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U.S. FDA

@US_FDA

18 Dec

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…

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U.S. FDA

@US_FDA

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…

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…

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U.S. FDA

@US_FDA

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

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U.S. FDA

@US_FDA

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…

@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

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.

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U.S. FDA

@US_FDA

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.

https://twitter.com/US_FDA/status/1336809070884495360

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.

https://twitter.com/US_FDA/status/1336809070884495360

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U.S. FDA

@US_FDA

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…

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.

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