Share this page!

U.S. FDA Profile picture
Twitter logo
13 Apr, 7 tweets, 2 min read
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.
CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential significance. FDA will review that analysis as it also investigates these cases.
Until that process is complete, we are recommending this pause. This is important to ensure that the health care provider community is aware of the potential for these adverse events and can plan due to the unique treatment required with this type of blood clot.
Please join us via YouTube for an audio press conference at 10 a.m. EDT. We will keep the public updated as we learn more. youtube.com/USFoodandDrugA…
#COVID19 vaccine safety is a top priority for the federal government, and we take all reports of health problems following COVID-19 vaccination very seriously.

• • •

Missing some Tweet in this thread? You can try to force a refresh
　

Keep Current with U.S. FDA

U.S. FDA Profile picture

Stay in touch and get notified when new unrolls are available from this author!

Read all threads

This Thread may be Removed Anytime!

PDF

Twitter may remove this content at anytime! Save it as PDF for later use!

Try unrolling a thread yourself!

how to unroll video
  1. Follow @ThreadReaderApp to mention us!

  2. From a Twitter thread mention us with a keyword "unroll"
@threadreaderapp unroll

Practice here first or read more on our help page!

More from @US_FDA

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…
The FDA issued an Emergency Use Authorization (EUA) to Quidel for its QuickVue At-Home #COVID19 Test for at-home use with a prescription.
Read 7 tweets
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.
Read 5 tweets
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
U.S. FDA Profile picture
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… 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 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

Did Thread Reader help you today?

Support us! We are indie developers!

This site is made by just two indie developers on a laptop doing marketing, support and development! Read more about the story.

Become a Premium Member ($3/month or $30/year) and get exclusive features!

Become Premium

Too expensive? Make a small donation by buying us coffee ($5) or help with server cost ($10)

Donate via Paypal Become our Patreon

Thank you for your support!

Follow Us on Twitter!

Like this author's thread?

Get emails when @US_FDA has new unrolls!

Check out other threads from @US_FDA!

Read all threads by @US_FDA