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U.S. FDA

@US_FDA

2 Mar

In our ongoing response to the #COVID19 pandemic, we’ve taken several actions. Here’s our update: fda.gov/news-events/pr…

We’ve updated our FDA COVID-19 Response At-A-Glance Summary, which provides a quick look at facts, figures and highlights on the FDA's response efforts. fda.gov/media/137005/d…

https://twitter.com/US_FDA/status/1366391563006394375

The FDA issued an Emergency Use Authorization (EUA) to Quidel for its QuickVue At-Home #COVID19 Test for at-home use with a prescription.

https://twitter.com/US_FDA/status/1366391563006394375

Read 7 tweets

U.S. FDA

@US_FDA

19 Dec 20

Today, FDA issued an emergency use authorization (EUA) for the second vaccine for the prevention of #COVID19 caused by SARS-CoV-2. The emergency use authorization allows the vaccine to be distributed in the U.S for use in individuals 18 years and older. fda.gov/news-events/pr…

@SteveFDA

“With the availability of two vaccines now for the prevention of #COVID19, the FDA has taken another crucial step in the fight against this global pandemic that is causing vast numbers of hospitalizations and deaths in the United States each day.” – FDA Commissioner @SteveFDA

The FDA has determined that the #COVID19 vaccine has met the statutory criteria for issuance of an EUA. The totality of the available data provides clear evidence it may be effective in preventing #COVID19.

Read 5 tweets

U.S. FDA

@US_FDA

18 Dec 20

Today, FDA’s Vaccines & Related Biological Products Advisory Committee met to discuss a request by ModernaTX, Inc. for emergency use authorization (EUA) for a vaccine for #COVID19 prevention. A final decision will be made by FDA’s career officials. fda.gov/advisory-commi…

Also today, we posted a new webpage: Pfizer-BioNTech COVID-19 Vaccine Frequently Asked Questions. Questions cover specifics, such as what data did the FDA use to make the decision to authorize the vaccine for emergency use, to more general questions. fda.gov/emergency-prep…

Read 5 tweets

U.S. FDA

@US_FDA

17 Dec 20

FDA has taken more steps to help combat #COVID19 and to protect public health. Here’s a look at some of our latest activities. fda.gov/news-events/pr…

We issued a new EUA for BinaxNOW COVID-19 Ag Card Home Test for at-home use with a prescription. The test is authorized for use in patients age 4+ who are suspected of COVID-19 by their healthcare provider & are within the first 7 days of symptom onset. fda.gov/news-events/pr…

Yesterday, we issued an EUA for the first OTC, at-home, rapid diagnostic test for #COVID19. The Ellume COVID-19 Home Test is authorized for people age 2+ with or without symptoms. It can be used completely at home without a prescription. fda.gov/news-events/pr…

Read 5 tweets

U.S. FDA

@US_FDA

16 Dec 20

FDA is aware of reports of an anaphylactic reaction in a #COVID19 vaccine recipient. The agency will continue to work with CDC and Pfizer to better understand what occurred. fda.gov/covid19vaccines

FDA takes seriously reports of any adverse events and requires Pfizer and vaccination providers to report the following serious adverse events, among other things, to the Vaccine Adverse Event Reporting System.

Importantly, fact sheets that provide important information, including dosing instructions, & information about the benefits & risks of the Pfizer-BioNTech COVID-19 Vaccine, are required to be made available to vaccination providers and vaccine recipients. go.usa.gov/xAYge

Read 4 tweets

U.S. FDA

@US_FDA

12 Dec 20

Today, FDA issued the first emergency use authorization (EUA) for a vaccine for the prevention of #COVID19 caused by SARS-CoV-2 in individuals 16 years of age and older. The emergency use authorization allows the vaccine to be distributed in the U.S. fda.gov/news-events/pr…

@SteveFDA

“The FDA’s authorization for emergency use of the first #COVID19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world.” – FDA Commissioner @SteveFDA

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