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18 May, 4 tweets, 2 min read
Here is today's update on some of the actions we’ve taken in our ongoing response to the #COVID19 pandemic. fda.gov/news-events/pr…
We provided info about the status of the monoclonal antibody investigational drug, leronlimab, for the treatment of #COVID19. The data from CytoDyn, Inc.’s recent clinical trials do not support the clinical benefit of leronlimab for COVID-19 treatment.
We updated the Johnson & Johnson #COVID19 vaccine fact sheet for recipients and caregivers to be available in multiple languages. fda.gov/emergency-prep…
As of today, 374 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 272 molecular tests and sample collection devices, 78 antibody and other immune response tests, and 24 antigen tests.

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More from @US_FDA

U.S. FDA Profile picture
10 May
The FDA’s Center for Biologics Evaluation and Research @FDACBER will convene a virtual meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) on June 10, 2021, via webcast. fda.gov/news-events/pr…
During the meeting the agency will provide a status update on our approach to emergency use authorization (EUA) for #COVID19 vaccines intended for use in individuals 12 through 17 years of age.
The committee will also discuss the data needed to support an EUA and a biologics license application (BLA) for a #COVID19 vaccine intended for use in children less than 12 years of age. The committee will not discuss any specific products.
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13 Apr
Today FDA and @CDCgov issued a statement regarding the Johnson & Johnson #COVID19 vaccine. We are recommending a pause in the use of this vaccine out of an abundance of caution.
As of 4/12, 6.8m+ doses of the J&J vaccine have been administered in the U.S. CDC & FDA are reviewing data involving 6 reported U.S. cases of a rare & severe type of blood clot in individuals after receiving the vaccine. Right now, these adverse events appear to be extremely rare
Treatment of this specific type of blood clot is different from the treatment that might typically be administered.
Read 7 tweets
U.S. FDA Profile picture
2 Mar
In our ongoing response to the #COVID19 pandemic, we’ve taken several actions. Here’s our update: fda.gov/news-events/pr… Image
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…
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U.S. FDA Profile picture
27 Feb
Today, FDA issued an emergency use authorization (EUA) for the third vaccine for the prevention of #COVID19 caused by SARS-CoV-2. The EUA allows the vaccine to be distributed in the U.S for use in individuals 18 years and older. fda.gov/news-events/pr… Image
“The authorization of this vaccine expands the availability of vaccines, the best medical prevention method for #COVID19, to help us in the fight against this pandemic, which has claimed over half a million lives in the United States.” – Acting FDA Commissioner @DrWoodcockFDA
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
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…
“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.
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U.S. FDA Profile picture
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

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