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U.S. FDA

12 Dec, 5 tweets, 2 min read

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.

The data also support that the known and potential benefits outweigh the known and potential risks supporting the vaccine’s use in millions of people 16 years of age and older, including healthy individuals.

In making this determination, the FDA can assure the public and medical community that it has conducted a thorough evaluation of the available safety, effectiveness and manufacturing quality information.

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More from @US_FDA

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

Read 5 tweets

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.

Read 5 tweets

U.S. FDA

@US_FDA

20 Oct

Here’s a look at some of the FDA’s latest activities in our ongoing response to the #COVID19 pandemic. fda.gov/news-events/pr…

@AnandShahFDA

We posted a new #FDAInsight podcast with @AnandShahFDA, and Dr. Peter Marks, Director of @FDACBER, discussing the upcoming Vaccines and Related Biological Products Advisory Committee meeting on Oct. 22, 2020. fda.gov/news-events/fd…

In a new #FDAVoices, “FDA’s Vaccines and Related Biological Products Advisory Committee and its Role in Advising the Agency on COVID-19 Vaccines,” Dr. Peter Marks highlights the value of transparency.. fda.gov/news-events/fd…

Read 5 tweets

U.S. FDA

@US_FDA

15 Aug

@Yale

Today, we issued an emergency use authorization to @Yale for its SalivaDirect #COVID19 diagnostic test, which uses a new method of processing saliva samples. This is the 5th test FDA has authorized using saliva as a sample for testing. fda.gov/news-events/pr…

With this test, a saliva sample can be collected in any sterile container. The test doesn’t need a special swab or collection device, or a separate nucleic acid extraction step.

Being able to perform a test without extraction kits can increase testing capacity and reduce the strain on resources. Also, the test can be used more broadly with different combinations of commonly used reagents and instruments.

Read 4 tweets

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