina is suggesting is similar to the daily COVID-19 testing carried out by the NFL and other professional sports leagues — which is meant to regularly sweep for infections before they lead to outbreaks — albeit on a much larger scale.

  • Those leagues use PCR tests, which are more accurate than rapid antigen tests, but also more expensive and require lab processing.
  • But rapid antigen tests can cost as little as $5, and entirely at-home tests take labs out of the picture.
  • The economic benefits of mass, rapid COVID-19 screening would exceed the costs — which they pegged at around $28 billion — by 4–15 times, even without adding in the value of the lives that might be saved, according to a paper published by Mina and a team of economists in October.

The catch: Using less-accurate antigen tests would inevitably result in both false negatives — meaning cases that would be missed — and false positives.

  • Such testing errors could end up "eroding confidence to the point where people don’t trust it," Amanda Harrington, director of the clinical microbiology laboratory at Loyola University Medical Center in Illinois, told the New York Times in September.
  • Opponents also worry any plan that puts regular tests in the home introduces the possibility of human error, as ordinary people need to remember to take — and correctly interpret and ideally report — tests on a regular basis.
  • As infectious disease experts Matthew Pettengill and Alexander McAdam wrote in a journal editorial earlier this year, it remains "an open issue whether such tests can be developed and produced at the massively needed scale any more quickly than vaccines."

Yes, but: Mina has argued while rapid tests will miss some cases that PCR diagnostics would pick up, antigen tests are particularly good at identifying when people are most contagious.

  • The false-positive problem can be countered by having those who test positive take another rapid test for confirmation.
  • As for feasibility, Mina told New York magazine it's largely a matter of will. "If the government really wanted to do that, that is not hard to do at all."

What's next: For all the U.S.' struggles around testing, the pandemic has seen an explosion in innovation around at-home diagnostics, as my Axios colleague Marisa Fernandez reported.

  • Companies like LetsGetChecked and Everlywell have experienced a surge in demand for at-home tests for other conditions like Lyme disease and vitamin deficiencies.
  • Wearables that track biometrics have shown some success in identifying probable COVID-19 cases before clear symptoms even begin to show up.
  • "One of the good things to come out of this terrible year is that we've gotten used to doing more testing," says Isaac Turner, the CIO of Curative, a startup that handles some 10% of COVID-19 testing each day in the U.S. "There are many diseases where extra testing would be fantastic."

The bottom line: Technology will push more diagnostics into the home, and while that comes with regulatory challenges, the benefits of more ubiquitous mass testing appear to outweigh the concerns — especially in an age when pandemics like COVID-19 could become more frequent.

Go deeper

Updated 48 mins ago - Politics & Policy

Coronavirus dashboard

Illustration: Aïda Amer/Axios

  1. Vaccines: CDC director maintains Pfizer booster recommendation for high-risk workers — CDC director approves Pfizer boosters, adds eligibility for high-risk workers — FDA approves Pfizer boosters for high-risk individuals, people 65 and up.
  2. Health: America's mismatched COVID fears — Some experts see signs of hope as cases fall — WHO: Nearly 1 in 4 Afghan COVID hospitals shut after Taliban takeover — D.C. goes further than area counties with vaccine mandates.
  3. Politics: Bolsonaro isolating after health minister tests positive at UN summit — United Airlines says 97% of U.S. employees fully vaccinated — Mormon Church to mandate masks in temples.
  4. Education: Health care workers and teachers caught up in booster confusion — Asymptomatic Florida students exposed to COVID no longer have to quarantine — Education Department investigating Texas mask mandate ban.
  5. Variant tracker: Where different strains are spreading.
Jan 29, 2021 - Health

WHO says most pregnant women can now receive coronavirus vaccine

A doctor administering Moderna's coronavirus vaccine at a university hospital in Essen, Germany, on Jan. 18. Photo: Lukas Schulze/Getty Images

The World Health Organization has altered its guidance for pregnant women who wish to receive the coronavirus vaccine, saying now that those at high risk of exposure to the COVID-19 or who have comorbidities that increase their risk of severe disease, may be vaccinated.

Why it matters: The WHO drew backlash for its previous guidance that did not recommend pregnant women be inoculated with vaccines made by Pfizer-BioNTech or Moderna, even though data indicated that pregnancy increased the risk of developing severe illness from the virus.

Jan 29, 2021 - Health

J&J says its one-shot vaccine is 66% effective against moderate to severe COVID

Photo: Thiago Prudêncio/SOPA Images/LightRocket via Getty Images

Johnson & Johnson announced Friday that its single-shot coronavirus vaccine was 66% effective in protecting against moderate to severe COVID-19 disease in Phase 3 trials, which was comprised of nearly 44,000 participants across eight countries.

Between the lines: The vaccine was 72% effective in the U.S., but only 57% effective in South Africa, where a more contagious variant has been spreading. It prevented 85% of severe infections and 100% of hospitalizations and deaths, according to the company.

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