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Coronavirus Updates: FDA Approves First At-Home COVID-19 Test

Elizabeth Kim

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Ben Yakas

Published Nov 18, 2020

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Testing for NYC public school students in Seth Low Park performed in September.

Michael Appleton/Mayoral Photography Office

Elizabeth Kim

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Ben Yakas

Published Nov 18, 2020

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This is our daily update of breaking COVID-19 news for Wednesday, November 18th, 2020. Previous daily updates can be found here, and up-to-date statistics are here.

New York City is in Phase 4 of reopening now, which includes zoos, botanical gardens, museums, and gyms, as well as 25% indoor dining. Certain parts of Brooklyn and Staten Island under a zoned shutdown. Get answers to questions youmay have with our "Ask An Epidemiologist" series, or learn more about NYC COVID-19 testing options with our explainer. Here are some local and state hotlines for more information: NYC: 311; NY State Hotline: 888-364-3065; NJ State Hotline: 800-222-1222.

Here's the latest:

2:15 p.m. The Federal Drug Administration announced on Wednesday that it had granted emergency use authorization for the first at-home coronavirus test that provides rapid results.

The FDA has authorized the use of Lucira COVID-19 All-In-One Test Kit tests, which are available by prescription only, for home use with self-collected nasal swab samples. The test has been approved for people 14 and older with suspected COVID-19, and people under 13 when performed by a health care provider.

According to a press release, the test works by "swirling the self-collected sample swab in a vial" that is then placed in the test unit; after about 30 minutes or less, the results can be read directly from the test unit’s light-up display, which shows whether a person is positive or negative for the virus.

"While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home. This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission,” said FDA Commissioner Stephen M. Hahn. “Today’s action underscores the FDA’s ongoing commitment to expand access to COVID-19 testing.”

While some officials like Health and Human Services Secretary Alex Azar praised the rapid at-home tests, other health experts urged caution.

"The data is just still emerging," Tom Bollyky, the director of the global health program at the Council on Foreign Relations, told CNN. "Obviously with some past emergency use authorizations it pays to be cautious with what the FDA has put out here, but it's certainly a promising sign."

The Atlantic wrote last month about the Trump administration's push for more rapid testing, and the myriad of problems with those tests—including the fact that many COVID-19 infected patients might be missed by such tests.

Pfizer Completes Final Trial, Says Vaccine Is 95% Effective

Pedestrians walk past Pfizer world headquarters in New York.

Bebeto Matthews/AP/Shutterstock

The pharmaceutical giant Pfizer said Wednesday that the latest round of data from a late stage trial found its coronavirus vaccine to be 95% effective after two doses, marking another milestone in the global vaccination development race.

“The study results mark an important step in this historic eight-month journey to bring forward a vaccine capable of helping to end this devastating pandemic," said Dr. Albert Bourla, Pfizer Chairman and CEO, in a statement. “With hundreds of thousands of people around the globe infected every day, we urgently need to get a safe and effective vaccine to the world.”

Among the 8,000 patients in the study, only a very small number suffered side effects of fatigue and headache.

One public health expert described the results as "phenomenal."

The news put Pfizer, which is working with the German company BioNTech, at the head of the pack of 10 drugmakers working on a vaccine. Pfizer said the two companies were planning to apply to the Food and Drug Administration for emergency authorization “within days." The data from their study will also be provided to regulatory agencies around the world.

Pfizer has said that it expected to produce 50 million doses by the end of the year, and up to 1.3 billion by the end of next year. Under a $2 billion deal, the company has agreed to supply the United States government with 100 million doses, an amount that would only provide a fraction of the necessary doses for 330 million Americans.

But at least one other vaccine may also be approved soon. On Monday, the drug maker Moderna announced that its vaccine was 94.5% effective. The company also said that unlike Pfizer's vaccine, which will require specially designed storage units with dry ice, could be kept under refrigeration and at room temperature for longer periods that previously reported. Moderna said it would seek approval in the coming weeks.

The prospect of one or more effective vaccines could not come at a more urgent time. The outlook for many states grows bleaker with each passing day, as cases and deaths continue to climb. At least 247,000 Americans have died and more than 11 million have been infected since the pandemic first broke.

Europe is also battling a second wave, with several countries currently undergoing new lockdowns and curfew orders.

In another piece of good news, a new Gallup poll released Tuesday found that 58% of Americans recently said they would be willing to receive a COVID-19 vaccine. That's up from a low of 50% in September.

The share of people who said they would not get a vaccine decreased, to 42% from 50% in September.

Tagged

covid-19 updates

vaccine

coronavirus

Elizabeth Kim

Elizabeth Kim is a reporter on the People and Power desk who covers mayoral power. She previously covered the pandemic, housing, redevelopment and public spaces. A native of Queens, she speaks fluent Mandarin. Got a tip? Email [email protected]

Ben Yakas

Ben Yakas is a former Gothamist reporter.

Gothamist is funded by sponsors and member donations

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