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18 Dec, 5 tweets, 2 min read
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…
We issued a warning letter to Phoenix Biotechnology Inc. and Avila Herbals LLC for offering for sale an unapproved drug product, Oleander 4X, with false & misleading claims it can mitigate, prevent, treat, diagnose or cure #COVID19 and other conditions. fda.gov/inspections-co…
As of today, 304 tests and sample collection devices are authorized by FDA under EUAs; these include 232 molecular tests and sample collection devices, 62 antibody tests, and 10 antigen tests.

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More from @US_FDA

U.S. FDA Profile picture
19 Dec
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… Image
“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 Profile picture
17 Dec
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… Image
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 Profile picture
16 Dec
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 Profile picture
12 Dec
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…
“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
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 COVID-19.
Read 5 tweets
U.S. FDA Profile picture
11 Dec
Here’s a look at our latest actions as we work to protect the public health and fight #COVID19. fda.gov/news-events/pr…
Today, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC), made up of outside scientific and public health experts from around the country, met to discuss the first request for emergency use authorization for a #COVID19 vaccine.
FDA issued an EUA to LabCorp for its Pixel COVID-19 Test Home Collection Kit for use with LabCorp’s COVID-19 RT-PCR Test for non-prescription use. The Pixel COVID-19 Test Home Collection Kit is the first COVID-19 direct-to-consumer test system.
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U.S. FDA Profile picture
22 Oct
Today, we gave the first FDA approval for a #COVID19 treatment. The drug was approved for adults and children ages 12 and older for the treatment of #COVID19 requiring hospitalization. fda.gov/news-events/pr… Image
This approval does not include the entire population that had been authorized to use the drug under an Emergency Use Authorization (EUA). An approval is different from the standard used for an EUA.
While children younger than 12 are not covered in this approval, children under 12 weighing at least 3.5 kg (about 8 pounds) are covered in a revised EUA for the drug.
Read 5 tweets

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