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The new home test for COVID marks the first that doesn’t have to be sent to a lab to receive the results.
Health officials with the FDA have authorized more than 225 diagnostic tests for COVID-19 since the start of the pandemic, including more than 25 tests that allow for home collection of samples, which are then sent to a lab for testing.
“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,” FDA Commissioner Stephen Hahn said when announcing the tests’ approval.
“As we continue to authorize additional tests for home use, we are helping expand Americans’ access to testing, reducing the burden on laboratories and test supplies, and giving Americans more testing options from the comfort and safety of their own homes.”
Jeff Shuren, the director of FDA’s Center for Devices and Radiological Health added: “This test, like other antigen tests, is less sensitive and less specific than typical molecular tests run in a lab.
"However, the fact that it can be used completely at home and return results quickly means that it can play an important role in response to the pandemic.”
Millions of Moderna vaccine doses are expected to be distributed to states as soon as next week pending likely FDA emergency authorization, providing a second weapon in combating COVID-19, to go along with Pfizer’s vaccine, which has already been circulated to hospitals across the country.
The FDA confirmed Moderna’s assessment that the vaccine has an efficacy rate of just above 94 percent in a trial of 30,000 people.
With the vaccine proven to be effective to FDA researchers, the findings will now go to an independent advisory panel, which will vote on whether to recommend FDA authorization.
Barring any unforeseen circumstances, the FDA is likely to authorize emergency use of Moderna’s vaccine by Friday, Dec. 18.
According to the FDA, new data found that the first dose of the Moderna vaccine - vaccinations protecting against the virus require two doses administered either 21 or 28 days apart for full effectiveness - can reduce infections and have shown no signs of adverse symptoms. The Pfizer second dose is administered after three weeks, Moderna's after four weeks.
The FDA analysis found the Moderna vaccine appeared more effective in younger people than in seniors. Vaccine efficacy was 95.6 percent among test subjects between the age of 18 and 64, and 86.4 percent among those 65 and older.
“This is great news, as this now brings us to two products with high levels of efficacy,” said Rupali Limaye, an associate scientist at Johns Hopkins Bloomberg School of Public Health said in the New York Times.
“We’re worried about severe cases that lead to hospitalization, which leads to death,” she added. “The fact that they were able to prevent any cases of severity — I mean, that’s huge.”
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